Wyeth sued a U.S. generic-drug making unit of Switzerland's Novartis AG (Sandoz) alleging infringement of a 2002 patent for the oral contraceptive Lybrel.
Lybrel, which went on sale in July, leaves women without any menstrual periods.
The U.S. Food and Drug Administration delayed release of the drug for 11 months to gather more data about pregnancy rates and bleeding problems among women who took the drug.
Wyeth, based in Madison, New Jersey, contends Sandoz Inc. applied to market a copy of Wyeth's one-dose-a-day hormonal pill before the patent expires, according to federal court papers.
At issue is patent 6,500,814, issued in December 2002. The application was filed in June 2000, and Knobbe, Martens, Olson & Bear of Irvine, California handled the application.
Wyeth sued generics maker Watson Pharmaceuticals Inc. in federal court in Delaware in March for infringing the patent.
The complaint can be read here.
(Source:www.bloomberg.com)
Friday, May 30, 2008
Dr Reddy's launches atorvastatin and ramipril combo in India
Dr Reddy's Laboratories Ltd. has launched Atocor-R (Atorvastatin + Ramipril) in India. It is the first such combination to be approved by DCGI and has completed a multi-centre clinical trial data on Indian patients.
It is a one of its kind combination that has two blockbuster molecules, atorvastatin and ramipril combined together for the first time as a fixed dose combination.
Atocor-R is used in the treatment of patients with both essential hypertension and hypercholesterolemia. It is available in two fixed dose combinations of Atocor-R 2.5 (atorvastatin 10mg + ramipril 2.5 mg) and Atocor-R 5 (atorvastatin 10mg + ramipril 5 mg) and comes is packs of 10.
According to ORG IMS March 2008, Atorvastatin market is currently valued at Rs 300 crore growing at over 34 per cent annually and Ramipril market is about Rs 145 crore growing at over 15 per cent annually.
(source:www.pharmabiz.com)
It is a one of its kind combination that has two blockbuster molecules, atorvastatin and ramipril combined together for the first time as a fixed dose combination.
Atocor-R is used in the treatment of patients with both essential hypertension and hypercholesterolemia. It is available in two fixed dose combinations of Atocor-R 2.5 (atorvastatin 10mg + ramipril 2.5 mg) and Atocor-R 5 (atorvastatin 10mg + ramipril 5 mg) and comes is packs of 10.
According to ORG IMS March 2008, Atorvastatin market is currently valued at Rs 300 crore growing at over 34 per cent annually and Ramipril market is about Rs 145 crore growing at over 15 per cent annually.
(source:www.pharmabiz.com)
Glenmark receives US FDA approval for mometasone cream
Glenmark Generics Ltd (GGL), a subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark), has received ANDA approvals for mometasone furoate ointment USP, 0.1 per cent.
Mometasone furoate cream USP, 0.1 per cent and metformin hydrochloride tablets USP 500 mg, 850 mg and 1000 mg and will soon commence marketing and distribution of these products in the US market.
The details can be read here.
Mometasone furoate cream USP, 0.1 per cent and metformin hydrochloride tablets USP 500 mg, 850 mg and 1000 mg and will soon commence marketing and distribution of these products in the US market.
The details can be read here.
Zydus Cadila acquires Spain based Laboratories Combix
The Ahmedabad based 4th largest Indian pharmaceutical company Zydus Cadila has forayed into Spain with the acquisition of 100 per cent stake in Laboratories Combix.
Laboratories Combix which has a pure generics focus provides the right fit for Zydus entry strategy into a market that is estimated at US $1.7 billion and is growing at 21.5 per cent compared to 6 per cent for the overall pharmaceutical market in 2007. The Spanish pharmaceutical market is the fifth largest in Europe.
The details can be read here.
Laboratories Combix which has a pure generics focus provides the right fit for Zydus entry strategy into a market that is estimated at US $1.7 billion and is growing at 21.5 per cent compared to 6 per cent for the overall pharmaceutical market in 2007. The Spanish pharmaceutical market is the fifth largest in Europe.
The details can be read here.
Merck Receives CHMP Positive Opinion for Marketing Authorization for Erbitux Including First-Line Colorectal Cancer in the European Union
May 30, 2008 - Merck KGaA announced today that it received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), for its application to broaden the use of the targeted cancer therapy Erbitux® (cetuximab) to an enlarged label, also including 1st-line treatment of metastatic colorectal cancer (mCRC) in patients with KRAS wild-type tumors. The CHMP recommends the use of Erbitux in the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer, in combination with chemotherapy and as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.
The details can be read here.
The details can be read here.
Novo Nordisk Files for Regulatory Approval of Liraglutide in Both the US and Europe
May 30, 2008-Novo Nordisk today announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the US as well as a marketing authorisation application to the European Medicines Agency (EMEA) in Europe, for the approval of liraglutide, a once-daily human GLP-1 analogue, for the treatment of people with type 2 diabetes.
The details can be read here.
The details can be read here.
AstraZeneca Submits sNDA for Nexium I.V. for Peptic Ulcer Bleed Indication
AstraZeneca today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for NEXIUM(R) I.V. (esomeprazole sodium) for Injection to seek approval for use in patients with peptic ulcer bleeding (PUB) following therapeutic endoscopy. The regulatory submission incorporates data from the NEXIUM I.V. Peptic Ulcer Bleed study, a multinational, randomized trial of 767 patients with peptic ulcer bleeding (PUB). To date, there is no proton pump inhibitor (PPI) therapy globally approved for this indication. Presently, NEXIUM I.V. for Injection is indicated for the short-term treatment (up to 10 days) of GERD adult patients with a history of erosive esophagitis, as an alternative to oral therapy in patients when therapy with NEXIUM(R) (esomeprazole magnesium) Delayed-Release Capsules is not possible or appropriate.
The details can be read here.
The details can be read here.
Lupin Receives USFDA Approval for Topiramate Tablets
Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Topiramate tablets, 25 mg, 50 mg, 100 mg and 200 mg from the U.S. Food and Drug Administration (USFDA).
Lupin's Topiramate tablets are the AB-rated generic equivalent of Ortho-McNeil's TOPAMAX(R) tablets, indicated for the treatment of seizures. The brand product had annual sales of approximately $2.2 billion for the twelve months ended March 2008, based on IMS Health sales data.
The details can be read here.
Lupin's Topiramate tablets are the AB-rated generic equivalent of Ortho-McNeil's TOPAMAX(R) tablets, indicated for the treatment of seizures. The brand product had annual sales of approximately $2.2 billion for the twelve months ended March 2008, based on IMS Health sales data.
The details can be read here.
Teva Introduces Cetirizine Hydrochloride Syrup
May 30, 2008 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Cetirizine Hydrochloride Syrup. This product is AA rated and bioequivalent to Zyrtec®* Syrup. Cetirizine Hydrochloride Syrup is available in a 5 mg/5 mL strength, in bottle sizes of 120 mL and 473 mL.
“Generic pharmaceuticals are playing an increasingly important role in healthcare cost containment,” states John Denman, V.P. Sales and Marketing. “Teva Pharmaceuticals continues to lead the way with timely new product launches.”
(Source:www.pharmalive.com)
“Generic pharmaceuticals are playing an increasingly important role in healthcare cost containment,” states John Denman, V.P. Sales and Marketing. “Teva Pharmaceuticals continues to lead the way with timely new product launches.”
(Source:www.pharmalive.com)
Teva Introduces Budeprion XL
May 30, 2008— Teva Pharmaceuticals is pleased to announce the introduction and availability of Budeprion XL® [Bupropion Hydrochloride Extended-Release Tablets USP (XL)], 150 mg. This product is AB rated and bioequivalent to Wellbutrin XL®* Tablets. With the addition of this new strength, Teva now offers Budeprion XL® Tablets in 150 mg and 300 mg strengths, in bottle sizes of 30 and 500.
The details can be read here.
The details can be read here.
Thursday, May 29, 2008
UCB sues Sun Pharmaceuticals for Xyzal
UCB SA (Belgian drug maker) and its US partner Sepracor sued Sun pharmaceuticals for Xyzal. They have filed second law suit in two months to stop the generic entry of Xyzal.
The law suit was filed on wednesday on US district court for the Eastern District of North Carolina. UCB alleged that Sun pharmaceuticals Industries ltd. infringed the company's patent for levocetirizine hydrochloride 5mg by filing an ANDA with USFDA.
xyzal tablet 5mg was approved by USFDA in May 2007. There is only one patent (US5698558) listed for this product in the orange book for this product. The patent covers:
"A method of treating the symptoms of seasonal and perennial allergic rhinitis in a human which comprises administering to a human in need of such symptomatic relief therapy an amount of (-) cetirizine, or a pharmaceutically acceptable salt thereof, substantially free of its (+) stereoisomer, said amount being sufficient to alleviate or palliate said allergic rhinitis."
As per my opinion this claim is difficult to design around so Sun might be having invalidation strategy against this patent.
The law suit was filed on wednesday on US district court for the Eastern District of North Carolina. UCB alleged that Sun pharmaceuticals Industries ltd. infringed the company's patent for levocetirizine hydrochloride 5mg by filing an ANDA with USFDA.
xyzal tablet 5mg was approved by USFDA in May 2007. There is only one patent (US5698558) listed for this product in the orange book for this product. The patent covers:
"A method of treating the symptoms of seasonal and perennial allergic rhinitis in a human which comprises administering to a human in need of such symptomatic relief therapy an amount of (-) cetirizine, or a pharmaceutically acceptable salt thereof, substantially free of its (+) stereoisomer, said amount being sufficient to alleviate or palliate said allergic rhinitis."
As per my opinion this claim is difficult to design around so Sun might be having invalidation strategy against this patent.
Lipid Sciences receives delipidation technology patent
Lipid Sciences, Inc. has announced the issuance of a second patent covering the company's HDL selective delipidation technology. US Patent No. 7,375,191 further extends Lipid Sciences' ownership over therapeutic HDL compositions provided by the company's proprietary extracorporeal delipidation process.
This new patent, together with Patent No. 7,361,739 issued on April 22, 2008, creates a broad ownership position in this important therapeutic space. The company plans to capitalize on this strong IP position and recent encouraging clinical trial data by aggressively pursuing ongoing partnership discussions supporting commercialization of this promising medical technology.
The details can be read here.
This new patent, together with Patent No. 7,361,739 issued on April 22, 2008, creates a broad ownership position in this important therapeutic space. The company plans to capitalize on this strong IP position and recent encouraging clinical trial data by aggressively pursuing ongoing partnership discussions supporting commercialization of this promising medical technology.
The details can be read here.
Jubilant acquires Canada base Draxis for US $253 mn
Jubilant Organosys Ltd., (Jubilant) an integrated pharmaceutical industry player and India's largest custom research and manufacturing services, has acquired Canada based Draxis Speciality Pharmaceuticals Inc. (Draxis).
Draxis is a debt free company and Jubilant is financing US $253 million transaction using a combination of proceeds from a previous FCCB issue and debt amounting to US $160 million. Given the attractiveness of the business model and the opportunities available in radiopharmaceuticals the transaction is likely to have a very attractive payback.
The details can be read here.
Draxis is a debt free company and Jubilant is financing US $253 million transaction using a combination of proceeds from a previous FCCB issue and debt amounting to US $160 million. Given the attractiveness of the business model and the opportunities available in radiopharmaceuticals the transaction is likely to have a very attractive payback.
The details can be read here.
Orphan Therapeutics Announces Initiation of Rolling NDA Submission for Lucassin (terlipressin) for the Treatment of Hepatorenal Syndrome Type 1
Orphan Therapeutics today announced that it has begun submission of the rolling Lucassin(R) (terlipressin) New Drug Application (NDA) for the treatment of hepatorenal syndrome (HRS) type 1 in patients with late-stage liver cirrhosis. LUCASSIN(R) had previously been granted orphan status and fast track designation for this indication by the U.S. Food and Drug Administration (FDA). Currently no drug is approved in the U.S. to treat HRS type 1, a rare and life-threatening condition in late-stage liver disease.
The whole story can be read here.
The whole story can be read here.
Wyeth Receives FDA Fast Track Designation for its 13-valent Pneumococcal Conjugate Vaccine for Infants and Toddlers
Wyeth Pharmaceuticals, a division of Wyeth , today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company's investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers. Wyeth is seeking a pediatric indication for active immunization against invasive pneumococcal disease (IPD) and otitis media caused by serotypes included in the vaccine. The vaccine includes six new serotypes (1, 3, 5, 6A, 7F and 19A) in addition to the seven serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) included in PREVNAR(R), Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), also known as PCV7.
The details can be read here.
The details can be read here.
Discovery Labs and FDA to Meet On June 18, 2008 to Clarify Limited Items in SURFAXIN Approvable Letter
Discovery Laboratories, Inc. (Nasdaq:DSCO), announced that it has received written notification from the U.S. Food and Drug Administration (FDA) that a meeting has been scheduled for June 18, 2008 via teleconference. This meeting is intended to confirm with the FDA Discovery Labs' approach to address the limited key remaining items necessary to gain U.S. marketing approval of SURFAXIN(r) (lucinactant) for the prevention of RDS in premature infants. On May 1, 2008, Discovery Labs received an Approvable Letter from the FDA for SURFAXIN that reflected notable progress towards gaining FDA approval.
The details can be read here.
The details can be read here.
GlaxoSmithKline Announces New Drug Application and Phase III Results for Rezonic/Zunrisa (Casopitant)
GlaxoSmithKline (GSK) today announced the submission of a new drug application to the U.S. Food and Drug Administration and new data from two Phase III trials for Rezonic(TM)/Zunrisa(TM) (casopitant), a novel, investigational NK-1 receptor antagonist. The data demonstrated a significant and clinically meaningful reduction in the number of patients experiencing chemotherapy-induced nausea and vomiting (CINV). Adding a single oral dose regimen of casopitant to the standard dual therapy of Zofran(R) (ondansetron HCI) and dexamethasone, achieved this effect in patients taking highly emetogenic chemotherapy (HEC) and those on moderately emetogenic chemotherapy (MEC) treatment regimens. CINV can be a serious, feared and distressing side effect of chemotherapy for patients and their families. CINV can last for about five days and the risk of nausea and vomiting without prophylaxis is greater than 90 percent for patients receiving HEC and 30-90 percent for patients receiving MEC.
The details can be read here.
The details can be read here.
Wyeth Receives Approvable Letter from FDA for TYGACIL for the Treatment of Patients with Community-Acquired Pneumonia
Wyeth Pharmaceuticals, a division of Wyeth , announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for the first-in-class antibiotic TYGACIL(R) (tigecycline) for the treatment of adult patients with community-acquired pneumonia (CAP).
