I will be taking a break from blogging from today onwards for about a month. I am sorry for this.
Thanks
Rahul
Wednesday, July 30, 2008
Lupin acquires German based Hormosan Pharma
Lupin Limited, a Rs 2700 crore plus company based in Mumbai, has acquired Hormosan Pharma GmbH (Hormosan), a German sales and marketing generics company specialized in the supply of pharmaceutical products for the Central Nervous System (CNS).
Hormosan, with total sales of €6.8 million for the year ended December 2007, develops, licenses and markets a range of generics in Germany. Hormosan has a complementary product portfolio with products in the central nervous system and cardiovascular therapeutic segments.
The details can be read here.
Hormosan, with total sales of €6.8 million for the year ended December 2007, develops, licenses and markets a range of generics in Germany. Hormosan has a complementary product portfolio with products in the central nervous system and cardiovascular therapeutic segments.
The details can be read here.
Bayer’s Novel Anticoagulant Rivaroxaban Submitted for Approval in the U.S.
Bayer’s cooperation partner Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) has submitted the new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for rivaroxaban (Xarelto®), a novel anticoagulant taken as one tablet, once-daily. It seeks approval for the use of rivaroxaban in the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.
The details can be read here.
The details can be read here.
Bridion (sugammadex) Injection - First and Only Selective Relaxant Binding Agent - Approved in European Union
Schering-Plough Corporation today announced that the European Commission (EC) has approved BRIDION(R) (sugammadex) injection, the first and only selective relaxant binding agent (SRBA) and the first major pharmaceutical advance in the field of anesthesia in two decades. BRIDION is indicated for routine reversal of the commonly used muscle relaxants rocuronium or vecuronium and for immediate reversal of rocuronium in adults, and for routine reversal following rocuronium in children and adolescents (2-17 years of age). Rocuronium and vecuronium are given as part of general anesthesia to relax a patient's muscles during surgery, and are marketed in Europe under the trade names ESMERON(R) and NORCURON(R), respectively.
The details can be read here.
The details can be read here.
Noven Announces Final FDA Approval of Stavzor for the Treatment of Bipolar Disorder, Seizures and Migraine Headaches
Noven Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Stavzor™ (valproic acid delayed release capsules) in 125 mg, 250 mg and 500 mg strengths. Stavzor is approved for the treatment of manic episodes associated with bipolar disorder, as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures, and for prophylaxis of migraine headaches. The product will be marketed and sold by Noven Therapeutics, LLC, Noven’s specialty pharmaceutical subsidiary, and is expected to be available in pharmacies in the second half of August.
The details can be read here.
The details can be read here.
NuGEN Receives Patent for Global Nucleic Acid Amplification
NuGEN Technologies, Inc., a privately held company that develops and commercializes nucleic acid amplification and labeling systems announced today that it has received US Patent No. 7,402,386, “Global amplification using random priming by a composite primer.”
The patent describes a global whole genome amplification methodology using composite DNA/RNA primers able to anneal to multiple sites within the template polynucleotide. The resulting amplified nucleic acid is suitable for use with a wide array of analytical and investigative approaches and applications.
The details can be read here.
The patent describes a global whole genome amplification methodology using composite DNA/RNA primers able to anneal to multiple sites within the template polynucleotide. The resulting amplified nucleic acid is suitable for use with a wide array of analytical and investigative approaches and applications.
The details can be read here.
Peptimmune Announces Grant of United States Patent for PI-2301 Peptide Copolymer for Multiple Sclerosis
Peptimmune, Inc. a privately held biotechnology company, announced today the grant of US Patent Number 7,381,790 (the '790 patent) which protects the composition of matter for its PI-2301 peptide copolymer for the treatment of autoimmune diseases.
The details can be read here.
The details can be read here.
Caraco Pharmaceutical Laboratories, Ltd. to Market Generic Depakote Delayed Release Tablets
Caraco Pharmaceutical Laboratories, Ltd. announced today, that it has launched divalproex sodium delayed release tablets on behalf of Sun Pharmaceutical Industries Ltd. (Sun Pharma). Sun Pharma recently received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Depakote(R) delayed release tablets.
The details can be read here.
The details can be read here.
Teva Introduces Divalproex Sodium Delayed-Release Tablets USP
July 29, 2008 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Divalproex Sodium Delayed-Release Tablets USP. This product is AB rated and bioequivalent to Depakote®* Tablets. Divalproex Sodium Delayed-Release Tablets are available in 125 mg strength, in bottles sizes of 100, and in 250 mg and 500 mg strengths, in bottle sizes of 100 and 500.
Sun Pharma Gets USFDA Approval for Generic Depakote Delayed Release Tablets
July 30, 2008- Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the Company’s Abbreviated New Drug Application (ANDA) for generic Depakote ®, divalproex sodium delayed release tablets.Divalproex sodium delayed release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures, as sole and adjunct therapy for patients with simple and complex absence seizures, for the treatment of the manic episodes associated with bipolar disorders, as well as for prophylaxis of migraine headaches.
The details can be read here.
The details can be read here.
Tuesday, July 29, 2008
Industry begins submitting rationality profile of remaining 156 FDCs to DCGI
The industry associations, which are working expeditiously to prepare the rationality profile of the remaining 156 fixed dose combination (FDC) drugs to submit it to the DCGI office for its approval, have started submitting the scientific data of these drugs to the DCGI office.
The details can be read here.
The details can be read here.
Alexza initiates second phase 3 trial of Staccato loxapine
Alexza Pharmaceuticals, Inc. has initiated its second phase 3 clinical trial with AZ-004 (Staccato loxapine). AZ-004 is an inhalation product candidate being developed for the treatment of acute agitation in patients with schizophrenia or bipolar disorder. Alexza believes the novel, non-invasive nature and rapid pharmacokinetic (PK) properties resulting from inhaled loxapine administration via the Staccato system have the potential to make AZ-004 a viable product to treat acute agitation. AZ-004 is being developed through Symphony Allegro, a product development partnership formed between Alexza and Symphony Capital, LLC.
The details can be read here.
The details can be read here.
MedWatch - Mitoxantone (marketed as Novantrone and generics): Updated Cardiotoxicity Warnings/Recommendations
July 29, 2008--FDA reminded health care professionals who treat patients with mitoxantrone about recommendations that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and prior to administering each dose of mitoxantrone. FDA offered additional recommendations for cardiac monitoring to detect late-occurring cardiac toxicity, and provided information for patients with multiple sclerosis who receive the drug. These recommendations were established in 2005 in response to post-marketing reports and case reports in the medical literature that described decreases in LVEF or frank congestive heart failure in patients with MS who had received cumulative doses of mitoxantrone that were lower than 100 mg/m2. Since that time, FDA has received information from a post-marketing safety study that demonstrated there is poor adherence to these recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to cardiac monitoring recommendations for patients with MS.
The details can be read here.
The details can be read here.
Orexo: The FDA Has Accepted for Filing the Registration Application for Sublinox
The submitted registration application for SublinoxTM (OX22) has been accepted by the FDA as complete for substantive review after initial evaluation. SublinoxTM contains the well-known active substance zolpidem and is based on Orexo’s sublingual technology, involving a rapidly disintegrating tablet placed under the tongue.
The details can be read here.
The details can be read here.
Antares Pharma and Teva Announce Filing of sNDA for Needle-Free Injector with Human Growth Hormone
Antares Pharma, Inc., a specialty pharmaceutical company focused on improving pharmaceuticals through advanced drug delivery systems, and its partner, Teva Pharmaceutical Industries Ltd. today announced the filing of a Supplemental New Drug Application (sNDA) in order to add “needle-free injection” to the product drug label.
The details can be read here.
The details can be read here.
UCB Receives Not-Approvable Letter from FDA for Lacosamide for Diabetic Neuropathic Pain
July 29, 2008--UCB announced today that it received a not-approvable letter from the U.S. Food and Drug Administration (FDA) for lacosamide for the treatment of diabetic neuropathic pain in adults.
The details can be read here.
The details can be read here.
FDA Advisory Committee Recommends Approval of Actemra (tocilizumab) for the Treatment of Rheumatoid Arthritis
Roche today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) by a near unanimous (10-1) vote recommended approval of ACTEMRA(R) (tocilizumab), a novel interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody, for reducing the signs and symptoms in adults with moderate to severe rheumatoid arthritis (RA).
The details can be read here.
The details can be read here.
Health Canada Approves Orencia (abatacept) for the Treatment of Moderate-to-Severe Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
Bristol-Myers Squibb Canada today announced that Health Canada has approved ORENCIA(R) (abatacept) for reducing signs and symptoms of moderately to severely active juvenile idiopathic arthritis (JIA)/juvenile rheumatoid arthritis in pediatric patients 6 years of age and older who have had an inadequate response to one or more DMARDs, such as MTX .
The details can be read here.
The details can be read here.
European Commission Grants Marketing Authorization for MediGene's Drug Oracea
July 29, 2008. MediGene AG announced that the European Commission has acted on the recommendation by the European regulatory authority EMEA of April 2008, and granted marketing authorization for the drug Oracea for the treatment of rosacea. The regulatory authorities in the individual countries are to implement this decision within 30 days by granting domestic approvals.
The details can be read here.
The details can be read here.
Schweizerhall: Clopidogrel in Germany – Court Orders Immediate Execution of Approval
July 29, 2008--In May 2008 Cimex AG had received approval from the BfArM (Federal Institute for Drugs and Medical Devices, Germany) for clopidogrel (original product: Plavix® / Iscover® by Sanofi-Aventis / Bristol-Myers Squibb) in Germany and transferred it to its marketing partners.
The details can be read here.
The details can be read here.
