Caraco Pharmaceutical Laboratories Ltd. Wins Summary Judgment on Generic Ultracet Continued...

As earlier reported that Caraco Pharmaceutical laboratories ltd. has won the summary judgement on generic Ultracet tablets.

The summary of the story can be read here

The whole judgement can be read here.

Exclusivity parking still possible: Loop hole in Modernisation medicare amendments: Teva's exclusivity ruling

In a decision earlier this year related to the 180 day exclusivity determination for the generic player Teva for its generic granisetron injection. The decision highlights some holes in Modernisation Medicare Amendments Act 2003. The parking of exclusivity is still possible as per that ruling.

The final decision for this can be read here.

I welcome comments on this topic as this is debatable at the IP front.

Spectrum receives US FDA approval for Levoleucovorin for injection

Spectrum Pharmaceuticals, Inc. has received marketing approval from the US Food and Drug Administration (FDA) for Levoleucovorin for Injection. It is indicated after high-dose methotrexate therapy in patients with osteosarcoma, and to diminish the toxicity and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists.

Levoleucovorin is the only commercially available formulation comprised only of the pharmacologically active enantiomer of leucovorin (Levoleucovorin or (6S)-leucovorin). The company currently expects its commercial launch by June 2008.

The whole story can be read here

Acusphere Submits New Drug Application for FDA Approval of Imagify

April 28, 2008 - Acusphere Inc. (NASDAQ: ACUS) announced today the submission of a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for approval to market its lead product candidate, Imagify(TM) (Perflubutane Polymer Microspheres for Injectable Suspension). Imagify is an ultrasound imaging agent for the detection of coronary artery disease, the leading cause of death in the United States. The NDA includes data from studies of Imagify in more than 1,000 patients worldwide, including two pivotal international multi-center Phase III clinical trials, RAMP-1 and RAMP-2 (Real-Time Assessment of Myocardial Perfusion).

Imagify is the first ultrasound imaging agent designed to assess blood flow in the heart (myocardial perfusion), a sensitive marker of coronary artery disease. The Company believes it is also the first ultrasound imaging agent to demonstrate in large clinical trials clinically equivalent accuracy to nuclear stress testing, the current standard for assessing myocardial perfusion. Currently, perfusion information is not available using cardiac ultrasound, but must be obtained using a nuclear stress test, an expensive and time-consuming test that involves injecting the patient with a radioactive imaging agent. More than 10 million stress imaging procedures are done each year in the U.S. to detect coronary artery disease.

The whole story can be read here.

FDA Approves Second Improvement to Unigene's Calcitonin Manufacturing Process

Apr 29, 2008 - The U.S. Food and Drug Administration (FDA) has approved the use of a new clone for the manufacture of calcitonin, the active ingredient in Fortical(R), Unigene Laboratories, Inc.'s (OTCBB: UGNE, http://www.unigene.com) nasal spray product for the treatment of osteoporosis. This is the second improvement to the production process approved by the FDA this year. The combination of these improvements is expected to increase batch yields of the product by a factor of three.

"We believe that these improvements to our manufacturing process will reduce our future costs and allow us to increase capacity for Fortical," said Dr. Warren Levy, President and CEO of Unigene. "Given the safety concerns reported for certain other osteoporosis products, we believe that the availability of alternative products may become important for osteoporosis sufferers. The global history of calcitonin products has shown that these products are effective with no significant side effects. Also, FDA approval of our improved manufacturing process should provide additional capacity for other peptide products."

FDA MedWatch- Digitek (digoxin tablets)-Class I Recall Because Tablets May Contain Twice The Approved Level Of Active Ingredient

April 29, 2008-Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient. The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions.

Read the entire story at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Digitek

Teva Announces Approval of Generic Flolan(R) for Injection

April 28, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) to market its epoprostenol, the first generic version of GlaxoSmithKline's Flolan(R) for Injection. Teva's approval is for the 0.5 mg base/vial and 1.5 mg base/vial strengths as well as the sterile diluent. The brand product had annual sales of approximately $80 million in the United States for the twelve months that ended February, 2008, based on IMS sales data.

This product is indicated for the long term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy.

"The cost of specialty pharmaceuticals today can be a barrier for patients with pulmonary hypertension. Teva's introduction of epoprostenol is important in reducing the overall financial burden of treating this life threatening disease," stated a leading authority on pulmonary hypertension, Dr. Richard Channick, Professor of Medicine at the University of California, San Diego Medical Center.

(Source: www.pharmalive.com)

Mylan Announces Final FDA Approval for Trandolapril Tablets

Mylan Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Trandolapril Tablets, 1 mg, 2 mg and 4 mg.

Trandolapril Tablets are the generic version of Abbott Laboratories' Mavik(R) Tablets. Brand and generic versions of this product had total U.S. sales of approximately $34 million for the 12 months ending Dec. 31, 2007, for the same strengths, according to IMS Health.

USPTO again refuses to reissue Lipitor Patent

The USPTO has again refused to issue the lipitor patent, covering one of the major products of Pfizer. US5273995 was invalidated by the US court because of wrong dependencies of the claim. In August 2007, Pfizer had asked the USPTO to reissue the patent in order to retain its market grip on Lipitor through 2011 but this is for the second time USPTO has refused to reissue the patent.

Schering-Plough/Merck Pharmaceuticals Receives Not-Approvable Letter from FDA for Loratadine/Montelukast

April 25, 2008 /PRNewswire/ -- Schering-Plough/Merck Pharmaceuticals today confirmed that it received a not-approvable letter from the U.S. Food and Drug Administration (FDA) for a proposed fixed combination of loratadine and montelukast for the treatment of allergic rhinitis symptoms in patients who want relief from nasal congestion.

The New Drug Application filing for loratadine/montelukast was accepted by the FDA for standard review on August 26, 2007. The medicine is a single tablet that contains the active ingredients of CLARITIN (R) (loratadine) and SINGULAIR(R) (1) (montelukast sodium), both of which are indicated for the relief of symptoms of seasonal allergic rhinitis and perennial allergic rhinitis.

Schering-Plough/MERCK Pharmaceuticals is evaluating the agency's response.

The FDA decision does not impact the availability or continued use of CLARITIN or SINGULAIR.

EU Approval for Zevalin as First-Line Consolidation Treatment for Follicular Lymphoma

April 28, 2008 - The European Commission has extended the marketing authorization for Zevalin® ([90Y]-ibritumomab tiuxetan) in Europe. Zevalin can now be used in the course of a first-line therapy after remission induction in previously untreated patients with follicular lymphoma. The aim of such a consolidation therapy is the improvement of the effect of an initial induction therapy. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established. Zevalin was initially approved in Europe in 2004. It combines the tumor-targeting ability of an anti-CD20 monoclonal antibody and the tumor-destroying power of localized yttrium-90 radiation. Follicular lymphoma is one of the most common types of Non-Hodgkin’s Lymphoma, a tumor of the lymphatic system.

"This news means that many patients with follicular lymphoma will now have access to Zevalin's proven clinical benefits," said Dr. Gunnar Riemann, member of the Board of Management of Bayer Schering Pharma AG. "The approval in first-line consolidation treatment will also help us to further exploit the potential of Zevalin."

The decision by the European Commission to grant extended marketing authorization to Zevalin is based on data from the pivotal Phase III First-Line Indolent Trial (FIT). It showed that Zevalin, when used as first-line consolidation therapy, significantly prolonged the median progression-free survival time from 13.5 months (control arm) to 37 months (p<0.0001). The data were presented for the first time at the 49th Annual Meeting of the American Society of Hematology (ASH) in December 2007.

"It is particularly impressive that with one single infusion of Zevalin, we have achieved prolongation of median progression-free survival by two years, with a favorable toxicity profile," said Professor Anton Hagenbeek, Academic Medical Centre, Amsterdam, the Netherlands, lead investigator of the FIT trial. "The results also show that radioimmunotherapy is a very effective single agent in the treatment of follicular lymphoma."

The whole story can be read here.

Lupin Announces Launch of Suprax 400mg Tablets

Lupin Pharmaceuticals, Inc. announced today the launch of Suprax(R) 400mg Tablets (Cefixime USP) in the US.

This line extension further extends the brand franchise of Lupin's flagship anti-infective brand Suprax(R) (Cefixime for oral suspension 100mg/5ml and 200mg/5ml).

Suprax(R) 400mg Tablets will help Lupin to further increase its share of the $450 Million antibiotic market for the treatment of urinary tract infections. It will also extend use of Suprax(R) to the patient population of children of the age of 12 yrs and older.

"Suprax(R) 400mg Tablets offers an additional value proposition to pediatricians by covering adolescent and teenage patient population. The incidence of urinary tract infections is high in children and pediatricians are the 5th largest specialty prescribing antibiotics for this indication. I expect Suprax(R) 400mg Tablets to add substantial value to the Suprax franchise," said Vinita Gupta, President, LPI.

Suprax(R) 400mg Tablets will be promoted by a 60 strong specialty pediatric sales force. Lupin is also evaluating additional options of reaching out to other specialty doctors. Its efforts will be supplemented by innovative promotional campaigns.

The Suprax(R) brand basket now includes Suprax(R) (Cefixime for oral suspension 100mg/5ml and 200mg/5ml and Suprax(R) 400mg Tablets (Cefixime USP).

(Source:www.pharmalive.com)

Neuralstem Announces Issuance of Core Technology Patent in Europe

Stem cell company, Neuralstem, Inc., announced today that the European Patent Office has granted Neuralstem a European patent EP0915968, covering the "Isolation, Propagation and Directed Differentiation of Stem Cells from Embryonic and Adult Central Nervous System of Mammals." The European patent has been validated in several European countries including France, Germany, Ireland, Spain, Sweden, Switzerland and the United Kingdom.

The whole story can be read here

Elixir Pharmaceuticals Announces Issuance of SIRT Patent Covering Development of New Therapies Based on Breakthrough Science

Apr 28, 2008 - Elixir Pharmaceuticals, Inc., announced today issuance of U.S. Patent No. 7,351,542, which covers the discovery of new and existing chemical entities that modulate the activity of a human sirtuin, SIRT 2. Elixir's rights to this patent were made possible through an exclusive license.

The whole story can be read here

Apotex Sues FDA to Recover 180-Day Exclusivity on Generic Plavix

In November 2001, Apotex became the first company to file an ANDA for a generic version of Plavix (clopidogrel bisulfate) with a paragraph IV certification. In March 2002, Sanofi-Synthelabo and Bristol-Myers Squibb sued Apotex for infringing the Orange Book-listed patent, U.S. Patent No. 4,847,265, thereby initiating an automatic 30-month stay of FDA approval of Apotex's ANDA.

With the patent litigation still pending, the stay expired in May 2005. In January 2006, FDA granted final approval to Apotex's ANDA. The litigation was proceeding toward trial when, on August 8, 2006, Apotex launched its generic clopidogrel bisulfate product at risk, starting its 180-day exclusivity period. 23 days later, the U.S. District Court for the Southern District of New York preliminarily enjoined Apotex from continuing to sell its generic version of Plavix. Thus, Apotex was enjoined, but its exclusivity continued to run.

The Federal Circuit affirmed the preliminary injunction in December 2006. After a bench trial, the district court ruled in June 2007 that Apotex failed to prove that the '265 patent is invalid and entered a permanent injunction. Apotex appealed that decision to the Federal Circuit, which heard oral argument on March 3, 2008. A decision from the Federal Circuit could come at any time.

Meanwhile, other generic drug companies were pursuing their own ANDAs for generic Plavix. Dr. Reddy's, Teva and Cobalt each filed ANDAs with paragraph IV certifications and were sued by Sanofi and BMS. Teva and Cobalt are permanently enjoined, pending the outcome of Apotex's appeal. Dr. Reddy's, however, is not enjoined. Instead, according to Apotex, Dr. Reddy's agreed with Sanofi and BMS that it would provide ten days' notice before launching its generic product. Presumably, such notice would allow Sanofi and BMS sufficient time to prepare and file a motion for a preliminary injunction against Dr. Reddy's. On January 14, 2008, FDA granted final approval to Dr. Reddy's ANDA, thereby clearing Dr. Reddy's for a commercial launch.

On February 13, 2008, Apotex filed a Petition for Stay of Action with FDA, seeking "only to stay the effective date of Dr. Reddy's formal approval in a manner that would protect Apotex's remaining 156 days of generic exclusivity but would permit unrestricted generic competition at the end of that exclusivity period." See FDA Law Blog. Apotex asked FDA to respond no later than March 15, 2008. FDA has not yet responded, and therefore, last Wednesday, Apotex filed suit against FDA in the U.S. District Court for the District of Columbia, requesting declaratory and injunctive relief.

In its complaint, Apotex seeks "to set aside FDA's refusal to stay the effectiveness of" Dr. Reddy's final approval. According to Apotex, "[a]bsent a stay, Dr. Reddy's will be permitted to distribute generic clopidogrel bisulfate tablets during the remainder of the 180 days during which Apotex is entitled to be the sole generic manufacturer of that drug under the [Hatch-Waxman Act]."

Apotex alleges that FDA's action violates the Food, Drugs and Cosmetics Act and must be set aside by the court as "arbitrary, capricious, an abuse of discretion and otherwise not in accordance with law," in violation of the Administrative Procedure Act. Specifically, Apotex asserts that the language of the Hatch-Waxman Act

demonstrates a clear congressional intent to provide the first ANDA applicant to file a paragraph IV certification for a listed patent with the economic benefit of 180 days of generic marketing exclusivity to encourage prompt challenges to questionable or inapplicable patents. The "not earlier than" language provides a safety valve to ensure that the 180-day period will not be unfairly curtailed by, for example, an improvidently granted injunction issued during the period of marketing exclusivity against a first filer who commences commercial marketing prior to a determination that a listed patent is invalid or not infringed.

Apotex further asserts that unless the district court grants the relief sought, "Dr. Reddy's would be able to commence marketing almost immediately in the event of a CAFC decision of invalidity, while Apotex would remain bound by injunction until the mandate issues." If the Federal Circuit invalidates the '265 patent (which is a pretty big "if," given that it previously affirmed the preliminary injunction), Sanofi/BMS would certainly file a request for rehearing or rehearing en banc, which would likely delay the issuance of a mandate for several weeks. Thus, according to Apotex, "[n]ot only would Apotex be denied its remaining 156 days of exclusivity, but Dr. Reddy's would have a significant head start over Apotex in the marketplace, a marketplace that would be made available only by Apotex's challenge to the '265 patent."

The complete complaint can be read here.

(Source: www.orangebookblog.com)

Apotex Files Motion to Intervene in Generic RISPERDAL Litigation and in response Teva Quickly Files Opposition

As ealier reported that Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia issued a 2-page order in Teva Pharmaceuticals USA, Inc. v. Leavitt siding with Teva over the reslisting of U.S. Patent #5,158,952 (“the ‘952 patent”) in the Orange Book covering Janssen Phaemaceutica’s RISPERDAL (risperidone) Tablets. Teva sued FDA in March 2008 after the Agency denied a citizen petition Teva submitted to FDA in August 2007 requesting that the Agency relist the ‘952 patent in the Orange Book and confirm Teva’s eligibility for 180-day exclusivity. Judge Lamberth’s order declared that the delisting of the ‘952 patent was unlawful, ordered FDA to relist the patent in the Orange Book and restore Teva’s Paragraph IV patent certification, and enjoined FDA from approving any generic RISPERDAL Tablets ANDAs until Teva’s 180-day exclusivity expires.


Absent the relisting of the ‘952 patent in the Orange Book and any 180-day exclusivity available to Teva, the only obstacle for generic applicants to obtain full approval of their ANDAs is U.S. Patent #4,804,663 (“the ‘663 patent”). This patent expired in December 2007, but is covered by a period of pediatric exclusivity scheduled to expire on June 29, 2008. Since the April 11, 2008 order, companies with a stake in the outcome of this litigation have been patiently waiting to learn whether FDA or Mylan Pharmaceuticals, Inc., which entered the case as an intervenor-defendant, would appeal the decision to the U.S. Court of Appeals for the District of Columbia Circuit. At least one company does not want to wait any longer.


On April 22, 2008, Apotex, Inc. filed a motion to intervene in the case “to safeguard its substantial interests in the outcome of this litigation.” According to Apotex’s motion, the company “expected to receive approval of its ANDA in time to launch its generic risperidone tablets by June 29, 2008 and to begin commercial marketing immediately.” Apotex’s ANDA is not yet tentatively approved. (Only Mylan and Pliva have tentative ANDA approvals.) If Judge Lamberth grants Apotex’s motion, then the company “intends to file a notice of appeal and immediately pursue the appropriate appellate remedies to obtain a stay of the District Court’s ruling pending appeal, and/or review of the ruling on an emergency or expedited basis prior to the June 29, 2008 launch date.”


So why has Apotex only now decided to attempt to intervene in the litigation? According to the company’s motion, “Apotex’s grounds to intervene arose post-judgment, when it became apparent that neither the Federal Defendants nor Mylan would immediately appeal this Court’s decision, and that even if they appeal, may not prosecute the appeal timely so as to try to dissolve or stay the injunction prior to June 29, 2008” when the period of pediatric exclusivity applicable to the ‘663 patent expires.


Teva quickly filed its opposition to Apotex’s motion to intervene. According to Teva’s filing, “Litigants who wait to intervene until an adverse judgment has been entered face an especially heavy burden – and Apotex has not come close [to] discharging that burden here . . . . No court has ever granted a post-judgment motion to intervene on such a thin demonstration of need, and this Court should not wield its substantial discretion to become the first.” Teva's opposition also goes on to argue that any speculative risks to Apotex were well known at the outset of the case when Apotex decided not to intervene, and cites industry periodicals and “widely read blogs," including genericspatent blog.

(Source: FDA LAW blog)

Sygnis Receives Orphan Drug Designation from the European Commission for AX200 in the treatment of Amyotrophic Lateral Sclerosis

April 24, 2008 - SYGNIS Pharma AG, today announced that it has received Orphan Drug designation from the European Commission for AX200 in the treatment of Amyotrophic Lateral Sclerosis (ALS). This follows the positive recommendation that SYGNIS received from the EMEA in February.

Orphan Drug designation can be granted for a product that is intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union. During the development phase certain incentives are given to the developing company to facilitate the product's registration and market authorization. These incentives include reductions in fees, an accelerated registration procedure and a period of up to 10 years market exclusivity once the product is approved.


ALS is a progressive neurodegenerative disease caused by the degeneration of nerve cells innervating skeletal muscles and affects an estimated 50,000 to 100,000 people in the industrialized nations. Patients with ALS suffer from progressive muscle wasting throughout their bodies resulting in increasing disabilities and their lifespan is cut short. Death in ALS patients normally occurs within only a few years after diagnosis and there are currently only inadequate therapies available.

Neupro Recommended for Approval in Europe for Restless Legs Syndrome

25 April, 2008 - UCB today announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMEA has issued a positive opinion recommending that the European Commission grants a marketing authorisation for Neupro® (rotigotine transdermal patch) in the symptomatic treatment of moderate-to-severe idiopathic Restless Legs Syndrome (RLS) in adults.

The details can be read here.

European Commission Approves Viread for Chronic Hepatitis B

Apr 25, 2008 - Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the European Commission has granted marketing authorisation for Viread(R) (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B in all 27 member states of the European Union.

A once-daily tablet, Viread works by blocking hepatitis B virus (HBV) DNA polymerase, the enzyme that is necessary for the virus to replicate in liver cells. Viread has been approved in the European Union for use in adult chronic HBV patients with compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. The product was recently approved for the treatment of chronic hepatitis B in Turkey and New Zealand, and marketing applications are currently pending regulatory review in the United States, Canada and Australia.

The details can be read here.

Urigen Announces US Patent Office Notice of Allowance of Claims for URG101

April 25, 2008 - Urigen Pharmaceuticals, Inc. (OTCBB: URGP), http://www.urigen.comannounced that the U.S. Patent and Trademark Office issued a notice of allowance for claims for the first patent application for URG101, an investigational, bladder instillation for the treatment of Painful Bladder Syndrome/Interstitial Cystitis (PBS). These claims broadly cover URG101 and its use in the treatment of PBS by administering a glycosaminoglycan (such as heparin) and a local anesthetic.

Urigen recently closed a Phase II study of URG101 due to positive, statistically significant results at interim analysis with 50 percent patient enrollment. The Phase II study was a multi-center, double-blind, placebo-controlled, crossover designed clinical trial of URG101 in patients with PBS.

Ranbaxy Receives Final Approval to Manufacture and Market Cetirizine Hydrochloride Oral Solution

Ohm Laboratories Inc, a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received final approval from the U.S. Food and Drug Administration to manufacture and market Cetirizine Hydrochloride Oral Solution (Allergy) and Children's Cetirizine Hydrochloride Oral Solution (Hives-Relief), 1 mg/mL (OTC). The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ohm formulation to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Children's Zyrtec Oral Solution (Allergy) and Children's Zyrtec Oral Solution (Hives-Relief), 1mg/mL of McNeil Consumer Healthcare. Total annual market sales for Cetirizine Hydrochloride Syrup as a prescription only product were $157 million.

Cetirizine Hydrochloride is indicated for the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies. Other indications include relief from itching due to hives (urticaria).

"We are pleased to receive this final approval for Cetirizine Hydrochloride Oral Solution that has proven its clinical value and utility in both adults and children. We are pleased to offer this preferred formulation that will meet the needs of all patients who need this medication in response to allergic reactions as an over-the-counter product. This product formulation further expands our portfolio of affordable generic alternatives and will be launched immediately to all classes of trade participating in the OTC private label market," said Jim Meehan, Vice President of Sales and Distribution for Ohm Laboratories, a wholly owned subsidiary company of RLL.

Ohm, based in North Brunswick, New Jersey, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company. Ohm is engaged in the sale and distribution of generic and branded private label, OTC products in the U.S. healthcare system.

(Source: www.pharmalive.com)

Bristol-Myers, Watson Settle Pravastatin Suit

In a press release on April 25, 2008, Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced that under a distribution agreement with Bristol-Myers Squibb Company, the Company has initiated shipments of pravastatin sodium tablets in the 10, 20 and 40 mg. strengths.

Pravastatin sodium distributed by Watson, is the authorized generic version of Bristol-Myers Squibb's Pravachol(R) product and is indicated along with diet to reduce the risk of both first heart attack in patients with elevated cholesterol and recurrent heart attack or a stroke in patients with heart disease, when diet and exercise are not enough. For the 12-months ending December 2005, Pravachol(R) had sales of approximately $1.7 billion, according to IMS Health data.

Genentech posts update on phase III study of Avastin

Genentech, Inc. posted an update for the previously reported Roche-sponsored international phase III clinical study (AVAiL) of Avastin (bevacizumab) in combination with gemcitabine and cisplatin chemotherapy, in patients with advanced, non-squamous, non-small cell lung cancer (NSCLC). The update confirmed the clinically and statistically significant improvement in the primary endpoint of progression free survival (PFS) for the two different doses of Avastin studied in the trial (15 mg/kg and 7.5 mg/kg) compared to chemotherapy alone.

The whole story can be read here.

High-dose Lipitor reduces risk of heart attack in chronic kidney disease patients

Pfizer's Lipitor (atorvastatin calcium) 80 mg reduced the risk of heart attack and stroke by 32 per cent in patients who have heart disease and chronic kidney disease compared with patients taking the 10 mg dose of Lipitor, according to a five-year Treating to New Targets (TNT) study.