Before granting approval, the FDA requested that Wyeth provide additional analyses to support the safety and efficacy of TYGACIL for the treatment of patients with CAP with illness severe enough to require hospitalization, including those who are at higher risk of mortality.
In addition, the FDA requested information regarding the benefit/risk of TYGACIL for any potential of liver toxicity. Wyeth recently provided that information to the agency during the review period and believes that its response adequately addresses the issues raised by the FDA. However, the agency acknowledged in its letter that it had not yet reviewed that information.
The details can be read here.
Before granting approval, the FDA requested that Wyeth provide additional analyses to support the safety and efficacy of TYGACIL for the treatment of patients with CAP with illness severe enough to require hospitalization, including those who are at higher risk of mortality.
In addition, the FDA requested information regarding the benefit/risk of TYGACIL for any potential of liver toxicity. Wyeth recently provided that information to the agency during the review period and believes that its response adequately addresses the issues raised by the FDA. However, the agency acknowledged in its letter that it had not yet reviewed that information.
The details can be read here.
Lilly Submits Cymbalta Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
Eli Lilly and Company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a new indication for Cymbalta(R) (duloxetine HCl) for the management of chronic pain, the company announced today. The submission is based on outcomes of clinical trials in chronic osteoarthritis pain of the knee and chronic low back pain, in addition to data from previously completed pain studies in diabetic peripheral neuropathic pain (DPNP) and fibromyalgia. Cymbalta was studied in chronic pain of at least moderate severity in adults who required daily treatment for an extended period of time.
According to the International Association for the Study of Pain (IASP), pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.(i) Chronic pain persists beyond acute pain or beyond the expected time for an injury to heal.(ii)
(Source:www.pharmalive.com)
According to the International Association for the Study of Pain (IASP), pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.(i) Chronic pain persists beyond acute pain or beyond the expected time for an injury to heal.(ii)
(Source:www.pharmalive.com)
China Biologic Products Announces SFDA Approval for the Production and Sale of Human Albumin 12.5g/vial (25%, 50 ml)
China Biologic Products, Inc. ("CBP," or the "Company"), one of the leading plasma-based pharmaceutical companies in the People's Republic of China ("China" or the "PRC"), today announced that the Company has been approved by the Chinese State Food and Drug Administration (the "SFDA") to commence the production of Human Albumin 12.5g/vial (25%, 50 ml).
Human Albumin 12.5g/vial (25%, 50 ml), contains the highest concentration and delivers the highest dosage of the Human Albumin family products in Mainland China, and has a better effect on the clinical application for ascites due to liver cirrhosis, external injuries, hydrocephalus due to cerebral hemorrhage, serious hypoproteinemia, and other major diseases. With this approval, CBP is now one of the few producers offering the widest range of Human Albumin products available in China.
"We are pleased to receive approval from the SFDA to produce this concentration and dosage of Human Albumin," said Mr. Chaoming Zhao, CFO of China Biologic. "The approval represents a significant milestone for our Company."
The Company has already commenced the production and marketing of this new product.
(Source:www.pharmalive.com)
Human Albumin 12.5g/vial (25%, 50 ml), contains the highest concentration and delivers the highest dosage of the Human Albumin family products in Mainland China, and has a better effect on the clinical application for ascites due to liver cirrhosis, external injuries, hydrocephalus due to cerebral hemorrhage, serious hypoproteinemia, and other major diseases. With this approval, CBP is now one of the few producers offering the widest range of Human Albumin products available in China.
"We are pleased to receive approval from the SFDA to produce this concentration and dosage of Human Albumin," said Mr. Chaoming Zhao, CFO of China Biologic. "The approval represents a significant milestone for our Company."
The Company has already commenced the production and marketing of this new product.
(Source:www.pharmalive.com)
Aphios Corporation Awarded Japanese Patent for Phospholipid Nanosomes Technology Platform
May 29, 2008 - Aphios Corporation today announced that it has been awarded a Japanese Patent No. 4,107,680, issued on April 11, 2008, for its phospholipid nanosomes technology platform for the encapsulation of hydrophobic drugs.
Phospholipid nanosomes are small, uniform liposomes manufactured utilizing SuperFluids(TM). SuperFluids(TM) are normally gases which, when compressed, exhibit enhanced solvation, penetration and expansive properties. These fluids are reverse-engineered to form phospholipid nanosomes for encapsulating and improving the delivery of protein therapeutics, vaccine antigens and sRNAi molecules as well as small molecule therapeutics and hydrophobic drugs such as paclitaxel, camptothecin and bryostatin 1. Dr. Castor, the inventor of this technology platform, points out "this technology does not utilize organic solvents that could be harmful to the therapeutic, the recipient and/or the environment and is rapid, broadly-applicable and scalable while enhancing drug delivery."
The details can be read here.
Phospholipid nanosomes are small, uniform liposomes manufactured utilizing SuperFluids(TM). SuperFluids(TM) are normally gases which, when compressed, exhibit enhanced solvation, penetration and expansive properties. These fluids are reverse-engineered to form phospholipid nanosomes for encapsulating and improving the delivery of protein therapeutics, vaccine antigens and sRNAi molecules as well as small molecule therapeutics and hydrophobic drugs such as paclitaxel, camptothecin and bryostatin 1. Dr. Castor, the inventor of this technology platform, points out "this technology does not utilize organic solvents that could be harmful to the therapeutic, the recipient and/or the environment and is rapid, broadly-applicable and scalable while enhancing drug delivery."
The details can be read here.
Wednesday, May 28, 2008
Taro calls off deal with Sun Pharma
Close on the heels of the failure of the MTN-Bharti deal, yet another Indian company has lost out on a foreign acquisition. Sun Pharma, India's largest pharma company by market capitalisation, has failed to clinch the deal for Israeli major Taro Pharma.
Sun Pharma on Wednesday informed BSE of a notice received from Taro terminating the merger agreement with its subsidiary company — Alkaloida Chemical Company Exclusive Group. The merger deal, signed on May 18, 2007, stipulated a price of $7.75 per share to be paid by Sun to acquire Taro, with either of the parties having freedom to terminate the agreement after December 31, 2007.
The details can be read here.
Sun Pharma on Wednesday informed BSE of a notice received from Taro terminating the merger agreement with its subsidiary company — Alkaloida Chemical Company Exclusive Group. The merger deal, signed on May 18, 2007, stipulated a price of $7.75 per share to be paid by Sun to acquire Taro, with either of the parties having freedom to terminate the agreement after December 31, 2007.
The details can be read here.
Osmotica Pharma gets US FDA nod for venlafaxine XR
Osmotica Pharmaceutical Corp. has received notice of final approval for its venlafaxine hydrochloride extended-release 37.5 mg, 75 mg, 150 mg and 225 mg tablets NDA from FDA for major depressive disorder and social anxiety disorder.
The Osmotica product provides a controlled release tablet form of venlafaxine HCl including a previously unavailable 225 mg dosage strength. Equal doses of venlafaxine HCl Extended-release tablets are bioequivalent to Effexor XR capsules, a leading product marketed by Wyeth, when administered under fed conditions. Osmotica expects to launch the new product line for the two FDA-approved indications in the near future.
The whole story can be read here.
The Osmotica product provides a controlled release tablet form of venlafaxine HCl including a previously unavailable 225 mg dosage strength. Equal doses of venlafaxine HCl Extended-release tablets are bioequivalent to Effexor XR capsules, a leading product marketed by Wyeth, when administered under fed conditions. Osmotica expects to launch the new product line for the two FDA-approved indications in the near future.
The whole story can be read here.
New Eloxatin (oxaliplatin injection) Prescribing Information in the U.S. Includes Six-Year Overall Survival Data
Sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental new drug application (sNDA) to include six-year overall survival analysis from the MOSAIC trial in the Eloxatin(R) (oxaliplatin injection) prescribing information (PI). The new PI also reports five-year disease free survival (DFS) data in Stage III colon cancer patients treated following surgery to remove the primary tumor.
The whole story can be read here.
The whole story can be read here.
Watson Announces Oxybutynin Topical Gel NDA Accepted for Filing by FDA for the Treatment of Overactive Bladder
Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that its New Drug Application (NDA) for oxybutynin chloride topical gel (OTG), has been accepted for filing by the U.S. Food and Drug Administration (FDA). Watson is seeking marketing approval of this novel transdermal gel of oxybutynin hydrochloride for the treatment of overactive bladder (OAB).
The details can be read here.
The details can be read here.
The Medicines Company Receives FDA Review Letter for Angiomax Supplemental Filing
May 28, 2008 - The Medicines Company (NASDAQ: MDCO) announced receipt of a not approvable letter from the U.S. Food and Drug Administration (FDA) on a supplemental New Drug Application (sNDA) for an additional dosing regimen for Angiomax(R) (bivalirudin) in the treatment of acute coronary syndromes (ACS) initiated in the emergency department.
The primary basis of the filing was the ACUITY trial, whose results have been published in New England Journal of Medicine, Journal of the American Medical Association and Lancet. The Company believes that the ACUITY results are consistent with those demonstrated in clinical trials of over 47,000 patients across a broad spectrum of cardiovascular risk, including: REPLACE-2, BAT, and most recently, the HORIZONS-AMI trial. These trials demonstrate that utilizing Angiomax instead of heparins not only provides comparable protection against ischemic events but also reduces bleeding and costs.
The details can be read here.
The primary basis of the filing was the ACUITY trial, whose results have been published in New England Journal of Medicine, Journal of the American Medical Association and Lancet. The Company believes that the ACUITY results are consistent with those demonstrated in clinical trials of over 47,000 patients across a broad spectrum of cardiovascular risk, including: REPLACE-2, BAT, and most recently, the HORIZONS-AMI trial. These trials demonstrate that utilizing Angiomax instead of heparins not only provides comparable protection against ischemic events but also reduces bleeding and costs.
The details can be read here.
Sanofi-Aventis Withdraws Its Marketing Authorisation Application for Aquilda (satavaptan)
May 28, 2008-The European Medicines Agency (EMEA) has been formally notified by sanofi-aventis of its decision to withdraw the application for a centralised marketing authorisation for the medicine Aquilda (satavaptan) 5 and 25 mg film-coated tablets. Aquilda was intended to be used for the treatment of euvolaemic and hypervolaemic dilutional hyponatraemia, a metabolic condition in which the body’s blood sodium level falls below normal.
The application for marketing authorisation for Aquilda was submitted to the EMEA on 30 May 2007.
The details can be read here.
The application for marketing authorisation for Aquilda was submitted to the EMEA on 30 May 2007.
The details can be read here.
Medtronic Awarded $250 Million Damages in Patent Case against Boston Scientific
May 27, 2008 - Medtronic, Inc. (NYSE: MDT) today announced that a federal jury found that Boston Scientific Corporation has infringed three patents owned by Medtronic, and awarded Medtronic $250 million in damages.
Medtronic sued Boston Scientific in 2006 asserting that Boston's Taxus Express2, Express2, Liberte, Maverick, Maverick2, and Quantum Maverick products infringed the Fitzmaurice and Anderson catheter patents owned by Medtronic. The trial began on Friday, May 16, 2008.
The Fitzmaurice patents cover angioplasty catheters with narrowed distal ends, which improve the deliverability of angioplasty catheters. The Anderson patent covers semicompliant angioplasty balloons. The Anderson balloons provide sufficient strength to withstand repeated inflations allowing custom vessel sizing.
(Source:www.pharmalive.com)
Medtronic sued Boston Scientific in 2006 asserting that Boston's Taxus Express2, Express2, Liberte, Maverick, Maverick2, and Quantum Maverick products infringed the Fitzmaurice and Anderson catheter patents owned by Medtronic. The trial began on Friday, May 16, 2008.
The Fitzmaurice patents cover angioplasty catheters with narrowed distal ends, which improve the deliverability of angioplasty catheters. The Anderson patent covers semicompliant angioplasty balloons. The Anderson balloons provide sufficient strength to withstand repeated inflations allowing custom vessel sizing.
(Source:www.pharmalive.com)
LifeCycle Pharma A/S Announces Successful Completion of Pilot Studies on LCP-Feno
May 28, 2008 - LifeCycle Pharma A/S (OMX:LCP) today announced the successful completion of pilot studies for LCP-Feno, a product for the treatment of dyslipidemia which is being developed in collaboration with Sandoz Inc. LCP-Feno is designed to be an AB-rated, substitutable version of Tricor(R) 145 mg, currently marketed in the US by Abbott under the name Tricor(R) and in Europe by Solvay S.A. under the name Lipanthyl (R). In collaboration with Sandoz, LifeCycle Pharma is currently preparing for the initiation of pivotal studies to complete all the necessary requirements for a US ANDA filing.
"We are extremely pleased to have shown bioequivalence of LCP-Feno and Tricor(R) in this pilot study," said Dr. Michael Beckert, LifeCycle Pharma's Chief Medical Officer and Executive Vice President. "This is another important milestone for the company, and a clear validation of the breadth of application as well as versatility of the MeltDose(R) technology. The next step will be to prepare for pivotal pharmacokinetic studies to confirm these results."
The details can be read here.
"We are extremely pleased to have shown bioequivalence of LCP-Feno and Tricor(R) in this pilot study," said Dr. Michael Beckert, LifeCycle Pharma's Chief Medical Officer and Executive Vice President. "This is another important milestone for the company, and a clear validation of the breadth of application as well as versatility of the MeltDose(R) technology. The next step will be to prepare for pivotal pharmacokinetic studies to confirm these results."
The details can be read here.
Schweizerhall: Clopidogrel From Cimex Approved in Germany
May 28, 2008 --- Cimex AG received the first approval from the BfArM (Federal Institute for Drugs and Medical Devices, Germany) for the antiplatelet agent clopidogrel. Two marketing partners are expected to launch clopidogrel (original product: Plavix® / Iscover® by Bristol-Myers Squibb / Sanofi-Aventis) in Germany.
The approval of clopidogrel in Germany represents a milestone for the Schweizerhall Group. Clopidogrel, developed by Cimex, will be the first more cost-effective alternative of this drug in the German market“, said Luzi A. von Bidder, Chairman of the Board of Schweizerhall Holding AG. Applications for approval in additional European countries are in preparation.
The approval of clopidogrel in Germany represents a milestone for the Schweizerhall Group. Clopidogrel, developed by Cimex, will be the first more cost-effective alternative of this drug in the German market“, said Luzi A. von Bidder, Chairman of the Board of Schweizerhall Holding AG. Applications for approval in additional European countries are in preparation.
