Sequence Listing e-Filing Options Using EFS-Web

Since the launch of EFS-Web in the fall of 2006, applicants have had the option of e-filing sequence listings as text (.txt) files only, rather than filing sequence listings in both paper and computer readable copies. Several biotech prosecutors in our office have had recent discussion and debate about what files and statements can or must be filed with an EFS-Web filed sequence listing in order to be compliant with the requirements under the Legal Framework and in order for it to be considered as part of the original application.

As we discussed in November 2006 (see "Hassle-Free Filing of Sequence Listings on EFS-Web Version 1.1"), the early version of EFS-Web was limited because it allowed submission of files in .pdf format only and was not able to handle sequence listing filings because they needed to be submitted as text files (.txt). Since the upgrade to EFS-Web 1.1 in October of 2006, practitioners have been able to electronically submit text files such as sequence listings, computer program listings, and mega tables.

The details can be read here.

Merck launches Femibion for anaemia in women

Aiming to reach out to women with iron deficiency in India, the Consumer Health Care division of Merck Limited (India), a subsidiary of Merck KGaA of Germany, announced the launch of Femibion - Sharp & Active capsules in the country. The product mainly targets non-pregnant women and is looking forward for the market size of around Rs 700 crore.

The details can be read here.

Zydus Cadila gets US FDA nod for three anti-epileptic drugs

Zydus Cadila has received three product approvals from the US FDA in quick succession. The group has received approvals to market lamotrigine chewable tablets in strengths of 2 mg, 5 mg and 25 mg. lamotrigine tablets -25 mg, 50 mg, 100 mg, 150 mg, 200mg and 250mg and divalproc sprinkle capsules, 125 mg.

The details can be read here.

Alexion's Soliris (eculizumab) Receives Marketing Approval in Canada for All Patients with PNH

Jan 29, 2009 - Alexion Pharmaceuticals, Inc., today announced that Canada's national healthcare regulatory agency, Health Canada, has approved the use of Soliris (eculizumab) for the treatment of all patients in Canada with paroxysmal nocturnal hemoglobinuria (PNH), a rare, debilitating and life-threatening blood disorder defined by chronic red blood cell destruction, or hemolysis. Soliris is the first therapy approved in Canada for the treatment of PNH.

The details can be read here.

Actelion Pharmaceuticals Ltd - Zavesca (miglustat) receives EU approval

Actelion Ltd announced today that Zavesca (miglustat) has been approved in the European Union for the treatment of progressive neurological manifestations in adult patients and pediatric patients with Niemann-Pick type C disease (NPC).

The details can be read here.

Biota Holdings Limited: UK Government Orders 10.6 Million Courses of Relenza

Biota Holdings Limited today announced that GlaxoSmithKline has been awarded a significant contract by the UK Department of Health for 10.6 million treatment courses of RelenzaTM (zanamivir).

The details can be read here.

Bedford Laboratories to Begin Shipping Irinotecan HCl Injection

Bedford Laboratories(TM), a division of Ben Venue Laboratories, Inc., announced the launch of Irinotecan HCl Injection. This product is AP rated and is equivalent to Camptosar(R).

The details can be read here.

ETHEX Corporation Issues Nationwide Voluntary Recall of Products

ETHEX Corporation, a subsidiary of KV Pharmaceutical , is issuing, as previously disclosed by KV Pharmaceutical Company on January 26, 2009, a nationwide voluntary recall of the products identified below at a wholesale or a retail level as a precautionary measure because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs).

The details can be read here.

Mylan Receives Final FDA Approvals for Generic Versions of Lamictal Tablets and Lamictal CD

Mylan Inc. today announced that its subsidiaries Mylan Pharmaceuticals Inc. and Genpharm ULC received final approvals from the U.S. FDA for their Abbreviated New Drug Applications for Lamotrigine Tablets.

The details can be read here.

Taro Receives Final FDA Approval for Lamotrigine Tablets ANDA

Jan 28, 2009 - Taro Pharmaceutical Industries Ltd. reported today that it has received final approval from the U.S. FDA for its Abbreviated New Drug Application for Lamotrigine Tablets 25 mg, 100 mg, 150 mg, and 200 mg. Taro had received tentative approval for this ANDA in March 2008.

The details can be read here.

Jubilant Organosys incurs net loss of Rs 88 cr in Q3

Jubilant Organosys, a Noida-based pharmaceutical and largest custom research and manufacturing services company, has suffered heavy setback during the third quarter ended December 2008 on account of foreign exchange loss of Rs 131.37 crore as compared to gain of Rs 13.34 in the last period and higher interest burden. The company's consolidated net loss touched to Rs 87.57 crore as against the net profit of Rs 89.44 crore in the corresponding period of last year. The profit before exceptional items and taxation declined by 21.3 per cent to Rs 80.50 crore from Rs 102.25 crore in the similar period of last year.

The details can be read here.

Inspire Initiates Phase 3 Prolacria Dry Eye Trial under Special Protocol Assessment Agreement

Jan 27, 2009 - Inspire Pharmaceuticals, Inc. announced today it has reached agreement with the U.S. FDA through a Special Protocol Assessment (SPA) on the design of a Phase 3 clinical trial for Prolacria (diquafosol tetrasodium ophthalmic solution) 2% for the treatment of dry eye disease and has recently initiated enrollment in the trial.

The details can be read here.

FDA Issues an Early Communication about an Ongoing Safety Review of clopidogrel bisulfate (marketed as Plavix)

This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a cause and effect relationship between the drug products and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.

The FDA is aware of published reports that clopidogrel (marketed as Plavix) is less effective in some patients than it is in others. Differences in effectiveness may be due to genetic differences in the way the body metabolizes clopidogrel, or that using certain other drugs with clopidogrel can interfere with how the body metabolizes clopidogrel.

The details can be read here.

KV Pharmaceutical's Launch of Gestiva Delayed

January 26, 2009 -- KV Pharmaceutical has been notified that the pending New Drug Application for Gestiva (alpha hydroxyprogesterone caproate) will not be approved by the U.S. FDA until further conditions are met.