"People with chronic kidney disease are more likely to die from heart disease than to develop kidney failure," said Dr. James Shepherd, a member of the TNT steering committee and clinical academic consultant, department of pathological biochemistry, University of Glasgow Medical School. "It is critical for us to find new ways to reduce cardiovascular burden in these patients. Intensive statin therapy seems to be at least part of the solution."

Whole story can be read here.
(Source: www.pharmabiz.com)

Committee For Medicinal Products For Human Use Summary Of Positive Opinion For Janumet, Latixa, Tyverb and Relistor

LONDON, April 24, 2008-On 24 April 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion,** recommending to grant a marketing authorisation for the medicinal product Janumet, 50 mg/850 mg and 50mg/1000 mg film-coated tablet intended for treatment of type 2 diabetes mellitus. The applicant for this medicinal product is Merck Sharp & Dohme Ltd.

On 24 April 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion,** recommending to grant a marketing authorisation for the medicinal product Latixa, 375 mg, 500 mg and 750 mg prolonged-release tablets intended for treatment of patients with stable angina pectoris. The applicant for this medicinal product is CV Therapeutics Europe Limited.

On 24 April 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending to grant a conditional marketing authorisation for the medicinal product Tyverb, 250 mg, film-coated tablet, intended for treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2) and who have received prior therapy including anthracyclines, taxanes and trastuzumab. The applicant for this medicinal product is Glaxo Group Limited.

April 24, 2008 -- Wyeth Pharmaceuticals, a division of Wyeth , and Progenics Pharmaceuticals, Inc. , today announced that the companies have received a positive opinion for Relistor (methylnaltrexone bromide) subcutaneous injection from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA). The companies are seeking the approval of Relistor in Europe for the treatment of opioid-induced constipation in advanced-illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.

Biovail Receives FDA Approval for Aplenzin (BVF-033)

Apr 23, 2008 - Biovail Corporation announced today that it has received Approval from the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for Aplenzin(TM) (formerly known as BVF-033), a once-daily formulation of bupropion hydrobromide developed by Biovail for the treatment of depression in adults.

Aplenzin(TM) is an alcohol-resistant formulation of a new bupropion salt and has been approved in 174mg, 348mg, and 522mg extended-release tablets. The 522mg dosage strength provides patients requiring the maximum allowable dose of bupropion the only single tablet, once-daily option.

Biovail remains in active partnership discussions for the commercialization rights for Aplenzin(TM) in the United States.

The Long-Acting Opioid Market Was Valued At Over $3 Billion in 2007, and Is Due To Grow Until the Patent Expiry of Market Leader Oxycontin In 2011

Apr 24, 2008 - Research and Markets (http://www.researchandmarkets.com/reports/c89861) has announced the addition of Commercial and Pipeline Insight: Opioids - Short acting and anti-abuse technologies set to fragment and grow the market to their offering.

The opioid market is currently valued at $7.7 billion and is set to increase over the next 10 years at a CAGR of 2.4%. Despite this market being exclusively comprised of old genericized molecules, novel formulations and delivery methods have stimulated growth over the last 5 years. This growth is set to continue as current market players instigate lifecycle management strategies to retain value.

(source: www.pharmalive.com)

Cephalon Notified of Generic Fentanyl Buccal Tablet Filing

Cephalon, Inc., today announced its receipt of a Paragraph IV Certification Notice Letter relating to an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) by Watson Laboratories, Inc., requesting approval to market and sell a generic version of FENTORA(R) (fentanyl buccal tablet) [C-II]. In its Notice Letter, Watson alleges that the U.S. Patent Numbers 6,200,604 and 6,974,590 covering FENTORA are invalid, unenforceable and/or will not be infringed by Watson's manufacture, use or sale of the product described in its ANDA.

Cephalon currently is reviewing the Notice Letter and, by statute, has 45 days to initiate a patent infringement lawsuit against Watson. Such a lawsuit would automatically prevent the FDA from approving the Watson ANDA until the earlier of a district court decision or 30 months from the company's receipt of the Notice Letter.

Cephalon has a three-year period of marketing exclusivity for FENTORA that extends until September 2009. Additionally, the method of use patents described above expire in 2019.

Strides Arcolab Receives 2 ANDA Approvals for Ondansetron Injection USP, 2 mg/ml (20 ml vials) and 2 mg/ml (2 ml vials)

April 24, 2008-Strides Arcolab today announced receipt of 2 ANDA approvals for Ondansetron Injection USP, 2 mg/ml (20 ml vials) and 2 mg/ml (2 ml vials).

The product is licensed to Akorn-Strides, LLC, which is a Joint Venture that was formed in 2004 by Akorn, Inc and Strides Arcolab Limited.

Mr.Arun Kumar - Vice Chairman and Group CEO of Strides Arcolab stated:


"These approvals reflect yet another significant milestone for the Akorn-Strides partnership which now has approvals for five sterile injectable products and plans for commercialization are underway. "

Lannett Company Receives Approval for Dipyridamole Tablets USP, 25 mg, 50 mg, and 75 mg

Apr 24, 2008 - Lannett Company, Inc. (AMEX:LCI), a manufacturer of generic pharmaceuticals, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Dipyridamole Tablets USP, 25mg, 50mg, and 75mg, the generic equivalent of Persantine(R) Tablets manufactured by Boehringer Ingelheim GmbH. According to Wolters Kluwer, total sales of generic Dipyridamole Tablets were $46 million a year in 2007 at average wholesale price (AWP).

Dipyridamole Tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.

Lupin receives approvals for 10 products in Japan

The Mumbai based leading pharmaceutical company Lupin Ltd has announced that its subsidiary in Japan, Kyowa Pharmaceutical Industry Co Ltd, (Kyowa) received approvals for 10 products from the Ministry of Health & Labour Welfare, Japan (MHLW) and expects to launch these in July 2008 post NHI listing.

Kyowa's expanded product basket will now include 10 more products and these are amlodipine (CVS), risperidone (line extension; CNS), cabergoline (CNS), milnacipran (CNS), tandospirone (CNS), meloxicam (NSAID), fluticasone (line extension for paediatrics; anti-asthma), quazepam (line extension; CNS), ethyl Icosapentate (line extension) and maprotiline (line extension; CNS). The combined market size of these molecules in Japan is JPY 265 bn (US $2.65 billion) as per IMS 2007.

Kyowa has a strong position in the CNS and CVS segment and through additional six products in the CNS category it is further consolidating its position as an indomitable player in this segment.

Amlodipine is the largest molecule in Japan, with sales of over JPY 184 billion (US $1.84 billion) as per IMS 2007. Kyowa plans to aggressively market this product through its trained medical field force. In order to garner a dominating market share in this segment the company has also out-licensed this product to two other generic partners in Japan.

In case of Risperidone, Kyowa is currently the second largest generic player and with the recent approval for the line extension the company expects to consolidate its position in this molecule.

Expressing his pleasure at the development, Vinod Dhawan, president - Asia-Pacific, Middle East, Africa and Latin America, Lupin Ltd. said, "We expect that these newly registered molecules will significantly add to Kyowa's growth over the next few years. It is our intention to leverage the advantage of an early entry in the progressive opening up of the generic pharma market of Japan. We intend to rapidly introduce an array of generic therapies from our global portfolio".

Lupin had acquired Kyowa in October 2007 and it is currently focusing on enriching its product basket and expanding its therapy width. These fresh approvals will strengthen Lupin's position in the worlds' second largest pharmaceutical market.

(Source: www.pharmabiz.com)

Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn's Disease

April 22, 2008— UCB announced today that the US Food and Drug Administration (FDA) has approved Cimzia® (certolizumab pegylated), the first and only PEGylated anti-TNFa (Tumor Necrosis Factor alpha) antibody indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have an inadequate response to conventional therapy.

"The approval of Cimzia® in the US is a significant milestone for both UCB and our Cimzia® team, but especially for people suffering from Crohn's disease," said Roch Doliveux, Chief Executive Officer of UCB Group. "Cimzia® is a UCB biological innovation that will provide a monthly treatment option for patients suffering from Crohn's disease. Cimzia® will be available to doctors and Crohn's patients in the United States, which represents 70% of the world Crohn's anti-TNF market, within the next 48 hours."

The approval of Cimzia® was based on safety and efficacy data from clinical trials in more than 1 500 patients with Crohn's disease. Each pivotal study demonstrated that a statistically significant greater proportion of moderate to severe Crohn's disease patients achieved and sustained clinical response with Cimzia® for up to six months, compared to placebo. These data also showed that of the patients who were in remission after initial dosing, the majority maintained remission with no dose escalation.

Cimzia® is the first and only PEGylated anti-TNFa. Cimzia® is dosed subcutaneously every four weeks after initial dosing, making it a convenient option for people with moderate to severe Crohn's. Cimzia® has demonstrated a low incidence of injection site reactions and injection site pain in clinical trials. The most common reported adverse events in the pivotal studies were upper respiratory tract infection (cold, flu), urinary tract infection (bladder infection) and joint pain. As seen with the use of the other anti-TNFa agents, serious, but infrequent infections and malignancies have been reported.

"The clinical trials program has shown Cimzia® to be an effective subcutaneously-administered treatment, with a low rate of injection site reactions," said Stephen Hanauer, M.D., Professor of Medicine and Clinical Pharmacology at the University of Chicago. "The approval of Cimzia® provides a new option for people with Crohn's disease to achieve relief from this debilitating condition with a convenient, stable administration once every four weeks."

FDA Approves Vyvanse (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults

April 23, 2008 -- Shire plc , the global specialty biopharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for VYVANSE(TM) (lisdexamfetamine dimesylate), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults. VYVANSE, introduced in July 2007 for the treatment of ADHD in children aged 6 to 12 years, is now the first and only once-daily prodrug stimulant approved to treat adults with ADHD. In its first eight months of availability, more than one million VYVANSE prescriptions have been filled.(2)

"We are very pleased with this FDA approval of the adult indication for VYVANSE," said Matthew Emmens, Chief Executive Officer of Shire. "This approval provides physicians a new treatment option that can help their adult patients by significantly improving their ADHD symptoms. VYVANSE has been well accepted by the medical community. With Shire's experience as a leader in the development and commercialization of ADHD medications, we are confident that this approval for adult patients will help continue to increase prescription share and volume of VYVANSE."

"Many people may think of ADHD as only a childhood disorder but the fact is that the majority of children diagnosed with ADHD still have symptoms as an adult. These symptoms can significantly impact them at work, home and in relationships, where they have important responsibilities," said David W. Goodman, assistant professor of psychiatry and behavioral sciences at and director of the Adult Attention Deficit Disorder Center of Maryland. "The good news is that in a clinical study with adults, one daily dose of VYVANSE significantly improved ADHD symptoms of inattention, such as the ability to focus and organize, as well as hyperactivity and impulsivity."

Since VYVANSE became available for children with ADHD in July 2007, the product has achieved a U.S. market share of 6.9 percent based on weekly branded prescription volume VYVANSE formulary coverage has been positive, with the top six managed care plans now covering the product in a preferred formulary position.

VYVANSE is a therapeutically inactive prodrug, in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to pharmacologically active d-amphetamine.(3) The conversion of VYVANSE to d-amphetamine is not affected by gastrointestinal pH and is unlikely to be affected by alterations in normal GI transit times.(4)

VYVANSE is currently available in three dosage strengths of 30 mg, 50 mg and 70 mg, each for once-daily dosing. Additional dosage strengths of 20 mg, 40 mg and 60 mg VYVANSE have also been FDA-approved and are expected to be available in pharmacies this summer.

(Source: www.pharmalive.com)

Avastin Used in Combination with Drugs from BMS Has Advantages in Survival Rates Over the Current Sales-Leading Therapy for Advanced ovarian cancer

April 23, 2008 -- Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that surveyed oncologists say that a therapy's effect on overall survival is the attribute that most influences their prescribing decisions in advanced ovarian cancer. Clinical data and expert opinion show that Roche/Genentech/Chugai's Avastin (bevacizumab) plus the regimen of paclitaxel (Bristol-Myers Squibb's Taxol, generics) and carboplatin (Bristol- Myers Squibb's Paraplatin, generics) has advantages in this attribute over the combination of paclitaxel/carboplatin, the current sales leader in ovarian cancer treatment.

The new report entitled Ovarian Cancer (Advanced): Therapies Must Increase Survival over Paclitaxel/Carboplatin to Successfully Enter this Generic Market finds that, according surveyed oncologists, a drug that offers improved median overall survival compared with paclitaxel/carboplatin would earn a 50 percent patient share in the ovarian cancer market. Surveyed oncologists indicated that they would prescribe Avastin plus paclitaxel/carboplatin to 29 percent of their patients with advanced ovarian cancer. As a result, Avastin plus paclitaxel/carboplatin will earn a 22 percent patient share in the U.S. advanced ovarian cancer market in 2016.

The report also finds that Avastin plus paclitaxel/carboplatin will earn the clinical gold-standard status for treatment of advanced ovarian cancer in 2011, following its approval for the indication in 2010. Surveyed oncologists indicated that Avastin plus paclitaxel/carboplatin has competitive advantages in efficacy over paclitaxel/carboplatin, the current gold standard.

"Avastin plus paclitaxel/carboplatin has the same delivery attributes and only marginally different safety attributes when compared with paclitaxel/carboplatin," said Jenna Avent, analyst at Decision Resources. "However, the regimen of Avastin plus paclitaxel/carboplatin has better efficacy when compared to the current gold standard, paclitaxel/carboplatin, and oncologists rate efficacy as the most important parameter in the treatment of advanced ovarian cancer."


(Source: www.pharmalive.com)

PAION AG acquires world-wide rights to anticoagulant flovagatran from UK company Trigen

23 April 2008 - PAION AG today announced that it has acquired the world-wide rights to flovagatran, a direct thrombin inhibitor, from UK-based Trigen Limited for an upfront payment of approximately EUR 0.3 million. PAION will be required to make a milestone payment in the event flovagatran receives regulatory approval or is licensed or sold in a major market but will not be required to pay ongoing royalties.

Flovagatran is a chemically synthesized anticoagulant for intravenous administration. It directly blocks the activity of thrombin, thereby preventing the formation of blood clots. The substance has been tested in two small Phase IIa clinical trials for dialysis and percutaneous transluminal coronary angioplasty (PTCA), which is one of the most common procedures for opening damaged or obstructed coronary arteries.

Wolfgang Söhngen, CEO of PAION AG commented: "Flovagatran nicely complements our current portfolio in the area of antithrombotics. We believe that it has potential as an anticoagulant for use in a variety of hospital-based interventions. As an initial step, we intend to conduct additional preclinical studies, on the basis of which we will formulate a clinical development strategy for flovagatran."

(Source: www.pharmalive.com)

Viralytics USA Patent Issued:

April 23, 2008-Viralytics Limited (VLA) advises that it has been granted a patent in the United States of America for the use of its family of 4 Coxsackie viruses for the treatment of all cancers bearing expression of the ICAM-1 molecule

Numerous cancers have elevated levels of ICAM-1 on their cell surfaces and the presence of this molecule allows our family of viruses to lock onto the surface of cancer cells, infect and destroy them

Professor Darren Shafren (Director and Inventor of the technology) said “The issuance of this patent is a significant milestone for the company as it covers the company’s core oncolytic virus technology. As the USA represents approximately 40% of the world market for cancer treatments the granting of a patent in this market is a major step towards the successful commercialisation of an anti-cancer product”

The granting of this core patent adds significant value to the company’s intellectual property portfolio

It is important to note that the scope of the granted patent covers the use of the company’s lead product, CAVATAKTM (which is currently undergoing clinical evaluation in two Phase I monotherapy trials in late stage melanoma, breast and prostate cancer patients) and also 3 additional strains of Coxsackie A group viruses currently under pre-clinical development by Viralytics

This patent provides an exclusive use of our family of Coxsackie A group viruses for the treatment of cancers until 2022 with up to a five year extension to 2027 potentially available under US legislation

The patent granted (US patent number 7,361,354) is entitled “Methods for treating malignancies expressing ICAM-1 using Coxsackie A group viruses”. Similar patents addressing the anti-cancer activity of the company’s Coxsackie A group viruses have already granted in Australia and New Zealand. The patenting process for these viruses and the company’s other oncolytic virus technology, EVATAKTM (Echovirus type 1) is continuing in other major world markets


(Source: www.pharmalive.com)

Perrigo files ANDA for monistat combination pack and in result J & J sues Perrigo for patent infringement

Perrigo Company today announced that it has filed an ANDA for over-the-counter (OTC) Miconazole Nitrate Vaginal Cream, 2% and Suppository, 1.2g, a generic version of Monistat(R) 1 Combination Pack. The Company believes that it is the first to file an ANDA with a Paragraph IV certification against Monistat 1.

Monistat 1 Combination Pack (miconazole nitrate vaginal cream, 2% and suppository, 1.2g) is an antifungal medication indicated for the treatment of vaginal yeast infections, and had sales of approximately $50 million for the 12 months ended March 2008.

Perrigo filed its ANDA for Miconazole Nitrate Vaginal Cream, 2% and Suppository 1.2g containing a Paragraph IV Certification with the USFDA and notified J & J, the NDA holder for Monistat 1 Combination Pack, and McNeil-PPC, Inc., the listed patent owner, of its filing. On April 18, 2008, McNeil filed suit alleging patent infringement in the United States District Court for the District of New Jersey to prevent Perrigo from proceeding with the commercialization of its product. This action formally initiates the patent process under the Hatch-Waxman Act and will lead to 30 months stay for the approval of ANDA for this product.

There are two patents listed in OB for this product i.e. US5514698 and US6153635 expiring in March 2014 and Nov. 2018 respectively. The patents cover the composition, method of treatment and kit comprising miconazole nitrate as active ingredient.

Sciele Pharma Announces FDA Acceptance of NDA for Addrenex Pharmaceuticals' CloniBID to Treat Hypertension

April 22, 2008 - Sciele Pharma, Inc. (NASDAQ:SCRX) today announced that the U.S. Food & Drug Administration (FDA) has accepted the New Drug Application (NDA) submitted by Addrenex Pharmaceuticals for CloniBID to treat hypertension. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 19, 2008. Upon FDA approval, Sciele expects to launch this product in early 2009.

In June 2007, the Company licensed CloniBID from Addrenex Pharmaceuticals for the treatment of hypertension. CloniBID is a 12-hour, sustained-release formulation of clonidine hydrochloride.

Clonidine hydrochloride, the active ingredient in CloniBID, is a centrally acting alpha-2 agonist approved for the treatment of hypertension. During 2007, approximately 11.7 million prescriptions were dispensed for clonidine hydrochloride tablets and approximately 1.8 million prescriptions were dispensed for clonidine patches, according to IMS Health's National Prescription Audit Plus data.

Patrick Fourteau, Chief Executive Officer of Sciele Pharma, said, "We are very excited about this new development and congratulate Addrenex on the acceptance of this NDA by the FDA. Our partnership with Addrenex provides us with the opportunity to further expand and diversify our product portfolio, and we look forward to launching CloniBID for hypertension in early 2009."

Ark Receives Positive Opinion Letter from EMEA for Cerepro Paediatric Investigation Plan

22 April 2008 - Ark Therapeutics Group plc today announces that the Paediatric Committee at the European Medicines Agency (EMEA) has given a positive opinion on the Company's Investigation Plan for Cerepro(R) in paediatric patients with high grade glioma. The opinion was adopted by the Committee on 11 April 2008.

As from 26 July 2008, the new European Paediatric Use Regulation requires all new products seeking marketing authorisation in the EU to have an approved plan to ensure they are developed appropriately for the paediatric population.

The plan allows Ark to develop Cerepro(R) for operable high grade glioma in children from 1 month up to 18 years old. The paediatric work will not commence until a European Marketing Authorisation for Cerepro has been granted for the treatment of adults; the Company has been allowed 4 years to complete the work.

Dr Nigel Parker, CEO at Ark commented: 'We continue to be successful in advancing the regulatory process for this breakthrough product. Acceptance of the Paediatric Investigation Plan is now an essential part of the centralised regulatory approval process in Europe and we are very pleased to have successfully achieved this step. Although paediatric cases of glioma are relatively few, it is clearly important that products such as Cerepro(R) are made available to them.'

Cimzia Approved in the US for the Treatment of Moderate to Severe Crohn's Disease

April 22, 2008— UCB announced today that the US Food and Drug Administration (FDA) has approved Cimzia® (certolizumab pegol), the first and only PEGylated anti-TNFa (Tumor Necrosis Factor alpha) antibody indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have an inadequate response to conventional therapy.

"The approval of Cimzia® in the United States is a significant milestone for both UCB and our Cimzia® team, but especially for people suffering from Crohn's disease," said Roch Doliveux, Chief Executive Officer of UCB Group. "Cimzia® is a UCB biological innovation that will provide a monthly treatment option for patients suffering from Crohn's disease. Cimzia® will be available to doctors and Crohn's patients in the United States, which represents 70% of the world Crohn's anti-TNF market, within the next 48 hours."

The approval of Cimzia® was based on safety and efficacy data from clinical trials in more than 1 500 patients with Crohn's disease. Each pivotal study demonstrated that a statistically significant greater proportion of moderate to severe Crohn's disease patients achieved and sustained clinical response with Cimzia® for up to six months, compared to placebo. These data also showed that of the patients who were in remission after initial dosing, the majority maintained remission with no dose escalation.

Cimzia® is the first and only PEGylated anti-TNFa. Cimzia® is dosed subcutaneously every four weeks after initial dosing, making it a convenient option for people with moderate to severe Crohn's. Cimzia® has demonstrated a low incidence of injection site reactions and injection site pain in clinical trials. The most common reported adverse events in the pivotal studies were upper respiratory tract infection (cold, flu), urinary tract infection (bladder infection) and joint pain. As seen with the use of the other anti-TNFa agents, serious, but infrequent infections and malignancies have been reported.

"The clinical trials program has shown Cimzia® to be an effective subcutaneously-administered treatment, with a low rate of injection site reactions," said Stephen Hanauer, M.D., Professor of Medicine and Clinical Pharmacology at the University of Chicago. "The approval of Cimzia® provides a new option for people with Crohn's disease to achieve relief from this debilitating condition with a convenient, stable administration once every four weeks."

Nucleonics Says USPTO Rejects All Claims for Fourth Time in Re-Exam of Benitec's Patent

Apr 22, 2008 - Nucleonics, Inc., a biotechnology company focused on the development of novel expressed RNA interference-based (eiRNA) therapeutics, announced today that the U.S. Patent and Trademark Office has issued a fourth rejection of all of the claims of Benitec's U.S. Patent No. 6,573,099, which is the subject of litigation Benitec brought against Nucleonics in March 2004.

"Nucleonics remains confident in its freedom to operate and expects the final office action to be consistent with the patent office findings to date, namely that all of the claims of the Benitec patent are invalid," said Robert Towarnicki, Nucleonics President and Chief Executive Officer. "We continue to assert that the '099 patent and all its related patent applications, including numbers 10/346,853, 10/759,841, 10/821,726, 09/646,807, 10/646,070 and 10/821,710, suffer the same fatal flaws that have caused the USPTO to repeatedly reject all claims despite Benitec's arguments and interviews."

Mr. Towarnicki noted that Benitec's "pleasure" in having the USPTO modify its prior art rejection in view of the key Fire-Mello patent from an "anticipatory" to an "obviousness" rejection relates only to Benitec's dual promoter constructs, having a promoter-sense sequence and a separate promoter-antisense sequence.