Nventa Wins European Patent Challenge Covering Lead Product Candidate HspE7 and Other HPV Therapeutics
Nventa Biopharmaceuticals Corporation announced today that it has received a favorable decision from the Technical Board of Appeal of the European Patent Office (EPO) for the company's European Patent Number 1,002,110. This patent, which allows exclusively through 2018, covers compositions of fusion proteins comprised of a human papillomavirus (HPV) antigen fused to a heat shock protein (Hsp), as well as DNA encoding such fusion proteins. This decision dismisses an appeal announced on January 30, 2006, and upholds the EPO Opposition Division's favorable decision of October 2005.
The details can be read here.
The details can be read here.
Lorus Therapeutics Announces Allowance of New United States Patent for its Anticancer Drug LOR-2040
July 29, 2008- Lorus Therapeutics Inc., a biopharmaceutical company specializing in the research and development of pharmaceutical products and technologies for the management of cancer, today announced the allowance of a new patent from the United States Patent and Trademark Office for its clinical-stage anticancer drug LOR-2040.
The details can be read here.
The details can be read here.
Public Interest Groups Back FC Appeal to Implement New U.S. Patent Rules; Proposed Regulations Would Curtail Abusive Behavior by Patent Applicant
A coalition of consumer advocacy and public interest groups today filed legal papers supporting new U.S. Patent Office (USPTO) rules that would curtail abusive behavior by patent applicants and improve patent quality. The tactics are used frequently by drug companies to get patents they don't deserve.
The details can be read here.
The details can be read here.
IMPAX Sued Based on ANDA Amendment for Additional Dosage Forms of Generic Opana ER
IMPAX Laboratories, Inc. today announced Endo Pharmaceuticals, Inc. (“Endo”) and Penwest Pharmaceuticals, Co. (“Penwest”) have filed suit for patent infringement based on the Company’s amendment to its existing Abbreviated New Drug Application (“ANDA”) for oxymorphone hydrochloride extended-release tablets CII, generic of Opana® ER, adding new 7.5 mg, 15 mg and 30 mg strengths. In connection with this amendment, IMPAX provided notice to Endo and Penwest that its submission includes a Paragraph IV certification stating the Company believes its product does not infringe any valid and enforceable patent, including U.S. Patent Nos. 7,276,250, 5,662,933 and 5,958,456.
The details can be read here.
The details can be read here.
Barr Confirms Patent Challenge of Sensipar Tablets, 30mg, 60mg and 90mg
Barr Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Amgen Inc. in connection with its Sensipar(R) Tablets (cincalcet hydrochloride), 30mg, 60mg and 90mg.
Barr's Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Sensipar product was received as acceptable for filing by the U.S. Food & Drug Administration (FDA) on March 10, 2008, the first date the FDA could accept an ANDA with a paragraph IV certification for this product. 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
The details can be read here.
Barr's Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Sensipar product was received as acceptable for filing by the U.S. Food & Drug Administration (FDA) on March 10, 2008, the first date the FDA could accept an ANDA with a paragraph IV certification for this product. 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
The details can be read here.
PhotoCure Sues PTO after the Office Denies a PTE for METVIXIA; Lawsuit Challenges PTO’s “First Permitted Commercial Marketing” Interpretation
In the second lawsuit in as many months, the Patent and Trademark Office (“PTO”) has been sued over a decision to deny a Patent Term Extension (“PTE”). As we previously reported, Wyeth sued the PTO and FDA in June 2008 concerning the appropriate PTE regulatory review period determination for a patent covering the company’s new animal drug CYDECTIN (moxidectin) Pour-On.
The details can be read here.
The details can be read here.
Monday, July 28, 2008
Novartis sues Israel's Teva over patents
Swiss pharmaceutical giant Novartis said Monday it had filed a lawsuit in the United States against Israeli generic drugmaker Teva, over patents for two medications to treat bone diseases.
The lawsuit, which was filed on Thursday, aims to prevent Teva -- the world's largest generic drug company -- from selling generic versions of the two drugs, Zometa and Reclast, until their patents expire in 2013, a Novartis spokesman said.
The details can be read here.
The lawsuit, which was filed on Thursday, aims to prevent Teva -- the world's largest generic drug company -- from selling generic versions of the two drugs, Zometa and Reclast, until their patents expire in 2013, a Novartis spokesman said.
The details can be read here.
MorphoSys licenses RapMAT technology to Astellas
MorphoSys AG announced that Astellas Pharma Inc. has exercised a pre-existing option to use MorphoSys's proprietary RapMAT technology for faster antibody optimization as part of the existing technology transfer agreements between the two companies. As a result, Astellas will have access to MorphoSys's RapMAT technology module alongside the existing installation of the company's proprietary antibody library HuCAL GOLD at Astellas' research site in Tsukuba, Japan.
The details can be read here.
The details can be read here.
Ikaria Receives FDA Orphan Drug Designation for Inhaled Carbon Monoxide for Delayed Graft Function in Solid Organ Transplants
Ikaria Holdings, Inc., a fully integrated critical care biotherapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for inhaled carbon monoxide for use in the reduction of the incidence and severity of delayed graft function (DGF) in patients undergoing solid organ transplantation.
The details can be read here.
The details can be read here.
Polyphenon Pharma Receives Orphan Drug Designation for Its Botanical Drug, Polyphenon E, for the Treatment of CLL
Polyphenon Pharma, an emerging research-based pharmaceutical company, today announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation to its botanical drug, Polyphenon E(R), for the treatment of chronic lymphocytic leukemia (CLL). A Phase II study is currently underway at the Mayo Clinic in Rochester, Minnesota where researchers are studying the effects of an oral daily dose of Polyphenon E in CLL patients.
The details can be read here.
The details can be read here.
CVT Announces That FDA Continues to Review Ranexa Applications
CV Therapeutics, Inc. announced today that it has been informed by the U.S. Food and Drug Administration (FDA) that it is continuing its review of CV Therapeutics' pending applications for Ranexa(R) (ranolazine extended-release tablets) past the Prescription Drug User Fee Act (PDUFA) action date of July 27, 2008. The applications seek a first line angina indication and promotable claims for the reduction of hemoglobin A1c (HbA1c) and ventricular arrhythmias in patients with coronary artery disease. The FDA has informed CV Therapeutics that the Company should receive draft labeling in the next few weeks, and the Company plans to promptly communicate when the labeling is complete.
The details can be read here.
The details can be read here.
Vanda Pharmaceuticals Announces Receipt of Not Approvable Letter From FDA for Iloperidone
Vanda Pharmaceuticals Inc. announced today the receipt of a not approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application for iloperidone, an investigational atypical antipsychotic that was reviewed for the treatment of schizophrenia.
The FDA stated that Vanda had demonstrated the effectiveness of iloperidone at 24 mg/day in the 3101 study for which the company reported results in December, 2006, and that the efficacy was similar to the active comparator, ziprasidone (Geodon(R), Pfizer Inc.). In addition, the FDA also stated that iloperidone was superior to placebo in patients with schizophrenia at doses of 12-16 mg/day and 20-24 mg/day in a prior study. However, the FDA expressed concern about the efficacy of iloperidone in patients with schizophrenia relative to the active comparator, risperidone (Risperdal(R), Johnson & Johnson), used in prior studies. The FDA indicated that it would require an additional trial comparing iloperidone to placebo and including an active comparator such as olanzapine (Zyprexa(R), Eli Lilly & Company) or risperidone in patients with schizophrenia to demonstrate the compound's efficacy further. The FDA also stated that it would require Vanda to obtain additional safety data for patients at a dose range of 20 to 24 mg/day.
The details can be read here.
The FDA stated that Vanda had demonstrated the effectiveness of iloperidone at 24 mg/day in the 3101 study for which the company reported results in December, 2006, and that the efficacy was similar to the active comparator, ziprasidone (Geodon(R), Pfizer Inc.). In addition, the FDA also stated that iloperidone was superior to placebo in patients with schizophrenia at doses of 12-16 mg/day and 20-24 mg/day in a prior study. However, the FDA expressed concern about the efficacy of iloperidone in patients with schizophrenia relative to the active comparator, risperidone (Risperdal(R), Johnson & Johnson), used in prior studies. The FDA indicated that it would require an additional trial comparing iloperidone to placebo and including an active comparator such as olanzapine (Zyprexa(R), Eli Lilly & Company) or risperidone in patients with schizophrenia to demonstrate the compound's efficacy further. The FDA also stated that it would require Vanda to obtain additional safety data for patients at a dose range of 20 to 24 mg/day.
The details can be read here.
Arpida Submits Marketing Authorisation Application for Intravenous Iclaprim in Europe
Arpida Ltd. today announced that it has submitted a Marketing Authorisation Application (MAA) for intravenous iclaprim for the treatment of complicated Skin and Soft Tissue Infections (cSSTI) to the European Medicines Agency (EMEA). Iclaprim is a hospital antibiotic drug candidate with potent bactericidal (killing) activity against MRSA and an extended range of important pathogens.
The details can be read here.
The details can be read here.
Nexavar Approved for Liver Cancer in China
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that the State Food and Drug Administration (SFDA) of China has approved Nexavar(R) (sorafenib) tablets for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC), or liver cancer. Nexavar is the first and only oral targeted therapy to significantly improve overall survival in patients with the disease.
The details can be read here.
The details can be read here.
Barrier Therapeutics Introduces Dual-Component Xolegel CorePak for Seborrheic Dermatitis
Barrier Therapeutics, Inc. announced today the introduction of Xolegel CorePak(tm) for the treatment of seborrheic dermatitis. Now, patients with this chronic skin condition need only one prescription to get quick itch relief and to safely manage the overall condition long term.
The details can be read here.
The details can be read here.
Ranbaxy Launches Omeprazole 40 mg Capsules
Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), Gurgaon, India announced today that under an agreement with AstraZeneca Pharmaceuticals it has launched an authorized generic of Omeprazole 40 mg Capsules in the U.S. healthcare system. Omeprazole 40 mg is indicated for the treatment of acid-related disease, including gastric ulcer and Zollinger-Ellison syndrome. The most common side effects of Prilosec(R) are headache, diarrhea and abdominal pain. Prilosec(R) 40 mg had sales in the U.S. market of $204.2 million (IMS: March 2008 MAT).