The details can be read here.

Sirion Therapeutics New Drug Application for Ganciclovir is Accepted for Review by the FDA for the Treatment of Ocular Herpes

Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, today announced that its New Drug Application (NDA) for ganciclovir ophthalmic gel, 0.15%, has been accepted for review by the U.S. Food and Drug Administration (FDA). Sirion Therapeutics is seeking approval for ganciclovir as a treatment for herpetic keratitis, an ocular disease caused by the herpes simplex virus. The FDA has issued an action date in late fall of 2009, under the Prescription Drug User Fee Act.

The details can be read here.

Theravance Submits U.S. NDA for Telavancin for the Treatment of Hospital-Acquired Pneumonia

January 26, 2009 - Theravance, Inc. announced today that it submitted a New Drug Application (NDA) to the U.S. FDA for telavancin, a novel, bactericidal, once-daily injectable investigational antibiotic, for the proposed indication to treat nosocomial pneumonia caused by Gram-positive bacteria such as methicillin-resistant Staphylococcus aureus

The details can be read here.

Targin (oral oxycodone/naloxone prolonged-release tablet) now launching across Europe to control severe chronic pain with reduced risk of constipation

26 January 2009 - Mundipharma today announced that 13 countries to date have received approval of Targin, a new combination therapy designed to control severe chronic pain whilst counteracting opioid-induced constipation, a common and often debilitating side effect associated with opioid treatment.1,2,3 A period of European launches will now be initiated.

The details can be read here.

Life Technologies Wins Verdict on its SOLiD Sequencing System

Jan 27, 2009 - Life Technologies Corporation announced today that a jury in the U.S. District Court for the Northern District of California rendered a verdict in its favor in its patent-infringement dispute with Illumina, Inc.

The details can be read here.

Perrigo Company Appointed Generic Distributor by Medimetriks Pharmaceuticals

Medimetriks Pharmaceuticals announced today that the Company has entered into a Distributor Agreement with Perrigo Company, a leading manufacturer in the generic prescription marketplace, designating Perrigo as the Exclusive Authorized Distributor of generic versions of Medimetriks' branded products in the U.S.

The details can be read here.

New Biologic Stelara Receives Approval In Europe For Treatment Of Moderate To Severe Plaque Psoriasis

Janssen-Cilag announced today that STELARA (ustekinumab), the first in a new class of biologics, has been approved by the European Commission for use across Europe.

The details can be read here.

Health Canada Approves Zeldox for the Treatment of Acute Manic or Mixed Episodes Associated With Bipolar Disorder

Pfizer Canada Inc. announced today that Health Canada has approved ZELDOX (ziprasidone hydrochloride), for use in the treatment of acute manic or mixed episodes associated with bipolar disorder. Prompt and effective control of acute manic or mixed episodes is an important goal as patients are at an increased risk for impulsive and dangerous behaviors, often requiring psychiatric hospitalization.

The details can be read here.

Antares Pharma Receives Milestone Payment from Teva for Pen Injector Device Filing

Jan 22, 2009 - Antares Pharma, Inc. announced that the Company received a milestone payment from Teva Pharmaceutical Industries Ltd. related to the filing of a Device Master File for a novel disposable pen injector. The pen injector is being developed under a license agreement signed in January 2008 between the companies where Antares will supply a custom proprietary pen for two self-administered drugs that ultimately will be marketed by Teva.

The details can be read here.

Novartis Launches Extavia, A New Therapeutic Option To Help Patients Combat Devastating Symptoms Of Multiple Sclerosis

January 22, 2009 - Novartis has today announced the launch of Extavia, a new version of the standard-of-care for relapsing forms of multiple sclerosis (MS), providing patients and physicians with an alternative option to help manage this devastating disease.

the details can be read here.

Johnson & Johnson net earnings jumps by 22.4% in 2008

Johnson & Johnson (J&J) has generated higher net profit of US$ 12,949 million during the year ended 2008 as against $10,576 million in the previous year, a strong growth of 22.4 per cent.

The details can be read here.

Jubiliant develops advanced software solution for high-throughput drug molecule screening

Jubilant Organosys Ltd, headquarted at Noida, near New Delhi, announced that its subsidiary Jubilant Biosys Ltd based in Bangalore has developed a next generation screening solution, Legend NGSS, that will further enable the process of high throughput screening, accelerating global drug discovery. The software to be launched in the US and Europe initially, allows scientists to capture, store, and analyze Oracle 9i/10g based screening data with greater flexibility, accuracy and speed.

The details can be read here.

Delhi HC allows CPAA a party in Bayer's litigation against Cipla on Nexavar

The Delhi High Court has allowed the Cancer Patients Aids Association, an NGO working for the welfare and rights of thousands of cancer patients in India, as party to the on-going legal battle between the multinational pharma company Bayer and the Indian generic major Cipla over the Bayer's kidney cancer drug Nexavar (Sorafenib tosylate).

The details can be read here.

Insmed and Premacure Announce European Orphan Designation for IPLEX in Retinopathy of Prematurity in Infants

Insmed Inc. , a developer of follow-on biologics and biopharmaceuticals, and Premacure AB, a biopharmaceutical company dedicated to the development of, diagnosis and prevention of complications in neonates due to premature birth, today announced that the European Medicines Agency (EMEA) has granted Premacure orphan designation for Insmed's IPLEX(TM) product, also known as mecasermin rinfabate, for the prevention of retinopathy of prematurity (ROP) in neonates of less than 32 weeks of gestational age.

The details can be read here.

Four innovative Novartis Medicines for Cancer, Asthma, High Blood Pressure and Wet AMD Approved in Japan

January 21, 2009 - Patients in Japan stand to benefit from the approval of four innovative medicines - Tasigna for the treatment of a life-threatening form of leukemia, Xolair for severe asthma, Co-Dio [*] for high blood pressure, and Lucentis® for wet age-related macular degeneration (AMD), an eye disease that is a major cause of blindness in people over the age of 50 in Japan.

