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)