"Even if Benitec were able to successfully argue the non-obviousness of such constructs over Fire, which we believe is doubtful, it would not impact Nucleonics or likely anyone else as this type of construct is highly inefficient for the creation of siRNA and would never be utilized commercially," commented Mr. Towarnicki.

Nucleonics also said today that the company has learned that the U.S. Supreme Court will not grant Nucleonics' petition for writ of certiorari in the Benitec v. Nucleonics litigation concerning the '099 patent. The case was dismissed at the district court level on Benitec's motion, citing lack of jurisdiction. The Federal Circuit upheld the dismissal in a 2-1 decision and now the Supreme Court has declined to review the case. All that a denial of a petition for a writ of certiorari means is that fewer than four members of the Court thought it should be granted. The Supreme Court has rigorously insisted that such a denial carries with it no implication whatever regarding the Court's views on the merits of a case that it has declined to review. In light of the recent USPTO action we are not overly concerned with this decision. With all remaining patent claims rejected yet again, the Court action may well prove irrelevant to Nucleonics.

(source: www.pharmalive.com)

Taro Receives Final FDA Approval for Cetirizine Hydrochloride Oral Solution ANDA

April 22, 2008 - Taro Pharmaceutical Industries Ltd. reported today that it has received final approval from the USFDA for its ANDA for cetirizine hydrochloride oral solution, 1 mg / 1 mL. The product will be marketed by Taro's U.S. affiliate, Taro Pharmaceuticals U.S.A., Inc.

Taro's Cetirizine Oral Solution is bioequivalent to McNeil Consumer Healthcare's Zyrtec(R) Oral Solution. Cetirizine Oral Solution is an over-the-counter antihistamine used for the relief of sneezing, runny nose, itchy, watery eyes and itchy throat or nose due to indoor and outdoor allergies and for the relief of itching due to hives. According to industry sources, annual U.S. sales of this product, when it was previously sold by prescription only, were approximately $160 million.

District Court Upholds Validity of Takeda's Patents on Prevacid, Rejecting Teva's Obviousness Arguments Contd...

As earlier published that District Court has upheld Validity of Takeda's Patents on Prevacid, Rejecting Teva's Obviousness Arguments. The details of the case and complete opinion can be read here.

The summary of the opinion can be read here

Pfizer Japan Receives Manufacturing and Marketing Authorization for Sutent

Apr 21, 2008 - Pfizer Japan Inc announced that on April 16, the company received an approval for the manufacturing and marketing authorization of the anti-tumor drug/kinase inhibitor "SUTENT(R) Capsule 12.5 mg" (sunitinib malate) indicated for Gastrointestinal Stromal Tumor (GIST) after failure of imatinib treatment due to resistance and for Renal Cell Carcinoma (RCC) not indicated for curative resection and Metastatic Renal Cell Carcinoma.

Sutent is a new oral-dose anti-tumor drug referred to as a kinase inhibitor, and a low-molecular-weight compound capable of selectively inhibiting the tyrosine kinase receptor involved in tumor growth and vascularization. In the treatment of renal cell carcinoma, Sutent suppresses the growth primarily by inhibiting the intracellular signal transduction related to the vascular endothelial growth factor receptor (VEGFR) and the platelet derived growth factor receptor (PDGFR). It also suppresses the growth of GIST primarily by inhibiting the intracellular signal transduction related to PDGFR-(alpha) and KIT (CD117).

Meda Has Settled The U.S. Astelin Patent Litigation with Apotex

April 21, 2008 - Meda, through its wholly owned U.S. subsidiary, Meda Pharmaceuticals Inc., has entered into a settlement agreement with Apotex Inc. and Apotex Corp. (hereafter Apotex) that resolves the U.S. patent litigation between the companies regarding Apotex's proposed generic versions of Astelin(R) and Optivar(R). Astelin(R) (azelastine hydrochloride nasal spray) is used for treatment of allergic and non-allergic rhinitis and Optivar(R) (azelastine hydrochloride ophthalmic solution) is used for treatment of allergic conjunctivitis. These products are protected in the U.S. by a patent that expires on 1 November 2010, with paediatric exclusivity extending until 1 May 2011.

The settlement agreement resolves patent infringement actions filed by Meda after Apotex's submission of ANDAs (Abbreviated New Drug Applications) to the U.S. FDA (Food & Drug Administration) for generic versions of Astelin(R) and Optivar(R) in 2006 and 2007, respectively. Under the settlement agreement, Apotex admits infringement of Meda's patent. Given the settlement agreement, the parties will jointly request that scheduled trials regarding Apotex's proposed generic version of Astelin(R) in May 2008 and proposed generic version of Optivar(R) in February 2009 be adjourned and the actions closed.

The settlement agreement allows Apotex to launch a generic version of Astelin(R), under a license from Meda, on 1 March 2010. In such case, Apotex will pay 32.5% of their net sales of this product to Meda until 1 February 2011. The agreement also allows Apotex to launch a generic version of Optivar(R), under license from Meda, on 1 December 2009, without further payments to Meda.

"This settlement agreement brings clarity to Meda's intellectual property rights on the U.S. patent for Astelin(R) and Optivar(R)," said Anders Lonner, CEO Meda.

In compliance with U.S. law, the settlement agreement will be submitted to the U.S. Federal Trade Commission and Department of Justice and is subject to their review.

This settlement agreement does not settle the two remaining patent infringement actions brought by Meda in the U.S. against Sun Pharmaceutical Industries Ltd. (hereafter Sun) regarding a proposed generic version of Optivar(R) and Cobalt Pharmaceuticals Inc. (hereafter Cobalt) regarding a proposed generic version of Astelin(R). The trial with Sun is scheduled to start on 20 July 2009. The trial with Cobalt has not been scheduled.

Bayer Challenges Watson and Sandoz U.S. ANDA Filings on Yasmin

Bayer has filed a patent infringement lawsuit in U.S. Federal Court in the Southern District of New York (New York) against Watson Pharmaceuticals, Inc., Watson Laboratories, Inc. and Sandoz, Inc. Bayer Schering Pharma’s suit concerns Watson’s and Sandoz’s respective applications to the FDA for approval to market a generic form of Bayer Schering Pharma’s oral contraceptive Yasmin®. The patent at issue in the suit is Bayer Schering Pharma’s U.S. Patent No. 5,569,652.

Mylan Announces Final FDA Approval for Felodipine Extended-Release Tablets, USP

Mylan Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its ANDA for Felodipine Extended-release Tablets USP, 2.5 mg, 5 mg and 10 mg.

Felodipine Extended-release Tablets USP are the generic version of AstraZeneca Pharmaceutical's Plendil(R) Extended-release tablets, which had U.S. sales of approximately $251 million for the 12 months ending Dec. 31, 2007, according to IMS Health.

Heritage Introduces Nimodipine Soft Gel Capsules

Heritage Pharmaceuticals Inc. announced the immediate availability of Nimodipine Soft Gelatin Capsules in 30 mg strength. Heritage's development and manufacturing partner, Banner Pharmacaps Inc., received final approval of its ANDA for an AB Rated equivalent of Nimotop(R) on January 17, 2008.

Nimodipine Soft Gel Capsules are the generic equivalent of Nimotop(R) Capsules marketed by Bayer. Nimodipine is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage. Nimodipine had U.S. brand and generic sales of approximately $30 million for the 12-month period ending Dec. 31, 2007 according to IMS Health.

Commenting on the launch, Heritage President & CEO, Jeffrey Glazer, stated, "The launch of Nimodipine represents the first of several soft gelatin capsule generic products from our partnership with Banner. This product will enable Heritage's sales team to begin supplying the Institutional/Hospital class of trade and broadens our national account coverage. In addition, Nimodipine expands our niche, high-value product offerings as we continue to grow our global portfolio."

(Source: www.pharmalive.com)

APP Pharmaceuticals Receives FDA Approval for Colistimethate For Injection, USP

April 21, 2008--APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Colistimethate for Injection, USP, 150 mg, the generic equivalent of JHP Pharmaceuticals' Coly-Mycin(R) M Parenteral. APP has immediately commenced marketing and shipping the product. APP's colistimethate is AP-rated, bar-coded and latex-free. According to IMS data, U.S. sales of colistimethate in the United States were approximately $15.4 million in 2007.

Colistimethate is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by pseudomonas aeruginosa.

(Source: www.pharmalive.com)

Akorn, Inc. Announces FDA Approval of Diclofenac Sodium Ophthalmic Solution 0.1%

April 18, 2008 - Akorn, Inc. (NASDAQ: AKRX) today announced that the U.S. Food and Drug Administration (FDA) has granted approval for Akorn's Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Ophthalmic Solution, 0.1%.

Diclofenac Sodium Ophthalmic Solution is a non-steroidal anti-inflammatory agent used to treat cataract and refractive surgery patients. Annual sales for Diclofenac Sodium Ophthalmic Solution were approximately $14 million in 2007, according to IMS sales data.

Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "We are pleased to announce the ANDA approval for Diclofenac. This is our first product approval in 2008 for our Somerset, NJ facility, and represents another important addition to our ophthalmic product line. We expect to launch Diclofenac in the second quarter of 2008."

Federal Court in Canada Upholds Pfizer's Norvasc Patent; Decision Prevents Launch of Generic Amlodipine Besylate Product by Pharmascience until 2010

Apr 17, 2008 - Pfizer Inc said today that the Canadian Federal Court has upheld a Pfizer patent covering amlodipine besylate, the active ingredient in Norvasc. The court issued an order prohibiting regulatory approval of Pharmascience's proposed product in Canada until Pfizer's amlodipine besylate patent - Canadian Patent No. 1,321,393 - expires in August 2010. Pharmascience may appeal the decision to the Federal Court of Appeal of Canada.

The company noted that legal challenges to this patent in Canada by other generic manufacturers are still pending.

Caraco Pharmaceutical Laboratories Ltd. Wins Summary Judgment on Generic Ultracet

Caraco Pharmaceutical Laboratories, Ltd. has confirmed that the United States District Court of New Jersey has granted Caraco's motion for summary judgment that the claims of U.S. Patent No. 39,221 that Ortho-McNeil Pharmaceutical, Inc. asserted against Caraco are invalid. Caraco's Tramadol with Acetaminophen product is a generic version of Ortho-McNeil's Ultracet. The Company commenced shipment of Tramadol with Acetaminophen following the FDA's approval to manufacture, market and distribute the generic product on December 19, 2005, and it has remained on the market since that time.

UCB sues Synthon over alleged Xyzal patent infringement

Belgian healthcare group UCB S.A. has filed a legal action against Dutch group Synthon for allegedly infringing the patent on its antihistamine drug Xyzal in the federal court of Delaware.

UCB said the company has filed a lawsuit in the U.S., together with American partner Sepracor, claiming Synthon used the active Xyzal ingredient levocetirizine in the treatment of allergic rhinitis.

UCB said the move is a response to Synthon's statement at the end of March that it believes itself to be the 'single first filer' of an Abbreviated New Drug Application for the Xyzal drug product.

As a result (of the filing) Synthon expects to be eligible for 180 days exclusivity upon the first commercial marketing of the generic drug product.

The Hatch-Waxman Act allows generics to win USFDA approval on the submission of bioequivalence studies and grants a period of additional marketing exclusivity to make up for the time a patented pipeline drug remains in development.

Synthon declined to comment on the action by UCB.

Xyzal is the successor to blockbuster drug Zyrtec, whose patent has expired.

Shionogi Receives Marketing and Manufacturing Approval for Irbetan 50mg and 100mg Tablets

April 17, 2008 -- Shionogi & Co., Ltd. today announced that it received marketing and manufacturing approval for 50mg and 100mg formulations of Irbetan® (generic name: Irbesartan), a hypertension treatment, on April 16. Shionogi plans to launch the product pending its National Health Insurance (NHI) price listing.
Discovered by French pharmaceutical company Sanofi-Aventis and codeveloped in overseas countries by Sanofi-Aventis and Bristol Myers Squibb, a U.S. pharmaceutical company, Irbesartan is a long-acting angiotensin II receptor blocker (ARB). In addition to having a stable hypotensive effect lasting 24 hours on mild to severe hypertension, Irbesartan has received a high evaluation outside Japan since its launch in 1997 as the only ARB with evidence of its renoprotective action in early to end stage nephropathy patients from the large-scale clinical trials including IDNT and IRMA 2 which are often cited in the major guidelines abroad.

The drug is on the market in 86 countries. Worldwide sales in 2007 totaled about 300.0 billion Japanese yen, making it one of the leading ARB brand. In conjunction with the approval of Irbetan®, which offers outstanding renoprotective action, Shionogi has enlisted Atsuya Furuta, former manager of the Yakult Swallows pro baseball team to symbolize the product character with his image for our effective promotional activities to healthcare providers under the catch-phrase of ‘Beat the CKD’. This initiative is aimed at raising awareness of the importance of renal protection and of the diagnosis and treatment of chronic kidney disease (CKD).

(Source: www.pharmalive.com)

Dainippon Antihypertensive Drug Avapro approved by Japanese Authority

Dainippon Sumitomo Pharma Co., Ltd. announced that the Company has obtained a manufacturing and marketing approval for “Avapro® tablet 50 mg / 100 mg” (generic name: irbesartan) as of April 16, 2008 from Ministry of Health, Labor and Welfare.

Avapro® is a long-acting ARB (angiotensin II receptor antagonist) with a long half-life in blood and a 24-hour-lasting blood pressure-lowering effect, having high anti-hypertensive effect in mild to severe hypertension.

The Company intends to launch Avapro® after it is listed in the national health insurance drug price standard.

The Company sells a variety of antihypertensive drugs including Amlodin®, a long-acting calcium antagonist, and anticipates further contribution to treatment of high blood pressure through the expansion of antihypertensive product line with the addition of Avapro®.

Genomics Likely to Replace Traditional Drug Therapies in Treating CHF

The market for congestive heart failure (CHF) drug treatments was estimated at $18 billion in 2007, and is expected to reach $30 billion by 2017, according to a new report by Kalorama Information, Congestive Heart Failure: Major World Markets, Volume I: Pharmaceutical Management. Growth is being driven by three factors: an increased incidence of CHF, the application of innovative technologies in search of targeted therapies which is creating opportunity for new entrants into this market, and physicians prescribing multi-drug regimens in response to the failure of traditional drugs to treat CHF.

CHF is a complex disorder for which prevention is more effective than treatment, and as part of the larger cardiovascular markets, it is mostly treated with drugs used to treat many other cardiovascular disorders. The lack of targeted treatments means drugs will continue to be applied liberally for prevention and sales will grow disproportionately to the CHF patient population.

"The future of CHF drug treatments lies in newer technologies such as biotechnology and genomics," notes Kenneth Krul, the report's analyst. "The identification of fetal genes associated with CHF, new treatments that address the endothelium and cell therapy to regenerate damaged heart muscle tissue present some promising areas."

The market for drugs to treat CHF will continue to be dominated by major pharmaceutical companies which supply product lines with broad cardiovascular applications. There are, however, many smaller companies focusing primarily on CHF and biotech, and their numbers are growing with the realization that this disease presents a major economic opportunity for which there is currently no adequate answer.

(Source: www.pharmalive.com)

Santarus Announces Receipt of Notice of Allowance for Additional U.S. Patent Covering Zegerid Products

April 17, 2008 - Santarus, Inc., a specialty pharmaceutical company, today announced that its licensor, the University of Missouri, has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for U.S. patent application number 10/641,732, which has claims covering methods for treating acid-caused gastrointestinal disorders by administering a solid pharmaceutical composition comprising non-enteric coated omeprazole and certain antacids. Subject to final issuance by the USPTO, the newly allowed claims will have a July 2016 expiration date.

"We are pleased to receive this Notice of Allowance and believe that the allowed patent claims, when issued, will further enhance the intellectual property coverage for our immediate-release ZEGERID(R) (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension products," said Gerald T. Proehl, president and chief executive officer of Santarus.

Santarus has licensed rights to the 10/641,732 patent application, as well as other patents and pending patent applications, under an exclusive, worldwide license agreement with the University of Missouri relating to specific formulations of proton pump inhibitors (PPIs) with antacids and other buffering agents and methods of using these formulations. Currently, five U.S. patents have been issued and several U.S. patent applications are pending. In addition to the U.S. patent coverage, several international patents have been issued, including in Australia, Canada, India, Mexico, New Zealand, Russia, Singapore, South Africa and South Korea, as well as in countries within the European Patent Organization, and several international patent applications are pending.

IMPAX Reports FDA Finding That Budeprion XL 300 mg Is Safe and Effective

April 17, 2008 - IMPAX Laboratories, Inc. (OTC: IPXL) reports that the U.S. Food and Drug Administration (FDA) has issued its report concerning the Therapeutic Equivalence of Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg and found that our generic buproprion extended-release tablets, marketed as Budeprion XL 300 milligram by our partner Teva Pharmaceutical USA, is a safe and effective choice for consumers in treating depression. In addition, it has been shown to meet all requirements for approval, including bioequivalence to the branded drug, Wellbutrin XL(R) 300 milligram.

"We are committed to providing patients with high quality, lower cost alternatives to branded pharmaceutical products. Recent patient concerns about the bioequivalence of our buproprion product to Wellbutrin XL 300 mg can now be put to rest," commented Larry Hsu, Ph.D., president and chief executive officer of IMPAX Laboratories. "IMPAX is pleased that the study confirms the confidence we have had in our product all along."

The full FDA Report can be viewed at:

http://www.fda.gov/cder/drug/infopage/bupropion/TE_review.htm

(Source: www.pharmalive.com)

Teva Announces Tentative Approval of Generic Maxalt Tablets

April 17, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Merck's migraine pain treatment Maxalt(R) (Rizatriptan Benzoate) Tablets, equivalent to 5 mg and 10 mg base. Final approval of this product is anticipated upon expiration of patent protection for the brand product in June 2012.

The brand product had annual sales of approximately $193 million in the United States for the twelve months that ended December 30, 2007, based on IMS sales data.

(Source: www.pharmalive.com)

Teva Announces Tentative Approval of Generic Evista Tablets

Apr 17, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Lilly's osteoporosis treatment Evista(R) (Raloxifene Hydrochloride) Tablets, 60 mg.

The brand product had annual sales of approximately $691 million in the United States for the twelve months that ended December 31, 2007, based on IMS sales data.

Teva is currently involved in patent litigation concerning this product in the U.S. District Court for the Southern District of Indiana. A trial date has not been set.

Meda acquires marketing rights of Sublinox & OX-NLA from Orex

Meda, an international specialty pharma company that concentrates on marketing and market-adapted product development, has acquired the exclusive world-wide commercialisation rights from Orexo of two patented drugs in late development phase; Sublinox and OX-NLA.

Sublinox (treatment of insomnia) contains the well-documented active substance zolpidem, one of the world´s most used substances for this disorder. Sublinox uses a unique and patented tablet formulation for fast and effective absorption. A recent phase III study confirmed that Sublinox gave faster onset of action than other zolpidem tablet formulations. Regulatory submission to the Food and Drug Administration (FDA) in the United States is expected before the 3rd quarter 2008.

Meda´s gross margin for Sublinox and OX-NLA is estimated to become higher than 70 per cent.

"This is a landmark event for Orexo. We believe Meda is going to be an excellent marketing partner for Sublinox and OX-NLA with their pan-European and US presence" said Torbjörn Bjerke, president and CEO Orexo. We believe Meda provides Orexo a commercial partner with global reach".

OX-NLA is a patented nasal spray formulation with the antihistamine substance cetirizine. The liposomes in OX-NLA give the product unique features. OX-NLA is being documented for the treatment of allergic and non-allergic rhinitis, one of Meda´s major therapeutic areas. The product is entering phase III and Meda will fund continued development. Meda also has exclusive rights to develop and commercialise combination products based on OX-NLA.

"I´m really glad that two Swedish based pharma companies managed to secure this deal. We strengthen Meda´s pipeline and add another significant marketing opportunity in the US in the near term with Sublinox", stated Anders Lönner, CEO, Meda.

(Published at www.pharmabiz.com)

Repligen Receives FDA Fast Track Designation for RG1068 for Pancreatic Imaging

Repligen Corporation RGEN announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the development program for RG1068, synthetic human secretin, to improve the assessment of pancreatic duct structures by magnetic resonance imaging (MRI). Fast track is a process designed to facilitate the development and expedite the review of drugs that treat serious diseases and fill an unmet medical need. Once a drug receives Fast Track designation, frequent communication between the FDA and the sponsor is encouraged throughout the development and review process. In addition, many drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review, under which the time it takes the FDA to review a new drug application is reduced. The goal for completing a Priority Review is six months.

"We are very pleased that the FDA has recognized the urgent need for a safe procedure to assess pancreatic abnormalities," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "We expect to complete patient enrollment in our Phase 3 clinical trial this year and, if successful, file an NDA in 2009."

Repligen is currently conducting a Phase 3 clinical trial to evaluate the use of RG1068, synthetic human secretin, to improve the assessment of pancreatic duct structures by magnetic resonance imaging (MRI). The Phase 3 study is a multi-center, baseline-controlled, single dose study in which approximately 250 patients will receive an unenhanced MRI followed by a secretin-enhanced MRI of the pancreas. The study is designed to assess the sensitivity and specificity of secretin-enhanced MRI to improve the ability to detect pancreatic duct abnormalities relative to MRI alone. Detailed visual assessment of the pancreatic ducts is important in the assessment, diagnosis and treatment of diseases such as acute and chronic pancreatitis. The study is being conducted at approximately 30 clinical sites within the United States and Canada.

(Published at: http://www.pharmalive.com/News/index.cfm?articleid=531950&categoryid=56)

Tocilizumab approved in Japan for treatment of Rheumatoid Arthritis

April 16, 2008-Roche and Chugai (alliance partners) has received approval for their product Actemra (tocilizumab), for the treatment of patients suffering from rheumatoid arthritis (RA).


Actemra was approved by the Japanese authorities for the indication of RA and two forms of the disease that affect children, known as juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis.


Japan is the first market worldwide to get access to Actemra for the treatment of RA. The approval is based on compelling data from clinical trials conducted in Japan that showed Actemra was highly effective in controlling the symptoms and progression of this serious disease.


Actemra is the first of a new class of drug with a novel mechanism of action that brings new hope to RA patients. It is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody, which works by suppressing the activity of IL-6, an important trigger of the inflammatory process. This novel mode of action reduces inflammation of the joints and relieves the systemic effects of RA.


Since 2005, Actemra has been marketed in Japan for the treatment of patients with a rare auto-immume condition known as Castleman's disease. Actemra licence applications have also been filed for treatment of RA in the US and the European Union in 2007, and are currently under review.

Humira (adalimumab) Approved in Japan for the Treatment of Rheumatoid Arthritis

Abbott announced today that it has received approval from the Japanese Ministry of Health, Labour and Welfare for HUMIRA(R) (adalimumab) for the treatment of RA (Rheumatoid Arthritis)in patients with inadequate response to conventional therapy. Abott and Eisai has codeveloped this product and will market jointly. HUMIRA is now approved in 75 countries for RA and other autoimmune disease indications.

"The approval of HUMIRA in Japan is a significant milestone for Abbott," said Glenn Warner, vice president, Pharmaceuticals, Japan, Abbott.

HUMIRA is expected to become available to patients in Japan in the coming months, following the standard pricing approval process.

"The clinical studies of HUMIRA in Japanese patients demonstrated the efficacy and safety of this medicine," said Prof. Nobuyuki Miyasaka, who was involved in the development of HUMIRA for the treatment of RA in Japan.