The details can be read here.

Parkinson’s Disease Drug “Trerief” Obtained Manufacturing and Marketing Approval

Jan. 21, 2009-Dainippon Sumitomo Pharma Co., Ltd. announces that the Company has obtained a manufacturing and marketing approval for “TRERIEF tablet 25 mg” (zonisamide) as of January 21, 2009 from Ministry of Health, Labor and Welfare.

The details can be read here.

New Drug Application Approval for Ecard HD and Ecard LD in Japan

January 21, 2009 – Takeda Pharmaceutical Company Limited announced today that a New Drug Application for ECARD, a fixed dose combination tablet of Blopress (generic name: candesartan cilexetil) and a low-dose diuretic (generic name: hydrochlorothiazide) for treatment of hypertension, was approved on January 21 by the Japanese Ministry of Health, Labour and Welfare.

The details can be read here.

Recalbon Tablets / Bonoteo Tablets Approved for the Osteoporosis Treatment,

Ono Pharmaceutical Co., Ltd. and Astellas Pharma Inc. today announced that RECALBON Tablets 1 mg (Ono) / Bonoteo® Tablets 1 mg (Astellas) (generic name: minodronic acid hydrate) was granted a Japanese marketing approval on January 21, 2009.

The details can be read here.

RoActemra Approved in Europe to Treat Patients Suffering From Rheumatoid Arthritis

21 January 2009 - Roche today announced that the European Commission has approved RoACTEMRA (tocilizumab, known as Actemra outside of the EU), to treat patients with rheumatoid arthritis. RoACTEMRA, in combination with methotrexate is indicated for the treatment of adult patients with moderate to severe RA who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor antagonists.

The details can be read here.

King Pharmaceuticals Reports Intent to Appeal Skelaxin Summary Judgment Order

Jan 21, 2009 - King Pharmaceuticals, Inc. reported today that the U.S. District Court for the Eastern District of New York in the case of King Pharmaceuticals, Inc., et al. v. Eon Labs, Inc., Case No. 04-cv-5540 (DGT), issued an Order invalidating United States Patent Nos. 6,407,128 and 6,683,102, two patents relating to SKELAXIN (metaxalone).

The details can be read here.

Actavis Receives Approval of Levetiracetam Oral Solution in the US

Jan. 21, 2009-Actavis has received approval from the US FDA to market Levetiracetam Oral Solution. Distribution of the product has commenced.

The details can be read here.

APP Pharmaceuticals Launches Rocuronium Bromide Injection

Jan 20, 2009 - APP Pharmaceuticals, Inc., a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has launched Rocuronium Bromide Injection, the generic equivalent of Organon's Zemuron.

The details can be read here.

US FDA opens office in Delhi, around 100 approved plants to come under vigilance

Around 100 US FDA approved pharma plants in different parts of the country will come under the direct radar of the US regulatory authorities, as the US FDA has opened its first office in the country in New Delhi on January 15. By establishing its offices in India, the US FDA aims for better coordination with the regulatory authorities and the industry in India to ensure safety of food and medicinal products being exported to the US from India.

The details can be read here.

US FDA seeks additional data from Pfizer's osteoporosis drug lasofoxifene

Pfizer Inc said it has received a complete response letter from the US FDA asking for additional information on the company's application for lasofoxifene. The investigational compound is currently under review for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

The details can be read here.

Dr Reddy's Labs consolidated net jumps by 156% in Q3 to Rs 159 cr

Dr Reddy's Laboratories, the second largest pharmaceutical company in India with consolidated net sales over Rs 4900 crore, has posted impressive performance during the third quarter ended December 2008. The company's consolidated net profit has taken quantum jump and touched to Rs 159.16 crore from Rs 62.55 crore in the corresponding period of last year.

The details can be read here.

FDA Grants Orphan Drug Designation to ChemGenex's Omacetaxine for the Treatment of Myelodysplastic Syndromes

Jan 19, 2009 - ChemGenex Pharmaceuticals Limited announced today that the United States FDA has granted Orphan Drug designation to omacetaxine for the treatment of Myelodysplastic Syndromes (MDS).

The details can be read here.

Review of Takeda's Febuxostat New Drug Application Continues Past PDUFA Date

January 19, 2009 -- Takeda Pharmaceutical Company Limited today announced that Takeda Global Research & Development Center, Inc., a wholly owned United States subsidiary, received notification from the U.S. FDA that FDA will not be able to complete its review of the febuxostat New Drug Application by the Prescription Drug User Fee Act (PDUFA) date of January 18, 2009.

The details can be read here.

3SBio Inc. Files for SFDA Approval for TPIAO Label Extension for the Treatment of ITP

January 20, 2009 -- 3SBio Inc. , a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, today announced that it filed on December 30, 2008 with the Chinese State Food and Drug Administration for approval of a TPIAO label extension for the treatment of idiopathic thrombocytopenic purpura (ITP) in China. If the extension is approved, 3SBio expects that TPIAO for ITP will be the only treatment of this kind available in China.

The details can be read here.

FDA Issues Complete Response Letter to SCOLR Pharma's Abbreviated New Drug Application for CDT 12-Hour Pseudoephedrine

SCOLR Pharma, Inc. today announced that the U. S. FDA has issued a Complete Response letter for its Abbreviated New Drug Application for pseudoephedrine. The application, filed by SCOLR on August 5, 2008, seeks approval to market a 120 mg 12 hour pseudoephedrine tablet based on its patented Controlled Delivery Technology (CDT(R)) platform.

The details can be read here.

Stallergenes: Oralair Grasses Obtains a Pediatric MA in Germany

Stallergenes S.A. today announced that the Paul Ehrlich Institute, the German agency in charge of regulating biological products, has approved its application for a pediatric extension (5-17 years) of the indications for Oralair(R) Grasses, sublingual tablets for desensitization to grass pollens.

The details can be read here.