Australian Full Federal Court Upholds Basic Lipitor Patent, Preventing Launch of Generic Ranbaxy Product
May 28, 2008 - Pfizer Inc said today that the Australian Full Federal Court in Victoria has upheld on appeal the exclusivity of its basic patent covering atorvastatin, the active ingredient in Lipitor. The ruling, the culmination of a lawsuit filed in 2005 by generic drug manufacturer Ranbaxy, preserves Lipitor's patent coverage in Australia through May 2012. Ranbaxy can appeal the decision.
The court found that a proposed Ranbaxy generic product would infringe Pfizer's basic Lipitor patent (AU 601,981). A second patent covering the calcium salt of atorvastatin (AU 628,198), which expires in September 2012, was ruled invalid by the court. Pfizer has the opportunity to appeal that ruling.
The Australian decision will not impact ongoing Lipitor patent actions in other countries, including the United States. Pfizer said it will continue to vigorously defend against challenges to its intellectual property, noting that patents provide the necessary incentive to invest in new and life-saving medicines that benefit millions of patients globally.
The whole Judgement can be read here.
The court found that a proposed Ranbaxy generic product would infringe Pfizer's basic Lipitor patent (AU 601,981). A second patent covering the calcium salt of atorvastatin (AU 628,198), which expires in September 2012, was ruled invalid by the court. Pfizer has the opportunity to appeal that ruling.
The Australian decision will not impact ongoing Lipitor patent actions in other countries, including the United States. Pfizer said it will continue to vigorously defend against challenges to its intellectual property, noting that patents provide the necessary incentive to invest in new and life-saving medicines that benefit millions of patients globally.
The whole Judgement can be read here.
Barr Confirms Patent Challenge of Entocort, 3mg Enteric Coated Capsules
Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by AstraZeneca LP in connection with its Entocort(R) Enteric Coated Capsules (budesonide), 3mg. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Entocort EC.
Barr filed its ANDA containing a paragraph IV certification for a generic Entocort EC product with the U.S. Food & Drug Administration (FDA) in January 2008. Following receipt of the notice from the FDA that Barr's ANDA had been accepted for filing, Barr notified the New Drug Application (NDA) and patent holder.
On May 22, 2008, AstraZeneca filed suit in the U.S. District Court for the District of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.
Entocort EC (budesonide) had annual sales of approximately $125 million in the U.S., based on IMS sales data for the twelve-month period ending March 2008.
(Source:www.pharmalive.com)
Barr filed its ANDA containing a paragraph IV certification for a generic Entocort EC product with the U.S. Food & Drug Administration (FDA) in January 2008. Following receipt of the notice from the FDA that Barr's ANDA had been accepted for filing, Barr notified the New Drug Application (NDA) and patent holder.
On May 22, 2008, AstraZeneca filed suit in the U.S. District Court for the District of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.
Entocort EC (budesonide) had annual sales of approximately $125 million in the U.S., based on IMS sales data for the twelve-month period ending March 2008.
(Source:www.pharmalive.com)
Tuesday, May 27, 2008
Cyclacel's Sapacitabine Receives Orphan Designation for AML & MDS From EU Regulators
May 27, 2008 - Cyclacel Pharmaceuticals, Inc. announced that the European Medicines Evaluation Agency (EMEA) designated sapacitabine as an orphan medicine in two separate indications: Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS).
Specifically the EMEA's Committee for Orphan Medicinal Products (COMP) adopted a positive opinion on the company's application to designate sapacitabine as an orphan medicinal product for the indications of AML and MDS. The objective of European orphan medicines legislation is to stimulate research and development of medicinal products for rare diseases by providing incentives to industry.
The details can be read here.
Specifically the EMEA's Committee for Orphan Medicinal Products (COMP) adopted a positive opinion on the company's application to designate sapacitabine as an orphan medicinal product for the indications of AML and MDS. The objective of European orphan medicines legislation is to stimulate research and development of medicinal products for rare diseases by providing incentives to industry.
The details can be read here.
EpiCept Files Re-Examination Documentation for Marketing Authorization of Ceplene in Europe
May 27, 2008 - EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that it has submitted the documentation to support a re-examination of its Marketing Authorization Application (MAA) in Europe for Ceplene(TM) to the Committee for Medicinal Products for Human Use (CHMP). Ceplene (histamine dihydrochloride) is intended for the remission maintenance and prevention of relapse in patients with Acute Myeloid Leukemia (AML) in first remission. The Company anticipates that appeal proceedings in response to this filing will take place in the third quarter of this year.
During the last few months, EpiCept has received new written support from key opinion leaders in hematology representing numerous European countries, who have unanimously recommended the approval of Ceplene in order to have immediate access to this therapy for their patients. "We have met with many of Europe's leading hematologists and have received overwhelming support for the approval of Ceplene in Europe to address this critical unmet medical need for AML patients," said Stephane Allard, M.D., Chief Medical Officer of EpiCept.
The details can be read here.
During the last few months, EpiCept has received new written support from key opinion leaders in hematology representing numerous European countries, who have unanimously recommended the approval of Ceplene in order to have immediate access to this therapy for their patients. "We have met with many of Europe's leading hematologists and have received overwhelming support for the approval of Ceplene in Europe to address this critical unmet medical need for AML patients," said Stephane Allard, M.D., Chief Medical Officer of EpiCept.
The details can be read here.
Sanofi Pharma Bristol-Myers Squibb SNC Withdraws Its Marketing Authorisation Application for Duoplavin
May 27, 2008- The European Medicines Agency (EMEA) has been formally notified by Sanofi Pharma Bristol- Myers Squibb SNC of its decision to withdraw its application for a centralised marketing authorisation for the medicine DuoPlavin (fixed-dose combination tablets of 75 mg clopidogrel/75 mg acetylsalicylic acid and 75 mg clopidogrel/100 mg acetylsalicylic acid). DuoPlavin was expected to be used by patients already taking clopidogrel and acetylsalicylic acid for the approved indication of prevention of atherothrombotic events in acute coronary syndrome.
The application for marketing authorisation for DuoPlavin was submitted to the EMEA on 30 May 2007. At the time of the withdrawal, it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP)
The details can be read here.
The application for marketing authorisation for DuoPlavin was submitted to the EMEA on 30 May 2007. At the time of the withdrawal, it was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP)
The details can be read here.
Extavia Approved in European Union for Treatment of Multiple Sclerosis, First in Planned Portfolio of Therapies from Novartis
May 26, 2008 - The European Commission has approved Extavia® (interferon beta-1b) for the treatment of early and relapsing forms of multiple sclerosis (MS) - the first in a new portfolio of medicines from Novartis that is planned to include both established treatments and innovative therapies for patients with MS.
Extavia is the Novartis branded version of interferon beta-1b, a first-line disease-modifying therapy injected every other day for the treatment of MS. Interferon beta-1b has been available globally for more than 13 years and is supported by more than 700,000 patient-years of experience[1].
Formerly known as NVF233, Extavia is the same medicine as Betaferon®/Betaseron®, which is marketed by Bayer-Schering and was the first beta interferon treatment for MS. Novartis gained rights to its own branded version of this medicine in agreements with Bayer-Schering related to the acquisition of Chiron.
The details can be read here.
Extavia is the Novartis branded version of interferon beta-1b, a first-line disease-modifying therapy injected every other day for the treatment of MS. Interferon beta-1b has been available globally for more than 13 years and is supported by more than 700,000 patient-years of experience[1].
Formerly known as NVF233, Extavia is the same medicine as Betaferon®/Betaseron®, which is marketed by Bayer-Schering and was the first beta interferon treatment for MS. Novartis gained rights to its own branded version of this medicine in agreements with Bayer-Schering related to the acquisition of Chiron.
The details can be read here.
ZymoGenetics Announces FDA Approval of RECOTHROM 20,000-IU Vial Size and Co-Packaging with Spray Kit
May 27, 2008 - ZymoGenetics, Inc. (NASDAQ:ZGEN) announced today that the United States Food and Drug Administration (FDA) has approved a Prior Approval Supplement application for a 20,000 international unit (IU) vial of RECOTHROM(TM) Thrombin, topical (Recombinant) and also approved co-packaging of the 20,000-IU vial with the ZymoGenetics Spray Applicator Kit.
"RECOTHROM, the first and only recombinant thrombin, is now available in both 5,000 and 20,000-IU vial sizes," said Bruce L.A. Carter, Chief Executive Officer of ZymoGenetics. "Within two weeks, we'll be ready to ship the 20,000-IU vials, as well as spray kits co-packaged with the larger vial. This product introduction will provide our customers with flexibility to meet their needs while enhancing our ability to convert hospital thrombin usage to RECOTHROM. Additionally, we believe that our spray kit has design and convenience advantages, based on market research conducted with surgeons."
The details can be read here.
"RECOTHROM, the first and only recombinant thrombin, is now available in both 5,000 and 20,000-IU vial sizes," said Bruce L.A. Carter, Chief Executive Officer of ZymoGenetics. "Within two weeks, we'll be ready to ship the 20,000-IU vials, as well as spray kits co-packaged with the larger vial. This product introduction will provide our customers with flexibility to meet their needs while enhancing our ability to convert hospital thrombin usage to RECOTHROM. Additionally, we believe that our spray kit has design and convenience advantages, based on market research conducted with surgeons."
The details can be read here.
Shire Announces Approval of Elaprase (idursulfase) in Brazil
May 27, 2008 -- Shire Limited , the global specialty biopharmaceutical company, announced that Elaprase(R) (idursulfase), a human enzyme replacement therapy for the treatment of Hunter syndrome, has been approved by the Brazilian Regulatory Agency, Agencia Nacional de Vigilancia Sanitaria (ANVISA). ELAPRASE, developed by Shire Human Genetic Therapies (HGT), a business unit of Shire focused on genetic diseases, is the first and only enzyme replacement therapy approved for people suffering from Hunter syndrome. Brazil is the largest economy in Latin America and the ninth largest in the world[1]. With this approval, ELAPRASE is now cleared for marketing in two countries in the region - Brazil and Mexico.
The details can be read here.
The details can be read here.
Intas Biopharma to market lung cancer drug Gefitinib in India
May 26, 2008 - Intas Biopharmaceuticals Limited is all set to market Lung Cancer drug, GEFITINIB, under brand name "GEFFY", in Indian market. In line with company's sales strategy to market novel targeted therapies, Intas Biopharmaceuticals will market GEFFY for treatment of Lung cancer especially non-small cell lung cancer (NSCLC). The new drug GEFFY is a class of anti-cancer medications called epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply.
The details can be read here.
The details can be read here.
AMITIZA (lubiprostone) 8 mcg Now Available to Treat Irritable Bowel Syndrome with Constipation in Adult Women
May 27, 2008 -- Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals North America, Inc. today announced that AMITIZA(R) (lubiprostone) 8 mcg capsules are now available by prescription in pharmacies across the U.S. for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in women 18 years and older. AMITIZA 24 mcg capsules have been available by prescription to treat Chronic Idiopathic Constipation in adults since 2006.
AMITIZA is the only widely available FDA-approved prescription treatment option that can provide overall symptom relief for the millions of adult women in the U.S. with IBS-C.
The details can be read here.
AMITIZA is the only widely available FDA-approved prescription treatment option that can provide overall symptom relief for the millions of adult women in the U.S. with IBS-C.
The details can be read here.
Patents Issued
HYDERABAD, India May 27, 2008 – Suven Life Sciences Ltd has announced that two product patents were granted in Russia and Australia for two of their new chemical entities (NCEs) for the treatment of disorders associated with neuro-degenerative diseases and these patents are valid until 2023.
May 27, 2008 - Optimer Pharmaceuticals, Inc. announced today that the United States Patent and Trademark Office has issued U.S. Patent No. 7,378,508 entitled "Polymorphic Crystalline Forms Of Tiacumicin B." This patent includes claims covering a novel polymorphic form of the active pharmaceutical ingredient in the investigational drug candidate, OPT-80. The patent specifically claims the Form A polymorph of OPT-80, as well as all dosage forms and pharmaceutical compositions including the Form A polymorph of OPT-80. OPT-80 is currently in two Phase 3 clinical trials for the treatment of Clostridium difficile infection, or CDI, also known as C. difficile-associated disease, or CDAD.
Lipid Sciences, Inc. announced the issuance of a second patent covering the Company's HDL Selective Delipidation technology. U.S. Patent No. 7,375,191 further extends Lipid Sciences' ownership over therapeutic HDL compositions provided by the Company's proprietary extracorporeal delipidation process.
Microbix Biosystems Inc. has been granted a patent by the State Intellectual Property Office of the People's Republic of China for its Virusmax technology which enables egg-based vaccine manufacturers to significantly increase the amount of influenza vaccine they produce each year.
May 27, 2008 - Orexigen Therapeutics, Inc., a biopharmaceutical company focused on the treatment of central nervous system disorders, including obesity, today announced that the U.S. Patent and Trademark Office (USPTO) issued U.S. Patent Number 7,375,111 with broad claims covering sustained release (SR) compositions of bupropion and naltrexone combined in a single dosage form. These two drugs are the active constituents in Contrave, the company's lead obesity product candidate, now in Phase III clinical trials.
May 27, 2008 - Optimer Pharmaceuticals, Inc. announced today that the United States Patent and Trademark Office has issued U.S. Patent No. 7,378,508 entitled "Polymorphic Crystalline Forms Of Tiacumicin B." This patent includes claims covering a novel polymorphic form of the active pharmaceutical ingredient in the investigational drug candidate, OPT-80. The patent specifically claims the Form A polymorph of OPT-80, as well as all dosage forms and pharmaceutical compositions including the Form A polymorph of OPT-80. OPT-80 is currently in two Phase 3 clinical trials for the treatment of Clostridium difficile infection, or CDI, also known as C. difficile-associated disease, or CDAD.
Lipid Sciences, Inc. announced the issuance of a second patent covering the Company's HDL Selective Delipidation technology. U.S. Patent No. 7,375,191 further extends Lipid Sciences' ownership over therapeutic HDL compositions provided by the Company's proprietary extracorporeal delipidation process.
Microbix Biosystems Inc. has been granted a patent by the State Intellectual Property Office of the People's Republic of China for its Virusmax technology which enables egg-based vaccine manufacturers to significantly increase the amount of influenza vaccine they produce each year.
May 27, 2008 - Orexigen Therapeutics, Inc., a biopharmaceutical company focused on the treatment of central nervous system disorders, including obesity, today announced that the U.S. Patent and Trademark Office (USPTO) issued U.S. Patent Number 7,375,111 with broad claims covering sustained release (SR) compositions of bupropion and naltrexone combined in a single dosage form. These two drugs are the active constituents in Contrave, the company's lead obesity product candidate, now in Phase III clinical trials.