Abbott has submitted an application for approval of HUMIRA for plaque psoriasis, and is also developing HUMIRA in Japan for Crohn's disease, ankylosing spondylitis, juvenile rheumatoid arthritis and ulcerative colitis.

Sumatriptan and Naproxen Sodium combination Tablets Approved by FDA for Acute Treatment of Migraine

GlaxoSmithKline and POZEN Inc. announced today that the FDA has approved Treximet (Sumatriptan and Naproxen Sodium) tablet for the acute treatment of migraine attacks with or without aura in adults. Treximet is the first and only migraine product designed to target multiple mechanisms of migraine by combining a triptan, a class of migraine-specific medicines pioneered by GSK, and an anti-inflammatory pain reliever in a single tablet.

Treximet contains 85 mg sumatriptan, formulated with RT Technology(TM), and 500 mg naproxen sodium. In clinical trials, Treximet provided a significantly greater percentage of patients migraine pain relief at two hours compared to sumatriptan 85 mg or naproxen sodium 500 mg alone. In addition, Treximet provided more patients sustained migraine pain relief from two to 24 hours compared to the individual components.

"Migraine patients want their medicine to work early, and to continue to provide relief," said Dr. Stephen Silberstein, professor of neurology and director of the Jefferson Headache Center at and an investigator who participated in clinical trials. "The FDA approval of Treximet is good news for migraine patients because clinical trials showed that Treximet produced sustained migraine pain relief for a significant number of patients." Further, Silberstein said, significantly fewer patients on Treximet required the use of a rescue medication to treat their migraine attack than those taking sumatriptan 85 mg.

About RT technology....

GSK’s RT Technology, which is currently used in currently marketed Imitrex® tablets, is designed to enhance the dispersion and dissolution of oral tablets in the stomach, even in the presence of gastric stasis. Gastric motility is commonly slowed during a migraine. Imitrex tablets formulated with RT Technology™ quickly disintegrate and rapidly release into the bloodstream.

Teva Pharmaceuticals USA Responds to FDA Findings on Budeprion XL 300 mg

Apr 16, 2008 - Teva Pharmaceuticals USA issued the following statement in response to the FDA's "Review of Therapeutic Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg":


As the largest generic drug company in the world, Teva's first
priority is to ensure that patients receive products with
unquestioned safety and effectiveness. Teva Pharmaceutical
Industries Ltd. is committed to making affordable, quality
healthcare accessible to patients. We constantly work to ensure
that all of our products meet FDA's comprehensive regulations
governing the review and approval of generic drugs.

Teva commends the actions taken by the FDA, to assure patients
that Budeprion is both "bioequivalent and therapeutically
equivalent to (interchangeable with) Wellbutrin XL 300 mg." Teva
is pleased that after their thorough review of Budeprion, the FDA
has released this important information to the public.

Akorn, Inc. Announces FDA Approval of Ofloxacin Ophthalmic Solution USP, 0.3%

Apr 16, 2008 - Akorn, Inc. (NASDAQ:AKRX) today announced that the U.S. Food and Drug Administration (FDA) has granted approval for Akorn's Abbreviated New Drug Application (ANDA) for Ofloxacin Ophthalmic Solution USP, 0.3%.

Ofloxacin Ophthalmic Solution is an anti-infective used to treat infections caused by bacteria in conjunctivitis and corneal ulcers. Annual sales for Ofloxacin were approximately $7.5 million in 2007, according to IMS sales data.

Pepcid Patent's Invalidity affirmed by federal circuit

A federal appellate court has affirmed a lower court ruling finding a patent (58317340) for Johnson & Johnson and Merck & Co.’s popular over-the-counter heartburn drug Pepcid Completely invalid.

Earlier in June 2007, Judge William H. Pauley III of the U.S. District Court for the Southern District of New York ruled that Merck's patent on the formulation for Pepcid Complete is invalid as obvious, clearing the way for Perrigo Co. to sell its own generic version of the medication. The decision was one of the first pharmaceutical patent decisions to rely on and quote extensively from the Supreme Court's April 30 decision in KSR v. Teleflex.

The earlier district court decision can be read here.

The latest order from the federal circuit can be seen here.

This decision further affirms the impact of KSR v. Teleflex on litigations based on obviousness grounds.

Roche to acquire UK-based Piramed

Roche said it would acquire Piramed Limited, a privately-owned UK company focusing on therapeutics targeting PI3-kinase (PI3-K). The PI3-K pathway is known to play an important role in disease progression and in resistance to chemotherapeutics in cancer cells. Pre-clinical studies have demonstrated the activity of PI3-K inhibitors in a broad range of tumours such as breast and lung cancer, as well as their potential importance in treating inflammatory diseases such as rheumatoid arthritis.

Through this acquisition, Roche's R&D pipeline is strengthened by Piramed's two major research programmes targeting PI3-K-alpha in oncology and PI3K-delta in inflammatory disease. The PI3-K-alpha programme has a compound in phase I of clinical development and is currently being developed in collaboration with Genentech, in whom Roche has a majority ownership interest. The previously unpartnered PI3-K-delta programme, while at a pre-clinical stage, will be integrated into the Roche Group's rich inflammatory R&D portfolio.

"The integration of Piramed's promising research and development reaffirms and further strengthens Roche's leadership in oncology", said William M. Burns, CEO, pharmaceuticals division, Roche. "While innovative medicines have undoubtedly transformed cancer treatment, cancer remains a major cause of death and we are committed to investing in the development of new treatment options. In addition, this acquisition augments our research efforts in debilitating diseases such as rheumatoid arthritis".
Under the terms of the agreement, Roche will acquire 100 per cent of Piramed's shares for USD 160 million, plus a milestone payment of USD 15 million, which is due upon the commencement of phase II clinical trials for the company's oncology programme. The final transaction value will be adjusted by the net cash balance remaining upon closing. Closing of the transaction is subject to standard conditions including review by anti-trust authorities. Completion is expected during the second quarter of 2008.

Michael Moore, chief executive, Piramed, said, "Since Piramed was formed in 2003, we have struck a significant licensing deal with Genentech and advanced our highly promising first oncology product into the clinic. Today's acquisition by Roche underlines the value of our pipeline and is a testament to the quality of the science developed by our team. With Roche's undisputed excellence in oncology and inflammatory disease, Piramed has found a secure long term home for some world class science."

PI 3-kinases are implicated in both cancer and immune inflammatory disease. In cancer, up-regulation of the PI 3-K pathway is a very common characteristic and several components of the pathway are implicated in the development of cancer. In addition, persistent signalling through the PI 3-K pathway has been shown to be a major mechanism of resistance to potential chemotherapeutic agents targeting the epidermal growth factor receptor. Pre-clinical data clearly point to the potential widespread anti-cancer utility of agents that inhibit the pathway at the level of PI3-K, particularly the alpha isoform. Such agents are expected to inhibit proliferation and overcome resistance to cytotoxic agents in cancer cells.

The delta isoform of PI3-K is strongly implicated in immune inflammatory disease, primarily through the acquired immune system. Inhibitors of PI3-K delta down-regulate certain functions of B and T cells, mast cells and neutrophils and have demonstrated significant activity in various experimental models of human immune inflammatory disorders. These data indicate a potential for broad clinical utility as new therapeutic agents in this diverse disease area.

Pfizer updates Exubera labelling in the US

Pfizer Inc has updated the US product labelling for Exubera (insulin human [rDNA original]) inhalation powder to include a warning with safety information about lung cancer cases observed in patients who used Exubera.

The update is based on an ongoing review of the data from the Exubera clinical trial programme and post-marketing experience by Pfizer and the Food and Drug Administration (FDA). Since the inception of the programme, Pfizer has continuously monitored respiratory safety. Over the course of the clinical trial programme, 6 of the 4,740 Exubera-treated patients versus 1 of the 4,292 patients not treated with Exubera developed lung cancer. In addition there was a post-marketing report of lung cancer in one Exubera-treated patient. The update to the labelling states that all patients who developed lung cancer had a prior history of cigarette smoking, and that there were too few cases to determine whether the development of lung cancer is related to the use of Exubera.
"Pfizer is vigilant in monitoring adverse drug reports for all its products, including Exubera, which has shown in clinical trials to be a safe and effective medicine in the treatment of adults with type 1 or type 2 diabetes," said, Joe Feczko, chief medical officer, Pfizer.

Pfizer announced in October 2007 that it would stop marketing Exubera because it did not meet customers' needs or the company's financial expectations. Nektar Therapeutics has also stopped its search for a new marketing partner. Pfizer would be discussing the timing of marketing authorisation withdrawals with regulatory agencies.

"Some patients continue to take Exubera, including those enrolled in extended transition programs or clinical trials. We are working closely with patients and their physicians to ensure the continued orderly transition from Exubera to alternative therapies. Physicians should seek alternate treatment options to maintain patients' glycemic control," said Dr. Feczko.

Kiadis Pharma Receives Orphan Drug Designation for Rhitol From the FDA

April 15, 2008 -- Biopharmaceutical company Kiadis Pharma announced today that the U.S. Food and Drug Administration (FDA) has granted its product Rhitol(TM) Orphan Drug Designation for the treatment of chronic Graft versus Host Disease (GvHD). This complication of allogeneic bone marrow transplantation is highly disabilitating and can become life threatening when the patient is unresponsive to steroid treatment. Rhitol(TM) has completed a multicenter phase I/II study for patients with severe steroid resistant chronic GvHD. A phase III study is anticipated to start in 2008.

"The decision by the FDA to grant Rhitol(TM) orphan drug designation in this area of blood cancer with unmet medical need advances our efforts to develop an innovative treatment" says Dr. Manja Bouman, Chief Executive Officer of Kiadis Pharma.

The FDA's orphan drug designation is reserved for new therapies being developed to treat diseases or conditions that affect fewer than 200,000 people in the United States. The orphan drug designation provides for an accelerated review process, tax benefits, exemption from user fees and a seven-year period of market exclusivity in the United States after product approval.

Rhitol(TM) is under development as a treatment for patients with chronic GvHD resistant or intolerant to immunosuppressive agents. Rhitol(TM) treatment targets activated T cells that cause GvHD and results in immune modulation within patients with chronic GvHD, restores immune tolerance and attempts to achieve disease remission.

Lev Pharmaceuticals Announces Submission of Complete Response to FDA for Cinryze for Hereditary Angioedema

April 15, 2008--Lev Pharmaceuticals, Inc. today announced that it has formally submitted its complete response to the U.S. Food and Drug Administration's (FDA) complete response (or "approvable") letter for the Company's lead product candidate, Cinryze(TM) (C1 inhibitor). Lev is seeking marketing approval for Cinryze(TM) for both the acute and prophylactic treatment of hereditary angioedema (HAE), also known as C1 inhibitor deficiency.

A complete response letter is issued by FDA to request additional information in connection with its review. In its letter, FDA requested information with respect to chemistry, manufacturing, and controls (CMC), as well as additional analyses of existing efficacy data from the Cinryze(TM) trials. No additional safety information and no additional clinical trials have been requested to date.

In addition, Lev is scheduled to present to the Blood Products Advisory Committee (BPAC) on May 2, 2008. Advisory committees provide FDA with independent advice from outside experts. The BPAC meeting represents the next stage in the regulatory process for Lev as the Company continues to work with FDA toward obtaining market approval for Cinryze(TM).

FDA accepts Somaxon Pharmaceuticals NDA for Silenor

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology, today announced that the U.S. Food and Drug Administration (FDA) has notified the company that it has accepted for filing the company's New Drug Application (NDA) for SILENOR™(doxepin hydrochloride). Somaxon is seeking marketing approval of SILENOR™for the treatment of insomnia.

Acceptance of the filing means that FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive review. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, the NDA is considered filed as of March 31, 2008, and Somaxon expects that the FDA will complete its review and provide an action letter with respect to the NDA by December 1, 2008.

“We are pleased that the FDA has accepted our application for filing and we look forward to working with them as we seek approval for SILENOR™for the treatment of insomnia,”said David F. Hale, Somaxon’s executive chairman and interim chief executive officer. “While acceptance for filing of an NDA does not assure approval, we believe that the improvements in sleep onset, sleep maintenance and sleep duration and the favorable safety and tolerability profile demonstrated by our clinical development program will be sufficient to support a determination by the FDA that SILENOR can be approved for the treatment of insomnia.”

IMS Health Reports Global Prescription Sales Grew 6.4 Percent in 2007, to $712 Billion

April 15, 2008 – IMS Health, the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries, today announced that the 2007 global prescription market grew 6.4 percent over the prior year. This takes the estimated total global prescription market to $712 billion based on sales, an increase of $178 billion over the past five years.

The United States is still the largest single market at $286.5 billion. However, it contributed only 25.5 percent of the total growth to the global market in 2007 – the lowest-ever level of contribution.

Latin America markets continued their rapid expansion, with growth of 11.6 percent in 2007, while the Asian markets experienced double-digit growth due to the expansion of healthcare access in the region.

Across the five major European markets, growth in aggregate was 4.8 percent, largely reflecting the impact of health policy and funding initiatives.


(As per the article published on pharmalive.com)

Provectus Pharmaceuticals Receives Patent Allowance in the EU for PH-10 Dermatology Agent

April 15, 2008 - Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, has received allowance of its patent application in the European Union covering its lead dermatology agent, PH-10, along with a number of related agents and their use. Provectus has also received allowance of another patent application in Canada covering applicator devices used with PH-10 and related agents. The pending patents cover topical products for treatment of skin diseases such as psoriasis and eczema, along with certain medical devices for application of PH-10 to internal surfaces of the body.

"Coming on the heels of our recent patents in the U.S. and India for PH-10, these pending patents from the European Patent Office (EPO) and the Canadian Intellectual Property Office are further milestones validating our efforts to obtain maximum right of ownership for products that may be sold in major markets worldwide," said Craig Dees, PhD, CEO of Provectus. "The EPO patent will also cover topical products based on PH-12, our novel photoactive analog of PH-10."

MonoSol Rx Granted US Patent for Thin Film Manufacturing Process

MonoSol Rx, a drug delivery company specializing in quick dissolving thin film pharmaceutical products, today announced that it has been granted U.S. patent No. 7,357,891 from the United States Patent and Trademark Office (USPTO). The patent, which is expected to issue on April 15, 2008, relates to the Company's proprietary mixing system technology and controlled film drying process.

"Granting of this patent is a significant milestone for MonoSol Rx as it validates and protects our thin film drug delivery technology. As we strive to expand the patent protection of our thin film technology, this milestone serves to fortify our leadership position in the delivery of prescription drugs using thin film" said A. Mark Schobel, president and chief executive officer of MonoSol Rx. "Our proprietary mixing and drying processes enable us to maintain precise content uniformity of the drug, incorporate taste-masked drug encapsulations, and allow the manufacture of sensitive drug targets that may otherwise not be possible. Each of these factors, combined with the convenience and dosing benefits of thin film, are key to the success of our technology, and help to differentiate MonoSol Rx from similar thin film offerings and other modes of drug delivery."

The patent relates to MonoSol Rx's Dual Integrated Mixing System. This patented mixing process is designed to provide a continuous batch coating of a drug contained in the film to ensure product uniformity while delivering consistent organoleptic performance throughout the film manufacturing process.

Also encompassed in the patent is MonoSol Rx's controlled film drying process. This controlled drying process is critical to maintaining content uniformity of a drug within the film thereby ensuring accurate and predictable dosing for patients.

Mr. Schobel also said, "This is an important acknowledgement of the innovative technology that MonoSol Rx has developed for thin film drug delivery. We are committed to pursuing and developing technology that provides significant advantages for MonoSol Rx and its development partners."

AstraZeneca Settles US Nexium Patent Litigation with Ranbaxy

April 15, 2008--AstraZeneca today announced it has entered into a settlement agreement in its Nexium patent infringement litigation against Ranbaxy Laboratories Ltd. and its affiliates (“Ranbaxy”).

The agreement settles the patent infringement litigation filed by AstraZeneca following Ranbaxy’s submission to the United States Food & Drug Administration of an Abbreviated New Drug Application for a generic version of Nexium. Under the settlement agreement, Ranbaxy concedes that all six patents asserted by AstraZeneca in the patent litigation are valid and enforceable. Ranbaxy also accepts that four of the patents would be infringed by the unlicensed sale of Ranbaxy’s proposed generic product.

The settlement agreement will allow Ranbaxy to commence sales of a generic version of Nexium under a licence from AstraZeneca on 27 May 2014. This date marks the expiry of US Patent Numbers 5,877,192 and 6,875,872. AstraZeneca’s patents protecting Nexium have expiration dates that range from 2014 through 2019.

AstraZeneca and Ranbaxy have filed a Consent Judgment with the US District Court for the District of New Jersey reflecting the terms of the settlement agreement. With the Court now having entered the Consent Judgment, the settlement agreement is final, and the patent infringement litigation against Ranbaxy has been dismissed.

Merck & Co., Inc., through KBI Inc. and KBI-E and under the terms of Merck's restructured partnership with AstraZeneca announced in 1998, has also entered into the settlement agreement.

AstraZeneca’s Nexium patent infringement litigations against Teva/IVAX and Dr Reddy’s Laboratories remain ongoing.

“I believe that this agreement is the right business decision and gives increased clarity and stability to allow us to continue investing substantially in our growing pipeline of new medicines for patients. We continue to have confidence in the strength of our patents and will vigorously defend our intellectual property,” said David Brennan, Chief Executive Officer of AstraZeneca.

Study shows once-yearly Aclasta better than risedronate

New data show that a once-yearly infusion of Aclasta (zoledronic acid 5 mg) was significantly better than risedronate at increasing bone mass in patients with osteoporosis caused by glucocorticoids, commonly known as steroids. These medications are widely used to treat inflammatory conditions but can cause bone loss and osteoporosis.

Up to 50 per cent of patients receiving long-term glucocorticoid therapy are at increased risk of fracture due to osteoporosis, and approximately nine million people worldwide are affected by glucocorticoid-induced osteoporosis (GIO).

Results of a clinical study in 833 men and women were presented at the European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ECCEO) in Istanbul, Turkey.

"Recognizing and treating GIO is an important need, as glucocorticoid therapy is so widely used and presents an ongoing challenge for physicians," said Professor David M. Reid, head of the division of applied medicine at the University of Aberdeen, UK. "The significant efficacy of this once-yearly treatment, offering year-long bone protection, will provide a very valuable treatment option for healthcare professionals treating and managing osteoporosis induced by glucocorticoids".

The trial investigated both prevention (288 patients) and treatment (545 patients) of GIO. Results demonstrated that a single yearly infusion of Aclasta significantly increased bone mineral density (BMD) in the lumbar spine at 12 months compared to risedronate in both the treatment group.

Risedronate is one of the established treatments for GIO and, like Aclasta, is a member of the bisphosphonate class of drugs. Risedronate is taken in the form of a daily pill, whereas Aclasta is given as a once-yearly 15-minute infusion, promoting compliance with bisphosphonate treatment and providing annual protection against the consequences of osteoporosis.

Novartis is applying for an indication with the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) for the treatment and prevention of GIO.

Novartis' lung cancer drug enters phase 3 stage

Novartis announced that ASA404, its novel cancer agent, has entered into a phase III lung cancer trial following positive outcomes of a phase II trial. The novel mechanism of action of ASA404 may represent a new approach to treating the most prevalent cause of cancer death.

ASA404 is a Tumour-Vascular Disrupting Agent (Tumour-VDA) that selectively causes the collapse of existing tumour blood supply leading to extensive tumour cell death. The action of ASA404 is distinct from that of angiogenesis inhibitors, which inhibit the formation of new tumour blood vessels.

In a randomized phase II study, ASA404, in combination with chemotherapy, demonstrated a median overall survival advantage of more than five months in first-line treatment of advanced non-small cell lung cancer (NSCLC) compared with chemotherapy alone. A similar survival advantage was observed in a subsequent extension of the phase II study.
Non-small cell lung cancer, the potential lead indication for ASA404, accounts for about 85 per cent to 90 per cent of all lung cancers. Worldwide, lung cancer is the number one cause of death from cancer each year in both men and women, with 1.2 million new cases per year and 921,000 deaths.

"With the launch of ATTRACT-1, we look forward to exploring the unique mechanism of action of ASA404 in non-small cell lung cancer to potentially help the more than one million people who develop lung cancer each year," said Alessandro Riva, Executive vice president and global head of development of Novartis Oncology.

ASA404 is one of six novel oncology compounds Novartis is developing for potential registration over the next five years. The other investigational therapies which focus on a broad array of cancer targets include RAD001 (renal cell carcinoma and other cancers), SOM230 (Cushing's disease/refractory carcinoid tumours, acromegaly), LBH589 (cutaneous T-cell lymphoma and other cancers), EPO906 (ovarian cancer), and PKC412 (acute myelogenous leukaemia and aggressive systemic mastocytosis).

"Today, our broad and deep pipeline includes both small molecules and monoclonal antibodies that utilize a variety of mechanisms such as vascular-disruption, anti-angiogenesis, and kinase inhibition to treat cancer," said David Epstein, President and CEO of Novartis Oncology. "These exciting potential discoveries have the possibility to change medical treatment for patients suffering with many forms of cancer".

The trial will be a randomized, double-blind, placebo-controlled, multi-centre study of ASA404 in combination with paclitaxel and carboplatin as first-line treatment for locally advanced or metastatic (Stage IIIb/IV) NSCLC of squamous or nonsquamous histology.

ASA404 is a small-molecule tumour-VDA that selectively disrupts existing tumour blood vessels. Solid tumours rely on a network of blood vessels to survive and grow. ASA404 targets existing tumour blood vessels causing death of vessel endothelial cells and the collapse of tumoral blood vessels.

Novartis signed an exclusive licensing agreement with Antisoma plc for the worldwide rights to ASA404 in April 2007.

sNDA for Risperdal Consta Submitted to the FDA for the Treatment of Frequently Relapsing Bipolar Disorder

April 14, 2008--Alkermes, Inc. today announced that its partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), submitted a Supplemental New Drug Application (sNDA) for Risperdal Consta ((risperidone) Long-Acting Injection) to the U.S. Food and Drug Administration (FDA) seeking approval for adjunctive maintenance treatment to delay the occurrence of mood episodes in patients with frequently relapsing bipolar disorder (FRBD).

FRBD is defined as four or more manic or depressive episodes in the previous year that require a doctor's care. The condition may affect 10 to 20 percent of the 27 million people with bipolar disorder worldwide.(1,2)

The sNDA is based on results from a recent study comparing patients who received RISPERDAL CONSTA and standard treatment to those who received standard treatment combined with placebo. The study found that patients with FRBD had a significant delay in the time to an initial relapse when RISPERDAL CONSTA was combined with standard treatment. The study was presented at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disorders in Montreux, Switzerland on February 3, 2008.

RISPERDAL CONSTA was approved for the treatment of schizophrenia in the U.S. in 2003. RISPERDAL CONSTA is marketed by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., in the U.S. and is manufactured by Alkermes.

New Powerful Antihypertensive Micardisplus 80/25 (80mg Telmisartan/25mg Hydrochlorothiazide) Approved by EU Commission

14 April 2008 - Boehringer Ingelheim today announced that the European Commission has granted marketing authorisation of the new powerful strength of their fixed dose combination antihypertensive drug MicardisPlus® 80/25 in all 27 EU member states. It will be launched in Germany and Denmark in the coming weeks, followed soon by Ireland, the United Kingdom and the rest of EU, and when approved also in other countries around the world.