Intercell Signs Exclusive Agreement for Marketing and Distribution of its Japanese Encephalitis Vaccine in Japan and Korea

January 19, 2009 – Intercell AG announced it has signed an exclusive agreement with Novartis AG for the marketing and distribution of Intercell’s vaccine candidate to prevent Japanese Encephalitis, in Japan and Korea.

The details can be read here.

Court Report

About Court Report: Each week http://www.patentdocs.org/ report briefly on recently filed biotech and pharma cases, and they select few interesting cases for periodic monitoring.

Oscient Pharmaceuticals Corp. et al. v. Lupin Ltd. et al.1:09-cv-00083; filed January 14, 2009 in the District Court of Maryland

AstraZeneca AB et al. v. Sandoz, Inc.3:09-cv-00199; filed January 14, 2009 in the District Court of New Jersey

Medicis Pharmaceutical Corp. v. Mylan Inc. et al.1:09-cv-00033; filed January 13, 2009 in the District Court of Delaware

AstraZeneca Pharmaceuticals LP et al. v. Biovail Laboratories International SRL et al.3:09-cv-00128; filed January 9, 2009 in the District Court of New Jersey

Life Technologies Corp. v. Oxford Biomedical Research, Inc. et al.3:09-cv-00029; filed January 9, 2009 in the Middle District of Tennessee

Wyeth v. Torrent Pharmaceuticals Ltd. et al.1:09-cv-00019; filed January 8, 2009 in the District Court of Delaware

Alcon Research, Ltd. et al. v. Barr Laboratories, Inc.1:09-cv-00026; filed January 8, 2009 in the Southern District of Indiana

Dr. Reddy's Laboratories, Ltd. et al. v. Eli Lilly & Co,3:09-cv-00192; filed January 8, 2009 in the District Court of New Jersey

Abbott Laboratories et al. v Bayer Healthcare, LLC4:09-cv-40002; filed January 5, 2009 in the District Court of Massachusetts

The details and the complaints filed can be read here.

Rapid Generic Erosion of Branded Agents, Including Market-Leading Viagra, Will Cause Sales of Erectile Dysfunction Drugs Remain Flat Over Next decade

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, despite the anticipated launch of five emerging drugs during the 2007-2017 forecast period, total sales for erectile dysfunction therapies will remain relatively constant, totaling $2.2 billion in 2007 and $2.1 billion in 2017.

The details can be read here.

US FDA issues guidance for industry to improve safety of foods, feeds & drugs

The US Food and Drug Administration issued three guidance designed to help ensure the safety of FDA-regulated products in the supply chain.

The document issued include, final Guidance for Industry on Voluntary Third-Party Certification Programmes for Foods and Feeds; Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories; and Draft Guidance for Industry on Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages.

The details can be read here.

Nycomed gets rights to develop & market EffRx's osteoporosis drug alendronate

Nycomed and EffRx announced a licensing agreement on EffRx' drug EX101 (effervescent alendronate) for the treatment of osteoporosis.

The details can be read here.

Cypress Pharmaceutical, Inc. Receives FDA Approval of Levetiracetam Oral Solution

Jan 16, 2009 - Cypress Pharmaceutical, Inc., announced today that the U.S. FDA has granted final approval of the company's abbreviated new drug application for Levetiracetam Oral Solution, 100 mg/mL.

The details can be read here.

Lupin is Granted USFDA Approval for Levetiracetam Tablets

Lupin Pharmaceuticals, Inc. announced today that it has received final approval for the Company's Abbreviated New Drug Application for Levetiracetam Tablets 250mg, 500mg, 750mg and 1000mg from the U.S. FDA. Commercial shipments of the product have commenced.

the details can be read here.

Warner Chilcott Files New Lawsuit for Infringement of Doryx Patent

Warner Chilcott Limited announced today that one of its subsidiaries and Mayne Pharma International Pty. Ltd., a subsidiary of Hospira, Inc., have filed a lawsuit against Sandoz Inc. in the District Court for the District of New Jersey for infringement of Mayne's U.S. Patent No. 6,958,161 which covers DORYX, a tetracycline-class oral antibiotic.

The details can be read here.

Teva Introduces Levetiracetam Tablets

January 15, 2009 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Levetiracetam Tablets. This product is AB rated and bioequivalent to Keppra®* Tablets. Levetiracetam Tablets are available in 250 mg, 500 mg, and 750 mg strengths in bottles of 120, and 1000 mg strength in bottles of 60.

The details can be read here.

Roxane Laboratories, Inc. Announces the Launch of Levetiracetam Tablets and Oral Solution

Roxane Laboratories, Inc. announced today the approval of their Abbreviated New Drug Application for Levetiracetam Tablets, 250mg, 500mg, 750mg, 1000mg, and Oral Solution 100mg/mL. The product is available for immediate shipment to wholesalers and pharmacies nationwide.

The details can be read here.

ISTA Pharmaceuticals' New Drug Application for Bepreve Accepted for Review by U.S. Food and Drug Administration

ISTA Pharmaceuticals, Inc. today announced that ISTA's New Drug Application for Bepreve (bepotastine ophthalmic solution) has been accepted for review by the U.S. FDA.

The details can be read here.

U.S. FDA Issues Complete Response Letter for Saphris (asenapine) in the Acute Treatment of Both Schizophrenia and Bipolar I Disorder

January 14, 2009 -- Schering-Plough Corporation today announced that the U.S. FDA has issued a complete response letter for SAPHRIS (asenapine) sublingual tablets in the acute treatment of schizophrenia in adults and in the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy.

The details can be read here.

Forest and Cypress Announce FDA Approval of Savella for the Management of Fibromyalgia

Forest Laboratories, Inc. and Cypress Bioscience, Inc. today announced that Savella (milnacipran HCl), a selective serotonin and norepinephrine dual reuptake inhibitor, was approved by the U.S. FDA for the management of fibromyalgia.

The details can be read here.

Court of Appeals Overturns 2005 Patent Verdict Against Cordis

Jan 15, 2009 -- The Court of Appeals for the Federal Circuit in Washington, D.C. today found Boston Scientific Corporation's Ding patent invalid, and reversed a 2005 jury finding that Cordis Corporation's CYPHER Sirolimus-eluting Coronary Stent infringed that patent.