Akorn-Strides, LLC Announces FDA Approval for Rifampin for Injection USP, 600 mg/Vial
May 23, 2008 - Akorn-Strides, LLC today announced the approval of an ANDA for Rifampin for Injection USP, 600 mg/vial. This is the first lyophilized Injectable product approval for the Joint Venture.
Akorn-Strides, LLC is a Joint Venture that was formed in 2005 by Akorn, Inc. (NASDAQ: AKRX) and Strides Arcolab Limited (NSE: STAR) (BSE: 532531). The primary mission for the Joint Venture is to develop liquid, lyophilized and dry powder formulations of generic injectable products targeting several therapeutic markets with a major focus on anti-infectives, analgesics and CNS medicines.
The details can be read here
Akorn-Strides, LLC is a Joint Venture that was formed in 2005 by Akorn, Inc. (NASDAQ: AKRX) and Strides Arcolab Limited (NSE: STAR) (BSE: 532531). The primary mission for the Joint Venture is to develop liquid, lyophilized and dry powder formulations of generic injectable products targeting several therapeutic markets with a major focus on anti-infectives, analgesics and CNS medicines.
The details can be read here
Monday, May 26, 2008
Wyeth gets approvable letter From US FDA for bazedoxifene
Wyeth Pharmaceuticals, a division of Wyeth, announced that the US Food and Drug Administration (FDA) issued an approvable letter on May 21 for bazedoxifene, a selective estrogen receptor modulator, for the treatment of postmenopausal osteoporosis.
In the letter, the FDA requested information similar to that outlined in its approvable letter for bazedoxifene's New Drug Application (NDA) for the prevention of postmenopausal osteoporosis issued in December 2007. This included further analyses concerning the incidence of stroke and venous thrombotic events. The Agency also identified specific questions concerning data collection and reporting and requested additional source documents, a Wyeth press release said.
"Today's action is in line with our expectations," says Gary L. Stiles, M.D., executive vice president, chief medical officer, Wyeth Pharmaceuticals. "In our conference with the Agency earlier this year, they stated their desire to convene an advisory committee to review the pending new drug applications for both treatment and prevention of postmenopausal osteoporosis. We have been working closely with the FDA to address their questions and we are preparing a complete response which we expect to file by end of 2008. We remain committed to pursuing bazedoxifene as an important new option for the millions of postmenopausal women at risk for osteoporotic fracture."
(Source:www.pharmabiz.com)
In the letter, the FDA requested information similar to that outlined in its approvable letter for bazedoxifene's New Drug Application (NDA) for the prevention of postmenopausal osteoporosis issued in December 2007. This included further analyses concerning the incidence of stroke and venous thrombotic events. The Agency also identified specific questions concerning data collection and reporting and requested additional source documents, a Wyeth press release said.
"Today's action is in line with our expectations," says Gary L. Stiles, M.D., executive vice president, chief medical officer, Wyeth Pharmaceuticals. "In our conference with the Agency earlier this year, they stated their desire to convene an advisory committee to review the pending new drug applications for both treatment and prevention of postmenopausal osteoporosis. We have been working closely with the FDA to address their questions and we are preparing a complete response which we expect to file by end of 2008. We remain committed to pursuing bazedoxifene as an important new option for the millions of postmenopausal women at risk for osteoporotic fracture."
(Source:www.pharmabiz.com)
GVK Bio enters drug discovery pact with Wyeth Pharma
GVK Biosciences has entered into a research agreement with Wyeth Pharmaceuticals, a division of Wyeth, to discover drug candidates focused on pre-defined discovery targets. GVK Bio will utilize in-house capabilities in discovery chemistry, informatics, biology and ADME to advance this programme.
GVK Bio will be responsible for identifying drug candidates, which will be transferred to Wyeth to advance these compounds towards clinical studies.
The details can be read here.
GVK Bio will be responsible for identifying drug candidates, which will be transferred to Wyeth to advance these compounds towards clinical studies.
The details can be read here.
Zydus gets US FDA nod for benzepril pills
The Ahmedabad based leading Pharmaceutical company Zydus Cadila has obtained an approval from the US FDA to market benzepril tablets 5,10,20 and 40 mg. the drug falls in the cardiovascular segment and the combined sales of al the strengths as per NDC was estimated at US $301 million in 2007.
This marks the 38th AND approval for the group. So far, company has filled 78 ANDAs and 59 DMFs.
This marks the 38th AND approval for the group. So far, company has filled 78 ANDAs and 59 DMFs.
Friday, May 23, 2008
Gilead Sciences gets US patent for tenofovir
Gilead Sciences, Inc. announced that the US Patent & Trademark Office (PTO) has completed the first of four re-examination proceedings and has confirmed the patentability of US Patent No. 6,043,230, which covers a method of use for Viread (tenofovir disoproxil fumarate). The US PTO has not announced its ruling on the remaining three Viread patents under review.
The four US PTO review proceedings were initiated July 2007 in response to a challenge issued by the Public Patent Foundation (PUBPAT) in March 2007 for US Patents No. 5,922,695; 5,977,089; 5,935,946; and 6,043,230. In its request for the re-examinations, PUBPAT claimed that prior art existed that would have impacted the issuance of the original patents.
Upon completion of the first re-examination proceeding, the US PTO has confirmed the patentability of US Patent No. 6,043,230 with no reduction in the scope of the claims.
Source: www.pharmabiz.com
The four US PTO review proceedings were initiated July 2007 in response to a challenge issued by the Public Patent Foundation (PUBPAT) in March 2007 for US Patents No. 5,922,695; 5,977,089; 5,935,946; and 6,043,230. In its request for the re-examinations, PUBPAT claimed that prior art existed that would have impacted the issuance of the original patents.
Upon completion of the first re-examination proceeding, the US PTO has confirmed the patentability of US Patent No. 6,043,230 with no reduction in the scope of the claims.
Source: www.pharmabiz.com
Dr Reddy's launches 'Omez Insta' in India
Dr Reddy's Laboratories Ltd has launched Omez Insta (Omeprazole 20mg + Sodium bicarbonate 1680mg buffer) in Indian market. It is an innovative powder formulation that offers instant relief with a lasting effect in acute gastritis and is also ideal for critically ill patients on Ryle's tube feeding, in India.
It is an advanced formulation of Omeprazole, internationally referred to as IR -Ome (immediate release Omeprazole). IR-Ome is the first and only immediate release oral Proton Pump Inhibitor (PPI) available as powder for oral suspension with significantly improved pharmacokinetic profile. The formulation is approved by the USFDA and is available in the US market since October 2004. It reduces the intragastric acidity (acid concentration in stomach) by 78 per cent within first 30 minutes of ingestion.
Omez Insta fills the gap which was present in the PPI market by offering a PPI formulation available in drinkable form. It is available in sachets in a pleasant mint flavour.
source:www.pharmalive.com
It is an advanced formulation of Omeprazole, internationally referred to as IR -Ome (immediate release Omeprazole). IR-Ome is the first and only immediate release oral Proton Pump Inhibitor (PPI) available as powder for oral suspension with significantly improved pharmacokinetic profile. The formulation is approved by the USFDA and is available in the US market since October 2004. It reduces the intragastric acidity (acid concentration in stomach) by 78 per cent within first 30 minutes of ingestion.
Omez Insta fills the gap which was present in the PPI market by offering a PPI formulation available in drinkable form. It is available in sachets in a pleasant mint flavour.
source:www.pharmalive.com
Daiichi Sankyo to acquire U3 Pharma for $235 mn
Daiichi Sankyo Co., Ltd. has entered into an agreement to acquire the privately held firm, U3 Pharma AG, a German biotechnology company focusing on research into antibodies for the treatment of cancer.
Daiichi Sankyo will purchase 100 per cent of the stock and make a one-time payment of 150 million Euros ($235 million dollars) for the company. Closure of the transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and customary closing conditions.
The details can be read here.
Daiichi Sankyo will purchase 100 per cent of the stock and make a one-time payment of 150 million Euros ($235 million dollars) for the company. Closure of the transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and customary closing conditions.
The details can be read here.
Stride Arcolab receives approval for ANDA
Stride Arcolab has received approval for Rifampicin for Injection USP, 600mg/vial. The product is licensed to Akorn-Strides, LIC, which is a joint venture that was formed in 2004 by Akorn Inc. and Strides Arcolab Ltd.
Arun Kumar, vice chairman and Group CEO of Strides Arcolab, said, "These approvals reflect yet another significant milestone for the Akorn-Strides partnership which now has approvals for seven sterile injectable products and plans for commercialization are underway".
Arun Kumar, vice chairman and Group CEO of Strides Arcolab, said, "These approvals reflect yet another significant milestone for the Akorn-Strides partnership which now has approvals for seven sterile injectable products and plans for commercialization are underway".
Merck win appeal for propecia patent in UK court
May 21, 2008, A U.K. appellate court has reversed a lower court order revoking Merck & Co. Inc.'s patent for male pattern baldness treatment Propecia, finding that Actavis UK Ltd.'s challenge was an “unusual case” in which a change of dosage for a drug was patentable. The court has cited European patent law precedents for this decision.
The Judgement can be read here.
The Judgement can be read here.
Thursday, May 22, 2008
USPTOExaminers.com (A website to help IP professionals to anonymously review, rank and learn about patent/trademark examiners)
According to the website, USPTO Examiners (www.usptoexaminers.com) “is a website designed for professionals to anonymously review, rank, and learn about a patent examiner or a trademark examining attorney who works at the United States Patent and Trademark Office (USPTO).” Law Firms are also reviewed. The site’s motto is “We Examine the Examiners.”
The owners of the site are anonymous. In addition, the comments are anonymous, but pointed. As an example, the following comment was recently published about a particular examiner (named on the site):
“The work I have reviewed from him plainly indicates his incompetence. I have had to appeal every case where he was the examiner. And I got him reversed at the Board every time. I think he falls into some kind of job protected category. That is the only reason I can think of why he has not been fired.”
You can also find positive comments about particular examiners, such as the following:
“I have called Primary Examiner Truong several times regarding my searches. Primary Examiner Truong is helpful and knowledgeable about the topic and the classification system. If you are trying to do a search, I recommend calling Primary Examiner Truong. If Primary Examiner Truong is not available I recommend calling Primary Examiner Mendoza in the same Group Art Unit.”
The post is published on Patently-O.com. The excerpts between the owner of the site and the author of patently-O can be read here.
The owners of the site are anonymous. In addition, the comments are anonymous, but pointed. As an example, the following comment was recently published about a particular examiner (named on the site):
“The work I have reviewed from him plainly indicates his incompetence. I have had to appeal every case where he was the examiner. And I got him reversed at the Board every time. I think he falls into some kind of job protected category. That is the only reason I can think of why he has not been fired.”
You can also find positive comments about particular examiners, such as the following:
“I have called Primary Examiner Truong several times regarding my searches. Primary Examiner Truong is helpful and knowledgeable about the topic and the classification system. If you are trying to do a search, I recommend calling Primary Examiner Truong. If Primary Examiner Truong is not available I recommend calling Primary Examiner Mendoza in the same Group Art Unit.”
The post is published on Patently-O.com. The excerpts between the owner of the site and the author of patently-O can be read here.
BioAlliance acquires EU rights for ondansetron from NovaDel
BioAlliance Pharma SA a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV, announced that it has acquired the European commercial rights to ondansetron oral spray (OS) from NovaDel Pharma Inc.
The details can be read here.
The details can be read here.
Penwest in pact with Cobalt Labs for Timerx technology
Penwest Pharmaceuticals Co. has signed a development and licensing agreement with Cobalt Laboratories Inc. to develop a formulation of an undisclosed compound utilizing Penwest's TIMERx drug delivery technology. Under the terms of the agreement, Penwest will receive undisclosed fees and payments.
Jennifer L. Good, Penwest's President and CEO, said, "We are pleased to have signed this development and licensing agreement with Cobalt. This is the second collaboration we have entered into to license our proven TIMERx drug delivery technology outside our primary focus in neurology. These arrangements fit with our strategy of leveraging the value of our proprietary drug delivery technologies to provide additional financial benefit to Penwest while permitting us to focus our internal resources on building our own product pipeline."
Penwest is a drug development pharmaceutical company dedicated to bringing to the marketplace innovative products that help improve the lives of patients. The company's goal is to identify, develop and commercialize prescription products that address unmet medical needs, primarily for disorders of the nervous system.
Jennifer L. Good, Penwest's President and CEO, said, "We are pleased to have signed this development and licensing agreement with Cobalt. This is the second collaboration we have entered into to license our proven TIMERx drug delivery technology outside our primary focus in neurology. These arrangements fit with our strategy of leveraging the value of our proprietary drug delivery technologies to provide additional financial benefit to Penwest while permitting us to focus our internal resources on building our own product pipeline."
Penwest is a drug development pharmaceutical company dedicated to bringing to the marketplace innovative products that help improve the lives of patients. The company's goal is to identify, develop and commercialize prescription products that address unmet medical needs, primarily for disorders of the nervous system.
DOR BioPharma Provides Update on orBec European Regulatory and Development Strategy
May 22, 2008 - DOR BioPharma, Inc., a late-stage biopharmaceutical company developing products to treat the life-threatening side effects of cancer treatments, serious gastrointestinal diseases and vaccines against certain bioterrorism agents, announced today that it has voluntarily withdrawn its European Marketing Authorization Application (MAA) for its investigational drug orBec® (oral beclomethasone dipropionate) for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD). DOR reached this decision after consultation with the European Medicines Evaluation Agency (EMEA) and is based on the assessment that confirmatory evidence of clinical efficacy will be required for approval, which is consistent with the request made by the US Food and Drug Administration (FDA) in their October 18, 2007 non-approvable letter. The withdrawal of an MAA application does not prejudice the possibility of DOR making a new application at a later stage. As part of DOR's ongoing European regulatory and development strategy, DOR has entered into a letter of intent for a Named Patient Program (NPP) for orBec® for the treatment of GI GVHD with IDIS, worldwide specialists in the management of NPPs. The NPP will allow DOR to ensure that patients with GI GVHD, an unmet medical need, can access orBec® legally and ethically.
The details can be read here.
The details can be read here.
Indevus Pharmaceuticals Licenses Canadian Rights for Sanctura XR to Allergan, Inc.