The product is licensed for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on MicardisPlus® 80/12.5 (80 mg telmisartan/12.5 mg hydrochlorothiazide) or patients who have been previously stabilized on telmisartan and hydrochlorothiazide separately at the same dosages. 1,2

The new strength will be marketed by Boehringer Ingelheim in all 27 countries of the European Union under the brand name MicardisPlus® 80/25. It’s co-marketing partners will market the new drug in selected countries under their own brands.

“The approval of MicardisPlus® 80/25 provides physicians with a powerful new drug for patients with difficult to treat essential hypertension“, said Dr Andreas Barner, Member of the Board of Boehringer Ingelheim and responsible for Research, Development and Medicine.

European approval of MicardisPlus® 80/25 follows the submission of efficacy and safety data from 12 clinical trials performed in patients with mild to moderate hypertension. The core clinical development programme consisted of two consecutive trials designed to demonstrate the superiority of the fixed dose combination 80 mg telmisartan/25 mg hydrochlorothiazide (T80/H25) versus 80 mg telmisartan/12.5 mg hydrochlorothiazide (T80/H12.5).2 971 patients, who were inadequately controlled for their blood pressure (BP) on existing antihypertensive treatment, were enrolled in the programme. Treatment with T80/H25 provided superior diastolic and systolic blood pressure lowering power after 8 weeks of treatment1 compared to T80/H12.5. In the consecutive follow up trial 639 patients (633 patients evaluated for efficacy) were treated with the T80/H25 for further 6 months. At the end of this treatment interval the proportion of patients achieving DBP control had increased from 52.4% to 71.4%.2

No clinically meaningful differences in the adverse event profiles of T80/H25 and T80/H12.5 were detected. No specific increased incidence was identified for all adverse events. No additional specific safety issues have been identified1,2. Other studies considered by the EMEA showed clearly superior clinical benefits for a T80/H25-based treatment compared with 160 mg valsartan /25 mg hydrochlorothiazide, the market leading ARB´s high strength combination.

Advagraf (extended release tacrolimus) Is Now Available in Canada For Kidney Transplant Patients

April 14, 2008- Advagraf(TM) (tacrolimus extended release capsules), marketed by Astellas Pharma Canada, Inc., has been approved by Health Canada for the prevention of organ rejection in patients receiving an allogeneic kidney transplant.(1) Patients who have received a kidney transplant now have access to a new once-a-day immunosuppressant therapy.

"Kidney transplantation is a life-altering experience which places a great deal of responsibility on a patient to take multiple medications at different times of the day to avoid compromising the kidney transplant," says Dr. Sita Gourishankar, a nephrologist in the University of Alberta's Department of Nephrology. "A once-daily anti-rejection therapy will be of considerable benefit and will help simplify the drug regimen required by post-transplant patients."

Extended release tacrolimus is a new formulation of Prograf(R), (tacrolimus twice daily), a leading immunosuppressant agent developed and marketed by Astellas.(2) Tacrolimus twice daily has been available in Canada since 1997. Both extended release tacrolimus and tacrolimus twice daily, which is indicated for prevention of kidney, liver and heart transplant rejection, are indicated for use concomitantly with corticosteroids and mycophenolate mofetil (MMF).(3)

"Because this is a once-a-day therapy, Advagraf helps streamline the number of medications patients need to take. This is an important step forward to improve long-term adherence to immunosuppressant therapy," says Barbara Reynolds, Director of New Product Development at Astellas Pharma Canada, Inc. "Astellas is very pleased to be able to offer the Canadian transplant community a new therapeutic option that not only helps prevent organ rejection, but that is more convenient for patients."

Jazz Pharmaceuticals' Luvox CR Is Now Available for Patients With Social Anxiety Disorder (SAD) and Obsessive Compulsive Disorder (OCD)

Jazz Pharmaceuticals, Inc. announced today that Once-A-Day Luvox(R) CR (fluvoxamine maleate) Extended-Release Capsules is now available at pharmacies throughout the United States. LUVOX CR was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of social anxiety disorder (SAD) and obsessive compulsive disorder (OCD) in adult patients. SAD and OCD are two difficult-to-treat, underdiagnosed and undertreated anxiety disorders.

Jazz Pharmaceuticals is dedicated to helping patients suffering from serious psychiatric and neurological disorders. Jazz Pharmaceuticals is supporting a number of programs and resources for SAD and OCD patients and for physicians. These efforts include education kits, disease education Web sites and diagnostic screening tools. The company is also introducing CT STEPS(TM), a novel, Internet-based cognitive behavioral therapy (CBT) program to help OCD patients.

Earlier this month, Jazz Pharmaceuticals' sales team began communicating with office-based psychiatrists and select primary care physicians about the unique attributes of LUVOX CR. These sales professionals will provide samples of LUVOX CR in 100 mg and 150 mg dose strengths that physicians may choose to distribute to their patients.

LUVOX CR incorporates Elan's proprietary SODAS(R) (Spheroidal Oral Drug Absorption System) technology, which is designed to minimize peak-to-trough fluctuations in plasma levels over a 24-hour period. In three Phase III trials, LUVOX CR was shown to provide tolerability in two common areas of concern to patients(1,2). In the trials, LUVOX CR demonstrated a weight-neutral profile with no significant weight gain or loss(3,4,5,6). In addition, patients taking LUVOX CR had a low incidence of sexual adverse events in the trials(4). Less than 1 percent of patients treated with LUVOX CR discontinued therapy due to any individual sexual adverse event(3-6).

"We are very excited about the introduction of LUVOX CR to the United States market. The availability of LUVOX CR provides physicians with a new and effective treatment option for the millions of adults in the United States suffering from SAD and OCD," said Samuel Saks, M.D., chief executive officer of Jazz Pharmaceuticals. "Through our educational efforts, we hope to provide physicians and their patients with important information about SAD and OCD. As part of our commitment to helping patients, their families and caregivers, we are working with advocacy organizations to increase awareness about these serious and underdiagnosed conditions."

Patents Issued

April 14, 2008 - Pharmalink AB, a specialty pharma company, announces today that the U.S. Patent and Trademark Office has approved U.S. Patent No. 7,351,427, relating to the pharmaceutical composition, method of preparation and method of treatment by use of busulfan, which is the active agent in Pharmalink's Busulipo(tm). Busulfan is a well-established chemotherapy agent used for myeloablation (severe suppression of bone marrow activity) as a preconditioning regimen to bone marrow stem cell transplantation, for example, in the treatment of leukaemia. The patent application was filed in the U.S. in 2003 and will expire in 2020 (term adjusted).

April 14, 2008- Starpharma Holdings Ltd has filed a patent application for the use of SPL7013, the active ingredient in VivaGel, to inhibit hyaluronidase activity in the treatment or prevention of a number of diseases.

April 14, 2008 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited announced today that it had presented new data on its patented PG500 series of compounds at the annual American Association for Cancer Research (AACR) meeting being held in San Diego. The meeting brings together approximately 17,000 participants from around the world to discuss new and significant advances in the knowledge surrounding the causes, diagnosis, treatment and prevention of cancer.

Genta Incorporated today announced that the Company has received notice that its patent application covering novel pharmaceutical gallium compositions and complexes has been allowed by the U.S. Patent Office.

Teva Announces Brussels Court Decision To Revoke MSD's European Patent On Fosamax

April 11, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that on April 8, 2008, the Court of First Instance in Brussels, Belgium, decided to revoke the Belgium part of Merck Sharp & Dohme's ("MSD") European Patent No. 1,175,904, due to lack of inventive step. This patent relates to Fosamax® Once Weekly (Alendronate 70mg Once Weekly). This favorable decision follows a similar judgment rendered by the Hague District Court in the Netherlands regarding the same patent two months ago.

The decision may be appealed.

Teva's Alendronate products are subject to multiple European litigations between MSD, Teva and other parties, relating to both Alendronate 10mg and Alendronate 70mg. This patent is currently being litigated by Teva in France, Italy, Sweden and Spain as well as in the European Patent Office.

Teva is already marketing Alendronate 10mg and 70mg in various European countries and may market Alendronate 70 mg in Belgium starting April 15, 2008.

Lundbeck Wins Appellate Ruling On Cipralex Patent

A British appellate court has overturned a ruling that found claims in H. Lundbeck A/S’ patent for its antidepressant drug Cipralex insufficient, scoring a win for the Danish pharmaceutical company in an ongoing patent challenge brought by three generics makers.

The details of the case can be read here.

Nektar terminates negotiations for Inhaled Insulin after adverse reports

As a latest setback to the already faltering industry efforts to develop inhalable insulin, Nektar Therapeutics said it has ceased all negotiations with potential partners for its inhaled insulin programmes as a result of new data analysis from ongoing clinical trials conducted by Pfizer Inc. Nektar would also cease all spending associated with its inhaled insulin programmes and would not incur any additional charges related to this event.

An increase in the number of new cases of lung cancer was observed in inhaled insulin patients as compared to the control group, according to a Pfizer report. All new incidences of lung cancer were in patients that are former smokers.

"The concern over this new data analysis from ongoing clinical trials has resulted in the termination of all negotiations with potential partners," said, Howard W. Robin, president and CEO, Nektar. "Fortunately, over the past year Nektar has significantly transformed its business, moving away from inhaled insulin. We have made great progress expanding our research efforts and have built a deep pipeline of novel partnered and proprietary drugs in various stages of development."

The Exubera label was updated by Pfizer to include the new warnings. In clinical trials of Exubera, there have been 6 newly diagnosed cases of primary lung malignancies among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients. There has also been 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient. In controlled clinical trials of Exubera, the incidence of new primary lung cancer per 100 patient-years of study drug exposure was 0.13 (5 cases over 3900 patient-years) for Exubera-treated patients and 0.02 (1 case over 4100 patient-years) for comparator-treated patients. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking, according to a press release issued by Nektar.

La Roche moves Delhi HC against Cipla

Swiss pharma major Roche has filed an appeal before the Delhi High Court challenging the order of the single bench that refused to restrain Cipla from manufacturing and selling anti-cancer drug Tarceva, alleged to be a copy of La Roche's patent.

The Swiss pharma company, through its counsel Abhishek Manu Singhvi, raised the matter before a bench comprising Justice Manmohan Sarin and Justice Manmohan and asked for an urgent hearing of the case. But the court posted it for hearing on April 22.

Earlier on March 19, Cipla had won the first round of the battle to continue marketing of the disputed anti-cancer drug Tarceva (Erlotinib) in the country after the Delhi High Court rejected an injunction plea by Swiss drug major Roche who holds the Indian patent right to the drug.

Roche received patent for Tarceva in India last year, but has been subsequently facing post-grant patent opposition from Cipla and NGOs. Two months ago, Cipla decided to market copycat versions of the drug. On January 19 this year, Roche Scientific filed infringement lawsuit in the Delhi HC. This is the first test case after the new patent regime came into force in 2005.

Contending that the interim order should be quashed, Singhvi said the single bench allowed the infringement of its patent rights stating that it was in public interest. He contended that there was no correlation between patent law and public interest as patent is an absolute monopoly.

Takeda to acquire Millennium Pharmaceuticals for $8.8 bn

Takeda Pharmaceutical Company Limited and Millennium Pharmaceuticals, Inc. have entered into a definitive agreement pursuant to which Takeda will acquire Millennium for approximately $8.8 billion through a cash tender offer of $25.00 per share. The transaction was unanimously approved by the boards of directors of both companies.

Upon completion of the acquisition, Millennium will become a wholly-owned subsidiary of Takeda, and will continue operations in Cambridge, Massachusetts, as a standalone business unit. Millennium will be known as Millennium Pharmaceuticals, Inc., a Takeda Company.

Millennium is a leading biopharma company. In the US, markets Velcade (bortezomib) for injection - a novel, market-leading oncology product approved in more than 85 countries. Millennium has an innovation-driven discovery and development organisation, which is advancing a pipeline of novel product candidates in oncology and inflammation. This includes a potential therapy for inflammatory bowel disease (IBD), which is expected to enter phase III clinical trials in late 2008/early 2009. Millennium reported total revenues of approximately $528 million for 2007.

The acquisition of Millennium accelerates Takeda's vision of becoming a global leader in oncology with critical mass in the areas of oncology discovery, development, regulatory affairs and commercialisation. Millennium and Takeda have complementary research, development and commercialisation capabilities, which have the potential to create a powerful new drug development engine and accelerate the potential of an emerging drug pipeline.

"Millennium greatly strengthens Takeda's global oncology portfolio, led by the flagship product Velcade, and further enhances its pipeline with clinically differentiated, high-quality product candidates," said Yasuchika Hasegawa, president, Takeda Pharmaceutical Company Limited. "Takeda is committed to becoming a global leader in oncology by delivering novel therapies that improve the standards of care for patients. Millennium has strong discovery, development and commercial capabilities led by a well-established management team. We are pleased that Dr. Deborah Dunsire, president and chief executive officer, Millennium, and the current management team intend to continue to lead the company. Our strong desire is to retain Millennium employees, who have created an entrepreneurial and innovative culture."

Takeda said it expects that the acquisition of Millennium would provide access to a fully-integrated oncology discovery, development and commercial platform with a seasoned management team and talented employee base, add Velcade, a growing and market-leading oncology product with near-term worldwide blockbuster potential and supply access to Millennium world-class drug discovery organisation, including expertise in the novel research area of protein homeostasis. Takeda also said that capitalize on Millennium proven drug development capabilities and regulatory expertise, which allowed the company to bring Velcade to market rapidly, leverage the Millennium experienced sales force, established relationships with oncology thought leaders and highly-regarded marketing capabilities to launch future products; and expand Takeda's global pipeline in GI, adding a novel anti-a4ß7 antibody and an oral CCR9 inhibitor for the treatment of IBD.

Takeda will finance the acquisition through cash on hand. There is no financing condition to the tender offer or second step merger, the company informed in a press statement.

The acquisition is structured as an all cash tender offer for all of the outstanding shares of Millennium common stock, followed by a merger in which remaining shares of Millennium would be converted into the right to receive the same US$25.00 cash per share price paid in the tender offer.

The transaction has been unanimously approved by the Boards of Directors of Millennium and Takeda. The transaction is subject to the tender of a majority of Millennium common stock on a fully diluted basis as well as other customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the antitrust laws of applicable foreign jurisdictions. The transaction is expected to close in the second-quarter of 2008.

Amrubicinis Designated as an Orphan Medicinal Product by the European Commission for the Treatment of Small Cell Lung Cancer

April 11, 2008--Celgene International Sarl today announced that amrubicin hydrochloride has been designated as an orphan medicinal product by the European Commission (EC) for the treatment of small cell lung cancer following the favorable opinion of the European Medicines Agency's (EMEA) Committee for Orphan Medicinal Products.

Criteria for designation of orphan medicinal product require that the product be intended for the treatment of life-threatening or serious conditions that are rare and affect not more than 5 in 10,000 persons in the EU. In the European Union, small cell lung cancer affects more than 57,000 people and approximately 34,000 new cases of the disease will be diagnosed this year.

Orphan medicinal product designation is granted by the EC to provide special incentives for sponsors planning to test a product for use in a rare disease or condition. These incentives include eligibility for protocol assistance and possible exemptions or reductions of certain regulatory fees during development or at the time of application for marketing approval. Orphan designation will provide amrubicin with 10 years of marketing exclusivity following marketing approval for the treatment of small cell lung cancer.

"The decision by the European Commission to designate amrubicin hydrochloride an orphan medicinal product continues our efforts to deliver innovative therapies worldwide to patients in areas of great unmet medical need such as solid tumor cancers," said Graham Burton M.D., SVP, Global Regulatory Affairs and Pharmacovigilance for Celgene Corporation.

In March 2008, the Company also announced that the U.S. Food and Drug Administration has granted orphan drug designation for amrubicin in the treatment of small cell lung cancer.

FDA issues a Communication About an Ongoing Safety Review of CellCept and Myfortic

April 10, 2008--FDA is investigating a potential association between the use of CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid), medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease.

PML is a rare disorder that affects the central nervous system. When it occurs, it is usually in patients with immune systems suppressed by disease or medicines. It happens when the polyomavirus, also known as the JC virus, is activated. The JC virus is found in most adults but does not usually cause symptoms. Scientists do not know exactly how the JC virus is activated. Once activated, the JC virus attacks the cells that make myelin, the protective coating around nerve cells. Signs and symptoms of PML can include localized neurologic signs and symptoms including vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs. Many patients who develop PML die. Patients who survive may have permanent disability due to irreversible nerve damage.

Advanced Life Sciences Announces Plan to Submit NDA for Cethromycin

Advanced Life Sciences Holdings, Inc. , today announced that, based on a productive meeting with the U.S. Food and Drug Administration (FDA), the Company plans to submit a New Drug Application (NDA) in the third quarter of 2008 for its novel once-a-day oral antibiotic, cethromycin, to treat mild-to-moderate community acquired pneumonia (CAP).

"We are pleased with the outcome of the meeting because it allows us to remain on track with our NDA submission goal," said Dr. Michael T. Flavin, chief executive officer of Advanced Life Sciences. "In addition, we believe that achieving this milestone will enable our partnership discussions to continue toward a conclusion in a timely manner."

During the meeting, FDA officials agreed that the Company could submit the NDA for cethromycin to treat mild-to-moderate CAP based on the pivotal Phase 3 trial results previously reported. The FDA will review any submission the Company makes to determine whether it meets the requirements for filing. There can be no assurance that the FDA will file the NDA, or that once filed, it will be approved.

CV Therapeutics and Astellas Announce FDA Approval for Lexiscan (regadenoson) Injection

April 10, 2008 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. and Astellas Pharma US, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Lexiscan(TM) (regadenoson) injection, an A2A adenosine receptor agonist, for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging (MPI) -- a test that detects and characterizes coronary artery disease -- in patients unable to undergo adequate exercise stress.

Lexiscan is the first A2A adenosine receptor agonist shown to be safe and effective as a pharmacologic stress agent in MPI studies. Lexiscan is delivered as a rapid bolus (approximately 10 seconds) with no dose adjustment required for body weight. The A2A adenosine receptor is the adenosine receptor subtype responsible for coronary vasodilation.

MPI tests, commonly called cardiac stress tests, identify areas of poor blood flow in the heart to help detect and characterize coronary artery disease, the most common type of heart disease. Many patients exercise on a treadmill to generate the increase in coronary blood flow necessary to perform an MPI study. However, almost half of the patients undergoing the 7.5 to 9.3 million cardiac stress tests each year are unable to exercise adequately because of medical conditions. For these patients, a pharmacologic stress agent that temporarily increases blood flow through the coronary arteries is used to mimic the increase in coronary blood flow caused by exercise.

"Lexiscan represents the second novel chemical entity in cardiovascular medicine that CV Therapeutics has received approval for in just over two years," stated Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics. "We are very excited to have Astellas -- the clear market leader in pharmacologic stress for MPI -- commercializing Lexiscan."

"We are extremely pleased that the FDA has approved Lexiscan, an exciting new option for diagnosing coronary artery disease in patients who cannot undergo an exercise stress test," said Yoshihiko Hatanaka, president and chief executive officer of Astellas Pharma US, Inc. "We are preparing to launch Lexiscan soon after this approval in order to provide clinicians with this important new option for patients who need pharmacologic stress agents for MPI studies."

Breckenridge Pharmaceutical Signs Letter of Intent for Long Term Agreement With Orit Laboratories

Breckenridge announced today that it has entered into an agreement with Orit Laboratories to market 2 separate generic ANDA products. The first project is currently filed and pending FDA approval. The companies plan to file an ANDA with the FDA for the second product in the 3rd Quarter of 2008. Upon approval by the FDA, both products will be supplied by Orit Laboratories, and will be marketed and distributed by Breckenridge Pharmaceutical, Inc., on an exclusive basis in the USA.

Teva Receives Court Ruling Awarding Exclusivity for Generic Risperdal

Apr 11, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. District Court for the District of Columbia has granted a request of the Company's subsidiary, Teva Pharmaceuticals USA, Inc. that the U.S. Food and Drug Administration (FDA) relist in the Orange Book U.S. Patent No. 5,158,952 and grant Teva 180-day exclusivity for a generic version of Janssen Pharmaceutical's Risperdal(R) (Risperidone) Tablets. Teva expects final approval with exclusivity on June 29, 2008. The brand product had annual sales of approximately $2.5 billion in the United States for the twelve months that ended December 31, 2007, based on IMS sales data.

The decision may be appealed.

Whole story can be read here

Glenmark's monoclonal antibody GBR 500 completes preclinical study

Glenmark Pharmaceuticals SA (Switzerland) a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd has announced that its monoclonal antibody GBR 500 has completed crucial IND-enabling preclinical studies. Glenmark intends to file an IND application with the US FDA by August 2008 for initiation of phase I trials.

The company expects to complete phase I in this fiscal year immediately followed by a Proof of Concept phase IIa study. Glenmark has already manufactured sufficient antibody for conducting phase I and phase IIa clinical studies.

Glenmark intends to develop GBR 500 for indications such as MS (Multiple Sclerosis), COPD (Chronic Obstructive Pulmonary Disease) and IBD (Inflammatory Bowel Disease).

Glenmark would be among the first companies to target VLA-2. GBR 500, a monoclonal antibody, is an antagonist of the VLA-2 (a2ß1) integrin. VLA-2 mediates interactions of cells with the extracellular matrix. Integrin-mediated cell migration is required for the recruitment of immune cells to sites of inflammation, and Glenmark intends to develop GBR 500 as a modulator of inflammation.

The broad mechanism of GBR 500, a VLA-2 integrin antagonist is validated by marketed drugs. ReoPro (Centocor/Lilly), Raptiva (Genentech/Xoma) and Tysabri (Biogen/Elan) are marketed monoclonal antibodies which target integrins.

Speaking on this development, Glenn Saldanha, MD and CEO, Glenmark Pharmaceuticals Ltd., said, "We are happy to take our biologics programme forward with GBR 500 moving into phase I trials. This is Glenmark's first NBE to enter the clinics from our pipeline of 11 NCEs and NBEs, and demonstrates our steady progress in the drug discovery space.

Targanta Announces FDA Acceptance of Oritavancin New Drug Application

Apr 9, 2008 - Targanta Therapeutics Corporation (Nasdaq: TARG) today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review its New Drug Application (NDA) for its lead antibiotic candidate, oritavancin. The Company also announced it will hold a conference call and webcast today at 4:30 pm ET to discuss recent corporate achievements.

By granting standard review status to oritavancin, the FDA has established a target date to act on the NDA filing by December 8, 2008. The oritavancin NDA was submitted in early February seeking approval of the intravenous antibiotic for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram-positive organisms, including methicillin-resistant Staphylococcus aureus, or MRSA. These types of resistant infections have created a market that IMS Health estimated to be over one billion dollars in the U.S. in 2007 and growing rapidly.

"With an expected FDA response date in December, we have begun the exciting task of building a commercial infrastructure to position the company to begin marketing oritavancin in the U.S. in the first half of 2009," said Mark Leuchtenberger, President and CEO of Targanta. "In the meantime, we will continue to work closely with the FDA to facilitate its review of our NDA while preparing for an advisory committee meeting in the fall of 2008. In addition, we are on track to submit a Marketing Authorization Application for European Union approval of oritavancin by mid-2008 for the treatment of complicated skin and soft tissue infections, the European name for cSSSI, and, given our preliminary discussions with EU regulatory authorities and standard review times, we hope to receive approval of oritavancin in the EU in late 2009."