The details can be read here.

The whole judgement can be read here.

The Largest Pharma Fraud Whistleblower Case in U.S. History Totaling $1.4 Billion

January 15, 2009 -- Pharmaceutical giant Eli Lilly & Company will pay federal and state governments more than $1.4 billion to remedy a wide-ranging, off-label marketing scheme for its prescription drug, Zyprexa. This settlement is the largest settlement in the history of the False Claims Act.

The details can be read here.

Oscient Pharmaceuticals and Ethypharm SA File Lawsuit Against Lupin for Infringement of Antara Patent

Jan 15, 2009 - Oscient Pharmaceuticals Corporation today announced that it, its wholly owned subsidiary Guardian II Acquisition Corporation, and its licensor, Ethypharm SA, have filed a lawsuit against Lupin Limited and its subsidiary Lupin Pharmaceuticals, Inc. in the United States District Court for the District of Maryland for infringement of U.S. Patent No. 7,101,574, which covers ANTARA (fenofibrate) capsules.

The details can be read here.

Court Report

About Court Report: Each week http://www.patentdocs.org/ report briefly on recently filed biotech and pharma cases, and they select few interesting cases for periodic monitoring.

Eurand Inc. et al. v. Impax Laboratories Inc.1:09-cv-00018; filed January 7, 2009 in the District Court of Delaware (Amrix)

Galderma Laboratories, LP et al. v. Paddock Laboratories Inc.4:09-cv-00002; filed January 7, 2009 in the Northern District of Texas (Clobex)

OptiGen, LLC v. International Genetics, Inc. et al.5:09-cv-00006; filed January 5, 2009 in the Northern District of New York

Pozen Inc. v. Alphapharm Pty Ltd. et al.1:09-cv-00001; filed January 2, 2009 in the District Court of Delaware

Pozen Inc. v. Alphapharm Pty Ltd. et al.6:09-cv-00003; filed January 2, 2009 in the Eastern District of Texas (Treximet)

Endo Pharmaceuticals Inc. et al. v. Sandoz Inc.1:08-cv-00970; filed December 30, 2008 in the District Court of Delaware (Albuterol)

The details and the complaint can be read here.

Orion Sues Wockhardt USA LLC and Wockhardt Limited in the U.S. to Enforce Orion's U.S. Patents Covering its Proprietary Drug Stalevo

Jan. 15, 2009--Orion Corporation filed a patent infringement lawsuit in the United States to enforce U.S. Patent Nos. 5,135,950; 5,446,194; and 6,500,867 against Wockhardt USA LLC and Wockhardt Limited, who seek to market generic versions of Orion Corporation's proprietary drug, Stalevo® (specifically 25/200/100 mg, 37.5/200/150 mg, and 50/200/200 mg strengths of carbidopa/entacapone/levodopa) in the United States. Stalevo is an enhanced levodopa treatment originated by Orion Corporation and marketed in the United States by its exclusive licensee, Novartis, for the treatment of Parkinson's disease.

The details can be read here.

New Non-Drowsy Claritin Liqui-Gels Now Available

Schering-Plough Corporation today announces the introduction of new CLARITIN Liqui-Gels, the first and only non-drowsy allergy medicine in an easy-to-swallow liquid-filled capsule. Now available over-the-counter, CLARITIN Liqui-Gels provide powerful liquid relief for the worst allergy symptoms without causing drowsiness.

the details can be read here.

Vical Announces Issuance of U.S. Patent No. 7,470,675 for Composition, Delivery and Use of Gene-Based Interferon-Omega

Jan. 14, 2009 -- Vical Incorporated announced today the issuance of U.S. Patent No. 7,470,675 covering the composition, delivery and use of gene-based interferon-omega. Interferon-omega is part of the interferon family of proteins which are naturally produced by the immune system. Several interferons have been approved as treatments for infectious diseases, cancer and other diseases.

The details can be read here.

Advaxis Prevails in European Patent Court

Jan 14, 2009 - The European Patent Court in Munich, Germany has ruled in favor of Advaxis Incorporated and reversed a patent challenge made by Anza Therapeutics, Inc., formerly Cerus Corp. The Court's ruling is final and can not be appealed.

The challenge was made against elements of a patent filed, and subsequently published in 1994, by Dr. Yvonne Paterson, scientific founder of Advaxis. The patent describes the use of bacteria to deliver an antigen and generate an anti-tumor immune response.

The details can be read here.
I will be posting the whole judgement as soon as i will get it.

Wilex to acquire UCB's five preclinical oncology portfolio programmes

UCB Pharma S.A. (UCB) and Wilex AG, a company specialising in the development of drugs and diagnostic agents for cancer (Wilex), announced that they have agreed to enter into a strategic partnership.

The details can be read here.

Jubilant inks drug research partnership with BioLeap

Jubilant Organosys' Bangalore based subsidiary Jubilant Biosys Ltd, has entered into a drug discovery partnership with BioLeap, LLC, USA.

The details can be read here.

Soliris Receives Orphan Drug Designation in Japan

Alexion Pharmaceuticals, Inc. today reported that Soliris (eculizumab), its first-in-class complement inhibitor, has been designated as an orphan drug by the Ministry of Health, Labour and Welfare of Japan. As a result of the designation, a New Drug Application for Soliris would receive priority review from the Japanese regulatory authorities once it is submitted, and the drug would have 10 years of market exclusivity as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) in Japan.

The details can be read here.

Taisho Reaches Agreement on the Development and Sale of Anti-obesity Drug orlistat, in Japan

Jan. 13, 2009-Taisho Pharmaceutical Co., Ltd. has reached an agreement with Glaxo Group Limited, a subsidiary of GlaxoSmithKline plc to grant Taisho the rights for the development and marketing of the anti-obesity drug orlistat, in Japan.

The details can be read here.