May 22, 2008 -- Indevus Pharmaceuticals, Inc. today announced the signing of a License Agreement with Allergan Inc., a Canadian affiliate of Allergan, Inc., based in Irvine, CA, granting Allergan the right to market Sanctura XR(TM) (trospium chloride extended release preparation) throughout Canada. Indevus jointly granted the rights along with Rottapharm Madaus Group, an Italian pharmaceutical group, as required by a prior agreement between Indevus and Rottapharm Madaus. Indevus and Rottapharm Madaus will share equally in the proceeds from the license transaction. Under the terms of the agreement, Allergan will pay up to $9 million to each of Indevus and Rottapharm Madaus, including a $7 million up-front license fee and up to $2 million in sales threshold milestone payments. Allergan will be responsible for all regulatory and marketing activities in Canada.
The details can be read here
The details can be read here
AVEO Pharmaceuticals Granted Patent for Unique Genetic Screen to Identify Novel Cancer Drug Targets
May 22, 2008 - AVEO Pharmaceuticals, Inc., a biotechnology company leveraging breakthrough discoveries in cancer biology to discover, develop and commercialize targeted oncology therapies, today announced that on May 13, 2008, the United States Patent and Trademark Office granted U.S. Patent No. 7,371,515 covering AVEO's Mammalian Second Site Suppressor (MaSS) screen technology for identifying small molecule and antibody targets functionally relevant to cancer cell proliferation and survival. This patent adds to the intellectual property surrounding AVEO's proprietary and innovative cancer biology platform.
"We are very pleased to receive this patent recognizing AVEO's MaSS screen technology, the cornerstone of our unique biology platform, and our innovative work in antibody and small molecule target identification for cancer," said Tuan Ha-Ngoc, president and chief executive officer of AVEO Pharmaceuticals. "Currently available genetic screens used to develop new cancer therapies utilize cell culture models that cannot possibly capture the complex interactions occurring in real tumor environments. Our cutting-edge, in vivo MaSS screen technology identifies more relevant cancer targets which, together with our response biomarker platform, enables AVEO to be more efficient and effective in our antibody discovery and translational research efforts."
"We are very pleased to receive this patent recognizing AVEO's MaSS screen technology, the cornerstone of our unique biology platform, and our innovative work in antibody and small molecule target identification for cancer," said Tuan Ha-Ngoc, president and chief executive officer of AVEO Pharmaceuticals. "Currently available genetic screens used to develop new cancer therapies utilize cell culture models that cannot possibly capture the complex interactions occurring in real tumor environments. Our cutting-edge, in vivo MaSS screen technology identifies more relevant cancer targets which, together with our response biomarker platform, enables AVEO to be more efficient and effective in our antibody discovery and translational research efforts."
Patent Litigation Under a Future Biosimilars Act
Biopharmaceuticals, such as Epogen® (epoetin) and Erbitux® (cetuximab), are becoming increasingly important for the treatment of disease. U.S. sales of such drugs were about $40 billion in 2006 and are expected to rise to over $90 billion in 2009. Accordingly, political pressure is building to allow the sale of “biosimilar” drugs. Inspired by the success of the Hatch-Waxman Act, which has led to the wide use of generic “small molecule” drugs, four different biosimilars bills have been introduced in Congress in the past fifteen months. Three of the proposed bills would establish a complex scheme for patent litigation between brand-name and generic biopharmaceutical companies, especially as compared to the Hatch-Waxman Act.
The details can be read here.
(Source: Orange Book Blog)
The details can be read here.
(Source: Orange Book Blog)
Wednesday, May 21, 2008
Mymetics acquires malaria vaccine from Pevion Biotech
Mymetics Corporation, a vaccine development company, made the acquisition of a preventive malaria vaccine from Pevion Biotech AG, a privately-held biotech company based in Switzerland.
The Pevion vaccine has successfully completed human clinical trial phases I and II in Switzerland and in the UK, respectively, with only two of four contemplated antigens. The clinical trials are being conducted in connection with the application for approval of this vaccine under the European Union regulations. A phase 1b clinical trial has been launched in Tanzania to extend the protocol to children and teenagers in a naturally endemic area. A new cycle of phase I and II clinical trials with all four antigens is scheduled thereafter.
The details can be read here.
The Pevion vaccine has successfully completed human clinical trial phases I and II in Switzerland and in the UK, respectively, with only two of four contemplated antigens. The clinical trials are being conducted in connection with the application for approval of this vaccine under the European Union regulations. A phase 1b clinical trial has been launched in Tanzania to extend the protocol to children and teenagers in a naturally endemic area. A new cycle of phase I and II clinical trials with all four antigens is scheduled thereafter.
The details can be read here.
Bayer re-launches new liquid sargramostim in US
Bayer HealthCare announced that a reformulation of the liquid Leukine (sargramostim) 500 mcg vial has been approved by the United States Food and Drug Administration (FDA) and is now available for patients and physicians in the US. The new formulation does not contain EDTA (edetate disodium), which was used in the product's liquid 500 mcg vial manufactured from January 2006 to January 2008.
In January 2008, Bayer withdrew the previously marketed liquid Leukine 500 mcg vial from the US market, because of an increase in spontaneous reporting of certain labelled adverse events, including syncope (fainting). The timing of increased reporting of these adverse events coincided with the change in the formulation of liquid Leukine to include EDTA in 2006.
The details can be read here.
In January 2008, Bayer withdrew the previously marketed liquid Leukine 500 mcg vial from the US market, because of an increase in spontaneous reporting of certain labelled adverse events, including syncope (fainting). The timing of increased reporting of these adverse events coincided with the change in the formulation of liquid Leukine to include EDTA in 2006.
The details can be read here.
HIV/AIDS Update - Tentative approval of generic emtricitabine capsules
May 21, 2008-On May 9, 2008, FDA granted tentative approval for a generic formulation of emtricitabine capsules, 200 mg, manufactured by Aurobindo Pharma Limited, Hyberdad, India, for use in combination with other antiretrovirals in the treatment of HIV infection. The application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR[http://www.pepfar.gov/ ]), and represents the first tentative approval of a generic formulation of emtricitabine.
The details can be read here.
The details can be read here.
Adolor and GlaxoSmithKline Announce FDA Approval of Entereg (alvimopan) for the Management of Postoperative Ileus (POI)
May 20, 2008 - Adolor Corporation (Nasdaq:ADLR) and GlaxoSmithKline (NYSE:GSK) announced today that the U.S. Food and Drug Administration has approved Entereg(R) (alvimopan) capsules to help patients regain gastrointestinal (GI) function earlier following bowel resection surgery. Postoperative ileus (POI) is a condition that affects almost all patients undergoing this type of surgery and can cause significant discomfort in addition to prolonging hospital stays for patients. Entereg is indicated to accelerate upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis. Entereg will be available for short-term use in hospitals registered under the Entereg Access Support and Education (E.A.S.E.(TM)) program.
The details can be read here.
The details can be read here.
Perrigo Company Announces Collaborative Agreement for Generic Topical Products With Pentech
May 21, 2008 -- Perrigo Company today announced that it has entered into a collaborative agreement with Cobrek Pharmaceuticals, a newly formed entity of Pentech Pharmaceuticals Inc., a privately owned company that specializes in the research and development of niche generic dosage forms. Pentech will contribute its ANDA filing for a generic equivalent to Luxiq(R) foam, a $34 million branded pharmaceutical product, to the agreement. Perrigo will contribute two of its early stage generic topical pipeline products. The parties will share the development costs and profits generated by these products, with Perrigo being the exclusive distributor.
The details can be read here.
The details can be read here.
Teva Announces Approval of Generic Sarafem Pulvules
May 21, 2008 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Fluoxetine Capsules USP, 10 mg and 20 mg. Shipment of the product will begin immediately. As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
Teva's Fluoxetine Capsules are the AB-rated generic equivalent of Eli Lilly's Sarafem(R) Pulvules(R), and are indicated for the treatment of premenstrual dysphoric disorder (PMDD).
The brand product had annual sales of approximately $39 million in the United States for the twelve months that ended March 31, 2008, based on IMS sales data.
Teva's Fluoxetine Capsules are the AB-rated generic equivalent of Eli Lilly's Sarafem(R) Pulvules(R), and are indicated for the treatment of premenstrual dysphoric disorder (PMDD).
The brand product had annual sales of approximately $39 million in the United States for the twelve months that ended March 31, 2008, based on IMS sales data.
Tuesday, May 20, 2008
Wyeth nycomed sue novartis for over Protonix
Wyeth Nycomed GmbH filed a lawsuit against a Novartis AG (NVS) unit, alleging the unit's application to sell a generic version of Wyeth's heartburn drug Protonix violates a U.S. patent for the branded drug.
Novartis' Sandoz generic unit notified the companies in early April that it filed for U.S. Food and Drug Administration approval of a generic, injectable formulation of the drug, which Wyeth markets as Protonix I.V. Wyeth, which licenses the patent from Nycomed, also sells Protonix in tablet form.
The details can be read here.
Novartis' Sandoz generic unit notified the companies in early April that it filed for U.S. Food and Drug Administration approval of a generic, injectable formulation of the drug, which Wyeth markets as Protonix I.V. Wyeth, which licenses the patent from Nycomed, also sells Protonix in tablet form.
The details can be read here.
Granules signs agreements with 3 European firms to export tablets
The Hyderabad-based Granules India Ltd (GIL), manufacturer of active pharmaceutical ingredients (APIs) and pharmaceutical intermediates, has entered into agreements with three European companies for the export of tablets, it is learnt.
According to the company, it has entered into agreements with three European companies to export tablets. As per the agreement, Granules will manufacture tablets for the European firms and they would be marketing it under their brand name. Sources said that it would be more of like contract manufacturing business. It has recently received approval from the European regulatory authorities for its new six billion tablet facility located at Gagillapur in Andhra Pradesh. It is also in discussions with two more European firms for the export of tablets to the region, it is learnt.
The details can be read here.
According to the company, it has entered into agreements with three European companies to export tablets. As per the agreement, Granules will manufacture tablets for the European firms and they would be marketing it under their brand name. Sources said that it would be more of like contract manufacturing business. It has recently received approval from the European regulatory authorities for its new six billion tablet facility located at Gagillapur in Andhra Pradesh. It is also in discussions with two more European firms for the export of tablets to the region, it is learnt.
The details can be read here.
Everolimus cuts tumour growth in kidney cancer: Novartis
New data show RAD001 (everolimus) may provide an important new treatment option for patients with advanced kidney cancer who have failed standard therapies.
The interim study findings demonstrated that RAD001 significantly extended the time without tumour growth from 1.9 to 4 months and reduced the risk of cancer progression by 70 per cent. The study, RECORD-1 (REnal Cell cancer treatment with Oral RAD001 given Daily), will be presented at the 44th annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois, US on Saturday, May 31, 2008.
The details can be read here.
The interim study findings demonstrated that RAD001 significantly extended the time without tumour growth from 1.9 to 4 months and reduced the risk of cancer progression by 70 per cent. The study, RECORD-1 (REnal Cell cancer treatment with Oral RAD001 given Daily), will be presented at the 44th annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois, US on Saturday, May 31, 2008.
The details can be read here.
Pro-Pharmaceuticals Announces Submission of DMF for Davanat to FDA
May 20, 2008 - Pro-Pharmaceuticals, Inc. (Amex: PRW), a Company developing carbohydrate-based targeted therapeutic compounds to treat cancer and fibrosis, has completed an important step toward submission of a New Drug Application (NDA) for DAVANAT(R) by filing the Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA).
"The FDA recommended that we provide the chemistry, manufacturing and control information necessary to support an NDA. The DMF submission is an important step in our commercialization strategy for DAVANAT(R)," said Eliezer Zomer, Ph.D., Executive Vice President, Product Development & Manufacturing. "We are currently in discussions with potential pharmaceutical partners to broaden the use of DAVANAT(R) with other therapies. We are also in discussions to license, market and sell DAVANAT(R) on a regional basis internationally. The DMF filing will help to expedite these collaborations."
"The FDA recommended that we provide the chemistry, manufacturing and control information necessary to support an NDA. The DMF submission is an important step in our commercialization strategy for DAVANAT(R)," said Eliezer Zomer, Ph.D., Executive Vice President, Product Development & Manufacturing. "We are currently in discussions with potential pharmaceutical partners to broaden the use of DAVANAT(R) with other therapies. We are also in discussions to license, market and sell DAVANAT(R) on a regional basis internationally. The DMF filing will help to expedite these collaborations."
China Sky One Medical, Inc. Obtains SFDA Approval to Produce Two New Drugs
China Sky One Medical, Inc., announced today that its subsidiary, Heilongjiang Tianlong Pharmaceuticals, has obtained approvals for two new drugs; Oxymetazoline Hydrochloride Nasal Drops and Taurine Eye Drops, from the SFDA.
Oxymetazoline Hydrochloride Nasal Drops is approved for the treatment of acute and chronic rhinitis, sinusitis and allergic rhinitis. Taurine Eye Drops is approved for the treatment of acute and chronic conjunctivitis. The incidences of these diseases in China are extremely high. This is especially true in regions with colder weather as well as coastal regions.
The details can be read here.
Oxymetazoline Hydrochloride Nasal Drops is approved for the treatment of acute and chronic rhinitis, sinusitis and allergic rhinitis. Taurine Eye Drops is approved for the treatment of acute and chronic conjunctivitis. The incidences of these diseases in China are extremely high. This is especially true in regions with colder weather as well as coastal regions.
The details can be read here.
Launch of Highly Targeted Cancer Treatment Tasigna (nilotinib) Offers Potential Lifeline to Ph+ CML Patients Intolerant or Resistant to Imatinib
May 20, 2008 /PRNewswire-FirstCall/ --Tasigna(R) (nilotinib) is now available in the UK as a new option to treat adult patients who are intolerant or resistant to previous therapies for Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia (CML). The availability of Tasigna(R) means that the majority of patients with CML can now be effectively treated, even those who did not respond to or cannot tolerate previous therapies including Glivec(R) (imatinib).
The details can be read here.
The details can be read here.
Suven Life Sciences gets Two product patents for NCEs in South Africa and China
May 20, 2008 – Suven Life Sciences Ltd has announced that two product patents were granted in South Africa and China for two of their new chemical entities (NCEs) for the treatment of disorders associated with neuro-degenerative diseases and these patents are valid until 2024 and 2025 respectively.
The details can be read here.
The details can be read here.
Viralytics received Notice of Allowance on Core Technology
May 20, 2008-Viralytics Limited (VLA) is pleased to advise that it has received a Notice of Allowance from the European Patent Office for its patent application covering the use of its family of 4 Coxsackie viruses for the treatment of all cancers bearing expression of the ICAM-1 molecule.
A Notice of Allowance is formal advice (publicly available) that the European Patent Office intends to issue a patent, which is expected to be granted in the next six months.