The details can be read here.
The details can be read here.
Mylan Launches First Generic Version of Antihypertensive Sular ER in the United States
Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nisoldipine Extended-release (ER) Tablets, 20 mg, 30 mg and 40 mg.
Nisoldipine ER Tablets, indicated for the treatment of hypertension, are the generic version of Sciele Pharma's Sular(R) ER Tablets, which had annual U.S. sales of approximately $94 million for the 12 months ending March 31, 2008, for these three strengths. Mylan's Nisoldipine ER, which is being shipped immediately, is the first generic version of Sular ER to be introduced in the United States.
The details can be read here.
Nisoldipine ER Tablets, indicated for the treatment of hypertension, are the generic version of Sciele Pharma's Sular(R) ER Tablets, which had annual U.S. sales of approximately $94 million for the 12 months ending March 31, 2008, for these three strengths. Mylan's Nisoldipine ER, which is being shipped immediately, is the first generic version of Sular ER to be introduced in the United States.
The details can be read here.
Court Report
As reported by Sherri Oslick in their site i.e. patent docs, following are the details of new cases filed. More details can be obtained from http://patentdocs.typepad.com/
Shire LLC v. Actavis South Atlantic, LLC et al.
2:08-cv-00287; filed July 24, 2008 in the Eastern District of Texas
View the complaint here.
AstraZeneca LP et al. v. Mylan Pharmaceuticals Inc.
1:08-cv-00453; filed July 22, 2008 in the District Court of Delaware
View the complaint here.
Cephalon Inc. et al. v. Barr Pharmaceuticals Inc. et al.
1:08-cv-00455; filed July 22, 2008 in the District Court of Delaware
View the complaint here.
Astellas Pharma Inc. et al. v. Impax Laboratories, Inc.
5:08-cv-03466; filed July 18, 2008 in the Northern District of California
View the complaint here.
Hoffmann-La Roche Inc. v. Dr. Reddy's Laboratories, Ltd. et al.
2:08-cv-03607; filed July 18, 2008 in the District Court of New Jersey
View the complaint here.
Apotex Inc. v. Shire LLC
2:08-cv-03598; filed July 17, 2008 in the District Court of New Jersey
View the complaint here.
Source:http://patentdocs.typepad.com/
Shire LLC v. Actavis South Atlantic, LLC et al.
2:08-cv-00287; filed July 24, 2008 in the Eastern District of Texas
View the complaint here.
AstraZeneca LP et al. v. Mylan Pharmaceuticals Inc.
1:08-cv-00453; filed July 22, 2008 in the District Court of Delaware
View the complaint here.
Cephalon Inc. et al. v. Barr Pharmaceuticals Inc. et al.
1:08-cv-00455; filed July 22, 2008 in the District Court of Delaware
View the complaint here.
Astellas Pharma Inc. et al. v. Impax Laboratories, Inc.
5:08-cv-03466; filed July 18, 2008 in the Northern District of California
View the complaint here.
Hoffmann-La Roche Inc. v. Dr. Reddy's Laboratories, Ltd. et al.
2:08-cv-03607; filed July 18, 2008 in the District Court of New Jersey
View the complaint here.
Apotex Inc. v. Shire LLC
2:08-cv-03598; filed July 17, 2008 in the District Court of New Jersey
View the complaint here.
Source:http://patentdocs.typepad.com/
Sunday, July 27, 2008
Sanofi-aventis to acquire Acambis plc for £276 million
Sanofi-aventis, the third largest pharmaceutical company in the world, is acquiring the entire issued as well as new share capital of Acambis plc at 190 pence in cash for each share aggregating to £276 million. Sanofi is acquiring Acambis through Sanofi Pasteur Holding (the parent company of its Sanofi Pasteur vaccines division). Acambis is a London Stock Exchange listed UK vaccines company, developing novel vaccines that address significant unmet medical needs or substantially improve upon current standards of care.
The details can be read here.
The details can be read here.
Friday, July 25, 2008
Shire Sues Actavis Over Carbatrol ANDA
Shire LLC fired off its third infringement suit of the month Thursday when it sued Actavis Inc. for infringing two patents covering Shire's epilepsy drug Carbatrol.
The details can be read here.
The details can be read here.
Once-yearly Aclasta Recommended in EU to Treat Male Osteoporosis and Reduce Risk of New Fractures in Patients After Hip Fracture
July 25, 2008 – Once-yearly Aclasta®* (zoledronic acid 5 mg) has passed another important milestone with a recommendation for European Union approval to treat osteoporosis in men who are at increased risk of fractures. Osteoporosis is an important health concern for men, with an estimated one out of five over the age of 50 experiencing an osteoporotic fracture.
In addition, the Committee for Medicinal Products for Human Use (CHMP) has recommended broadening the label to include data showing that Aclasta reduced the risk of new clinical fractures by 35% in men and postmenopausal women who have recently had a low-trauma hip fracture (e.g. due to a fall from standing height or less). Aclasta is the only osteoporosis treatment to demonstrate this benefit.
The revised label also includes data showing that in this patient population, all-cause mortality was reduced by 28% in the Aclasta-treated group compared to patients receiving placebo or dummy drug.
The details can be read here.
In addition, the Committee for Medicinal Products for Human Use (CHMP) has recommended broadening the label to include data showing that Aclasta reduced the risk of new clinical fractures by 35% in men and postmenopausal women who have recently had a low-trauma hip fracture (e.g. due to a fall from standing height or less). Aclasta is the only osteoporosis treatment to demonstrate this benefit.
The revised label also includes data showing that in this patient population, all-cause mortality was reduced by 28% in the Aclasta-treated group compared to patients receiving placebo or dummy drug.
The details can be read here.
Bayer’s Novel Anticoagulant Rivaroxaban Recommended for Approval in the EU
July 25, 2008 – The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the anticoagulant rivaroxaban (Xarelto®), taken as one tablet, once-daily, for the prevention of venous blood clots in patients undergoing elective (planned) hip or knee replacement surgery. It is expected that final approval by the European Commission will follow in the next few months, providing marketing authorization for rivaroxaban in all EU member states. Rivaroxaban was invented in Bayer’s Wuppertal laboratories in Germany, and is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
The details can be read here.
The details can be read here.
Committee for Medicinal Products for Human Use Summary of Positive Opinion for Olanzapine Mylan
On 24 July 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion**, recommending the granting of a marketing authorisation for the medicinal product Olanzapine Mylan 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg film-coated tablets intended for the treatment of schizophrenia. The applicant for this medicinal product is Generics (UK) Ltd.
The active substance of Olanzapine Mylan is olanzapine which is an atypical antipsychotic (N05AH03).
The details can be read here.
The active substance of Olanzapine Mylan is olanzapine which is an atypical antipsychotic (N05AH03).
The details can be read here.
Ceplene Receives Positive European Opinion for Approval From CHMP
Jul 25, 2008 - EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion regarding the marketing authorization for Ceplene(R) (histamine dihydrochloride), for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. Ceplene is to be administered in conjunction with low-dose interleukin-2 (IL-2). This positive opinion was issued following a request made by EpiCept to have the initial negative opinion of March 2008 re-examined by the CHMP. Ceplene has been designated as an orphan medicinal product, and as such is entitled to 10 years of marketing exclusivity in the EU.
The details can be read here.
The details can be read here.
EMEA Recommends Restricted Use of Oral Norfloxacin-containing Medicines in Urinary Infections
July 24, 2008-The European Medicines Agency has recommended restricting the use of oral norfloxacin-containing medicines in urinary infections. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the marketing authorisations for oral norfloxacin-containing medicines, when used in the treatment of acute or chronic complicated pyelonephritis (kidney infection), should be withdrawn because the benefits of these medicines do not outweigh their risks in this indication. This is based on the fact that the efficacy has not been adequately demonstrated for this type of infection.
The details can be read here.
The details can be read here.
European Medicines Agency Recommends Restricting the Use of Oral Moxifloxacin-Containing Medicines
July 24, 2008-Finalising a review of the safety of moxifloxacin-containing medicines for oral use, the European Medicines Agency (EMEA) has concluded that these medicines should only be prescribed in the treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia when other antibiotics cannot be used or have failed. The Agency also recommended strengthening the warnings for oral moxifloxacin medicines.
The details can be read here.
The details can be read here.
Sagent Pharmaceuticals Launches Amiodarone HCl Injection, USP
Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced that it has launched amiodarone HCl injection, USP, a class III antiarrhythmic indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia -- a potentially life-threatening irregular heart beat. Sagent's amiodarone HCl injection will be available immediately in 150 mg/3 mL single dose prefilled syringes. According to IMS data, 2007 sales of injectable amiodarone in the United States were approximately $8 million. Amiodarone prefilled syringes are manufactured for Sagent by Gland Pharma.
The details can be read here.
The details can be read here.
Watson Launches Omeprazole Delayed-Release Capsules, 40MG
Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that its subsidiary has commenced commercial shipment of its Omeprazole Delayed-Release Capsules USP product in the 40mg strength from its Davie, Florida manufacturing facility. In conjunction with the launch, Watson has 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for the 40mg strength.
The details can be read here.
The details can be read here.
Warner Chilcott Announces New Information in USPTO Reexamination of Taclonex Patent
Warner Chilcott Limited announced today that LEO Pharma A/S ("LEO Pharma") has received a Right of Appeal Notice from the U.S. Patent and Trademark Office (the "USPTO"). In September 2006, the USPTO ordered a reexamination of LEO Pharma's US Patent No. 6,753,013 (the "013 Patent") in response to a request made by Galderma R&D. The 013 Patent covers TACLONEX(R) products and certain of LEO Pharma's products in development. Warner Chilcott markets and sells TACLONEX(R) products in the United States under a license agreement with LEO Pharma and has license rights to certain products in development.