Mona Haynes, Targanta's Chief Commercial Officer commented on the news as well: "We are very excited about the possibility of bringing a new choice to physicians treating patients with serious gram-positive skin and skin structure infections. We believe that the unique combination of characteristics of oritavancin could make it an attractive option for clinicians in both the hospital and outpatient settings, should it gain approval."

Endo provides updates on withdrawal of sNDA for Frova

Endo Pharmaceuticals Inc, a market leader in pain management and a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc, has notified the US Food and Drug Administration (FDA) of the withdrawal of the supplemental new drug application (sNDA) without prejudice to refiling as afforded under 21 CFR 314.65 for Frova (frovatriptan succinate) 2.5 mg tablets.

This sNDA was for the additional indication of Frova for the short-term (six days per month) prevention of menstrual migraine. Endo is continuing to evaluate development opportunities for Frova for this indication and other, related indications. Frova is already approved and marketed for the acute treatment of migraine with or without aura in adults where a clear diagnosis of migraine has been established.

"The decision to withdraw the unapproved supplemental application was complex; however, after a lengthy and detailed evaluation of the points raised in the FDA 'not approvable' letter, we have determined the withdrawal to be the appropriate course of action at this time," said Dave Holveck, president and chief executive officer, Endo. "We appreciate the guidance from the FDA during the development programme and its comprehensive review of the supplemental application."

In other matters, Endo announced that it intends to return the rights to Chronogesic, which it had licensed from Durect Corporation for the US and Canada. Chronogesic is a sufentanil-containing implantable device intended for the treatment of moderate-to-severe chronic pain. Under the current terms of this license agreement, Endo is not responsible for any development costs for Chronogesic prior to May 1, 2008 so long as written notification of termination of the agreement is provided to Durect by April 30, 2008. This return of Chronogesic rights has no effect on Durect and Endo's collaboration with respect to the sufentanil transdermal patch (Transdur-Sufentanil) licensed by Endo from Durect for the US and Canada.

Endo reiterated earlier announcements that it has withdrawn any guidance as to the potential NDA filing dates of its phase III development projects, the ketoprofen patch and Rapinyl. The company will not provide guidance on these or its other pipeline projects until the previously announced in-depth review of its R&D pipeline is complete.

Frova is indicated for the acute treatment of migraine attacks with or without aura in adults. It is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. The safety and effectiveness of Frova have not been established for cluster headache, which is present in an older, predominantly male population.

The most common side effects associated with the use of Frova are dizziness, fatigue, paresthesia, flushing, headache, dry mouth, hot or cold sensation, skeletal pain, chest pain, and dyspepsia.

Advanced Life Sciences Announces Plan to Submit NDA for Cethromycin

Advanced Life Sciences Holdings, Inc. , today announced that, based on a productive meeting with the U.S. Food and Drug Administration (FDA), the Company plans to submit a New Drug Application (NDA) in the third quarter of 2008 for its novel once-a-day oral antibiotic, cethromycin, to treat mild-to-moderate community acquired pneumonia (CAP).

"We are pleased with the outcome of the meeting because it allows us to remain on track with our NDA submission goal," said Dr. Michael T. Flavin, chief executive officer of Advanced Life Sciences. "In addition, we believe that achieving this milestone will enable our partnership discussions to continue toward a conclusion in a timely manner."

During the meeting, FDA officials agreed that the Company could submit the NDA for cethromycin to treat mild-to-moderate CAP based on the pivotal Phase 3 trial results previously reported. The FDA will review any submission the Company makes to determine whether it meets the requirements for filing. There can be no assurance that the FDA will file the NDA, or that once filed, it will be approved.

FDA MedWatch-Neupro (rotigotine transdermal system)- Product Recalled Due To The Formation Of Rotigotine Crystals In The Patches

April 10 2008-Schwarz Pharma informed healthcare professionals and patients of the recall of Neupro, a transdermal delivery system worn on the skin and used to treat early stage Parkinson's disease. The product is being recalled because of the formation of rotigotine crystals in the patches. When the drug crystallizes, less drug is available to be absorbed through the skin and the efficacy of the product may vary. Healthcare professionals should not initiate any new patients on Neupro and should begin to down-titrate all patients currently using the product per the guidelines in the product labeling. Patients should NOT abruptly discontinue therapy. Abrupt withdrawal of dopamine agonists has been associated with a syndrome resembling neuroleptic malignant syndrome or akinetic crises.

Read the complete 2008 MedWatch Safety Summary, including a link to the FDA's Drug Shortage Information Sheet regarding this issue at:

www.fda.gov/medwatch/safety/2008/safety08.htm#neupro

Hi-Tech Pharmacal Receives Tentative Approval for Dorzolamide Hydrochloride with Timolol Maleate Ophthalmic Solution

Apr 10, 2008 - Hi-Tech Pharmacal Co., Inc. announced today that the US Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for dorzolamide hydrochloride with timolol maleate ophthalmic solution. Hi-Tech's dorzolamide hydrochloride with timolol maleate ophthalmic solution is the generic equivalent of Merck's Cosopt(R) and is indicated for the treatment of glaucoma. According to IMS, Merck's Cosopt(R) had sales of $334 million in 2007. The Company believes that it has 180 days of marketing exclusivity for generic dorzolamide hydrochloride with timolol maleate ophthalmic solution, and will begin marketing the product upon the completion of Merck's pediatric exclusivity period in October 2008. The Company has a partner for the product who will share in the profits.

Abraxis BioScience Announces Approval to Market Abraxane for Metastatic Breast Cancer in Korea

Apr 9, 2008 - Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, today announced that the Korean FDA (KFDA) has granted marketing approval for ABRAXANE(R) (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease. The Phase III clinical trial results on which this approval was based demonstrated that ABRAXANE doubled the response rate and significantly prolonged progression-free survival and overall survival versus Taxol(R) in the approved indication. ABRAXANE is now approved for marketing in 34 countries.

As previously announced, Abraxis granted an exclusive license to Green Cross Corporation for the commercialization of ABRAXANE in Korea. Green Cross made an upfront payment and will pay a royalty on net sales of ABRAXANE in Korea as well as milestone payments. In a separate agreement, Green Cross has granted an exclusive license to Abraxis for the future commercialization of the following biosimilars in the U.S. and Canada: erythropoetin, pegylated G-CSF (granulocyte-colony stimulating factor), Interferon-Alpha, recombinant Factor VIII, and etanercept. Interferon Alpha has been launched in Korea by Green Cross. Green Cross filed for regulatory approval with the KFDA for recombinant Factor VIII in the second quarter of 2008 and Green Cross has completed Phase III studies for erythropoetin. Pegylated GCSF and etanercept are in early stages of development. Once approval has been received, Abraxis will pay Green Cross a milestone on each product in addition to royalties on net sales.

Green Cross currently expects to launch ABRAXANE in Korea in the first quarter of 2009 following pricing approval. Green Cross plans to establish a dedicated sales force for ABRAXANE and implement various marketing campaigns to support a successful launch. Abraxis has two additional global partnerships for the commercialization of ABRAXANE with Taiho Pharmaceuticals in Japan and Biocon Limited in India.

"The approval for ABRAXANE in Korea provides an effective new treatment option to physicians and patients in Korea in the fight against metastatic breast cancer. We look forward to expanding the global market presence of ABRAXANE," said Patrick Soon-Shiong, M.D., chairman and chief executive officer of Abraxis BioScience.

"This approval represents an exciting new direction for Green Cross's oncology business and we are very pleased to bring this unique and efficacious drug to cancer patients in Korea," said B.G. Rhee, Ph.D., executive vice president of Green Cross.

In Korea, there are approximately 20,000 cases of metastatic breast cancer. The Korean oncology market for 2007 is estimated at US$533 million of which the chemotherapy market and its taxanes component are estimated at US$400 million and US$77 million, respectively, per IMS.

In addition to the approval in Korea, ABRAXANE is approved for marketing in the U.S. and is currently co-promoted in collaboration with AstraZeneca Pharmaceuticals LP. ABRAXANE is the fastest growing taxane in the U.S.

ABRAXANE was approved in Canada in 2006 for the treatment of metastatic breast cancer including first-line disease. ABRAXANE was approved in India in November 2007 for the second-line treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Most recently, ABRAXANE was approved in the European Union in January 2008 for the treatment of metastatic breast cancer. ABRAXANE is currently under active review in Australia, Russia and China by their respective regulatory agencies.

Novagali Pharma announces the launch of Cationorm

April 9th, 2008 - Novagali Pharma, an ophthalmic specialty pharmaceutical company announces the commercial launch in France of its first product Cationorm®. This cationic emulsion is an innovative approach to treat dry eye symptoms. It has been developed on the basis of Novagali Pharma patented technology platform Novasorb®.

Dry eye syndrome is the second cause of consultation in ophthalmology. It concerns over 100 million people in the world and 14 % of the adults of more than 40 years. Due to a chronic lack of lubrication and moisture in the eye, its consequences range from irritation to ocular inflammation of the conjunctiva and corneal tissues of the eyes. People with dry eye have sandy-gritty irritation or burning in their eyes. In most severe cases, corneal lesions may lead to vision loss. Specific factors such as ageing populations, pollution, air conditioning, extended use of computers, contribute to an increase in the prevalence of the syndrome and in opportunities for the development of more efficient products.

Cationorm® brings a true innovation to the patients suffering from dry eye symptoms. The cationic emulsion reproduces the tear mechanisms of action to act on the different levels of the tear film. Cationorm® uniquely combines lubricating and hydrating properties, optimal spreading on the surface of the eye, replenishment of the tear film lipid layer and prevention of tear evaporation. The results of clinical study have clearly demonstrated Cationorm® advantages for patients: tolerance, long-lasting relief and optimal comfort.

These advantages are based on Novasorb®, the proprietary cationic emulsion technology platform of Novagali Pharma. Novasorb®, is designed to improve topical administration of ophthalmic medicines. It is based on the electrostatic attraction that occurs between the droplets of a positively-charged emulsion and the negatively charged cells of the ocular surface, including cornea and conjunctiva.

The commercial launch of Cationorm® in Europe and in the United States by the end 2008, where the product complies with the OTC status, is a major event for the development of Novagali Pharma. «Cationorm® commercial launch is very special to us being our first marketed product coming out of our pipeline. It is the result of many years of work for the entire Novagali team and we are very proud of the innovation Cationorm® brings for the treatment of dry eye symptoms », said Jérôme Martinez, CEO of Novagali Pharma.

Cationorm® is a medical device available in France since April 2008. The product is unpreserved and packaged in box of 30 sterile single vials.

Salix Receives Purported Notice of Paragraph IV Certification Against Patent for Moviprep

Apr 9, 2008 - Salix Pharmaceuticals, Ltd. today announced that the Company and its licensor, Norgine B.V., have received a purported notice of Paragraph IV Certification on behalf of Novel Laboratories, Inc. advising of the submission of an Abbreviated New Drug Application (ANDA) for MOVIPREP(R) (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution). Novel is a privately-held company that has been affiliated with Elite Pharmaceuticals, Inc.

Novel's letter alleges that U.S. Patent No. 7,169,381, owned by Norgine Europe B.V. and listed in the Orange Book for MOVIPREP, is invalid, unenforceable and/or will not be infringed by Novel's manufacture, use or sale of the product for which the ANDA is submitted. The expiration date for U.S. Patent No. 7,169,381 is September 1, 2024.

Salix has 45 days to commence a patent infringement lawsuit against Novel that would automatically stay, or bar, the U.S. Food and Drug Administration (FDA) from approving Novel's ANDA for up to 30 months or until a district court decision that is adverse to Salix, whichever may occur earlier.

Salix and Norgine have full confidence in the intellectual property rights that protect MOVIPREP. Moreover, Salix and Norgine intend to use all reasonable means at their disposal to vigorously defend MOVIPREP from any and all generic intrusion.

Ranbaxy gets nod for generic version of Amlodipine tabs in Japan

Ranbaxy Laboratories Ltd has received authorization from Ministry of Health and Labour Welfare (MHLW-Japan) for marketing the generic version of Amlodipine tablets 2.5mg & 5mg.

Amlodipine tablet is the first independent product approval received by Ranbaxy in Japan. It has the unique distinction of being the first product developed by any foreign generic pharmaceutical company outside Japan and subsequently being granted approval by MHLW (Japan).

Amlodipine tablets has a market size of around US $2 billion (Jan-Dec' 2007 - IMS - Japan). The product is currently the largest molecule which has gone off patent in Japan and represents the biggest generic opportunity so far in the Japanese generic market. The Government of Japan is encouraging generic substitution which is reflected in the growing genericization of medicines from 17 per cent by volume in 2007 to 30 per cent by volume in 2012.

Commenting on the approval, Malvinder Mohan Singh, CEO and managing director, said, "This is a significant milestone in our Japan initiative as it marks the acceptance of our high quality, affordable generic medicines in one of the most discerning markets. It also reflects strongly on our long term commitment to Japan".

Since 2004 Ranbaxy has filed 7 products in Japan and so far has 100 per cent success rate in getting approvals. Today Ranbaxy has a total of 4 products being marketed in the Japanese generics market and has a strong portfolio in the pipeline which will be introduced during 2008 and 2009.

Ranbaxy entered the Japanese market in the year 2002 through a strategic alliance with a mid sized research pharmaceutical company, Nippon Chemiphar Limited (NC) of Japan. At present its generic subsidiary Nihon Pharmaceutical Industry Limited (NPI) is a 50:50 joint venture between Ranbaxy and Nippon Chemiphar.

GlaxoSmithKline Confirms Receipt of FDA Letter on Regulatory Reporting

GlaxoSmithKline today confirmed it has received a warning letter from the US Food and Drug Administration (FDA) related to reporting requirements for approved medicines. The letter follows a routine FDA inspection of GSK's reporting processes conducted last year.

The observations from the inspection primarily relate to omissions from periodic reports to the FDA regarding Avandia(R) (rosiglitazone maleate), such as the start and progress of clinical trials, and summaries of final data from some clinical trials.

The FDA inspection also reviewed GSK's processes for reporting individual adverse events, which resulted in no inspection citations. The inspection found nothing to suggest that procedures for prompt reporting of adverse events was compromised.

"We take these findings seriously, and corrective steps to make sure we file periodic reports completely and promptly have been taken or are underway," said Dr. Ronald Krall, Chief Medical Officer at GlaxoSmithKline. "These omissions did not interfere with the timely reporting of adverse event information to the FDA."

GSK is committed to taking the appropriate steps to address the concerns raised by the FDA.

After the inspection, GSK initiated a review of applicable processes and reporting systems. The company has made and will continue progress in updating its procedures and improving compliance in this area of reporting, including additional training for employees to ensure that all procedures are followed across all product lines.

The FDA letter acknowledges that information not captured in the periodic reports was, in many cases, submitted to the Agency in other reports and communications. Beyond that, information about the start of clinical trials omitted from some reports was available through posting on clinicaltrials.gov. GSK submitted a corrected 2007 Avandia annual report to the FDA in September 2007, ahead of the FDA's updated final decision on approved labeling for Avandia in November 2007. Clinical trial results are also posted publicly to GSK's clinical trial register.

Kamada was Granted New Orphan Drug Designation by the FDA, for its Aerosolized AAT for the Treatment of Bronchiectasis

Apr 8, 2008 - Kamada (TASE: KMDA), a biopharmaceutical company which develops, manufactures and markets specialty life-saving therapeutics, announces today that the company was granted an Orphan Drug Designation to its Aerosolized Alpha-1 Antitrypsin (AAT) product to treat Bronchiectasis.

Kamada's aerosolized AAT product for treating Bronchiectasis, a lung disease that results in the distortion of one or more of the conducting bronchi or airways, is currently undergoing Phase II clinical trials.

According to David Tsur, CEO Kamada, "This significant recognition grants Kamada various benefits such as research fund support, tax incentives, reduced user fees and seven years of exclusive distribution rights, if the company's product is first on the US market for this indication."

According to Pnina strauss, Kamada's Clinical Trials and IP Director, "We believe that, pending the successful completion of the trials and registration process, the product will potentially both improve the quality of life and extend the life expectancy of Bronchiectasis patients. There is significant potential for the aerosolized version of AAT, which is an innovative form of treatment that addresses chronic inflammatory processes and prevents further degeneration of lung tissue and function."

According to Dr. Charles L. Daley, Chair of the Steering Committee for the COPD foundation's newly formed Bronchiectasis Registry and research consortium, "We see great potential in Kamada's aerosolized AAT product for treating the Bronchiectasis patient population, estimated at 100,000 in the US alone."

Collegium Pharmaceutical Announces FDA Filing for AllerNase, a Nasal Inhaled Steroid for the Treatment of Allergic Rhinitis

April 8, 2008 - Collegium Pharmaceutical, Inc., a specialty pharmaceutical company with a focus on respiratory and CNS disorders, today announced that it filed a Supplemental New Drug Application (sNDA) with the U.S. Federal Drug Administration (FDA) for the approval of AllerNase(TM) (triamcinolone acetonide, USP) Nasal Spray, 50 mcg, an aqueous based intranasal steroid indicated for the once daily treatment of nasal symptoms associated with both seasonal and perennial allergic rhinitis in adults and children twelve years of age and older.

Oncophage Approved in Russia for the Treatment of Intermediate-Risk Kidney Cancer

Apr 8, 2008 - Antigenics Inc. today announced that the Russian Ministry of Public Health has issued a registration certificate for the use of Oncophage(R) (vitespen) in the treatment of kidney cancer patients at intermediate risk for disease recurrence. The company expects to launch Oncophage in Russia in the second half of 2008.

"The registration of Oncophage in Russia represents an important treatment advancement for patients with intermediate-risk kidney cancer," said Garo H. Armen, PhD, chairman and CEO of Antigenics. "We are very pleased that Oncophage is the first personalized cancer vaccine that will be available in any major country. Additionally we hope to file for the conditional approval of Oncophage in Europe this year."

"The current standard of care for patients with nonmetastatic renal cell carcinoma consists of surgical removal of the kidney followed by observation," commented Professor Vsevolod Matveev of N.N. Blokhin's National Cancer Research Center of RAMS, Moscow. "Following surgery, these patients often request treatment options to help prevent or delay recurrence of their disease. This registration means patients in Russia with earlier-stage disease will now have Oncophage as a treatment option."

To comply with US regulations for exporting biologics, Antigenics applied for an export license from the US Food and Drug Administration (FDA). The company expects the FDA to take action on the license application within approximately 60 days of submission.

USFDA Approves Orencia (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis in 6 yrs & older patients

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has approved ORENCIA(R) (abatacept) for reducing signs and symptoms in pediatric patients six years and older with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA). ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX). ORENCIA should not be administered concomitantly with tumor necrosis factor (TNF) antagonists and is not recommended for use concomitantly with other biologic rheumatoid arthritis (RA) therapy, such as anakinra. This new indication for ORENCIA provides significant evidence of its durable efficacy and long-term safety in pediatric patients, including those initiating biologic therapy for the first time. The safety and efficacy of ORENCIA in JIA were assessed in a three-part study through one year. The approval of ORENCIA in JIA represents the ongoing commitment of Bristol-Myers Squibb in this therapeutic area.

"In a JIA clinical trial, ORENCIA provided meaningful and sustained improvements in this patient population across three major sub-types of JIA through one year," said Edward H. Giannini, M.Sc., Dr.P.H., Professor of Pediatrics, Division of Rheumatology, Cincinnati Children's Hospital Medical Center, OH.

The approval is based on the AWAKEN (Abatacept Withdrawal study to Assess efficacy and safety in Key Endpoints in juvenile idiopathic arthritis Not responding to current treatment) trial, which evaluated the efficacy and safety of ORENCIA(R) (abatacept) in patients six to 17 years of age with moderately to severely active polyarticular JIA who had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs), such as MTX or TNF antagonists.

"Juvenile idiopathic arthritis is the most prevalent form of arthritis in children(3)," said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer and president, Research and Development, Bristol-Myers Squibb. "This new indication for ORENCIA offers another treatment option to help improve signs and symptoms of this serious disease in pediatric and adolescent patients."

In addition to the approval for JIA, Bristol-Myers Squibb has added a post-marketing safety section to the package insert. This section states that the post-marketing adverse event profile that was observed in adult RA patients did not differ from that seen in the clinical trials of adult RA patients. The FDA also has revised the adult indication to remove the requirement that patients must first fail at least one DMARD before initiating therapy with ORENCIA. The new indication statement is: ORENCIA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active RA. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists. ORENCIA should not be administered concomitantly with TNF antagonists and is not recommended for use concomitantly with other biologic RA therapy, such as anakinra. The revised adult indication means that ORENCIA is an appropriate option for patients with moderate-to-severe RA, regardless of prior treatment received.

Patents issued

Diffusion Pharmaceuticals LLC, a clinical-stage drug-development company commercializing drugs utilizing a novel method of action that enhances oxygen diffusion, today announced that it has been granted U.S. patent no. 7,351,844 entitled "Bipolar Trans Carotenoid Salts and Their Uses." This patent includes claims to a family of first-in-class new chemical entities, known as trans biopolar carotenoid (or TBC) molecules. In addition, the Company also announced it has been granted corresponding patents from the South African and the New Zealand Patent Offices.

Apr 8, 2008 - Optimer Pharmaceuticals, Inc. has received a 'Notice of Allowance' on a US patent application from the United States Patent and Trademark Office protecting its lead drug candidate, OPT-80, which is being developed for the treatment of Clostridium difficile infection, or CDI.

April 8, 2008 - Idera Pharmaceuticals, Inc. today announced the issuance of several patents. The claims of these patents cover novel immune modulatory oligonucleotides (IMO) and chemical modifications of IMOs, each of which provide unique immune responses.

Apr 8, 2008 -LinkMed's portfolio company AbSorber has been granted a patent in the U.S. for an AB0 column that the company is developing to facilitate transplantations between individuals of different blood groups. The patent concerns a molecule that is being developed to adsorb antibodies and is a substance patent.

Repligen Announces Settlement with Bristol-Myers Squibb in Orencia Lawsuit

April 08, 2008, Repligen Corporation announced today that it has reached a settlement with Bristol-Myers Squibb Company in its lawsuit alleging infringement of U.S. Patent No. 6,685,941 ("the '941 patent"), based on Bristol-Myers Squibb's sale of Orencia(R) for the treatment of rheumatoid arthritis. The settlement provides for Bristol-Myers Squibb to make an initial payment of $5,000,000 and to pay royalties on the U.S. net sales of Orencia for any clinical indication at a rate of 1.8% for the first $500,000,000 of annual sales, 2.0% for the next $500,000,000 of annual sales and 4% of U.S. annual sales in excess of $1 billion for each year from January 1, 2008 until December 31, 2013. The settlement also provides for the grant by Repligen and co-plaintiff the to Bristol-Myers Squibb of an exclusive worldwide license under certain patent rights of Repligen and the . The settlement serves as the basis for Repligen and co-plaintiff the to dismiss the lawsuit against Bristol-Myers Squibb.

"We are very pleased by the settlement of this case which will provide us a substantial new source of revenue," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "Based on analysts' estimates of U.S. sales of Orencia(R), we expect total cash receipts from our Protein A business, Orencia(R) royalties, research and development and other income of greater than $30 million for fiscal year 2009, beginning April 1, 2008."

In January 2006, Repligen and the filed a complaint in the United States District Court for the Eastern District of Texas against Bristol-Myers Squibb alleging infringement of the '941 patent based on its sale of Orencia(R). The claims of the '941 patent relate to the use of CTLA4-Ig (Orencia(R)) for the treatment of specific auto-immune diseases, including rheumatoid arthritis. The '941 patent is owned by the and the United States Department of the Navy and is exclusively licensed to Repligen.