RegeneRx Receives Patent for Reversal of Skin Aging in Japan

REGENERX BIOPHARMACEUTICALS, INC. announced today that it received notice of patent allowance from the Japanese Patent Office for “Inhibition or Reversal of Skin Aging by Actin-Sequestering Peptides”.

The details can be read here.

QLT Announces Appeal Court Decision on Massachusetts Eye and Ear Infirmary Litigation

January 12, 2009 - QLT Inc. announced that the United States Court of Appeals for the First Circuit today affirmed the judgment of the United States District Court for the District of Massachusetts in the lawsuit brought against QLT by Massachusetts Eye and Ear Infirmary in connection with events related to U.S. patent # 5,798,349 and certain of MEEI's research results related to QLT's Visudyne(R).

The details can be read here.

Eyegate's corneal graft rejection drug gets orphan drug status from US FDA

EyeGate Pharma, the leader in ocular drug delivery, and a specialty pharmaceutical company using iontophoresis technology to safely and non-invasively deliver therapeutics to treat serious ocular diseases, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation for its lead clinical compound, EGP-437 (dexamethasone phosphate), delivered via the EyeGate II Iontophoretic Delivery System for the treatment of corneal graft rejection.

The details can be read here.

China Pharma Holdings, Inc. Receives SFDA Production Approval for Tiopronin Enteric-Coated Capsules

China Pharma Holdings, Inc. which develops, manufactures, and markets specialty pharmaceutical products in China, today announced that China's State Food and Drug Administration ("SFDA") approved the production of Tiopronin Enteric-Coated Capsules. Tiopronin is listed in the National Medical Insurance Program, thus allowing patients to obtain reimbursement.

The details can be read here.

U.S. Patent and Trademark Office Issues Mylan's Specialty Division, Dey L.P., Three Additional Patents Protecting Perforomist Inhalation Solution

Mylan Inc. today announced that its subsidiary Dey L.P. has been issued several additional U.S. patents protecting the company's Perforomist Inhalation Solution, a chronic obstructive pulmonary disease (COPD) treatment.

The details can be read here.

Warner Chilcott and Watson Pharmaceuticals Announce Agreements on Loestrin 24 and Femcon Fe Patent Litigation

Watson Pharmaceuticals, Inc and Warner Chilcott Limited announced today that they have entered into Settlement and License Agreements to resolve pending patent litigation related to Warner Chilcott's oral contraceptive products, Loestrin 24 and Femcon Fe. Separately, Warner Chilcott and Watson have entered into a Co-Promotion Agreement relating to Warner Chilcott's Femring product and License and Supply Agreements relating to a Warner Chilcott development-stage oral contraceptive product.

The details can be read here.

Global pharma companies rush to India for legal offshoring expertise

An increasing number of global pharma companies are keen to increase the legal off-shoring business with India because of the huge cost advantage. When legal offshoring is out-sourced from India, global majors save up to 40-50 per cent.

The details can be read here.

Daiichi Sankya seeks Chinese nod for silodosin to treat dysuria

Daiichi Sankyo Company, Limited announced that its subsidiary in China, Daiichi Pharmaceutical (Beijing) Co, Ltd filed an application for KMD-3213 (silodosin) to China's State Food and Drug Administration. The drug was developed for treatment of dysuria associated with benign prostatic hyperplasia.

The details can be read here.

Merck & Co., Inc. Receives Complete Response Letter from the Food and Drug Administration for Use of Gardasil in Women Ages 27 through 45

Jan 9, 2009 - Merck & Co., Inc. announced today that the U.S. FDA has issued a second complete response letter regarding the supplemental biologics license application for the use of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant] in women ages 27 though 45.

The details can be read here.

Anesiva Announces FDA Approval of Supplemental New Drug Application to Expand Zingo Indication

Anesiva, Inc. today announced that the U.S. FDA has approved Anesiva's supplemental New Drug Application to expand the indication for Zingo to treat the pain associated with blood draws to include adults.

The details can be read here.

GSK and XenoPort Resubmit New Drug Application for Solzira in Restless Legs Syndrome

Jan. 9 -- GlaxoSmithKline and XenoPort, Inc. announced today that GSK has resubmitted the New Drug Application to the U.S. FDA requesting approval of Solzira (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe

The details can be read here.

Azur Pharma Announces the Licensing of Niravam, Parcopa, Kemstro and Fluxid From UCB

January 9 -- Azur Pharma Limited today announced that it licensed the exclusive U.S. marketing rights for Niravam (alprazolam orally disintegrating tablets), Parcopa (carbidopa-levodopa orally disintegrating tablets), Kemstro (baclofen orally disintegrating tablets) and Fluxid (famotidine orally disintegrating tablets) from UCB. Financial terms were not disclosed.

The details can be read here.

NovaBay Issued Key Composition of Matter Patent for Aganocide Compounds

Jan 9, 2009 - NovaBay Pharmaceuticals, Inc reports that the United States Patent and Trademark Office has approved the issuance of U.S. Patent No. 7,462,361 to NovaBay for novel Aganocide compounds including its current lead compound, NVC-422 (N,N-dichloro-2,2-dimethyltaurine). The patent will expire on April 24, 2026.

The details can be read here.

Alkem's Mandva sucralose plant gets BRC nod

Alkem Laboratories has bagged British Retail Consortium Issue (BRC) Certificate of Conformity for global standard for food safety. This enables Alkem to offer its sucralose & sucralose based products directly or through other companies to any retail chain in the whole of Europe.

The details can be read here.

Medegen Receives FDA Clearance for MaxGuard Advanced Luer-Activated Device with Antimicrobial Technology

Jan 8, 2009 - Medegen, a leading innovator in infusion therapy products, today announced that it has received 510(k) clearance from the U.S. FDA for its new MaxGuard Advanced Luer Activated Device featuring Agion Antimicrobial Technology. MaxGuard is the first positive displacement needleless connector featuring impregnation of the antimicrobial additive into each of the components of the device.

The details can be read here.