The details can be read here.
The details can be read here.
FDA Grants Pediatric Exclusivity for Topamax, Extending the Marketing Exclusivity by Six Months
Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for TOPAMAX(R) (topiramate), based on studies submitted in response to a Written Request by the FDA to investigate the use of TOPAMAX in pediatric patients aged 1 to 24 months with partial onset seizures.
In addition to granting pediatric exclusivity, the FDA is continuing its review of the application to determine the safety and efficacy of TOPAMAX in this patient population. Based on the data submitted, no indication is sought for this age group.
The details can be read here.
In addition to granting pediatric exclusivity, the FDA is continuing its review of the application to determine the safety and efficacy of TOPAMAX in this patient population. Based on the data submitted, no indication is sought for this age group.
The details can be read here.
Thursday, July 24, 2008
IPO Reports on Rising RCE Filings
The Intellectual Property Owners Association (IPO) reported today on data compiled by Esther Kepplinger, the Director of Patent Operations for Wilson Sonsini Goodrich & Rosati, which the IPO believes "has received little attention and has contributed to misunderstanding of patenting trends." In particular, Ms. Kepplinger's analysis shows that Requests for Continued Examination (RCEs) rose from 8.3% in 1998 to 19.6% in 2007, while continuation and divisional filings remained relatively stable over the same period (continuation filings rose from 10.7% to 11%; divisional filings dropped from 5.1% to 4.8%).
The details can be read here.
The details can be read here.
AstraZeneca Sues Mylan Over Entocort ANDA
AstraZeneca LP has sued Mylan Pharmaceuticals Inc. in an effort to prevent it from selling a generic version of Entocort EC (budenoside), a drug used to treat Crohn's disease.
The details can be read here.
The details can be read here.
Roche to acquire Canada-based ARIUS Research for C$191 million
Roche and ARIUS Research Inc. announced that the two companies have signed a definitive agreement for Roche to acquire ARIUS in an all-cash transaction at a price of approximately C$191 million.
ARIUS, a Toronto, Ontario based developer of a proprietary antibody platform called FunctionFIRST, which rapidly identifies and selects antibodies based on their functional ability to affect disease before progressing into clinical development. The FunctionFIRST platform will allow Roche to further strengthen its developmental portfolio, initially within the areas of oncology and inflammatory diseases where this new technique offers potentially broad therapeutic applications.
The whole story can be read here.
ARIUS, a Toronto, Ontario based developer of a proprietary antibody platform called FunctionFIRST, which rapidly identifies and selects antibodies based on their functional ability to affect disease before progressing into clinical development. The FunctionFIRST platform will allow Roche to further strengthen its developmental portfolio, initially within the areas of oncology and inflammatory diseases where this new technique offers potentially broad therapeutic applications.
The whole story can be read here.
Exelixis begins phase 3 trial of thyroid cancer drug XL184
Exelixis, Inc. announced that the phase 3 registration trial of XL184 as a potential treatment for medullary thyroid cancer (MTC) has been initiated. XL184 is a small molecule anticancer compound targeting the MET, RET, and VEGFR2 receptor tyrosine kinases.
The details can be read here.
The details can be read here.
Talecris Biotherapeutics Receives Orphan Drug Designation for Aerosolized Form of Alpha1-Antitrypsin (AAT) From the European Commission
Jul 24, 2008 - Talecris Biotherapeutics, Inc. (http://www.talecris.com) announced today that the European Commission followed an opinion of the Committee for Orphan Medicinal Products (COMP) and has granted orphan drug designation to Talecris' alpha-1 proteinase inhibitor (human) for inhalation use in the treatment of congenital Alpha1-Antitrypsin Deficiency (also known as AAT Deficiency or Alpha-1). Currently, there are no approved aerosolized treatments available for augmentation therapy for AAT Deficiency.
The details can be read here.
The details can be read here.
Supplemental New Drug Application for Risperdal Consta Submitted to the FDA for the Treatment of Bipolar Disorder
July 24, 2008--Alkermes, Inc. today announced that its partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., submitted a supplemental New Drug Application (sNDA) for RISPERDAL(R) CONSTA(R) ((risperidone) Long-Acting Injection) to the U.S. Food and Drug Administration (FDA) for approval as monotherapy in the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in adults.
The details can be read here.
The details can be read here.
Santhera Receives First Product Approval: Health Canada Approves Catena for Treatment of Friedreich's Ataxia
July 24, 2008-Santhera Pharmaceuticals (SWX:SANN), a Swiss specialty pharmaceutical company focused on neuromuscular diseases, announced today that Health Canada has approved with conditions SNT-MC17/idebenone for the treatment of Friedreich's Ataxia. Health Canada's decision is the first marketing authorization worldwide for any Friedreich's Ataxia therapy. The new drug will be marketed in Canada under the brand name Catena®. Santhera has established a wholly owned Canadian subsidiary, Santhera Pharmaceuticals (Canada), Inc. recently incorporated in Montréal, Quebec, to address the needs of Canada's several hundred patients with this rare and severely progressive muscle disease. Launch of Catena is anticipated for the end of October 2008.
The details can be read here.
The details can be read here.
Sagent Pharmaceuticals Launches Ceftazidime for Injection, USP
Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, today announced that it has launched ceftazidime for injection, USP, a semisynthetic broad-spectrum, beta-lactam antibiotic. Sagent will offer ceftazidime in 1 and 2g single dose vials and 6g pharmacy bulk package vials. According to IMS data, 2007 sales of injectable amiodarone in the United States were approximately $45.7 million.
The details can be read here.
The details can be read here.
Barr Confirms Patent Challenge of Fentora Tablets
Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by Cephalon, Inc. in connection with its Fentora(R) Tablets (fentanyl citrate buccal tablets), equivalent to fentanyl base 100 mcg, 400 mcg, 600 mcg and 800 mcg.
Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Fentora product with the U.S. Food & Drug Administration (FDA) in February 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.
The details can be read here.
Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Fentora product with the U.S. Food & Drug Administration (FDA) in February 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.
The details can be read here.
Wednesday, July 23, 2008
Judge Rejects KV Sanctions Bid In Ritalin ANDA Suit
KV Pharmaceutical Co. has lost its bid for sanctions against pharmaceutical firms Celgene Corp. and Novartis Pharma AG for failing to conduct an infringement analysis before suing KV to stop it from marketing a generic version of Ritalin LA, which treats attention deficit disorder.
The details can be read here.
The details can be read here.
Paracetamol combinations lead list of FDCs being withdrawn voluntarily by industry
As many as 11 fixed doses combination (FDC) drugs involving paracetamol will be among the 28 FDCs that the industry has agreed to withdraw voluntarily from the market as part of the amicable settlement reached between the DCGI and the industry on the contentious FDC issue recently.
The FDCs that will be going off the market also include at least six combinations of dicyclomine. The meeting between the industry and the DCGI had arrived at consensus at revising the contentious list from 294 to 156, after removing the duplications and already banned combinations. The industry players had got approval for as many as 28 combination drugs after the former DCGI asked them to get them approved by the Central authority.
Now the new list of FDCs which need to be cleared by the DCGI for marketing would be placed before the DTAB and DCC before formally releasing them and assessing the rationality one by one.
The 15 combinations which were already banned but appeared in the list released by the former DCGI were analgin + dextripopoxyphene, analgin + diazepam, analgin + diazepam + diphenhydramine, analgin + diazepam + paracetamol, analgin + diazepam + propylene glycol, analgin + dicyclomine + diazepam, analgin + dihydroethaverine chloride, analgin + ketoprofen, analgin + KET-P-PIPER.ETH-O-CARB M, dicyclomine + paracetamol + analgin, fenpiverinium bromide + analgin + pitofenone hydrochloride, ibuprofen + paracetamol + oxyphenbutazone + phenylisopropyl pyrazolon, mebeverine + alprazolam, paracetamol + alprazolam, and paracetamol + analgin.
The FDCs that the industry has agreed to take back from the markets are:
1) chlorzoxazone + ibuprofen + paracetamol + diclofenac + oxyphenbutazone + magnesium pyrazolon;
(2) dicyclomine + paracetamol + phenylisopropyl pyrazolon,
(3) activated charcoal + fungal distae + lactic acid,
(4) allobarbitone + phospho-dimethyl-isopropyl-pyrazolone,
(5) artesunate + arteether + artemether,
(6) chlorzoxazone + paracetamol + ibuprofen + diclofenac sodium,
(7) norfloxacin + tinidazole + loperamide,
(8) paracetamol + diclofenac sodium + amoxicillin + cloxacillin + pantoprazole + lactic acid bacillus + serrapeptase,
(9) paracetamol + diclofenac sodium + magnesium trisilicate + chlorphenamine maleate
(10) ranitidine + omeprazole,
(11) 5-bromisalicy-4-chloranilide + salicylic acid,
(12) actorvastatin + acetyl salicylic acid + caffeine,
(13) chlormezanone + paracetamole + diclofenac sodium,
(14) chlormezanone + paracetamole + ibuprofen,
(15) ciprofloxacin + tinidazole + dicyclomine,
(16) diclofenac + paracetamol + chlormezanone,
(17) dicyclomine + dextromethorphan + paracetamol,
(18) dicyclomine + paracetamol + chlordiazepoxide,
(19) dicyclomine + serrartiopeptidase,
(20) ibuprofen + colchicine,
(21) ibuprofen + paracetamol + colchicine,
(22) ibuprofen + paracetamol + magnesium triscilicate,
(23) ibuprofen + paracetamol + magnesium trisilicate,
(24) mecobalamine + methenamine mandelate,
(25) norfloxacin + tinidazole + dicyclomine,
(26) ondansetron + paracetamol,
(27) ranitidine + cisapride,
(28) ranitidine + dicyclomine + clidinium bromide
(Source: www.pharmabiz.com)
The FDCs that will be going off the market also include at least six combinations of dicyclomine. The meeting between the industry and the DCGI had arrived at consensus at revising the contentious list from 294 to 156, after removing the duplications and already banned combinations. The industry players had got approval for as many as 28 combination drugs after the former DCGI asked them to get them approved by the Central authority.