The granted European patent will provide Viralytics protection over the exclusive use in Europe of our family of Coxsackie A group viruses in the treatment of ICAM-1 bearing cancers until 2020.
The details can be read here.
A Notice of Allowance is formal advice (publicly available) that the European Patent Office intends to issue a patent, which is expected to be granted in the next six months.
The granted European patent will provide Viralytics protection over the exclusive use in Europe of our family of Coxsackie A group viruses in the treatment of ICAM-1 bearing cancers until 2020.
The details can be read here.
Spear Pharmaceutical Inc.'s ANDA for Fluorouracil Cream 5%
Spear Pharmaceuticals, Inc. received FDA approval for, and began shipping, Fluorouracil Cream 5%, USP, a generic equivalent to Valeant's Efudex(R) Cream. On April 11, 2008, the FDA approved the ANDA (Abbreviated New Drug Application) based on Spear's 318 patient study proving bioequivalence to Efudex(R) for the precancerous Actinic Keratoses (AK) skin condition, the indication for which the product is overwhelmingly prescribed (approximately 98% of patients). The product is also useful in the treatment of superficial basal cell carcinoma (sBCC).
Since December 2004, Valeant Pharmaceuticals has taken action to make it far more difficult for any generic Efudex(R) product to gain FDA approval (Efudex(R) was first approved in 1970 and has been off patent for 20 years.) Specifically, Valeant filed in December, 2004 a Citizen Petition that delayed the approval of the Spear generic product from the industry average of 16.6 months to 39 months.
The details can be read here.
Since December 2004, Valeant Pharmaceuticals has taken action to make it far more difficult for any generic Efudex(R) product to gain FDA approval (Efudex(R) was first approved in 1970 and has been off patent for 20 years.) Specifically, Valeant filed in December, 2004 a Citizen Petition that delayed the approval of the Spear generic product from the industry average of 16.6 months to 39 months.
The details can be read here.
Teva Introduces Ropinirole Hydrochloride Tablets, 5 mg
May 20, 2008-Teva Pharmaceuticals announces the introduction and availability of Ropinirole Hydrochloride Tablets, 5 mg. This product is AB rated and bioequivalent to Requip(R)* Tablets.
Monday, May 19, 2008
GSK's flu vaccine gets EU authorisation
GlaxoSmithKline (GSK plc) announced that the European Commission has granted a marketing authorisation for its H5N1 adjuvanted pre-pandemic vaccine, Prepandrix, in all 27 EU member states. GSK is the first company to obtain a European licence for a pre-pandemic vaccine, thereby offering European governments the potential for protecting their population in advance or at the onset of an officially declared influenza pandemic.
The details can be read here.
The details can be read here.
Salix Pharmaceuticals Receives Approvable Letter from FDA for Balsalazide Tablet
May 17, 2008 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company has received an approvable letter from the U.S. Food and Drug Administration (FDA) for balsalazide tablet studied as a treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older.
"Late this afternoon Salix received a communication from the FDA that the Balsalazide Tablet NDA is approvable," stated Bill Forbes, Pharm.D., Vice President, Research and Development, and Chief Development Officer. "Salix will work diligently with the FDA over the next several days to compile a complete response to this approvable letter, which Salix believes will consist of referencing data already available."
The details can be read here.
"Late this afternoon Salix received a communication from the FDA that the Balsalazide Tablet NDA is approvable," stated Bill Forbes, Pharm.D., Vice President, Research and Development, and Chief Development Officer. "Salix will work diligently with the FDA over the next several days to compile a complete response to this approvable letter, which Salix believes will consist of referencing data already available."
The details can be read here.
Pharmaxis' Aridol Authorised for Sale in Germany
May 18, 2008 - Pharmaxis Ltd today announced that it has received national approval to market Aridol in Germany.
Aridol is indicated for measuring airway hyperresponsiveness and has been approved in 14 European countries under the mutual recognition procedure (MRP). The necessary national approvals that follow the MRP have now been received for Denmark, Germany, Ireland, The Netherlands, Portugal, Sweden, and the United Kingdom.
The details can be read here.
Aridol is indicated for measuring airway hyperresponsiveness and has been approved in 14 European countries under the mutual recognition procedure (MRP). The necessary national approvals that follow the MRP have now been received for Denmark, Germany, Ireland, The Netherlands, Portugal, Sweden, and the United Kingdom.
The details can be read here.
Tibotec Therapeutics Launches New Dosage Strength for Prezista
May 19, 2008 -- Tibotec Therapeutics today announced the availability of a new 600 mg tablet strength for Prezista (darunavir), a protease inhibitor (PI). The new dosage strength was approved by the U.S. Food and Drug Administration (FDA) on February 25, 2008. The recommended oral dose of PREZISTA for treatment-experienced adult patients with HIV-1 is 600 mg (one 600 mg tablet or two 300 mg tablets) taken twice daily with ritonavir 100 mg, in combination with other antiretroviral agents, and with food.
The details can be read here.
The details can be read here.
Lotus Pharmaceuticals, Inc. Obtains Patent and Exclusive Production Rights to Laevo-Bambutero Asthma Treatment
Lotus Pharmaceuticals, Inc. ("Lotus" or the "Company"), a pharmaceutical company in the People's Republic of China ("PRC"), today announced that it has signed the technology transfer agreement for Laevo- Bambutero with Dongguan Kaifa Biomedicine, Inc. ("Dongguan Kaifa"). Under the terms of agreement, Lotus obtained the patent and the exclusive production rights for Laevo-Bambutero in China.
The Company intends to market Laevo-Bambutero as a better alternative to Bambutero for the treatment of asthma, since it is uses an integrated method of composition and has fewer side effects. Lotus plans to launch the drug by 2012, pending on the approval from SFDA. Approximately 300 million people in the world suffer from asthma and that figure is expected to grow over the coming years due to increasing air pollution and other environmental factors. Lotus estimates that 400 million people will have asthma by 2015.
The Chinese government has granted a patent for Laevo-Bambutero. Lotus obtained the patent, along with exclusive production rights for Laevo-Bambutero in China, through the technology transfer agreement with Dongguan Kaifa for a cash payment of RMB 48 million and a 3% royalty on products sales. The Company has already paid RMB 20 million to Dongguan Kaifa.
"Through the technology transfer agreement with Dongguan Kaifa we have obtained exclusive production rights to a highly effective drug with a large addressable patient population," said Dr. Zhongyi Liu, Chairman, CEO and President of Lotus Pharmaceuticals, Inc. "We believe that the commercialization of Laevo-Bambutero will help to further strengthen and diversify our product portfolio and make a meaningful contribution to our revenue in the years ahead."
The Company intends to market Laevo-Bambutero as a better alternative to Bambutero for the treatment of asthma, since it is uses an integrated method of composition and has fewer side effects. Lotus plans to launch the drug by 2012, pending on the approval from SFDA. Approximately 300 million people in the world suffer from asthma and that figure is expected to grow over the coming years due to increasing air pollution and other environmental factors. Lotus estimates that 400 million people will have asthma by 2015.
The Chinese government has granted a patent for Laevo-Bambutero. Lotus obtained the patent, along with exclusive production rights for Laevo-Bambutero in China, through the technology transfer agreement with Dongguan Kaifa for a cash payment of RMB 48 million and a 3% royalty on products sales. The Company has already paid RMB 20 million to Dongguan Kaifa.
"Through the technology transfer agreement with Dongguan Kaifa we have obtained exclusive production rights to a highly effective drug with a large addressable patient population," said Dr. Zhongyi Liu, Chairman, CEO and President of Lotus Pharmaceuticals, Inc. "We believe that the commercialization of Laevo-Bambutero will help to further strengthen and diversify our product portfolio and make a meaningful contribution to our revenue in the years ahead."
PhytoPharmacon Strengthens Intellectual Property Position
May 19, 2008 - PhytoPharmacon LLC (formerly SaviPu Pharmaceuticals), a privately owned biopharmaceutical company, announced today the issuance of a new patent. The issued patent covers Myriceric acid derivatives for the treatment of cancer, cardiovascular and inflammatory diseases. The company is currently developing a Myriceric Acid A analog for the treatment of Androgen Refractory Prostate Cancer, one of the therapeutic areas of focus for PhytoPharmacon.
The patent also includes pharmaceutical compositions, methods of treatment for a number of other important inflammatory and cardiovascular diseases particularly arthritis, inflammatory bowel disease, asthma and COPD, osteoporosis, Alzheimer's, stroke, atherosclerosis, restenosis, diabetes, glomerulonephritis, cancer and cachexia.
The details can be read here.
The patent also includes pharmaceutical compositions, methods of treatment for a number of other important inflammatory and cardiovascular diseases particularly arthritis, inflammatory bowel disease, asthma and COPD, osteoporosis, Alzheimer's, stroke, atherosclerosis, restenosis, diabetes, glomerulonephritis, cancer and cachexia.
The details can be read here.
Biopure Wins European Patent Challenge
Biopure Corporation announced today that it has successfully defended a challenge at the European Patent Office (EPO) to its European Patent entitled, "A Method for Chromatographic Removal of Prions." This European Patent covers Biopure's innovative purification method for removing potentially infectious prion proteins from oxygen therapeutics and provides Biopure with granted patent rights to its method in France, Germany, the United Kingdom, Ireland, Italy, Spain, and Switzerland. The Opposition Division of the EPO supported Biopure's rights to all of the claims originally granted by the EPO without any modifications or restrictions. The patent challenge was brought in an Opposition by Switzerland-based Octapharma AG. Biopure also has granted patents covering its novel method in many additional countries, including the United States.
The details can be read here.
The details can be read here.
Intellect Neurosciences, Inc. Grants License for Certain Patents and Patent Applications to Wyeth and Elan Pharma International Ltd.
May 19, 2008 -- Intellect Neurosciences, Inc. , a biopharmaceutical company focused on development of disease-modifying therapeutic agents for the treatment and prevention of Alzheimer's disease (AD), announced today that it has entered into a license agreement with Wyeth and Elan Pharma International Ltd. ("Elan") regarding certain of Intellect's patents and patent applications related to antibodies and methods of treatment for Alzheimer's disease. Under the terms of the agreement, Wyeth and Elan may pay Intellect potential future milestone payments and royalties based on sales of potential products, if it is determined that they are covered by patents that issue from Intellect's patent applications.
The details can be read here.
The details can be read here.
Wyeth launches new anti-depressant in US
Wyeth Pharmaceuticals, a division of Wyeth, announced that Pristiq (desvenlafaxine), a new serotonin-norepinephrine reuptake inhibitor (SNRI) approved to treat adult patients with major depressive disorder (MDD), is now available in US retail pharmacies nationwide. The recommended dose of Pristiq is 50 milligrams (mg) once daily. The company begins full-scale selling and educational efforts regarding Pristiq for physicians this week.
The details can be read here.
The details can be read here.
Sunday, May 18, 2008
Ranbaxy gets USFDA approval for cyclobenzaprine
One of the India's largest pharma company has received US Food Drug and Administration approval for marketing its muscle relaxing drug cyclobenzaprine in US.
Ranbaxy will launch cyclobenzaprine hydrochloride in 5mg, 7.5 mg and 10 mg strength.
Ranbaxy will launch cyclobenzaprine hydrochloride in 5mg, 7.5 mg and 10 mg strength.
FDA Issues an FDA Alert and Information for Healthcare Professional Sheet for Mycophenolate Mofetil (CellCept) and Mycophenolic Acid (Myfortic)
May 16, 2008--FDA is aware of reports of infants born with serious congenital anomalies, including microtia and cleft lip and palate, following exposure to mycophenolate mofetil (MMF) during pregnancy. MMF, the active drug substance in CellCept, is an ester of the active metabolite mycophenolic acid (MPA), the active drug substance in Myfortic. In most cases, the mothers were taking MMF following an organ transplant to prevent organ rejection. However, some mothers taking MMF were being treated for immune-mediated conditions such as systemic lupus erythematosus (SLE) and erythema multiforme. Treatment began before their pregnancies and continued into the first trimester or until the pregnancy was detected. MMF is approved in the U.S. for use in the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants and MPA is approved in the U.S. for use in the prophylaxis of organ rejection in patients receiving allogeneic renal transplants. In patients who are transplant recipients, these drugs are almost always used in combination with other immunosuppressant drugs.
The details can be read here.
The details can be read here.
Arpida Announces FDA Acceptance of the Iclaprim New Drug Application
May 16, 2008 -- Arpida Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for intravenous iclaprim in the treatment of complicated Skin and Skin Structure Infections (cSSSI). Arpida completed the submission of the NDA to the agency in March 2008. FDA has assigned a standard ten month review to the iclaprim NDA and has established the Prescription Drug User Fee Act (PDUFA) action date for the NDA to be 16 January 2009.
The details can be read here.
The details can be read here.
Thursday, May 15, 2008
Zydus Cadila gets four US FDA approvals
Zydus Cadila has received four product approvals from US FDA. The group has received approvals to market Pravastatin' sodium tablets USP 10, 20, 40 and 80 mg and tentative approvals for Escitalopram Oxalate' tablets 5,10 and 20 mg, Losartan Potassium and Hydrochlorthiazide tablets 50 mgIl2.5 mg and 100 mgtl5 mg and Anastrazole tablets 1mg.
The US market of Pravatatin Sodium tablets, a lipid lowering agent which falls in the cardiovascular segment was estimated at US $1.9 billion in 2007. While the branded sales of Escitalopram Oxalate tablet, an anti - depressant was estimated at US $3 billions. Losartan potassium and hydrochlorthiazide tablets an anti hypertensive was estimated at US $785 million and that of Anastrazolc tablets, a hormone therapy to treat breast cancer, was estimated US $813 million in 2007 as per NDC.
The US market of Pravatatin Sodium tablets, a lipid lowering agent which falls in the cardiovascular segment was estimated at US $1.9 billion in 2007. While the branded sales of Escitalopram Oxalate tablet, an anti - depressant was estimated at US $3 billions. Losartan potassium and hydrochlorthiazide tablets an anti hypertensive was estimated at US $785 million and that of Anastrazolc tablets, a hormone therapy to treat breast cancer, was estimated US $813 million in 2007 as per NDC.
Terguride Receives FDA Orphan Drug Designation for the Treatment of Pulmonary Arterial Hypertension
May 15, 2008 -- Ergonex Pharma today announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation to Terguride for the treatment of pulmonary arterial hypertension (PAH). Terguride is currently being evaluated for PAH in a pivotal Phase II trial in Europe.
The details can be read here.
The details can be read here.