Collegium Pharmaceutical Announces FDA Approval of AllerNaze, a Nasal Inhaled Steroid for the Treatment of Allergic Rhinitis

Jan 8, 2009 - Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that the U.S. FDA has approved AllerNaze (triamcinolone acetonide, USP) Nasal Spray, 50 mcg, an aqueous based intranasal steroid indicated for the once daily treatment of nasal symptoms associated with both seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adults and children twelve (12) years of age and older.

The details can be read here.

Genta Announces Issuance of Two Key U.S. Patents for its Gallium Products Franchise

Jan 8, 2009 - Genta Incorporated announced today that two new patents related to the Company's franchise in gallium-containing products have issued in the United States.

The details can be read here.

IMPAX Confirms Patent Challenge Relating to Amrix Extended-Release Capsules, 15mg and 30mg

Jan 8, 2009 - IMPAX Laboratories, Inc. today announced that Eurand, Inc., Cephalon, Inc., and Anesta AG have filed suit for patent infringement in the United States District Court for the District of Delaware based on the Company's submission of Abbreviated New Drug Application for cyclobenzaprine hydrochloride extended release capsules (15 and 30 mg), generic of Amrix, to the FDA.

The details can be read here.

Delhi HC directs DCGI not to permit generic drugmakers for drugs already patented

New Delhi: The Delhi High Court has directed the drug controller general of India (DCGI) to not give marketing or manufacturing permission to generic drug makers for drugs that have already been granted patent in India.

The details can be read in Economic times.

Cubist Pharma submits 2 INDs with US FDA

Cubist Pharmaceuticals, Inc submitted two Investigational New Drug Applications (INDs) with the US FDA on December 23rd. The INDs signify the company's intentions to begin clinical investigation (human trials) for CB 182,804, a Cubist-discovered, potent, cidal, IV lipopeptide in development as therapy for the treatment of multi-drug resistant (MDR) Gram-negative infections, and CB-183,315, a Cubist-discovered, potent, oral, cidal lipopeptide in development for the treatment of Clostridium difficile associated diarrhoea.

The details can be read here.

arGentis Receives Favorable Opinion for European Orphan Drug Designation

Jan 6, 2009 - arGentis Pharmaceuticals, LLC announced today that the European Medicines Agency's Committee for Orphan Medicinal Products adopted a positive opinion recommending the company's product candidate ARG201 (native type 1 bovine collagen) for the treatment of diffuse systemic sclerosis, also known as systemic scleroderma (SSc) for designation as an orphan medicinal product to the European Commission.

The details can be read here.

First Geoclock Product, Lodotra, Approved in Europe

7 January 2009 -- SkyePharma PLC today announces that its partner Nitec has received the Final Assessment Report from the German BfArM, concluding that Lodotra is approvable for the treatment of rheumatoid arthritis and associated morning stiffness, in 15 European countries, including Germany as the Reference Member State, under the EMEA’s Decentralised Procedure.

The details can be read here.

Cerepro Application for Marketing Authorisation Accepted by EMEA

January 6, 2009 -- Ark Therapeutics Group plc is pleased to announce today that the Marketing Authorisation Application (MAA) for Cerepro, Ark's novel gene-based therapy for operable malignant glioma (brain cancer) which was recently filed with the European Medicines Regulatory Agency (EMEA), has cleared the validation stage.

The details can be read here.

MedImmune Submits Marketing Authorisation Application in European Union for Intranasal Vaccine to Prevent Seasonal Influenza

Jan. 6, 2009-The MAA submission for LAIV is based on data from 73 global clinical and U.S. post-marketing studies of more than 141,000 subjects ranging in age from 7 weeks to 97 years and conducted in 38 countries. Study objectives have included clinical safety and tolerability, clinical efficacy and effectiveness, and immunogenicity.

The details can be read here.

Ipsen: FDA's First-Cycle Review of Reloxin Extended

Ipsen today announced that the U.S. FDA provided notification that the Prescription Drug User Fee Act (PDUFA) action date for Reloxin (botulinum toxin of type A) Biologics License Application (BLA) in aesthetic indications (glabellar lines) has been extended to April 13, 2009.

The details can be read here.

MiddleBrook Pharmaceuticals to Launch Moxatag March 2009

MiddleBrook Pharmaceuticals, Inc. , today announced that the professional launch of Moxatag (amoxicillin extended-release) Tablets, 775mg, will begin on March 16, 2009. The Company has hired over half of its 270-person field force which will promote Moxatag, the first and only FDA-approved once-daily amoxicillin, to health care professionals nationwide. Moxatag is approved for the treatment of adults and pediatric patients 12 years and older with tonsillitis and/or pharyngitis.

The details can be read here.

Intellect Neurosciences, Inc. Grants to Top Tier Global Pharmaceutical Company License to Certain Alzheimer's Patents and Patent Applications

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 granted a non-exclusive License to a top-tier global pharmaceutical company regarding certain of Intellect's patents and patent applications related to antibodies and methods of treatment for Alzheimer's disease and to make, have made, use, sell, offer to sell and import certain licensed products.

The details can be read here.

Codexis, Teva in Licensing Agreement Final

Codexis, Inc. today announced a licensing agreement with Teva Pharmaceutical Industries Ltd., to produce an important publicly-undisclosed generic product, using a proprietary Codexis biocatalyst.

The details can be read here.

Sun Pharma receives USFDA approvals for 4 generic products; Company receives its first controlled substance product approval

January 7, 2009: Sun Pharmaceutical Industries Ltd. announced that together with its subsidiaries, it has received final approval from USFDA for several Abbreviated New Drug Applications. Approval was received for generic hydocodone bitartate with acetaminophen (APAP) tablets. Approval was also received for generic Aredia, pamidronate disodium for injection USP, generic Lopid, gemfibrozil tablets, USP, and generic Phenargan, promethazine hydrochloride tablets.

The details can be read here.