Now the new list of FDCs which need to be cleared by the DCGI for marketing would be placed before the DTAB and DCC before formally releasing them and assessing the rationality one by one.
The 15 combinations which were already banned but appeared in the list released by the former DCGI were analgin + dextripopoxyphene, analgin + diazepam, analgin + diazepam + diphenhydramine, analgin + diazepam + paracetamol, analgin + diazepam + propylene glycol, analgin + dicyclomine + diazepam, analgin + dihydroethaverine chloride, analgin + ketoprofen, analgin + KET-P-PIPER.ETH-O-CARB M, dicyclomine + paracetamol + analgin, fenpiverinium bromide + analgin + pitofenone hydrochloride, ibuprofen + paracetamol + oxyphenbutazone + phenylisopropyl pyrazolon, mebeverine + alprazolam, paracetamol + alprazolam, and paracetamol + analgin.
The FDCs that the industry has agreed to take back from the markets are:
1) chlorzoxazone + ibuprofen + paracetamol + diclofenac + oxyphenbutazone + magnesium pyrazolon;
(2) dicyclomine + paracetamol + phenylisopropyl pyrazolon,
(3) activated charcoal + fungal distae + lactic acid,
(4) allobarbitone + phospho-dimethyl-isopropyl-pyrazolone,
(5) artesunate + arteether + artemether,
(6) chlorzoxazone + paracetamol + ibuprofen + diclofenac sodium,
(7) norfloxacin + tinidazole + loperamide,
(8) paracetamol + diclofenac sodium + amoxicillin + cloxacillin + pantoprazole + lactic acid bacillus + serrapeptase,
(9) paracetamol + diclofenac sodium + magnesium trisilicate + chlorphenamine maleate
(10) ranitidine + omeprazole,
(11) 5-bromisalicy-4-chloranilide + salicylic acid,
(12) actorvastatin + acetyl salicylic acid + caffeine,
(13) chlormezanone + paracetamole + diclofenac sodium,
(14) chlormezanone + paracetamole + ibuprofen,
(15) ciprofloxacin + tinidazole + dicyclomine,
(16) diclofenac + paracetamol + chlormezanone,
(17) dicyclomine + dextromethorphan + paracetamol,
(18) dicyclomine + paracetamol + chlordiazepoxide,
(19) dicyclomine + serrartiopeptidase,
(20) ibuprofen + colchicine,
(21) ibuprofen + paracetamol + colchicine,
(22) ibuprofen + paracetamol + magnesium triscilicate,
(23) ibuprofen + paracetamol + magnesium trisilicate,
(24) mecobalamine + methenamine mandelate,
(25) norfloxacin + tinidazole + dicyclomine,
(26) ondansetron + paracetamol,
(27) ranitidine + cisapride,
(28) ranitidine + dicyclomine + clidinium bromide
(Source: www.pharmabiz.com)
Roche acquires Mirus Bio for US$ 125 million
Roche and Mirus Bio Corporation announced that they have entered into a definitive agreement under which Roche will acquire Mirus Bio Corporation, a privately-owned US company based in Madison, Wisconsin, that focuses on the discovery and development of innovative nucleic acid based technologies, including a proprietary RNAi (Ribonucleic Acid interference) delivery platform.
The whole story can be read here.
The whole story can be read here.
Ranbaxy launches generic Amlodipine tablets in Japan
Ranbaxy Laboratories Limited announced the day-1 launch of its first independently developed generic product, Amlodipine tablets 2.5mg & 5mg in Japan. Amlodipine is currently the largest molecule which has gone off patent in Japan and represents the biggest generic opportunity so far in the Japanese generic market. The product has a market size of around USD 2 billion (Jan-December, 2007 - IMS - Japan), a Ranbaxy press release said.
The details can be read here.
The details can be read here.
FDA Announces Important Safety-Related Label Update for Ziagen (abacavir sulfate)
On July 18, 2008, FDA approved changes to the package insert for Ziagen (abacavir sulfate) highlighting information about the association of the HLA-B*5701 allele (a part of a gene) and hypersensitivity reactions (HSR) caused by abacavir-containing therapy.
Abacavir is associated with serious and sometimes fatal HSR. Abacavir HSR is a multi-organ syndrome characterized by 2 or more clinical signs or symptoms including fever, rash, gastrointestinal symptoms (nausea, vomiting, diarrhea or abdominal pain), respiratory symptoms (dyspnea, cough or pharyngitis) and constitutional symptoms (generalized malaise, fatigue or myalgia). Occurrence of abacavir HSR requires immediate and permanent discontinuation of abacavir therapy.
The details can be read here.
Abacavir is associated with serious and sometimes fatal HSR. Abacavir HSR is a multi-organ syndrome characterized by 2 or more clinical signs or symptoms including fever, rash, gastrointestinal symptoms (nausea, vomiting, diarrhea or abdominal pain), respiratory symptoms (dyspnea, cough or pharyngitis) and constitutional symptoms (generalized malaise, fatigue or myalgia). Occurrence of abacavir HSR requires immediate and permanent discontinuation of abacavir therapy.
The details can be read here.
NexMed Receives FDA Response for Erectile Dysfunction Product
July 22, 2008 - NexMed, Inc. (Nasdaq: NEXM), today announced the receipt of a non approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for its topical treatment for erectile dysfunction (ED). The major regulatory issues raised by the FDA were related to the results of the transgenic mouse carcinogenicity study which NexMed completed in 2002.
Commenting on today's announcement, Vivian Liu, President and Chief Executive Officer of NexMed said, "The transgenic mouse concern raised by the FDA is product specific, and does not affect the dermatological products in our pipeline. While we are disappointed by the FDA's decision, the deficiencies cited in their letter were not unexpected. One positive outcome is the fact that the FDA did not cite the lack of completion of our long term open label safety study as a deficiency. We are encouraged that we do not need to redo this study, which would have taken up to 18 months to complete and at a substantial cost."
The details can be read here.
Commenting on today's announcement, Vivian Liu, President and Chief Executive Officer of NexMed said, "The transgenic mouse concern raised by the FDA is product specific, and does not affect the dermatological products in our pipeline. While we are disappointed by the FDA's decision, the deficiencies cited in their letter were not unexpected. One positive outcome is the fact that the FDA did not cite the lack of completion of our long term open label safety study as a deficiency. We are encouraged that we do not need to redo this study, which would have taken up to 18 months to complete and at a substantial cost."
The details can be read here.
BMS and AstraZeneca Submit NDA in the US and Marketing Authorization Application in Europe for Onglyza for the Treatment of Type 2 Diabe
July 23, 2008--Bristol-Myers Squibb Company and AstraZeneca today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on June 30th and validation of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for ONGLYZA(TM) (saxagliptin). Saxagliptin, a dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor, is an investigational drug under joint development by Bristol-Myers Squibb and AstraZeneca for the treatment of type 2 diabetes. The companies have proposed the name ONGLYZA which, if approved by the FDA and the EMEA, will serve as the trade name for saxagliptin.
The details can be read here.
The details can be read here.
Merck Serono Receives European Approval for Broader Usage of Erbitux in Metastatic Colorectal Cancer including 1st-Line Treatment
Merck KGaA announced today that it has been granted approval by the European Commission for Erbitux® (cetuximab), to update its license for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type mCRC (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.
Depomed's ProQuin XR Achieves First Marketing Authorization in Europe
Depomed, Inc. (NASDAQ:DEPO) and Rottapharm/Madaus announced today that the Marketing Authorization (MA) for ProQuin XR has been received from the Medical Products Agency in Sweden. Depomed's ProQuin XR is exclusively licensed to Rottapharm/Madaus for Europe and is a once-daily extended-release formulation of ciprofloxacin hydrochloride for the treatment of uncomplicated urinary tract infections.
"We are glad to see ProQuin XR be approved in Sweden as reference member state which is a first step to make it commercially available in Europe. We feel confident that our partner Rottapharm/Madaus with their strong market presence and local expertise in individual European countries will realize ProQuin XR's commercial potential in Europe. We anticipate the commercial rollout and pricing in other European countries will progress through next year," noted Carl A. Pelzel, president and chief executive officer of Depomed.
The details can be read here.
"We are glad to see ProQuin XR be approved in Sweden as reference member state which is a first step to make it commercially available in Europe. We feel confident that our partner Rottapharm/Madaus with their strong market presence and local expertise in individual European countries will realize ProQuin XR's commercial potential in Europe. We anticipate the commercial rollout and pricing in other European countries will progress through next year," noted Carl A. Pelzel, president and chief executive officer of Depomed.
The details can be read here.
Tuesday, July 22, 2008
USPTO Files CAFC Appeal Brief: Tafas v. Dudas
As expected, the USPTO continues its appeal after the district court ruled that the PTO lacked authority to limit the number of claims and continuations that applicants could file. OnJuly 18th, the PTO submitted a brief to the CAFC that presented the following 3 issues:
1. Whether the USPTO’s revised rules of practice for patent cases are within the scope of the Office’s statutory rulemaking authority.
2. Whether the revised rules conflict with the Patent Act.
3. Whether the USPTO must provide public notice and comment for rules that are not subject to notice and comment under the Administrative Procedure Act.
The details can be read here.
1. Whether the USPTO’s revised rules of practice for patent cases are within the scope of the Office’s statutory rulemaking authority.
2. Whether the revised rules conflict with the Patent Act.
3. Whether the USPTO must provide public notice and comment for rules that are not subject to notice and comment under the Administrative Procedure Act.
The details can be read here.
DCGI rules out expansion of OTC drugs list
After sitting over the proposal seeking to expand the over-the-counter (OTC) drugs list amid differences in the industry, the authorities have finally ruled out any change or revision of the list. However, pending amendment to Schedule K to exclude Aspirin and Quinine Sulphate IP from the list of household remedies may come through with a final notification in this regard.