Orexo Has Submitted the Registration Application for Sublinox (OX22) to the FDA
May 15, 2008-This 505 (b) (2) NDA which is based on the clinical data completed October 2007. This data shows unique properties for Sublinox (OX22) in insomnia patients, including an earlier onset of sleep as compared to Ambien®. In addition to the earlier onset of sleep, the data also shows maintenance of sleep throughout the night. Sublinox (OX22) also offers a more convenient way of administration compared to oral tablets since it does not need to be swallowed with water. The first evaluation will take about two months and FDA will thereafter decide if the file is accepted for final evaluation.
Meda AB acquired the exclusive world-wide commercialization rights Sublinox (OX22) on April 14, 2008.
"This is an important first step to get Sublinox (OX22) out on the world market and we are proud of this accomplishment" said Torbjörn Bjerke, Orexo´s President and CEO.
(Source:www.pharmalive.com)
Meda AB acquired the exclusive world-wide commercialization rights Sublinox (OX22) on April 14, 2008.
"This is an important first step to get Sublinox (OX22) out on the world market and we are proud of this accomplishment" said Torbjörn Bjerke, Orexo´s President and CEO.
(Source:www.pharmalive.com)
Nearly 40 Percent of GERD Patients Taking PPIs Experience Recurring Symptoms
May 15, 2008 -- Despite daily use of doctor-recommended proton pump inhibitors (PPIs) to control gastroesophageal reflux disease (GERD) symptoms, nearly 40 percent of patients who take them continue to experience breakthrough, which is a return of GERD symptoms, such as acid regurgitation and heartburn. These breakthrough symptoms lead more than half of GERD sufferers to use over-the-counter (OTC) remedies, according to a survey recently conducted by the American Gastroenterological Association (AGA) Institute.
The details can be read here.
The details can be read here.
Valeant Pharmaceuticals Announces FDA Has Initiated Reconsideration of Generic Efudex Approval
May 15, 2008 - Valeant Pharmaceuticals (NYSE:VRX) today announced that the Food and Drug Administration (the FDA) has entered an administrative order "in the public interest" to stay the approval of generic fluorouracil cream 5% until May 30, 2008 "because there are outstanding questions regarding this approval that the Agency must consider." The FDA hopes to conclude its review by May 30, 2008 and Spear has agreed to an administrative stay of its ANDA approval until May 30, 2008. According to the administrative order by the FDA, signed by Associate Commissioner for Policy and Planning, Jeffrey Shuren, "marketing, sales and shipment under ANDA 77-524 are prohibited during the pendency of this administrative stay."
The details can be read here.
The details can be read here.
Lannett Company Provides Update on Marketing Digoxin Tablets
May 15, 2008 - Lannett Company, Inc. (AMEX:LCI), a manufacturer of generic pharmaceuticals, said today that it continues to work closely with the U.S. Food and Drug Administration (FDA) to ensure that an uninterrupted and safe supply of Digoxin Tablets is available for U.S. patients, following the FDA's announced recall of Digitek(R) brand of Digoxin.
The details can be read here.
The details can be read here.
KV Pharmaceutical Company Announces Approval for the 50 mg Strength of Generic Version of Toprol-XL
May 15, 2008, KV Pharmaceutical Company , a fully integrated specialty pharmaceutical company that develops, manufactures, acquires and markets technology-differentiated branded products and generic/non-branded prescription pharmaceuticals, announced today that it has received final approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) to market its 50 mg strength of metoprolol succinate extended-release tablets. The Company expects to begin shipping immediately. This product is a generic version of AstraZeneca's branded product, Toprol-XL(R) and the 50 mg strength recorded total branded and generic dollar volume in 2007 of $585 million according to IMS America. The 50 mg strength is the largest of the four strengths in both units sold and dollar volume.
The details can be read here.
The details can be read here.
Federal Circuit Affirms Decision Holding Lovenox Patent Unenforceable
Earlier today, the Federal Circuit affirmed a district court decision holding Aventis's patent on Lovenox (enoxaparin) unenforceable. The district court had found that renowned Aventis scientist, Dr. Andre Uzan, committed inequitable conduct during the prosecution of U.S. Patent No. 5,389,618, later reissued as RE38,743. Judge Prost wrote for the Court, joined by Judge Moore. Judge Rader dissented.
Dr. Uzan was not an inventor on the patent. Instead, he assisted in drafting one of the examples (Example 6) in the originally filed application. He also submitted two declarations during the course of the U.S. prosecution. The prosecution revolved around whether the claimed admixture of low molecular weight heparin (LMWH) was novel and/or nonobvious over a similar LMWH mixture disclosed in European Patent 40,144.
Example 6 compares the plasma half life for a composition embodying the invention with the half life of the LMWH composition disclosed in the '144 patent. The district court found that Example 6, coupled with Dr. Uzan's discussions of it in his declarations, overstated the case for the patentability of the claimed invention. The data from the '144 patent were for a 60 mg dose, but Example 6 failed to mention the dose. The example presented 40-mg and 60-mg data for the claimed LMWH. The 40-mg dose had a longer half life than the LMWH of the '144 patent, while the 60-mg dose did not. The district court found that Example 6 presented these data in a manner that highlighted the favorable results for the 40-mg dose, while obscuring the unfavorable results for the 60-mg dose. The district court found that Dr. Uzan's declarations compounded these potentially misleading aspects of Example 6. Thus, the district court found that the patent would never have issued apart from Dr. Uzan's exaggerated efforts to use Example 6 to distinguish the claimed LMWH from the prior art's LMWH.
Inequitable conduct requires an accused infringer to demonstrate that (1) the withheld or erroneous information was material to patentability, and (2) that the lack of candor was borne out of intent to deceive. Upon such a showing, the district court evaluates the equities and determines an appropriate equitable remedy. In a prior decision, the Federal Circuit had already held that Dr. Uzan's (mis)use of Example 6 was material to patentabilty. The case was remanded to determine whether he acted with deceptive intent.
Aventis, however, took a different course in its appeal. It elected to demonstrate that Dr. Uzan's conduct was indeed reasonable, and that the District Court clearly erred in reaching its finding of deceptive intent. The Federal Circuit was unpersuaded. Particularly, the court noted that some of Dr. Uzan's explanations for his conduct did not emerge until mid-way through the litigation.
In a further twist, the majority and the dissent both appear to question the court's prior materiality determination. After all, Aventis surrendered its original patent, deleted Example 6, and was awarded a reissue patent on the claimed LMWH.
Judge Rader's dissent takes a policy-oriented approach to the question of inequitable conduct. In ignoring the particulars of the case, he appears to concede that a mechanical application of the Court's recent jurisprudence may support the result that the majority reaches. Nevertheless, he suggests that equity is not well served when such a disproportionately harsh punishment is visited upon Aventis for conduct that was not even sufficient to affect the validity of the patent. Judge Rader notes that the Court's 1988 Kingsdown decision sought to make inequitable conduct an extraordinary and rare remedy. But the promise of Kingsdown has not lasted.
Barring an en banc reversal, the enoxaparin patent is no longer an impediment to the marketing of generic versions of bioequivalent LMWH. Amphastar, Teva and Momenta/Sandoz are all seeking FDA approval for a generic version of enoxaparin. LMWH is not a typical small-molecule drug, however; it is a complicated admixture of polysaccharides of varying molecular weights. Therefore, demonstrating bioequivalence is not a simple matter. Some have suggested that generic manufacturers may need to conduct limited clinical trials to gain marketing approval. Momenta recently stated that the FDA has decided not to require it to conduct clinical trials to gain approval for its generic enoxaparin.
The whole judgement can be read here.
(Source:Orange book blog)
Dr. Uzan was not an inventor on the patent. Instead, he assisted in drafting one of the examples (Example 6) in the originally filed application. He also submitted two declarations during the course of the U.S. prosecution. The prosecution revolved around whether the claimed admixture of low molecular weight heparin (LMWH) was novel and/or nonobvious over a similar LMWH mixture disclosed in European Patent 40,144.
Example 6 compares the plasma half life for a composition embodying the invention with the half life of the LMWH composition disclosed in the '144 patent. The district court found that Example 6, coupled with Dr. Uzan's discussions of it in his declarations, overstated the case for the patentability of the claimed invention. The data from the '144 patent were for a 60 mg dose, but Example 6 failed to mention the dose. The example presented 40-mg and 60-mg data for the claimed LMWH. The 40-mg dose had a longer half life than the LMWH of the '144 patent, while the 60-mg dose did not. The district court found that Example 6 presented these data in a manner that highlighted the favorable results for the 40-mg dose, while obscuring the unfavorable results for the 60-mg dose. The district court found that Dr. Uzan's declarations compounded these potentially misleading aspects of Example 6. Thus, the district court found that the patent would never have issued apart from Dr. Uzan's exaggerated efforts to use Example 6 to distinguish the claimed LMWH from the prior art's LMWH.
Inequitable conduct requires an accused infringer to demonstrate that (1) the withheld or erroneous information was material to patentability, and (2) that the lack of candor was borne out of intent to deceive. Upon such a showing, the district court evaluates the equities and determines an appropriate equitable remedy. In a prior decision, the Federal Circuit had already held that Dr. Uzan's (mis)use of Example 6 was material to patentabilty. The case was remanded to determine whether he acted with deceptive intent.
Aventis, however, took a different course in its appeal. It elected to demonstrate that Dr. Uzan's conduct was indeed reasonable, and that the District Court clearly erred in reaching its finding of deceptive intent. The Federal Circuit was unpersuaded. Particularly, the court noted that some of Dr. Uzan's explanations for his conduct did not emerge until mid-way through the litigation.
In a further twist, the majority and the dissent both appear to question the court's prior materiality determination. After all, Aventis surrendered its original patent, deleted Example 6, and was awarded a reissue patent on the claimed LMWH.
Judge Rader's dissent takes a policy-oriented approach to the question of inequitable conduct. In ignoring the particulars of the case, he appears to concede that a mechanical application of the Court's recent jurisprudence may support the result that the majority reaches. Nevertheless, he suggests that equity is not well served when such a disproportionately harsh punishment is visited upon Aventis for conduct that was not even sufficient to affect the validity of the patent. Judge Rader notes that the Court's 1988 Kingsdown decision sought to make inequitable conduct an extraordinary and rare remedy. But the promise of Kingsdown has not lasted.
Barring an en banc reversal, the enoxaparin patent is no longer an impediment to the marketing of generic versions of bioequivalent LMWH. Amphastar, Teva and Momenta/Sandoz are all seeking FDA approval for a generic version of enoxaparin. LMWH is not a typical small-molecule drug, however; it is a complicated admixture of polysaccharides of varying molecular weights. Therefore, demonstrating bioequivalence is not a simple matter. Some have suggested that generic manufacturers may need to conduct limited clinical trials to gain marketing approval. Momenta recently stated that the FDA has decided not to require it to conduct clinical trials to gain approval for its generic enoxaparin.
The whole judgement can be read here.
(Source:Orange book blog)
Wednesday, May 14, 2008
Lapatinib to be studied in early breast cancer
GlaxoSmithKline, in collaboration with the Breast International Group (BIG), a leading academic breast cancer research network, and one of its member groups, the Spanish Breast Cancer Cooperative Group (SOLTI), has announced the start of a global phase III study that will examine the role of lapatinib in the treatment of early breast cancer (EBC).
The details can be read here.
The details can be read here.
Forest and Daiichi Sankyo end hypertensive pact
Forest Laboratories, Inc. a U.S.-based pharmaceutical company, and Daiichi Sankyo, Inc. have terminated their co-promotion agreement for Azor (amlodipine and olmesartan medoxomil), Daiichi Sankyo's fixed-dose combination of two antihypertensives, the calcium channel blocker amlodipine besylate and the angiotensin receptor blocker olmesartan medoxomil.
Forest will record a one-time charge of $44.1 million which is composed of a one-time payment to Daiichi Sankyo of $26.6 million related to the termination and $17.5 million related to the unamortized portion of the initial upfront payment.
The details can be read here.
Forest will record a one-time charge of $44.1 million which is composed of a one-time payment to Daiichi Sankyo of $26.6 million related to the termination and $17.5 million related to the unamortized portion of the initial upfront payment.
The details can be read here.
FDA releases a Follow-up to the November 14, 2007, Communication about the Ongoing Safety Review of Cefepime (marketed as Maxipime)
May 14, 2008--On November 14, 2007, FDA announced that it was reviewing safety data that raised concerns about a potential increased mortality in patients treated with cefepime versus similar drugs noted in a meta-analysis published by Yahav et al. 1, and that FDA had requested additional data from the manufacturer, Bristol-Meyers Squibb (BMS) (Early Communication About an Ongoing Safety Review: Cefepime (marketed as Maxipime). FDA expected its preliminary review to take about 4 months and committed to communicate its conclusions and any resulting recommendations to the public at the completion of its review.
The details can be read here.
The details can be read here.
FDA Approves AstraZeneca's Seroquel for Maintenance Treatment in Bipolar Disorder
AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved SEROQUEL(R) (quetiapine fumarate tablets) for the maintenance treatment of patients with bipolar I disorder, as adjunct therapy to lithium or divalproex. SEROQUEL is approved by the FDA for the treatment of schizophrenia, and is also the only single agent approved by the FDA for the treatment of both depressive episodes in bipolar disorder and acute manic episodes associated with bipolar I disorder. (1,2)
The details can be read here.
The details can be read here.
Controller Decisions Goes Public
Indian Patent Office (IPO) has lately made Controller’s Decisions public by making an online search provision to search any of his decisions. Visit Indian Patent Office Patent Decision Search link. The search page is not that of global standards but still good enough to search. The decision can be searched using search condition restricted by any of the six options, (1) Patent Number, (2) Section, (3) Opponent, (4) Controller, (5) Application Number, and (6) Applicant Name.
IPO also made search option available for patent applications published under section 11A (18 months publication). However, search results are restricted to patent bibliographic details (more or less similar to details published in Patent Gazette), not full-text patent applications.
The link is here
(source: www.patentcircle.blogspot.com)
IPO also made search option available for patent applications published under section 11A (18 months publication). However, search results are restricted to patent bibliographic details (more or less similar to details published in Patent Gazette), not full-text patent applications.
The link is here
(source: www.patentcircle.blogspot.com)
Simcere Pharmaceutical Group Announces State FDA (China) Approval of Generic Biapenem Injection Anxin
Simcere Pharmaceutical Group , a leading manufacturer and supplier of branded generic pharmaceuticals and manufacturer of the patented anti-cancer biotech product Endu in China, today announced that it has received approval from the Chinese State Food and Drug Administration (SFDA) to manufacture and market a first- to-market generic Biapenem injection under the brand name Anxin.