Depomed Settles Patent Litigation Against IVAX

April 7, 2008 - Depomed, Inc. (NASDAQ:DEPO) announced today that it has reached a settlement with IVAX Corporation and its parent company, Teva Pharmaceuticals, of all claims associated with the patent infringement lawsuit filed by Depomed against IVAX in January 2006, in which Depomed alleged infringement of Depomed's patents (U.S. Patent Nos. 6,340,475 and 6,635,280) by IVAX's extended release metformin hydrochloride tablets.

The parties have entered into a settlement and license agreement that provides for a one-time payment to Depomed of $7.5 million, and a non-exclusive license to the asserted patents in favor of IVAX and Teva to continue to market their generic Glucophage(R) XR (metformin hydrochloride extended release tablets) product in the United States under Depomed's patents. Depomed will also receive ongoing royalty payments from Teva on sales by IVAX and Teva of generic Glucophage XR. The royalty is subject to a $2.5 million aggregate cap.

The agreement also provides for the parties to dismiss their pending patent litigation and for a release of all claims associated with the litigation.

"We are pleased to have reached a settlement of this matter without further distraction and expense of a trial," said Carl A. Pelzel, Depomed's president and chief executive officer.

"We feel that the rulings made in this case have strengthened the intellectual property estate around our AcuForm(TM) technology," added Matthew M. Gosling, Depomed's vice president and general counsel. "We intend to continue to defend and enforce our IP vigorously."

Jubilant Organosys acquires Canada's Draxis for $255 mn

MUMBAI: Jubilant Organosys Ltd and DRAXIS Health Inc. have entered into an agreement whereby a wholly-owned subsidiary of Jubilant will acquire all the outstanding common shares of DRAXIS for $6 per share in cash. The total value of this transaction is $255 million.

The purchase price represents 22.4 per cent premium over Thursday's closing price of DRAXIS's shares on NASDAQ and 41.2 per cent premium over the closing price of DRAXIS's common shares on NASDAQ on March 13, 2008, the last trading day on NASDAQ prior to the request by securities regulators to explain increased trading in DRAXIS's common stock on March 14, 2008.

The transaction was unanimously approved by the board of DRAXIS on April 4.

Commenting on the acquisition, Shyam S Bhartia, Chairman & Managing Director and Hari S Bhartia, Co-Chairman & Managing Director of Jubilant Organosys, said, "DRAXIS represents a unique opportunity in the North American market, offering Jubilant entry into the attractive, regulated, high growth and high margin radiopharmaceutical business. It also enables Jubilant to consolidate its position in the sterile and non-sterile contract manufacturing business. With this acquisition Jubilant will become one of the leading providers of contract manufacturing of small volume parenterals to large pharmaceuticals and biotech companies in North America. DRAXIS has an excellent regulatory track record, with its management and employees having a wealth of experience and expertise in radiopharmaceuticals and contract manufacturing. Jubilant is committed to grow DRAXIS by supporting management and employees through new product launches, entry into new markets and expansion of customer base."

Pharmion Thalidomide Receives Marketing Approval from Australian Therapeutic Goods Administration for Treatment of Newly Diagnosed Multiple Myeloma

April 7, 2008 Celgene International Sarl today announced the Australian Therapeutic Goods Administration (TGA) approved a supplemental filing granting Thalidomide Pharmion marketing approval for use in combination with melphalan and prednisone for patients with untreated multiple myeloma or ineligible for high dose chemotherapy. Additionally, Thalidomide Pharmion was granted marketing approval in combination with dexamethasone for induction therapy prior to high dose chemotherapy with autologous stem cell rescue, for the treatment of patients with untreated multiple myeloma.

This marketing approval represents the first oral cancer therapy ever registered for patients newly diagnosed with multiple myeloma in Australia.

Thalidomide Pharmion was previously approved by the TGA in 2003 as a treatment for patients with multiple myeloma after failure of standard therapies. In January 2008, the TGA granted the Company's leading oral cancer therapy REVLIMID(R) full marketing approval for use in combination with dexamethasone as a treatment for patients with multiple myeloma whose disease has progressed after one therapy.

"The TGA approval of Thalidomide Pharmion for newly diagnosed myeloma patients offers additional options in this critical disease area. When coupled with the approval of REVLIMID and dexamethasone earlier this year, we are advancing our goal of delivering vital therapies to patients in need worldwide," said Aart Brouwer, President of Celgene International. "Additionally, these approvals confirm our leadership role in blood cancer research and innovative oral therapies."

New Abbott Kaletra (lopinavir/ritonavir) Lower-Strength Tablet for Pediatric Use Approved in Europe

April 7, 2008 — Abbott announced today that it has received marketing authorization from the European Commission for the new, lower-strength tablet formulation of the company's leading HIV protease inhibitor, Kaletra® (lopinavir/ritonavir). The Kaletra tablet can be taken with or without food and does not require refrigeration. Lopinavir/ritonavir is marketed as Aluvia® in developing countries.

European approval is a critical step in Abbott's efforts to expedite registration filings for the lower-strength tablet formulation in countries around the world, including in developing countries where more than 2 million of the estimated 2.3 million children worldwide with HIV/AIDS live. In Europe, there are approximately 4,000 children living with HIV.

Currently, the lower-strength tablet is available or approved in 53 countries in Europe, Africa, Asia, Latin America and in North America, and is filed in an additional 11 countries. European Commission approval is significant for many developing countries because they require documentation of the marketing authorization to obtain a Certificate of Pharmaceutical Product (CPP) – often a prerequisite for regulatory filing in developing countries. In order to expedite review in developing countries, Abbott is working with regulatory agencies on a country-by-country basis to negotiate submissions before the CPP is available. Abbott intends to make the lower-strength tablet available or approved in 155 countries around the world, just as it has done with the adult tablet.

"The lower-strength Kaletra formulation is the first and only co-formulated protease inhibitor tablet that can be used in children of appropriate age, weight or body surface area, representing a significant breakthrough for clinicians treating children with HIV in both developed and developing countries," said Carlo Giaquinto, M.D., Department of Pediatrics, University of Padua, Italy, chair of PENTA (Pediatric European Network for Treatment of AIDS).

Antares Pharma Announces Issuance of Key Patent Covering ATD Technology

Apr 7, 2008 - Antares Pharma, Inc. (Amex:AIS) announced that a second patent extension covering its proprietary Advanced Transdermal Delivery (ATD(TM)) Gel System has been issued by the United States Patent and Trademark Office. The patent was issued on February 26, 2008 and is in effect until August 2021. Antares is the sole owner of the newly issued patent.

"The issuance of this patent is an important achievement in the strengthening of Antares Pharma's Intellectual Property portfolio," said Dario N. R. Carrara, Senior Vice President and Managing Director of the Pharmaceutical Group. "Initially developed for the transdermal delivery of hormones, ATD Technology exhibited the potential for the administration of many other active agents. A first patent extension had been granted in May 2007. This second extension demonstrates the potential flexibility of our ATD system technology to accommodate difficult to deliver drugs for the treatment of conditions such as pain, migraines, nauseas and neuro-degenerative disorders."

The ATD Gel System is responsible for the enhanced bioavailability of ANTUROL(R) (oxybutynin), Elestrin(TM) (estradiol), LibiGel(R) (testosterone), the Nestorone(R) and estradiol ATD contraceptive (currently being developed with the Population Council) and JZP-7 the ropinirole formulation (partnered with Jazz Pharmaceuticals).

ANTUROL for the treatment of overactive bladder (OAB) is presently in pivotal trials. Elestrin is our FDA approved treatment for symptoms associated with menopause and LibiGel recently entered into Phase III clinical development for the treatment of female sexual dysfunction (FSD). The contraceptive Nestorone completed Phase I at the end of 2007 and Phase II is slated to begin mid-year 2008. And a Phase III trial is currently planned for 4Q 2008 for JZP-7.

Jack E. Stover, President & Chief Executive Officer of Antares Pharma stated, "We are pleased with the issuance of this important patent to help protect additional drug products based on our ATD gel system. We believe this patent will strengthen our own commercial value proposition as well as further support the commercialization of licensed ATD Gel products."

Giaconda Receives European Patent for Myoconda

April 7, 2008-Giaconda Limited today announced that the European Patent Office (EPO) has granted its patent for its lead product, Myoconda, a combination therapy for patients with Crohn's Disease who are infected with MAP (Mycobacterium avium paratuberculosis).

The formal Decision to Grant from the EPO affords protection until April 2018 in all European member states and extension states, with patent number EP 98912149.6. The application was filed as part of a broader, international application under the Patent Cooperation Treaty (1970).


"The European Union is a key territory for MyocondaR," said Patrick McLean, Giaconda's Chief Executive Officer. "The protection of MyocondaR's intellectual property until 2018 in Europe provides an excellent window of opportunity for earnings. From the company's perspective, this milestone is another step in expanding our patent coverage and adding value to the IP portfolio."

VIVUS Enters into $30 Million Funding Collaboration for the Phase 3 Studies of Avanafil for Erectile Dysfunction

Apr 4, 2008 - VIVUS, Inc. announced today that it has entered into a $30 million funding collaboration with Deerfield Management. Under the terms of the agreements, Deerfield will provide funds for the phase 3 program for avanafil, a fast-acting, highly selective, phosphodiesterase type 5 inhibitor (PDE5i) for the treatment of erectile dysfunction (ED). The $30 million in funding will be provided by Deerfield from two sources: $20 million under a Royalty and Funding Agreement and $10 million from the sale of VIVUS common stock. VIVUS has granted Deerfield a royalty interest on sales of MUSE(R), our product currently marketed for the treatment of ED.

"The collaboration with Deerfield allows us to move avanafil into the phase 3 clinical trials on a timely basis. The funding collaboration provides us with financial flexibility and allows us to leverage the MUSE franchise for the benefit of avanafil development. Deerfield is a well-respected healthcare investment organization. Their interest in avanafil for ED and in becoming a shareholder of VIVUS is significant," commented Leland Wilson, President and Chief Executive Officer. "The market for ED therapies continues to grow. In 2007, sales of all PDE5i's exceeded $3 billion, an increase of 15% over the previous year. Given the profile of avanafil and the results seen to date, we believe that if approved, avanafil could offer patients suffering from ED a satisfying treatment alternative."


"Avanafil has a proven mechanism of action and a unique and attractive profile," said Howard Furst, M.D., a partner at Deerfield Management. "We are pleased to have entered into this collaboration with Vivus that provides full funding for phase 3 while avoiding significant shareholder dilution."

Under the terms of the Royalty and Funding Agreement, Deerfield will provide VIVUS $20 million of funding in the first 18 months of the collaboration. In consideration for the funding, Deerfield will receive a royalty on product sales of MUSE and if approved, product sales of avanafil. VIVUS and Deerfield have also entered into an Option and Put Agreement that allows VIVUS to purchase the royalty stream from Deerfield and allows Deerfield, under certain conditions, to require VIVUS to purchase the royalty stream from Deerfield. VIVUS, entirely at its discretion, can buy back the royalty stream at any time in the first three years of the collaboration for $25 million. In the fourth year, the purchase price increases to $28 million. For this purchase right, VIVUS will make a $2 million upfront payment to Deerfield which will be credited to the purchase price if VIVUS exercises its purchase option. Beginning the fourth year, Deerfield will have the right to sell its interests to VIVUS for a minimum of $17 million. Under certain circumstances, including a change in control, the right to sell the interests back to VIVUS held by Deerfield accelerates at amounts consistent with the VIVUS purchase rights. Once the royalty stream has been acquired by VIVUS, no additional royalty payments will be made to Deerfield.

Forsteo Receives Approval from the European Commission for the Treatment of Glucocorticoid-Induced Osteoporosis

Eli Lilly and Company (NYSE:LLY) today announced that the European Commission has approved a new indication for FORSTEO(R) (teriparatide [rDNA origin] injection) for the treatment of osteoporosis associated with sustained, systemic glucocorticoid therapy in women and men at increased risk for fracture. This approval follows the initial positive opinion issued in February by the Committee for Medicinal Products for Human Use (CHMP) of the EMEA.

Teriparatide stimulates new bone formation by increasing the number and action of bone-building cells called osteoblasts. Teriparatide, originally authorized for marketing in 2003 for the treatment of osteoporosis in postmenopausal women at high risk for fracture, received an expanded indication for the treatment of osteoporosis in men at increased risk for fracture in 2007.

"Chronic glucocorticoid therapy is the most common cause of secondary osteoporosis, often leading to bone loss and an increased risk for fracture," said Gwen Krivi, Ph.D., vice president of Lilly Research Laboratories. "We are pleased with the European Commission's decision to approve teriparatide for this new use."

Glucocorticoid-induced osteoporosis, or GIOP, is bone loss associated with chronic use of glucocorticoid medications. These medications are often prescribed for inflammatory conditions, such as rheumatoid arthritis and obstructive pulmonary disease. Globally, an estimated one to three percent of adults over the age of 50 use glucocorticoids. (1)

"Up to 50 percent of individuals on chronic glucocorticoid therapy will develop bone loss leading to an osteoporotic fracture,"(2) said Dr. Steven Boonen, professor of medicine at the Leuven University Centre for Metabolic Bone Diseases in Belgium. "This new indication for teriparatide provides physicians and patients with a new treatment option that builds bone."

The submission package to support the safety and efficacy profile of teriparatide included new data from the "Teriparatide or Alendronate in Glucocorticoid-Induced Osteoporosis" study, which was published in the November 15, 2007 issue of the New England Journal of Medicine. This head-to- head comparative study showed that in patients with glucocorticoid-induced osteoporosis, teriparatide significantly increased lumbar spine bone mineral density (BMD) from baseline (7.2 percent) compared to alendronate (3.4 percent) at 18 months of therapy.(3)

Takeda Wins Definitive Decision in Patent Infringement Litigation on Appeal against an ANDA Filer for Generic Actos

Takeda Pharmaceutical Company Limited announced today that, on March 31, 2008, the U.S. Supreme Court denied the Petition for a Writ of Certiorari by Alphapharm Pty Ltd.

The Supreme Court decision finally affirms the Appeals Court decision upholding the validity of Takeda’s U.S. Patent No. 4,687,777 (“777”) covering pioglitazone hydrochloride, the active ingredient in ACTOS®. The decision arises from a lawsuit brought by Takeda and TPNA in March 2004 in order to oppose an Abbreviated New Drug Application (ANDA) filed by Alphapharm Pty Ltd.

Based on this final decision, the FDA will not approve and Alpharpharm Pty Ltd. may not launch a generic version of pioglitazone until the “777” patent expires in 2011.

Takeda owns other U.S. patents covering certain methods of treatment using pioglitazone hydrochloride and certain compositions that include pioglitazone hydrochloride.

“We are very pleased that the fair and appropriate ruling regarding this litigation was confirmed by the Supreme Court,” said Mr. Yoichi Okumura, General Manager of Intellectual Property Dept. of Takeda. “We have profound respect for the protection of intellectual property rights because innovation is critical to us as an R&D-oriented pharmaceutical company.”

Pfizer terminates phase III trial of tremelimumab

Pfizer Inc discontinued a phase III clinical trial (A3671009), of single-agent tremelimumab (CP-675,206) in patients with advanced melanoma, after the review of interim data showed that the trial would not demonstrate superiority to standard chemotherapy.

Pfizer said it has communicated with worldwide regulatory authorities and investigators regarding the discontinuation of the trial. Investigators will work with their patients to determine if they are benefiting from treatment and therefore should continue treatment with tremelimumab, the company said.

"Although this outcome is disappointing, Pfizer remains committed to investigating new treatment options for patients with melanoma, a high risk area of research with significant unmet medical need. We continue to focus on additional studies involving tremelimumab alone and in combination with other therapies which are currently ongoing in patients with several types of cancer," said Charles Baum, M.D., Ph.D., vice president and head, Oncology Therapeutic Area, Pfizer Global Research and Development. "We will continue to assess the study data to understand the clinical benefit seen in some patients who received tremelimumab."

The full data set from study A3671009 is being analysed, and more details are expected to be available at the upcoming American Society for Clinical Oncology Annual Meeting in June 2008.

"We have a robust pipeline within Pfizer Oncology and we remain committed to the discovery and development of novel cancer treatments which hold promise for patients with cancer," said Dr. Baum. "We are extremely grateful for the strong support we have received for this clinical trial from the physicians, study staff, and most importantly from the patients."

Pfizer is developing several classes of agents in its Immuno-Oncology pipeline including CD40 agonists, toll-like receptor (TLR) agonists and vaccines.

Lipitor shows unexpectedly potent heart benefit in patients with chronic stable angina

Pfizer's Lipitor (atorvastatin calcium) 80 mg showed unexpectedly potent reduction in myocardial ischemia (a condition defined by insufficient blood supply and oxygen to the heart) in patients with chronic stable angina (chest pain). These results were presented at the annual meeting of the American College of Cardiology.

Lipitor significantly reduced the average number of ischemic events by nearly 70 per cent and total duration of events by more than 60 per cent from baseline to week 18 of the study, and sustained these effects until the end of the trial at week 26. In 60 per cent of the patients treated with Lipitor, all ischemic events were completely eliminated by the end of the study. This resulted in a substantial decrease in angina attacks and need for nitroglycerin treatment.

"Ischemia is a serious condition in which the collective effect of minor untreated events can lead to a weakening of the heart muscle and the death of heart cells," said Professor John Deanfield, British Heart Foundation Vandervell Chair of Congenital Heart Disease, professor of cardiology at University College London and lead investigator of the Double-Blind Atorvastatin Amlodipine (DUAAL) study. "These findings were a pleasant surprise because statins are not part of the current standard of care for the treatment of angina."

The DUAAL study was a randomised, double-blind, multi-country study comparing Lipitor (n=103), Norvasc (amlodipine besylate) (n=104) and a combination of the two (n=104) in patients with coronary artery disease and chronic stable angina. Patients received intensive usual care therapy for their coronary artery disease including beta- blockers, long acting nitrates and aspirin.

Lipitor also caused a significant reduction in C-reactive protein, a marker of inflammation that helps in identifying and stratifying individuals at risk for cardiovascular disease. The anti-ischemic results demonstrated by Lipitor alone were remarkably similar to those in patients taking Norvasc alone. Norvasc, a high blood pressure and anti-angina medication in the calcium channel blocker class, is a part of the standard of care for this patient population, so it was expected to have benefit on the patients studied. Norvasc also significantly reduced the average number of ischemic events by approximately 70 per cent and total duration of events by more than 60 per cent. This was mirrored by a substantial decrease in angina attacks and need for nitroglycerin treatment.

The combination of Lipitor and Norvasc also offered a significant reduction in ischemic events, but there was not an incremental benefit with the combination versus either Lipitor or Norvasc alone. Given the patient characteristics in this study along with the magnitude of ischemic benefits demonstrated by Lipitor and Norvasc individually, no additional benefits were demonstrated in the combination arm. The number of angina attacks and the need for nitroglycerin use was reduced to a similar degree as the ischemic events.

"Previous studies have suggested an anti-ischemic effect with Lipitor, but the magnitude of the benefit seen in this study is notable," said Dr. Rochelle Chaiken, vice president, Pfizer global medical. "This study complements the cardiovascular benefits of Lipitor in a broad range of patients as demonstrated in more than 10 completed cardiovascular outcomes trials involving Lipitor."

Dr Reddy's acquires Jet Generici Sri of Italy

Dr Reddy's Laboratories Ltd has acquired Jet Generici Sri, a company engaged in the sale of generic finished dosages in Italy. The deal has been completed via Dr Reddy's Italian subsidiary, Reddy Pharma Italia SpA, which has been engaged in building a pipeline of registrations since its incorporation. The acquisition provides access to an essential product portfolio, a pipeline of registration applications, and a sales and marketing organisation. Financial terms and conditions of the transaction are not being disclosed.

Commenting on the acquisition, VS Vasudevan, president and head-Europe operations said, "Dr Reddy's has taken a significant step forward by establishing its business in the third largest pharmaceutical market in Europe. The acquisition has been well timed, since Dr Reddy's will be able to immediately supplement the Jet Generici portfolio via its own pipeline. We already have registration for one significant Dr Reddy's product, and a strong pipeline of registration applications. We believe that this strategic investment will generate substantial opportunities for long-term value creation in one of the fastest growing generic markets of the world".

Eisai to Resume Clinical Study to Evaluate E2012 as a Potential Next Generation Alzheimer's Disease Treatment

April 3, 2008-Eisai Co., Ltd. announced that on April 2, 2008 (the U.S. Eastern Time), Eisai Medical Research Inc. (Headquarters: New Jersey, President: Masanori Tsuno), the U.S. clinical research subsidiary of Eisai, received a notification from the U.S. Food and Drug Administration (FDA) that it may proceed with the clinical study for E2012. E2012 is Eisai's potential next generation Alzheimer's disease treatment. The company had suspended the Phase I study for E2012 in the United States in February, 2007 and has been requesting for resuming the study with data required by the FDA. With this response from the FDA, Eisai will start preparations for resuming the study.

The need for a next generation disease modifying treatment that improves the underlying Alzheimer's disease is increasing. E2012, a novel compound discovered by Eisai, is a gamma-secretase modulator that suppresses the production of beta-amyloid, which is believed to be one of the causes of Alzheimer's disease.

As the leader in Alzheimer's disease therapy with its marketed product, Aricept® (donepezil hydrochloride), Eisai is pursuing the development of new therapies for the disease through multi-faceted approaches including investigation of genes responsible for the onset of the disease, immunotherapy and vaccine therapy. Through these efforts, the company is committed to contributing to increasing the benefit to Alzheimer's disease patients and their families.

Zelnorm (tegaserod maleate) Information

April 2, 2008-Novartis, the manufacturer of Zelnorm, has notified the FDA that they will no longer provide Zelnorm (tegaserod maleate) under a treatment investigational new drug application (T-IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55.

Novartis has agreed to continue to supply Zelnorm for use in emergency situations. Requests for Zelnorm for this purpose may be made to the FDA which in turn authorizes shipment of the drug by the manufacturer.

An emergency situation is defined as one that is immediately life-threatening or serious enough to qualify for hospitalization. FDA may deny authorization, even in life-threatening situations, if available evidence fails to provide a reasonable basis for concluding that Zelnorm may be effective for the intended use, or if exposure to Zelnorm would pose an unreasonable or a significant additional risk to patients. The following conditions are cause for denial of authorization:

prior history of heart attack or stroke
unstable angina
hypertension
hyperlipidemia
diabetes
age greater than 55 years
smoking
obesity
depression
anxiety
suicidal ideation

Lentigen Licenses Fundamental Lentiviral Vector Technology Patent From the University of Cambridge

Lentigen Corporation today announced an exclusive licensing agreement with Cambridge Enterprise, the organization responsible for licensing technologies from the University of Cambridge (U.K.), for a fundamental patent in the area of lentiviral vector technology. The technology was developed in the laboratory of Professor Andrew Lever at the University of Cambridge.

"The patent broadly claims fundamental compositions of HIV-based lentiviral vectors that are currently widely used in research and clinical studies," said Boro Dropulic, Ph.D., founder, president and chief scientific officer of Lentigen. He added "we are delighted to be working with Professor Lever in obtaining this patent license, and developing its application in biomedicine."

Following the acquisition of the Cell Genesys' lentiviral patent portfolio late last year by GBP Capital, the majority shareholder in Lentigen, this license further consolidates Lentigen's intellectual property position.