The details can be read here.
Biocon to offer cancer drug Abraxane at $400 against US price of $1,000
In a major effort to provide high quality affordable drugs to the cancer patients in the country, Biocon has now introduced Abraxane for breast cancer after failure of combination therapy. The drug, which is a paclitaxel protein-bound particles for injection suspension albumin-bound particles of approximately 130 nanometers is priced at $400 as against the current US price of $1,000 making it cheaper by 60 percent for scores of breast cancer patients.
The details can be read here.
The details can be read here.
Ranbaxy wins UK SFO case
Ranbaxy Laboratories Limited (Ranbaxy) announced that the UK Serious Fraud Office's (SFO) prosecution of its UK subsidiary, Ranbaxy (UK) Limited (RUKL), has been quashed by the English Crown Court. The Court also declined an application by the SFO for permission to appeal to the English Court of Appeal, although the SFO retains a right to appeal to the Court of Appeal directly.
Welcoming the decision of the English Crown Court, a company spokesman in a press statement said that Ranbaxy is a responsible company committed to providing high quality generic medicines at affordable prices to its customers and patients throughout the world.
Welcoming the decision of the English Crown Court, a company spokesman in a press statement said that Ranbaxy is a responsible company committed to providing high quality generic medicines at affordable prices to its customers and patients throughout the world.
Xanodyne Receives Approvable Letter From the FDA for Zipsor Capsules
Jul 22, 2008 - Xanodyne Pharmaceuticals, Inc. announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Zipsor, its candidate for the treatment of patients with mild to moderate acute pain. Zipsor is a proprietary immediate release liquid-filled soft gelatin capsule containing 25 mg of diclofenac potassium for oral administration.
"Xanodyne is pleased with this action and will work closely with the FDA to provide a complete response. Importantly, no additional clinical trials have been requested," said Gregory D. Flexter, President and Chief Executive Officer of Xanodyne. Zipsor is a unique formulation designed for rapid and consistent release while minimizing systemic exposure.
The details can be read here.
"Xanodyne is pleased with this action and will work closely with the FDA to provide a complete response. Importantly, no additional clinical trials have been requested," said Gregory D. Flexter, President and Chief Executive Officer of Xanodyne. Zipsor is a unique formulation designed for rapid and consistent release while minimizing systemic exposure.
The details can be read here.
'Janumet' (sitagliptin/metformin) Approved in the European Union for Treatment of Type 2 Diabetes
Merck & Co., Inc.'s new combination product for type 2 diabetes, has been granted a marketing authorisation from the European Commission (EC). 'Janumet' (sitagliptin/metformin) helps patients lower blood sugar levels to help reach their treatment goal through the efficacy of sitagliptin, a DPP-4 inhibitor, and metformin, a mainstay of diabetes therapy. Janumet has a low risk of weight gain and hypoglycaemia compared with metformin alone and targets all three key defects of diabetes: insulin deficiency from pancreatic beta cells, insulin release, and overproduction of glucose by the liver.
The details can be read here.
The details can be read here.
Celebrity Designer and ADHD Spokesperson Ty Pennington Partners With Shire to Announce the Launch of Vyvanse for the Treatment of ADHD in adults
Shire Limited , the global specialty biopharmaceutical company, today announced that it has launched Vyvanse(TM) (lisdexamfetamine dimesylate) for the treatment of adults with Attention Deficit Hyperactivity Disorder (ADHD). This launch follows the recent FDA approval of VYVANSE to treat ADHD in the adult population. VYVANSE is now available in U.S. pharmacies nationwide in six once-daily dosage strengths. To raise awareness of ADHD in adults and recognize the launch of VYVANSE for adults, Shire has partnered with celebrity designer Ty Pennington to shine the spotlight on living as an adult with ADHD. Pennington takes VYVANSE as part of his treatment plan to manage his ADHD symptoms so he can focus and get work done.
The whole story can be read here.
The whole story can be read here.
Tranzyme Pharma Receives Notices of Allowance from USPTO on Two Patents Protecting Company's Lead Pharmaceutical Development Programs
Jul 22, 2008 - Tranzyme Pharma, a leading biopharmaceutical company developing novel mechanism-based therapeutics for the treatment of gastrointestinal (GI) and metabolic disorders, announced today that the Company has received Notices of Allowance from the U.S. Patent and Trademark Office (USPTO) for two patent applications entitled "Macrocyclic Modulators of the Ghrelin Receptor" and "Spatially-Defined Macrocyclic Compounds Useful for Drug Discovery".
The details can be read here.
The details can be read here.
Cara Therapeutics Announces Issuance of U.S. Patent Covering Second Generation Kappa Opioid Receptor Agonists
Cara Therapeutics, Inc. announced today that The United States Patent and Trademark Office has issued U.S. Patent No. 7,402,564 entitled "Synthetic Peptide Amides" under its Accelerated Examination Program. The application was filed on November 12, 2007 and covers Cara's second generation, peripherally-selective kappa opioid receptor agonist compounds. These compounds include CR845, currently completing a Phase I clinical trial and in development for injectable and oral delivery for the treatment of acute and chronic pain of visceral, inflammatory and neuropathic origin, and for the treatment of pruritis (itch), a common disorder associated with several diseases and conditions.
The details can be read here.
The details can be read here.
IMPAX Sued Based on ANDA for Generic Flomax
July 22, 2008 - IMPAX Laboratories, Inc. today announced Boehringer Ingelheim Pharmaceuticals Inc. ("Boehringer") and Astellas Pharma Inc. ("Astellas") have filed suit for patent infringement in the United States District Court for the Northern District of California based on the Company's submission of Abbreviated New Drug Application ("ANDA") for tamsulosin hydrochloride capsules (0.4 mg), generic of Flomax(R), to the Food and Drug Administration. In connection with this ANDA, IMPAX provided notice to Boehringer and Astellas that its submission includes a Paragraph IV certification stating the Company believes its product does not infringe any valid or enforceable claim of U.S. Patent No. 4,703,063.
Flomax(R) capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia. According to Wolters Kluwer Health, U.S. sales of Flomax(R) capsules were approximately $1.5 billion in the 12 months ended May 2008.
Flomax(R) capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia. According to Wolters Kluwer Health, U.S. sales of Flomax(R) capsules were approximately $1.5 billion in the 12 months ended May 2008.
Teva Introduces Lamotrigine Tablets
July 22, 2008 – Teva Pharmaceuticals is pleased to announce the introduction and availability of Lamotrigine Tablets. This product is AB rated and bioequivalent to Lamictal®* Tablets. Lamotrigine Tablets are available in 25 mg and 100 mg strengths, in bottle sizes of 100, and in 150 mg and 200 mg strengths, in bottle sizes of 60.
The details can be read here.
The details can be read here.
Monday, July 21, 2008
Court Report
As published at http://patentdocs.typepad.com/ by Sherri Oslick the court report is as follows:
Endo Pharmaceuticals Inc. et al. v. Actavis South Atlantic LLC
2:08-cv-03482; filed July 11, 2008 in the District Court of New Jersey
View the complaint here. As reported here, Endo has previously asserted this patent against Actavis in response to Actavis' initial paragraph IV certification.
Sanofi-Aventis et al. v. Sun Pharmaceutical Industries Ltd. et al.
1:08-cv-06286; filed July 11, 2008 in the Southern District of New York
View the complaint here.
AstraZeneca Pharmaceuticals LP et al. v. Teva Pharmaceuticals USA
1:08-cv-00426; filed July 10, 2008 in the District Court of Delaware
View the complaint here.
Endo Pharmaceuticals Inc. et al. v. Actavis South Atlantic LLC
2:08-cv-03482; filed July 11, 2008 in the District Court of New Jersey
View the complaint here. As reported here, Endo has previously asserted this patent against Actavis in response to Actavis' initial paragraph IV certification.
Sanofi-Aventis et al. v. Sun Pharmaceutical Industries Ltd. et al.
1:08-cv-06286; filed July 11, 2008 in the Southern District of New York
View the complaint here.
AstraZeneca Pharmaceuticals LP et al. v. Teva Pharmaceuticals USA
1:08-cv-00426; filed July 10, 2008 in the District Court of Delaware
View the complaint here.
Fed. Circ. Upholds Eisai’s Aciphex Patent
With respect toEisai's patent infringement lawsuit against Teva Pharmaceuticals and Dr.Reddy's Laboratories concerning Aciphex(R) (generic name: rabeprazolesodium tablets) Eisai Co., Ltd. and its U.S. subsidiary Eisai Inc. today announce that the United States Court of Appeals for the Federal Circuit has affirmed both the United States District Court for the Southern District of New York'ssummary judgment ruling on the validity of Eisai's composition of matterpatent and its ruling on the enforceability of the composition of matterpatent.
Eisai filed the infringement actions in November 2003 contesting TevaPharmaceuticals and Dr. Reddy's Laboratories' submission of abbreviated newdrug applications (ANDAs) to the Food and Drug Administration forAciphex(R). In October 2006, Judge Gerard E. Lynch of the United StatesDistrict Court for the Southern District of New York granted partial summary judgment to Eisai, upholding the validity of the Aciphex(R) composition of matter patent. In a subsequent ruling in May 2007, JudgeLynch also determined that Eisai's patent is enforceable.
The details can be read here.
The whole judgement can be read here.
Eisai filed the infringement actions in November 2003 contesting TevaPharmaceuticals and Dr. Reddy's Laboratories' submission of abbreviated newdrug applications (ANDAs) to the Food and Drug Administration forAciphex(R). In October 2006, Judge Gerard E. Lynch of the United StatesDistrict Court for the Southern District of New York granted partial summary judgment to Eisai, upholding the validity of the Aciphex(R) composition of matter patent. In a subsequent ruling in May 2007, JudgeLynch also determined that Eisai's patent is enforceable.