Anxin is the first Biapenem injection approved for sale in China, and will be used for the treatment of serious infections. Biapenem is a member of the fast-growing carbenicillin family, like Tienam from Merck & Co. Inc. and Mepem from Sumitomo Pharmaceuticals Co. Ltd., with a potential market in China of RMB1.6 billion. This family of drug has seen an approximate 30% year over year growth rate in China over the last three years. As is the case with first-to- market branded generics in China, Anxin will enjoy an exclusive four-year market monitoring period, during which the SFDA will not accept further requests for approval of pharmaceuticals with the same chemical structure, dosage form and indication, that have not yet entered into clinical trial.
(Source: www.pharmalive.com)
Anxin is the first Biapenem injection approved for sale in China, and will be used for the treatment of serious infections. Biapenem is a member of the fast-growing carbenicillin family, like Tienam from Merck & Co. Inc. and Mepem from Sumitomo Pharmaceuticals Co. Ltd., with a potential market in China of RMB1.6 billion. This family of drug has seen an approximate 30% year over year growth rate in China over the last three years. As is the case with first-to- market branded generics in China, Anxin will enjoy an exclusive four-year market monitoring period, during which the SFDA will not accept further requests for approval of pharmaceuticals with the same chemical structure, dosage form and indication, that have not yet entered into clinical trial.
(Source: www.pharmalive.com)
Akorn-Strides, LLC Announces FDA Approval for Flumazenil Injection
May 14, 2008 - Akorn-Strides, LLC today announced the approval of an ANDA for Flumazenil Injection USP, 0.1 mg/mL, packaged in 5 mL and 10 mL Multiple Dose Vials. Akorn-Strides, LLC is a Joint Venture that was formed in 2005 by Akorn, Inc. (NASDAQ:AKRX) and Strides Arcolab Limited (NSE:STAR) (BSE:532531). The primary mission for the Joint Venture is to develop liquid, lyophilized and dry powder formulations of generic injectable products targeting several therapeutic markets with a major focus on anti-infectives, analgesics and CNS medicines.
Flumazenil Injection is indicated for the complete or partial reversal of the sedative effects of benzodiazepines. Recent IMS data estimates an annual market size of approximately $14 million.
The details can be read here.
Flumazenil Injection is indicated for the complete or partial reversal of the sedative effects of benzodiazepines. Recent IMS data estimates an annual market size of approximately $14 million.
The details can be read here.
Mylan Launches Paroxetine Hydrochloride Extended-Release Tablets
Mylan Inc. today announced that Mylan Pharmaceuticals Inc. has launched Paroxetine Hydrochloride (HCl) Extended-release (ER) Tablets, the generic version of GlaxoSmithKline's (GSK) Paxil CR(R). As the first company to successfully file an abbreviated new drug application (ANDA) containing a paragraph IV certification for the 12.5 mg and 25 mg tablets, Mylan has earned 180 days of marketing exclusivity for these two strengths. Reflecting a supply and distribution agreement with GSK, Mylan also has the right to market the 37.5 mg strength. Mylan is not aware of any other ANDA filers with paragraph IV certifications for this product.
The details can be read here.
The details can be read here.
Salix Commences Patent Infringement Litigation Against Novel Laboratories
May 14, 2008 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that Salix Pharmaceuticals, Inc.; Norgine, B.V. and Norgine Europe, B. V. have filed a lawsuit in the United States District Court for the District of New Jersey against Novel Laboratories, Inc. for infringement of Norgine's patent protecting MOVIPREP(R) (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution). Norgine licensed MOVIPREP to Salix for commercialization in the United States.
The lawsuit is in response to an Abbreviated New Drug Application (ANDA) filed by Novel with the US Food and Drug Administration regarding Novel's intent to market a generic version of MOVIPREP in the United States prior to the September 1, 2024 expiration of U.S. patent 7,169,381.
The details can be read here.
The lawsuit is in response to an Abbreviated New Drug Application (ANDA) filed by Novel with the US Food and Drug Administration regarding Novel's intent to market a generic version of MOVIPREP in the United States prior to the September 1, 2024 expiration of U.S. patent 7,169,381.
The details can be read here.
Perindopril tert-butyl amine polymorph patent held invalid by UK Supreme Court
In the patent spat between Servier (innovator) and Apotex (Generic), UK supreme court held the patent (EP1296947), covering crystalline polymorphic form α of perindopril tert-butylamine salt,invalid over the prior art patents i.e. EP0049658 and EP0380341.
This Judgement will be a setback for innovator companies attempting evergreening of products through polymorph patents.
The whole Judgement can be read here.
This Judgement will be a setback for innovator companies attempting evergreening of products through polymorph patents.
The whole Judgement can be read here.
Tuesday, May 13, 2008
Spectrum Pharma sells injectable generic drugs to Sagent Pharma
May 13, 2008: California based Spectrum Pharmaceuticals has sold its abbreviated new drug applications (ANDAs) for its injectable generic drugs, ondansetron, carboplatin, fludarabine, and mitoxantrone, to Sagent Pharmaceuticals.
“The sale of these non-core assets provides additional non-dilutive funding which will be used to further fund the advancement of our late stage clinical programs,” said Rajesh C. Shrotriya, Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals.
“This transaction allows us to quickly add these important near-term products to our pipeline of more than 200 products,” said Jeffrey M. Yordon, CEO, founder and chairman of the board of Sagent Pharmaceuticals. “Our extensive global development network will enable us to accelerate commercialization of these products at a comparatively low cost.”
(Source:www.biospectrumasia.com)
“The sale of these non-core assets provides additional non-dilutive funding which will be used to further fund the advancement of our late stage clinical programs,” said Rajesh C. Shrotriya, Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals.
“This transaction allows us to quickly add these important near-term products to our pipeline of more than 200 products,” said Jeffrey M. Yordon, CEO, founder and chairman of the board of Sagent Pharmaceuticals. “Our extensive global development network will enable us to accelerate commercialization of these products at a comparatively low cost.”
(Source:www.biospectrumasia.com)
Piramal Life Sciences begins phase I trial for type II diabetes in Europe
Piramal Life Sciences Ltd, part of the Piramal Group of companies, has commenced a phase I study of a new, orally active glucose-lowering compound, P1736, in The Netherlands.
P1736 is a non-PPAR compound and is being developed for the treatment of type II diabetes. The compound is significantly different from the currently marketed drugs, as it does not have any adverse side effects on liver function, blood plasma volume expansion or those related to weight gain.
The details can be read here.
P1736 is a non-PPAR compound and is being developed for the treatment of type II diabetes. The compound is significantly different from the currently marketed drugs, as it does not have any adverse side effects on liver function, blood plasma volume expansion or those related to weight gain.
The details can be read here.
Veeda Oncology acquires Paris based CRO firm Biologie et Industrie
Veeda Oncology, the subsidiary of one of the leading Global CRO's in India, Veeda Clinical Research, has completed the acquisition of Biologie et Industrie (B&I), an Oncology CRO founded in 1984, based in Paris, France. The acquisition of B&I, with over 20 years of oncology CRO experience, significantly compliments Veeda Oncology's capability within mainland Europe.
The details can be read here.
The details can be read here.
Aripiprazole gets expanded indications in Bipolar I disorder and Schizophrenia
Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company announced that Abilify (aripiprazole) received expanded indications in Bipolar I Disorder and Schizophrenia.
Abilify is now indicated for maintenance treatment of manic and mixed episodes associated with Bipolar I disorder with or without psychotic features in paediatric patients (aged 10-17) and maintenance treatment of Schizophrenia in adolescents (aged 13-17). In addition, Abilify is also granted an indication for adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with Bipolar I disorder with or without psychotic features in paediatric patients (aged 10-17).
The details can be read here.
Abilify is now indicated for maintenance treatment of manic and mixed episodes associated with Bipolar I disorder with or without psychotic features in paediatric patients (aged 10-17) and maintenance treatment of Schizophrenia in adolescents (aged 13-17). In addition, Abilify is also granted an indication for adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with Bipolar I disorder with or without psychotic features in paediatric patients (aged 10-17).
The details can be read here.
Barr gets nod for contraceptive generic (Yasmin)
Barr Pharmaceuticals, announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market a generic version of Yasmin (drospirenone and ethinyl estradiol), an oral contraceptive product manufactured and marketed by Bayer Schering Pharma, AG.
On March 3, 2008 Barr announced that the US District Court for the district of New Jersey had ruled in favour of its subsidiary, Barr Laboratories Inc., in the challenge of the patent listed by Bayer Schering Pharma, AG for its Yasmin product. In his ruling, Judge Peter G Sheridan found that the patent at issue was invalid, because it was obvious. On April 1, 2008, Bayer Schering appealed this ruling to the US Court of appeals for the Federal Circuit.
The details can be read here.
On March 3, 2008 Barr announced that the US District Court for the district of New Jersey had ruled in favour of its subsidiary, Barr Laboratories Inc., in the challenge of the patent listed by Bayer Schering Pharma, AG for its Yasmin product. In his ruling, Judge Peter G Sheridan found that the patent at issue was invalid, because it was obvious. On April 1, 2008, Bayer Schering appealed this ruling to the US Court of appeals for the Federal Circuit.
The details can be read here.
Aurobindo gets MCC approval for nine products
Aurobindo Pharma Ltd has received approvals from the Medicines Control Council (MCC) to manufacture and market nine products in South Africa. These products are estimated to have a generic market size of ZAR 165 million in the local market
The company has received approvals for Auro-Lisinopril Co (CVS), Auro-Amlodipine (CVS), Auro-Finasterid (BPH), Zinoxime (anti-infective), Zolid (CNS), Yomax (anti-infective), Lazivir (ARV) Lisinozide (CVS) and Profina (BPH).
(Source: www.pharmabiz.com)
The company has received approvals for Auro-Lisinopril Co (CVS), Auro-Amlodipine (CVS), Auro-Finasterid (BPH), Zinoxime (anti-infective), Zolid (CNS), Yomax (anti-infective), Lazivir (ARV) Lisinozide (CVS) and Profina (BPH).
(Source: www.pharmabiz.com)
S*BIO Receives Orphan Drug Designation for JAK2 Inhibitor SB1518 for the Treatment of Myeloproliferative Disorders
S*BIO Pte Ltd today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to SB1518, its potent and orally-active JAK2 inhibitor for the treatment of myeloproliferative disorders (MPD). The FDA accepted S*BIO's application upon review of preclinical data which demonstrated excellent anti-proliferative and anti-tumor activity, combined with very good tolerability of the JAK2 inhibitor.
The details can be read here.
The details can be read here.
Cipher provides regulatory update for CIP-TRAMADOL ER
Cipher Pharmaceuticals Inc. today announced that a revised New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) for CIP-TRAMADOL ER, its extended-release formulation of tramadol. In May 2007, the Company received an approvable letter from the FDA pertaining to its NDA for CIP-TRAMADOL ER.
Cipher's revised NDA includes data from additional pharmacokinetic studies conducted by the Company comparing CIP-TRAMADOL ER to Ultram(R) ER.
After considering feedback from the FDA appeal process and the results of the additional statistical sensitivity analysis of existing data suggested by the FDA, Cipher and its advisors concluded that submitting the revised NDA provided the most expeditious path to final regulatory approval.
Subject to FDA acceptance for filing, Cipher expects the review to be completed by October 2008. It is possible that the submission could trigger patent infringement litigation and a stay of up to 30 months under the Hatch-Waxman Act.
Cipher's revised NDA includes data from additional pharmacokinetic studies conducted by the Company comparing CIP-TRAMADOL ER to Ultram(R) ER.
After considering feedback from the FDA appeal process and the results of the additional statistical sensitivity analysis of existing data suggested by the FDA, Cipher and its advisors concluded that submitting the revised NDA provided the most expeditious path to final regulatory approval.
Subject to FDA acceptance for filing, Cipher expects the review to be completed by October 2008. It is possible that the submission could trigger patent infringement litigation and a stay of up to 30 months under the Hatch-Waxman Act.
FDA Approves Novo Nordisk's NovoSeven RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) for Hemophilia Patients With Inhibitors
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved NovoSeven(R) RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable), the first room temperature stable recombinant product available for the treatment of bleeding episodes in patients with hemophilia with inhibitors. NovoSeven(R) RT is a new formulation of NovoSeven(R) (Coagulation Factor VIIa [Recombinant]) designed to provide patients with added flexibility when treating their condition.
The details can be read here.
The details can be read here.
Calando Granted Broad Patent Rights to RNAi Technology in China
May 13, 2008 - Calando Pharmaceuticals, a majority owned subsidiary of Arrowhead Research Corporation (NASDAQ:ARWR), announced today the issuance of Chinese Patent No. 28266625, entitled "Methods and compositions for therapeutic use of RNA interference." The Chinese patent broadly covers all methods of using any RNA interference ('RNAi') construct formulated "in a supramolecular complex" to attenuate the expression of any target gene. Supramolecular complex formulations are any that are formed with any type of polymer. The patent also broadly covers all pharmaceutical compositions of matter containing RNAi constructs "adapted for pulmonary or nasal delivery" to the lungs.
The therapeutic potential of RNAi-based drugs cannot likely be fulfilled unless they can effectively be delivered to target tissues. The Chinese patent provides a basis for delivery of RNAi-based drugs in patients of the world's most populous country; and with respect to respiratory pharmaceuticals, the Chinese patent is not limited to any specific mode of siRNA delivery.
"We are pleased that the Chinese Patent Office has affirmed the pioneering efforts of Calando in the area of RNAi delivery," said James Hamilton, Calando's CEO. "This patent greatly enhances Calando's dominant international intellectual property position with respect to the delivery of RNAi-based drugs." Calando's CALAA-01 has been cleared by the FDA to begin phase I clinical trials and is on track to be the first clinical study using targeted, systemic delivery of siRNA and the first siRNA trial in oncology.
(Source:www.pharmalive.com)
The therapeutic potential of RNAi-based drugs cannot likely be fulfilled unless they can effectively be delivered to target tissues. The Chinese patent provides a basis for delivery of RNAi-based drugs in patients of the world's most populous country; and with respect to respiratory pharmaceuticals, the Chinese patent is not limited to any specific mode of siRNA delivery.
"We are pleased that the Chinese Patent Office has affirmed the pioneering efforts of Calando in the area of RNAi delivery," said James Hamilton, Calando's CEO. "This patent greatly enhances Calando's dominant international intellectual property position with respect to the delivery of RNAi-based drugs." Calando's CALAA-01 has been cleared by the FDA to begin phase I clinical trials and is on track to be the first clinical study using targeted, systemic delivery of siRNA and the first siRNA trial in oncology.
(Source:www.pharmalive.com)
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