"Licensing this fundamental technology patent from the University of Cambridge extends our strong intellectual property position and is consistent with our goal of becoming a leader in lentiviral-vector based biomedicine. It further enables Lentigen to pursue development and commercialization of biomedical products and services, to the benefit of patients, healthcare providers and the research community," said Tim Ravenscroft, chief executive officer of Lentigen.

"Lentigen are the ideal partner for this piece of fundamental lentiviral vector technology. We are pleased to be working with a team committed to developing the technology for patient benefit," added Dr Andrew Walsh, technology manager for Cambridge Enterprise, University of Cambridge.

Nabi Biopharmaceuticals Announces Settlement of Litigation

Nabi Biopharmaceuticals (Nasdaq:NABI) announced today a settlement of the patent infringement case against Roxane Laboratories that involved Nabi's former product, PhosLo(r) (calcium acetate) GelCaps. The settlement between Fresenius Medical Care Holdings, Inc., Roxane Laboratories, Inc. and Nabi was made to the mutual satisfaction of all parties and was reviewed and accepted by the U.S. District Court of the Southern District of Ohio. The terms of the settlement are confidential and the court dismissed the case with prejudice and without costs.

Nabi filed this lawsuit on September 27, 2005 under the Hatch-Waxman Act in response to a Paragraph IV Certification letter submitted by Roxane to the Company concerning Roxane's filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration to market a generic version of the Company's PhosLo GelCaps. Nabi filed the lawsuit on the basis that Roxane Laboratories' submission of its ANDA and its proposed generic product infringed a patent held by the Company. On November 12, 2006, Nabi completed the sale of PhosLo and related intellectual property to Fresenius USA Manufacturing, Inc. While Fresenius assumed primary responsibility for the intellectual property dispute, Nabi remained subject to a counterclaim by Roxane that alleged violations of antitrust law and, therefore, responsible for defense costs and for any liability arising from the counterclaim. As a result of this settlement, Nabi is not required to pay any sums to the other parties.

Taro Receives Tentative FDA Approval for Lamotrigine Tablets

Apr 3, 2008 - Taro Pharmaceutical Industries Ltd. reported today that it has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Lamotrigine Tablets 25 mg, 100 mg, 150 mg, and 200 mg.

Lamotrigine is a prescription product used for the treatment of seizures and is bioequivalent to GlaxoSmithKline's Lamictal(R) Tablets. According to industry sources, Lamictal(R) Tablets had annual U.S. sales of approximately $2.6 billion.

The tentative ANDA approval for Taro's Lamotrigine Tablets is an FDA determination that Taro's ANDA submission for this product currently satisfies the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities and restrictions (currently expected to occur during January 2009), or any new information that may come to the FDA's attention. Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission.

Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.

Eli Lilly begins phase 3 trial of 'LY450139' for Alzheimer's disease

Eli Lilly and Company has started a phase III clinical trial studying LY450139, an investigational gamma secretase inhibitor for the treatment of mild to moderate Alzheimer's disease. LY450139 is being tested to see if it can slow the progression associated with Alzheimer's disease by inhibiting gamma-secretase, an enzyme that can create a sticky protein called amyloid beta. Current Alzheimer's disease theory is that subtypes of amyloid beta clump together into plaques that eventually kill off brain cells. By blocking gamma secretase, there is less amyloid beta formed, potentially slowing brain-cell death.

Slowing the rate of disease progression could preserve independent functioning and quality of life for Alzheimer's patients in the milder stages of the disease, potentially delaying the onset of the severe stages of the disease. Currently available treatments for Alzheimer's disease have no documented effect on amyloid beta. They provide modest improvements in symptoms but do not slow the underlying disease process.

IDENTITY (Interrupting Alzheimer's Dementia by EvaluatiNg Treatment of AmyloId PaThologY) is a randomised, double-blind, placebo-controlled trial that would be conducted in the US and 21 additional countries. As part of IDENTITY, 1,500 patients will be studied for 21 months, and an open-label extension will be available to all participants completing the study. Patients who are taking currently available symptomatic treatments for Alzheimer's disease can continue treatment during their participation in IDENTITY. Because the IDENTITY study also incorporates a "randomised delayed start" design, even those subjects initially assigned to the placebo arm of the study will be started on active LY450139 treatment sometime before the end of the 21-month study period. Both the subjects and investigators will be blinded to the exact timing of this delayed start of study drug administration.

"Alzheimer's is a devastating disease that destroys brain cells, affecting everything from a patient's memory to their work and social life. Currently available medications treat the symptoms of Alzheimer's disease but have not been shown to change its underlying progression, creating an urgent unmet medical need. Today, we are proud to announce the start of the IDENTITY clinical trial and hold hope that LY450139 will represent an advance in the attempt to slow the progression of this fatal disease. We encourage patients or their caregivers to review the enrollment criteria for IDENTITY to see if they are eligible to participate," said Eric Siemers M.D., medical director, Alzheimer's disease research, Eli Lilly and Company.

Alzheimer's disease is a progressive neurodegenerative condition that is the most common cause of dementia in patients over 65 years of age. Estimates show that 6-8 per cent of people over age 65 are affected by Alzheimer's disease, totalling approximately 5 million people in the United States alone. Every 72 seconds, an American is developing Alzheimer's disease, and it is the seventh-leading cause of death in the United States. The direct and indirect health care costs associated with Alzheimer's disease in the US are estimated to be about $150 billion. In 2005, the total cost worldwide was estimated at $315.4 billion.

To more completely characterise the disease-modifying effects of LY450139, a number of optional biomarker sub-studies will be available to patients. These optional sub-studies will utilize new brain-scanning techniques to determine the amount of amyloid beta plaque in the brain, employ other, more established scanning techniques to examine brain structure and function, and evaluate a number of additional biochemical measures of Alzheimer's disease. By determining the effect of LY450139 on these objective biomarkers, a more complete understanding of the effect of LY450139 on underlying Alzheimer's disease pathology is possible.

LY450139 inhibits gamma secretase, an enzyme that cuts a protein, creating a shorter, sticky protein called amyloid beta. Alzheimer's disease theory suggests that some subtypes of amyloid beta clump together into plaques that eventually kill off brain cells. Clinical studies have examined the effect of LY450139 on amyloid beta in blood and cerebrospinal fluid. The most frequently occurring side effects experienced in earlier clinical studies with LY450139 include diarrhoea, upset stomach, and fatigue.

European Regulatory Agency Accepts Cell Therapeutics, Inc.'s Marketing Authorization Application for Xyotax for Lung Cancer for Review

Cell Therapeutics, Inc. (CTI) today announced that the European Medicines Agency (EMEA) has accepted for review CTI's Marketing Authorization Application (MAA) for XYOTAX(TM) (paclitaxel poliglumex, CT-2103) for first-line treatment of patients with non-small cell lung cancer (NSCLC) with ECOG (Eastern Cooperative Oncology Group) performance status 2 (PS2). CTI submitted the MAA at the beginning of March. The validation of the MAA for XYOTAX initiates the marketing approval review process, which generally takes 15 to 18 months. The application is based on advice from the Scientific Advice Working Party, or SAWP, at the EMEA. The EMEA agreed that switching the primary endpoint from superiority to non-inferiority is feasible if the retrospective justification provided in the marketing application is adequate. The discussions with the SAWP focused on using the STELLAR 4 study as primary evidence of non-inferiority and the STELLAR 3 study as supportive of the MAA.

In the STELLAR 4 trial, single-agent XYOTAX resulted in comparable survival to gemcitabine or vinorelbine in first-line patients and, with the exception of neuropathy known to be associated with taxane therapy, demonstrated significant reduction in several clinically meaningful toxicities, such as severe neutropenia and infection, and in the requirement for transfusions and use of hematopoietic growth factor support. In addition to improved tolerability, XYOTAX offered more convenient administration compared to currently used treatments and a reduction in overall utilization of medical resources compared to gemcitabine or vinorelbine.

"CTI looks forward to working with the EMEA as it begins the review process for XYOTAX," said James A. Bianco, M.D., President and CEO of CTI. "This is an important step toward making XYOTAX available for lung cancer patients in Europe."

US federal court sides with GSK, strikes down USPTO rules

Dear All,

We have been tracking this case from long time and finally the decision is here http://pdfserver.amlaw.com/dc/USPTO.pdf

IP lawyers rejoiced Tuesday as a federal judge rejected new rules for streamlining the patent process that had applicants apoplectic.

Eastern Virginia U.S. District Judge James Cacheris voided the rules because, he wrote, the U.S. Patent and Trademark Office doesn't have the authority to make the changes.

"There's a lot of good cheer going around," said Hans Troesch, a veteran patent prosecutor with Fish & Richardson in Redwood City, Calif. "It's a great relief to the practitioners."

The patent office was seeking to unclog the backlog of patent applications by reducing the number of claims, listed in each one to help define a patent, and the number of continuations, which are used to amend patent claims and contest those that are rejected. Claims would have been limited to 25, and continuations to just three. Currently, there are no limits.
But patent lawyers criticized the new rules for unfairly limiting complex patents and for retroactively affecting pending applications.

The rules were scheduled to go into effect on Nov. 1, 2007, but Triantafyllos Tafas, founder of medical technology company Ikonisys, and drug maker GlaxoSmithKline filed lawsuits last fall against the PTO and its director, Jon Dudas, to block them. Cacheris granted a preliminary injunction on Oct. 31, and GlaxoSmithKline and Tafas filed for summary judgment on Dec. 20.
In granting summary judgment Tuesday, Cacheris wrote that the patent office can't make "substantive" changes to the rules, only "procedural" ones.

"[B]ecause the Final Rules are substantive in nature, the court finds that the Final Rules are void as 'otherwise not in accordance with law' and 'in excess of statutory jurisdiction [and] authority,'" Cacheris wrote, citing 5 U.S.C. §706(2).

The patent office, which had argued that the changes were only procedural, said in a prepared statement that it did not agree with the court and is considering an appeal.

"We are disappointed with this court's decision, which rejects our view that the USPTO has the authority to implement the proposed rules about claims and continuations," the statement reads. "The USPTO believes that these rules are consistent with existing statutes and will strengthen the U.S. patent system for all stakeholders."

US court reverses ruling for Forest in Caraco suit

A federal appeals court reversed on Tuesday a ruling favoring Forest Laboratories Inc. in a patent dispute with generic drugmaker Caraco Pharmaceutical Laboratories over the blockbuster antidepressant drug Lexapro.

The U.S. Court of Appeals for the Federal Circuit reversed and remanded the case back to the U.S. District Court for the Eastern District of Michigan, which had dismissed Caraco's request for a declaratory judgment of noninfringement for US6916941.

The appeals court said there was no record the lower court considered two cases establishing the legal precedents to be taken into account in such a patent dispute.

In September, the same appeals court upheld the validity of a Lexapro patent and affirmed a decision by a federal court in Delaware that blocked generic forms Lexapro made by Teva Pharmaceutical TEVA.O and Cipla Ltd.

Lexapro's first patent is expected to expire in 2012.

Forest had Lexapro sales of about $2.5 billion in the 12-month period ending Sept. 30, according to the research firm IMS Health.

The opinion issued Tuesday can be found at:
http://www.cafc.uscourts.gov/opinions/07-1404.pdf

Labopharm Appeals FDA's Decision on Once-Daily Tramadol to Next Supervisory Level After Additional Analysis Supports Efficacy

Labopharm Inc. today announced that it has appealed the U.S. Food and Drug Administration's (FDA) decision on its once-daily tramadol formulation to the next supervisory level under the FDA's Formal Dispute Resolution process. Labopharm's continuation of the appeal process follows the completion of additional statistical analysis of existing data per the suggestion of Dr. John K. Jenkins, M.D., the FDA's Director for the Office of New Drugs, Center for Drug Evaluation and Research, as a means to potentially satisfy the FDA's requirements for regulatory approval. The Company believes that the additional analysis confirms the conclusions of efficacy of its once-daily tramadol formulation as demonstrated in previous analyses that were included in its New Drug Application (NDA) and additional submissions thereafter.

"We have maintained the position that our strong body of data warrants the approval of our once-daily tramadol formulation and believe that the additional analysis we conducted as proposed by the FDA confirms our position," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "We believe that continuing the Formal Dispute Resolution process, as opposed to submitting a complete response, is the most appropriate path to resolving the outstanding matter and achieving our objective of commercialization in the United States."
As part of the appeal process, Labopharm has requested a meeting with Dr. Janet Woodcock, M.D., the FDA's Director, Center for Drug Evaluation and Research. The Agency usually grants such requests within 30 days and typically provides a written response to the appellant within 30 days of a meeting.

BioDelivery Sciences Receives $2.5 Million and Announces Marketing Partner Meda AB has Filed for European Approval of BEMA Fentanyl

Apr 1, 2008 - BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that Meda AB, its commercialization partner for BEMA(TM) Fentanyl in North America and Europe, has submitted a dossier seeking approval to market BEMA(TM) Fentanyl for the treatment of breakthrough pain in opioid tolerant cancer patients to the German Federal Institute for Drugs and Medical Devices (BfArm). Meda has chosen to utilize the Decentralized Procedure to obtain marketing approval throughout the European Union with Germany serving as the reference member country.

BioDelivery Sciences received a $2.5 million milestone payment for completion of the clinical trial work supporting the dossier and expects to receive an additional milestone payment on approval, followed by revenues from a double digit royalty on net sales.

"This submission clearly reflects the priority Meda has placed on gaining approval for BEMA(TM) Fentanyl both in Europe and in the U.S.," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BioDelivery Sciences. "It also reflects our opinion there is a clear market opportunity for BEMA(TM) Fentanyl and underscores our unwavering focus toward providing a new treatment option for cancer patients experiencing breakthrough pain."
"Breakthrough pain is a common condition in cancer patients, so it is important to continue developing improved therapies in this area," stated Anders Lonner, Chief Executive Officer of Meda AB. "We are pleased with BioDelivery Sciences' progress and are eager to introduce BEMA(TM) Fentanyl for breakthrough cancer pain to the European market where current treatment modalities continue to prove suboptimal."

As previously disclosed, the U.S. Food and Drug Administration (FDA) accepted for filing BioDelivery Sciences' New Drug Application (NDA) for BEMA(TM) Fentanyl. BioDelivery Sciences is expecting a response from FDA on the BEMA(TM) Fentanyl NDA by August 31, 2008. In September 2007, BioDelivery Sciences announced a licensing agreement with Meda AB for the distribution rights in the U.S., Canada, and Mexico for BEMA(TM) Fentanyl. In August 2006, Meda AB secured from BioDelivery Sciences the rights to distribute BEMA(TM) Fentanyl in Europe.

Breakthrough cancer pain is characterized by the episodes of severe pain that "break through" the base opioid medications used to control persistent pain. The worldwide market for breakthrough cancer pain is expected to reach $2.5 billion by 2016 according to Datamonitor. In addition, a recent European Pain in Cancer (EPIC) survey revealed that 63 percent of cancer patients report they are affected by breakthrough pain. The study disclosed that only one-third of these patients take additional medications to treat their breakthrough pain, and merely 35 percent of patients taking additional medications report the medicine is effective.

About BEMA(TM) Fentanyl
BDSI's lead product under development is BEMA(TM) Fentanyl, a potential treatment for "breakthrough" pain (i.e., episodes of severe pain which "break through" the medication used to control the persistent pain). BEMA(TM) Fentanyl consists of a small, dissolvable, polymer disc, formulated with the opioid narcotic fentanyl for application to the buccal (inner lining of cheek) membranes. Fentanyl belongs to the group of medicines called narcotic analgesics, which are used to relieve pain. The BEMA(TM) delivery technology is particularly well suited for the delivery of products where rapid onset of activity and convenient administration are important. BDSI believes there is a clear need and growing market for additional narcotic agents in alternative dosage forms to provide rapid and convenient pain relief.

Wyeth and Progenics Announce RELISTOR Receives Canadian Marketing Approval

Apr 1, 2008 - Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX), today announced that Wyeth has received marketing approval from Health Canada, the Canadian Regulatory Agency, for RELISTOR(TM) (methylnaltrexone bromide injection) for subcutaneous use. RELISTOR is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness receiving palliative care. Health Canada's decision regarding RELISTOR marks the first regulatory approval of this novel medication anywhere in the world.

"Health Canada granted a priority review for RELISTOR, which underscores the important need that exists for an innovative medicine that addresses a serious health condition for which there had been limited medical advancement," says Joseph S. Camardo, M.D., senior vice president, Global Medical Affairs, Wyeth Pharmaceuticals. "Wyeth and Progenics are pleased to bring RELISTOR to patients as an example of our commitment to discover, develop and deliver important new medicines that work in novel ways to benefit patients who need them."

RELISTOR is the first approved therapy in a new class of drugs designed to relieve one of the significant side effects of opioids on the gastrointestinal tract without interfering with their ability to provide pain relief. When patient response to laxatives has been insufficient, RELISTOR should be used as an adjunct therapy to induce a prompt bowel movement. Wyeth expects that this product will be launched and available to patients in Canada within approximately 60 days.

"Progenics is proud to share this achievement with the Wyeth team, who have been instrumental in advancing this important new product to market," said Paul J. Maddon, M.D., Ph.D., Founder, Chief Executive Officer and Chief Science Officer, Progenics Pharmaceuticals, Inc. "We now await a decision from the U.S. Food and Drug Administration by the end of April on RELISTOR. In addition, we and Wyeth continue to work with the European and Australian regulatory authorities to expand the availability of RELISTOR."

DiaKine Therapeutics to Be Awarded Patent for Restoring Insulin Producing Cell Function in Diabetics

Apr 1, 2008 - DiaKine Therapeutics, Inc. today announced that the U.S. Patent and Trademark Office indicated its intent to grant a patent for the use of Lisofylline (LSF) to restore insulin-producing beta cell mass and function in people with diabetes. The patent application, entitled Pharmaceutical compositions and methods for restoring beta-cell mass and function, also covers the use of LSF in combination with a growth factor.

"We have clearly demonstrated in previous pre-clinical studies that our immune modulating drugs, alone or in combination with other specific small molecules or peptides, may be used as a means to prevent, treat or possibly arrest diabetes," said Dr. Jerry Nadler, DiaKine's Chief Scientific Officer and co-inventor. "The patent application should help us move our work forward as we seek to put an end to this devastating disease."

"This is the second key patent office action we have received in recent months and further strengthens our portfolio of intellectual property," said Keith Ignotz, President, and CEO of DiaKine. "These patents boost our claims to precisely limit the body's mistaken and destructive inflammatory actions that lead to diseases such as diabetes."

The patent application covers pharmaceutical compositions and methods for restoring beta-cell mass and function. The pharmaceutical compositions have a biological response modifier and a beta-cell growth factor in a mixture with a pharmaceutically acceptable carrier, adjuvant or vehicle. The invention provides for the use of compounds or agents that can block cytokine signaling or formation and thereby prevent autoimmune damage to regenerated/emerging new insulin producing cells. Without using an agent to block the autoimmune process, beta-cell differentiation and/or growth promoting agents will not be clinically effective because simultaneous regeneration of beta-cells and prevention of autoimmune reactions would not be realized.

Oncolin Therapeutics Obtains an Exclusive Worldwide Right to Option Patents Covering the Composition and Use of Genistein Analogs for Cancer Treatment

Apr 1, 2008 - Oncolin Therapeutics, Inc., (OTCBB:OCOL) announces that it has obtained an exclusive worldwide right to option patents covering the composition and use of Genistein analogs for cancer treatment. The technology was discovered and patented by the Pharmaceutical Research Institute of Warsaw Poland and involves compounds that appear to be novel antimicrotubule agents.

Given the widespread success of antimicrotubule therapies in curative and palliative cancer treatment, the microtubule is perhaps the single best cancer target identified to date and continues to be recognized as a strategic target against which to direct new development efforts.

The approved drugs from this mechanistic class include the Vinca alkaloids such as vincristine, the taxanes with paclitaxel and docetaxel and the epothilones with its first drug recently approved by Bristol Myers. Each of these different types of compound classes appear to interact at different parts of the microtubule and have different spectrums of activity and show effectiveness against resistant disease.

"We are happy to have obtained this exclusive agreement on what may be another unique antimicrotubule class of compounds. We will work closely with both the Pharmaceutical Research Institute of Warsaw Poland and the University of Texas MD Anderson Cancer Center to further evaluate the compounds' anticancer activity in order to advance a lead compound into clinical development," said Dr. Donald Picker, President and COO of the company.

Bayer Appeals Invalidity Ruling on Its Yasmin Patent Appeal Will Be Heard by the Federal Circuit

In continuation to the earlier published....
March 31, 2008 - Today, Bayer filed a Notice of Appeal in the United States District Court for the District of New Jersey.

Bayer is appealing from a March 3, 2008 opinion and order in which District Judge Peter G. Sheridan held that certain patent claims of Bayer Schering's U.S. Patent No. 6,787,531 for the company’s oral contraceptive Yasmin (drospirenone 3 mg and ethinyl estradiol 0.03mg) were invalid because they would have been obvious to the person of ordinary skill in the art.
Bayer had sued generic manufacturer Barr Laboratories for patent infringement in connection with Barr's application to the FDA for approval to market a generic version of Bayer's oral contraceptive Yasmin.
Bayer's appeal will be heard by the Federal Circuit, which is the federal court of appeals for patent cases.

Breckenridge Pharmaceutical Enters Agreement With Helm AG to Develop Additional ANDA Project

Breckenridge announced today that it has entered into another separate agreement with Helm AG to develop and manufacture a generic ANDA product. Under terms of this new agreement, Breckenridge will submit an ANDA to the U.S. Food and Drug Administration (FDA) for the product which will be developed by Helm AG. The product currently shows U.S. sales of approximately $279 million, and is patent protected until 2011.

The two companies previously announced plans to develop and manufacture a generic tablet ANDA product in December 2007. The product was recently filed with the U.S. Food and Drug Administration (FDA).

Update on Generic Prevacid Litigation

March 31, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of TAP Pharmaceutical Products Inc.'s Prevacid(R) (Lansoprazole) Delayed Release Capsules, 15 mg and 30 mg., holding that U.S. Patent No. 4,628,098 is valid and enforceable. Teva plans to appeal this decision.

As soon as I will get the details of the case I will post that.

Court Upholds Ortho-McNeil's Topamax Patent

A federal appeals court on Monday upheld a ruling that prevents generic drug maker Mylan (MYL.N: Quote, Profile, Research) from pursuing efforts to market a version of the epilepsy drug Topamax until Ortho-McNeil Pharmaceutical Inc's patent expires.

The U.S. Court of Appeals for the Federal Circuit found that a District Court in New Jersey district was correct in siding with Ortho-McNeil, a unit of Johnson & Johnson (JNJ.N: Quote, Profile, Research).

Ortho-McNeil said on its web site that the Topamax patent expires in September.

Under the Hatch-Waxman Act to encourage generic versions of drugs to be marketed quickly after a patent expires, Mylan had filed an application with the Food and Drug Administration saying it intended to bring out a version of Topamax. As part of that application, Mylan said Ortho-McNeil's patent was invalid.

But Ortho-McNeil disagreed, and filed a lawsuit saying its patent rights had been infringed.

http://www.cafc.uscourts.gov/opinions/07-1223.pdf

Bayer Appeals Yasmin Contraceptive Patent Invalidity

Bayer Schering Pharma AG has appealed a judge's recent finding that the patent at issue in the lawsuit against Barr Laboratories Inc. over the $488 million U.S. market for the contraceptive Yasmin is invalid due to obviousness.