The details can be read here.
The whole judgement can be read here.
Teva acquires Barr Pharmaceutical for $7.47 billion
Teva Pharmaceutical Industries Ltd has acquired Barr Pharmaceuticals, Inc. (Barr), the fourth largest generic drug company worldwide for a total consideration of $7.46 billion.
Under the terms of the agreement, each share of Barr common stock will be converted into $39.90 in cash and 0.6272 Teva ADRs. Teva expects the transaction to close in late 2008 and to become accretive to GAAP earnings in the fourth quarter after closing. This purchase price represents a premium of 32 per cent to Barr's average daily closing price on the New York Stock Exchange for the 52-week period ending on July 16, 2008, and 42 per cent to the closing price on July 16, 2008.
The details can be read here.FDA Rule and Companion Guidance Make Early Stage Clinical Drug Development Safe and Efficient
July 18, 2008--The U.S. Food and Drug Administration today issued a final regulation that makes early phase 1 clinical drug development safe and efficient by enabling a phased approach to complying with current good manufacturing practice (CGMP) statutes and FDA investigational requirements.
The details can be read here.
The details can be read here.
CSL Behring Submits BLA Requesting Approval of Human Fibrinogen Concentrate for the Treatment of Congenital Bleeding
CSL Behring announced today that it has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval to market its human fibrinogen concentrate in the United States for the treatment of congenital fibrinogen deficiency, a rare bleeding disorder resulting from deficiency of fibrinogen.
The details can be read here.
The details can be read here.
Ikaria's INOflo (Nitric Oxide) for Inhalation Approved in Japan
Ikaria Holdings, Inc., through its subsidiary INO Therapeutics LLC, announced today that Japan's Ministry of Health, Labor and Welfare (MHLW) has approved INOflo(R) (nitric oxide) for inhalation for improvement of hypoxic respiratory failure (HRF) with concurrent pulmonary hypertension in neonates. INOflo (brand name INOmax(R) in the United States) has been shown to improve oxygenation and reduce the need for ECMO, a highly invasive cardiopulmonary bypass procedure.
The details can be read here.
The details can be read here.
Rexahn Pharmaceuticals Receives U.S. Patent for New Cancer Compounds
July 21, 2008 - Rexahn Pharmaceuticals, Inc., a leader in innovative therapeutics for life-threatening and life-debilitating diseases, today announced that the U.S. Patent & Trademark Office has issued to the Company U.S. Patent 7,388,014, entitled "Quinazoline Derivatives and Therapeutic Use Thereof."
Patent 7,388,014 covers Rexahn's anticancer candidate, RX-0183 and related compounds, and are targeted, small molecule quinazoline analogues that inhibit key molecules such as c-Fos and Akt proteins. Akt and c-Fos proteins are cancer cell signaling targets involved in transduction, growth and proliferation. Preclinical studies showed that RX-0183 inhibited in vitro proliferation of cancer cells derived from many human solid tumors. It also inhibited tumor growth in xenograft human tumor models. Based on the preclinical data, RX-0183 demonstrates potent anticancer activity for treating multiple cancers.
The details can be read here.
Patent 7,388,014 covers Rexahn's anticancer candidate, RX-0183 and related compounds, and are targeted, small molecule quinazoline analogues that inhibit key molecules such as c-Fos and Akt proteins. Akt and c-Fos proteins are cancer cell signaling targets involved in transduction, growth and proliferation. Preclinical studies showed that RX-0183 inhibited in vitro proliferation of cancer cells derived from many human solid tumors. It also inhibited tumor growth in xenograft human tumor models. Based on the preclinical data, RX-0183 demonstrates potent anticancer activity for treating multiple cancers.
The details can be read here.
Sunday, July 20, 2008
MacroGenics acquires Raven Biotechnologies
MacroGenics, Inc, a privately held biotechnology company that develops immunotherapeutics to treat autoimmune disorders, cancer and infectious diseases, announced the acquisition of Raven Biotechnologies, Inc., a privately held biotechnology company in South San Francisco, California, focused on the discovery and development of monoclonal antibody therapeutics for oncology through its cancer stem cell program.
Raven has developed a portfolio of proprietary cancer stem cells from many types of primary tumours. These cancer stem cells are maintained in vitro, and small numbers of these cells can form both localized and metastatic tumours in vivo. Using its proprietary technology platform, Raven has generated more than 1,300 monoclonal antibodies, including many that target cancer stem cells and cancers of the lung, colon, pancreas, prostate, breast and ovary.
"Raven's discovery platform in cancer stem cell biology is highly complementary to MacroGenics' proprietary Fc-optimization and next-generation antibody platforms," said Scott Koenig, M.D., Ph.D., president and CEO of MacroGenics. "We believe that this acquisition provides MacroGenics with critical mass in oncology discovery, which is one of the most scientifically and commercially promising areas of drug development. With our internal capabilities in development and manufacturing, this transaction should result in the rapid production of new lead therapeutic candidates and increase the probability of clinical and commercial success. Moreover, with the wealth of these assets, we will expand our pursuit of collaborations and other strategic alliances with pharmaceutical and biotechnology companies."
"We are pleased that Raven's cancer stem cell antibody programme will be pursued by MacroGenics, a company with the resources and capabilities to accelerate the advancement of these projects into clinical development," stated George Schreiner, M.D., Ph.D., chief executive officer of Raven Biotechnologies. "MacroGenics' portfolio of novel therapeutic monoclonal antibodies, platform technologies and capabilities such as GMP manufacturing make this merger an excellent opportunity for Raven and its investors. The transaction significantly expands MacroGenics' opportunity to develop products for patients with various types of cancer."
MacroGenics will issue shares of its stock to purchase Raven. Other terms of the transaction were not disclosed. Montgomery & Co., LLC served as the financial advisor to Raven. Arnold & Porter LLP served as legal advisor to MacroGenics.
source: www.pharmabiz.com
Raven has developed a portfolio of proprietary cancer stem cells from many types of primary tumours. These cancer stem cells are maintained in vitro, and small numbers of these cells can form both localized and metastatic tumours in vivo. Using its proprietary technology platform, Raven has generated more than 1,300 monoclonal antibodies, including many that target cancer stem cells and cancers of the lung, colon, pancreas, prostate, breast and ovary.
"Raven's discovery platform in cancer stem cell biology is highly complementary to MacroGenics' proprietary Fc-optimization and next-generation antibody platforms," said Scott Koenig, M.D., Ph.D., president and CEO of MacroGenics. "We believe that this acquisition provides MacroGenics with critical mass in oncology discovery, which is one of the most scientifically and commercially promising areas of drug development. With our internal capabilities in development and manufacturing, this transaction should result in the rapid production of new lead therapeutic candidates and increase the probability of clinical and commercial success. Moreover, with the wealth of these assets, we will expand our pursuit of collaborations and other strategic alliances with pharmaceutical and biotechnology companies."
"We are pleased that Raven's cancer stem cell antibody programme will be pursued by MacroGenics, a company with the resources and capabilities to accelerate the advancement of these projects into clinical development," stated George Schreiner, M.D., Ph.D., chief executive officer of Raven Biotechnologies. "MacroGenics' portfolio of novel therapeutic monoclonal antibodies, platform technologies and capabilities such as GMP manufacturing make this merger an excellent opportunity for Raven and its investors. The transaction significantly expands MacroGenics' opportunity to develop products for patients with various types of cancer."
MacroGenics will issue shares of its stock to purchase Raven. Other terms of the transaction were not disclosed. Montgomery & Co., LLC served as the financial advisor to Raven. Arnold & Porter LLP served as legal advisor to MacroGenics.
source: www.pharmabiz.com
Validity of Allergan Patents Acknowledged by Jan Marini in Settlement of Allergan's Patent Infringement Suit Against Jan Marini Skin Research, Inc.
Jul 18, 2008 - Allergan, Inc. (NYSE:AGN) announced today that it has agreed to dismiss its legal action against Jan Marini Skin Research, Inc. ("Jan Marini"), one of the defendants in Allergan's patent infringement lawsuit pending in the United States District Court for the Central District of California. The dismissal is based on Jan Marini acknowledging the validity of Allergan's relevant patents covering the use of certain drug substances, such as prostaglandin analogs, to promote eyelash enhancement and also agreeing to cease its distribution of eyelash products containing these ingredients in the United States and other countries worldwide where Allergan owns related patents.
As recently announced, Allergan has completed a clinical program with its patented formulation of bimatoprost, a synthetic prostaglandin analog, and will pursue United States Food and Drug Administration approval to market a product to stimulate eyelash growth in the United States.
The details can be read here.
As recently announced, Allergan has completed a clinical program with its patented formulation of bimatoprost, a synthetic prostaglandin analog, and will pursue United States Food and Drug Administration approval to market a product to stimulate eyelash growth in the United States.
The details can be read here.
Thursday, July 17, 2008
Biocon ranked 20th top biotechnology companies worldwide
Biocon is ranked the 20th company among the top biotechnology companies in the world. The ranking is featured in the Med Ad News, a leading US trade publication, which provided the list of Leading Global Biotechnology Companies in 2007, based on revenue and income.
The report takes into consideration drug based firms, as these companies provide the best numbers to track the progress of the sector. Biocon Limited is the only Asian company to feature in the Top 25.
Earlier, the BioSpectrum-ABLE Biotech Industry Survey had revealed that Biocon was ranked second largest biotech company in the country after the Pune-based Serum Institute. Biocon merged as the second top company in the country with a Rs. 912 crore revenues as against Serum Institute which clocked revenues of Rs 987 crore.
The report takes into consideration drug based firms, as these companies provide the best numbers to track the progress of the sector. Biocon Limited is the only Asian company to feature in the Top 25.