U.S. Patent and Trademark Office Accepts Pfizer's Reissue Application on Lipitor Enantiomer Patent

Jan 6, 2009 - Pfizer Inc announced today that the U.S. PTO has issued a “Notice of Allowance” accepting the company's application to correct the technical defect in the ˜995 enantiomer patent for atorvastatin calcium, the salt form of atorvastatin sold as Lipitor. The company noted that certain formalities must be completed before the reissue patent will be granted. The reissued patent will have the same force and effect as the original ˜995 patent and the same June 2011 expiration date (including the six-month pediatric exclusivity period).

The details can be read here.

USPTO Denies PTE for PRILOSEC OTC

As per the post published on FDA law Blog by Mr. Kurst R Karst

USPTO has finalized the determination that U.S. Patent 5817338, which covers AstraZeneca’s PRILOSEC OTC (omeprazole magnesium) Delayed-Release Tablets, is not eligible for a Patent term Extension (“PTE”) because the PRILOSEC OTC New Drug Application was not the first permitted commercial marketing or use of omeprazole, and because the PTE application was not timely submitted. (The PTE application was submitted on the 61st day after the date of NDA approval).

The details can be read here.
The decision can be read here.

Govt finalises Rs 441 cr IDPL revival package, GoM to meet soon

The much-awaited Rs 441-crore financial package to revive the ailing Indian Drugs and Pharmaceuticals Ltd (IDPL) has been finalised and the government departments, involved in the process, are giving final fine-tuning to the package.

The details can be read here.

Genta Summarizes Phase 2 Activity and Receives Orphan Drug Designation in Gastric Cancer for Tesetaxel, a Leading Oral Taxane in Clinical Development

January 5, 2009 – Genta Incorporated announced today that the Company has received notice from the U.S FDA that tesetaxel, the latest addition to Genta’s oncology product portfolio, has been granted designation as an “Orphan Drug” for treatment of patients with advanced gastric cancer.

The details can be read here.

New Drug Application Submitted For Acurox Tablets

Jan. 2, 2009 -- Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. (NYSE:KG) today announced that Acura has submitted a New Drug Application for Acurox (oxycodone HCl/niacin) Tablets to the U.S. FDA including a request for priority review.

The details can be read here.

Prism Pharmaceuticals Receives FDA Approval of Nexterone for Life-Threatening Ventricular Fibrillation and Ventricular Tachycardia

January 05, 2009 -- Prism Pharmaceuticals announced today that the U.S. FDA has approved the new drug application for NEXTERONE (amiodarone HCl) Injection, a novel, patent-protected, cosolvent free formulation of the antiarrhythmic agent Amiodarone I.V., originally marketed in the US by Wyeth as Cordarone Intravenous.

The details can be read here.

CyDex Pharmaceuticals Announces Captisol Technology Used in Recently Approved Cosolvent-Free Formulation of Amiodarone I.V.

Jan 5, 2009 - CyDex Pharmaceuticals, Inc. today announced that Prism Pharmaceuticals' NEXTERONE, which recently received new drug application (NDA) approval from the U.S. FDA, is based on the patent-protected CyDex CAPTISOL technology platform. NEXTERONE is the first CyDex proprietary product to achieve the milestone of NDA approval.

The details can be read here.

BioSante Pharmaceuticals Announces Issuance of New Patent Covering Elestrin

Jan 5, 2009 - BioSante Pharmaceuticals, Inc. announced that a new patent has issued covering Elestrin (estradiol gel), which is approved in the U.S. for moderate-to-severe vasomotor symptoms, known as hot flashes, associated with menopause. BioSante received approval of Elestrin from the U.S. FDA in December 2006.

The details can be read here.

Alexion Pharmaceuticals and PDL BioPharma Resolve Patent Dispute

January 05, 2009 -- PDL BioPharma, Inc. and Alexion Pharmaceuticals, Inc. today jointly announced that the companies have entered into a definitive license agreement and settlement agreement that resolve the legal disputes between them relating to Alexion's humanized antibody, Soliris (eculizumab) and PDL's patents known as the Queen et al. patents.

The details can be read here.

COURT REPORT

About Court Report: Each week http://www.patentdocs.org/ report briefly on recently filed biotech and pharma cases, and they select few interesting cases for periodic monitoring.

Monsanto Co. et al. v. Pilman4:08-cv-02020; filed December 30, 2008 in the Eastern District of Missouri

Warner Chilcott Laboratories Ireland Ltd. et al. v. Impax Laboratories, Inc. et al.2:08-cv-06304; filed December 23, 2008 in the District Court of New Jersey

The details and the complaint can be read here.

Ranbaxy's failed to launch generic Imitrex in December

In an interesting piece of news reported by Khomba Singh of Economic Times, India’s largest drug manufacturer Ranbaxy has strangely missed their expected December 2008 deadline to launch generic version of Glaxo’s blockbuster anti-migraine drug Imitrex, generically known as Sumatriptan Succinate in the United States. ....

The details can be read here.
The news from Economic Times can be read here.

Share values of 23 major pharma cos decline by 33% during 2008

The year 2008 is marked by volatile movements on the stock market with heavy selling pressure by foreign financial institutions and general investors on account of recessionary conditions worldwide. The BSE Healthcare index of 23 major pharmaceutical companies drifted down by 33 per cent to 2966.19 as at the last day of 2008 as compared to 4418.65 points at the end of year 2007. However, the there was small gain across the counters on the first trading day of 2009 with little investors support.

The details can be read here.

Expert panel on FDC likely to meet on Jan 16-17

the expert panel on fixed dose combination (FDC), formed to resolve the lingering FDC issue, is likely to have its first meeting on January 16 and 17. The first meeting, which will be attended by senior health ministry officials including the DCGI and representatives of industry associations, will decide the fate of 43 of the remaining 156 combination drugs, it is learnt.

The details can be read here.

Watson receives US FDA marketing nod for mint coated Nicotine Gum

Watson Pharmaceuticals, Inc, a leader in generic and specialty branded pharmaceuticals, announced that its subsidiary, Watson Laboratories, Inc, has received approval from the United States Food and Drug Administration to market its over-the-counter Nicotine Polacrilex Gum USP, coated mint flavour, in the 2 mg and 4 mg strengths.

The details can be read here.