Earlier, the BioSpectrum-ABLE Biotech Industry Survey had revealed that Biocon was ranked second largest biotech company in the country after the Pune-based Serum Institute. Biocon merged as the second top company in the country with a Rs. 912 crore revenues as against Serum Institute which clocked revenues of Rs 987 crore.
Biocon & Abraxis to introduce breast cancer drug Abraxane in India
Biocon Limited and Abraxis BioScience Inc will soon launch the breast cancer drug Abraxane in India. Abraxane (paclitaxel protein-bound particles for injectable suspension is an albumin-bound) is indicated for the treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy.
Abraxane is now available in India as a single-use 100 mg vial (as a lyophilized powder, to be reconstituted for intravenous administration). It is approved for marketing in 35 countries including USA and Europe, stated Kiran Mazumdar-Shaw, chairman and managing director, Biocon Limited.
Abraxane is a solvent-free chemotherapy treatment option for metastatic breast cancer. Developed by using Abraxis BioScience's proprietary nab technology platform, Abraxane is a protein-bound chemotherapy agent, which combines paclitaxel with albumin, a naturally-occurring human protein, to deliver the drug and eliminates the need for solvents in the administration process. Because solvents are not used for administration, Abraxane allows for the delivery of a 49 per cent higher dose compared to solvent-based paclitaxel (Taxol) without compromising safety and tolerability. In a previous randomized phase III study of metastatic breast cancer patients, Abraxane demonstrated nearly double the overall tumour response rate compared to solvent-based paclitaxel.
Earlier Pharmabiz had reported that in the Asia-Pacific region, Abraxane was approved in India in November 2007 and in Korea in April 2008. Abraxane is under regulatory review by the Therapeutic Goods Administration (TGA) in Australia and by the Federal Authority for Healthcare and Social Development Regulation in Russia for the treatment of breast cancer. In March 2008, the Japanese licensee of Abraxis, Taiho Pharmaceutical Co., filed a New Drug Application (J-NDA) with the Ministry of Health, Labour and Welfare to market Abraxane for the treatment of breast cancer in Japan.
In addition, Abraxis has received approval from the China State Food and Drug Administration to market Abraxane Paclitaxel for injection (Albumin Bound) for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
Abraxane is now available in India as a single-use 100 mg vial (as a lyophilized powder, to be reconstituted for intravenous administration). It is approved for marketing in 35 countries including USA and Europe, stated Kiran Mazumdar-Shaw, chairman and managing director, Biocon Limited.
Abraxane is a solvent-free chemotherapy treatment option for metastatic breast cancer. Developed by using Abraxis BioScience's proprietary nab technology platform, Abraxane is a protein-bound chemotherapy agent, which combines paclitaxel with albumin, a naturally-occurring human protein, to deliver the drug and eliminates the need for solvents in the administration process. Because solvents are not used for administration, Abraxane allows for the delivery of a 49 per cent higher dose compared to solvent-based paclitaxel (Taxol) without compromising safety and tolerability. In a previous randomized phase III study of metastatic breast cancer patients, Abraxane demonstrated nearly double the overall tumour response rate compared to solvent-based paclitaxel.
Earlier Pharmabiz had reported that in the Asia-Pacific region, Abraxane was approved in India in November 2007 and in Korea in April 2008. Abraxane is under regulatory review by the Therapeutic Goods Administration (TGA) in Australia and by the Federal Authority for Healthcare and Social Development Regulation in Russia for the treatment of breast cancer. In March 2008, the Japanese licensee of Abraxis, Taiho Pharmaceutical Co., filed a New Drug Application (J-NDA) with the Ministry of Health, Labour and Welfare to market Abraxane for the treatment of breast cancer in Japan.
In addition, Abraxis has received approval from the China State Food and Drug Administration to market Abraxane Paclitaxel for injection (Albumin Bound) for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
FDA Accepts Labopharm's Response for Once-Daily Tramadol as Complete Class 2 Response
Labopharm Inc. today announced that the response that it submitted to the U.S. Food and Drug Administration (FDA) on July 2, 2008, including the additional analysis of existing data as suggested by the Agency, has been accepted as a complete, Class 2 response. The action date assigned by the FDA under the Prescription Drug User Fee Act (PDUFA) is January 2, 2009.
The details can be read here.
The details can be read here.
Merck: Erbitux Approved for Use in Metastatic Colorectal Cancer in Japan
Merck KGaA announced today that marketing authorization has been granted in Japan for the use of Erbitux® (cetuximab) in treating patients with epidermal growth factor receptor (EGFR)-positive, curatively unresectable (inoperable), advanced or recurrent colorectal cancer (CRC). On the basis of the submitted data, the label allows the use of Erbitux plus irinotecan in second- and further lines of metastatic colorectal cancer (mCRC).*
The details can be read here.
The details can be read here.
Biopten (Sapropterin Dihydrochloride) Approved by Japanese Ministry of Health for the Treatment of PKU
BioMarin Pharmaceutical Inc. announced today that Asubio Pharma Co., Ltd. (a subsidiary of Daiichi Sankyo), has received marketing approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for a label extension of Biopten(R) (sapropterin dihydrochloride), which contains the same active ingredient as Kuvan(R) in the U.S., for the treatment of patients with phenylketonuria (PKU). BioMarin will receive a milestone payment of $1.5 million for this marketing approval along with double-digit royalties on net sales of Biopten for PKU in Japan under an exclusive license of data and intellectual property contained in the Kuvan new drug application.
The details can be read here.
The details can be read here.
FDA Advisory Committee Provides Opinion of Doribax for the Treatment of Hospital-Acquired Pneumonia
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that the U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee voted in favor of the efficacy and safety data for DORIBAX(TM) (doripenem for injection) for the treatment of hospital-acquired pneumonia, or nosocomial pneumonia (NP), and ventilator-associated pneumonia (VAP).
The details can be read here.
The details can be read here.
Galderma Announces Approval for Differin Gel 0.1% in Japan
Galderma Pharma S.A., a global specialty pharmaceutical company focused on dermatology, announced today that Japan's Ministry of Health, Labor and Welfare has approved Differin(R) Gel 0.1% (adapalene), a novel topical treatment for acne vulgaris in Japan. The drug will be marketed in Japan by Galderma KK, the fully-owned Japanese arm of Galderma, and strategic alliance partner Shionogi.
The whole story can be read here.
The whole story can be read here.
Nasonex Now Approved in Japan for the Treatment of Allergic Rhinitis in Adult Patients
Schering-Plough Corporation today announced that Schering-Plough K.K., the company's country operation in Japan, has received marketing approval for NASONEX(R) (mometasone furoate monohydrate) Nasal Spray 50mcg* for the treatment of allergic rhinitis in adult patients.(1) NASONEX is an intranasal steroid that significantly improves nasal allergy symptoms when taken once each day. NASONEX is the first intranasal steroid to be approved in Japan for once-daily administration. NASONEX is currently approved in over 100 countries worldwide and is anticipated to be available in Japan this fall.
The details can be read here.
The details can be read here.
IpAuctions Selling Liver Disease Therapeutic Patent Portfolio
IpAuctions, Inc. will auction the worldwide biotherapeutic patents previously owned by Cell Works Inc., a Maryland-based biotech company, and acquired by CellPoint Diagnostics, Inc., based in Mountain View, Calif. These patents primarily consist of organ-targeted drug delivery systems to combat liver disease.
Fifteen major U.S. and worldwide medical patents and applications in three major treatment areas will be auctioned, including one associated with a liver cancer therapeutic drug that has been granted orphan drug status by the Food and Drug Administration (FDA). The orphan drug status designation is given to provide special benefits to encourage development of drugs to treat conditions having a prevalence of less than 200,000 cases in the U.S. The worldwide market for a liver cancer therapeutic is quite large, however, and U.S. orphan drug status includes other possible benefits such as research grants, assistance in negotiating the regulatory process and special tax credits. The IP portfolio currently for sale by IpAuctions consists of a therapeutic platform for a ligand-directed drug delivery system that can target the liver or the renal system for greater specificity and efficacy, with less toxicity to the patient.
The details can be read here.
Fifteen major U.S. and worldwide medical patents and applications in three major treatment areas will be auctioned, including one associated with a liver cancer therapeutic drug that has been granted orphan drug status by the Food and Drug Administration (FDA). The orphan drug status designation is given to provide special benefits to encourage development of drugs to treat conditions having a prevalence of less than 200,000 cases in the U.S. The worldwide market for a liver cancer therapeutic is quite large, however, and U.S. orphan drug status includes other possible benefits such as research grants, assistance in negotiating the regulatory process and special tax credits. The IP portfolio currently for sale by IpAuctions consists of a therapeutic platform for a ligand-directed drug delivery system that can target the liver or the renal system for greater specificity and efficacy, with less toxicity to the patient.
The details can be read here.
China Medicine Corporation Obtains Australian Patent for rADTZ
China Medicine Corporation , a leading distributor and developer of ethical and over-the-counter drugs, traditional Chinese medicines (TCMs), nutritional and dietary supplements, medical devices, and medical formulations in the People's Republic of China (PRC), announced today that it obtained a patent from Australia Patent Office for recombinant Aflatoxin Detoxifizyme (rADTZ). The patent is valid through January 13, 2025.
The details can be read here.
The details can be read here.
Impax Announces Final Settlement of Generic Effexor XR Patent Suit
July 16, 2008 - Impax Laboratories Inc. today announced that all conditions of a settlement of the U.S. patent infringement litigation pertaining to Impax's proposed generic capsule formulation of Wyeth's Effexor XR(R) antidepressant have been approved by the United States District Court for the District of Delaware. The Court entered a consent judgment resulting in termination of the litigation effective today.
Under the terms of the settlement, Wyeth has granted IMPAX a license that would permit IMPAX to launch its capsule formulation of Effexor XR on or after June 1, 2011, subject to earlier launch in limited circumstances, but in no event earlier than January 1, 2011. IMPAX will pay Wyeth a royalty on sales of this generic product.
The details can be read here.
Tuesday, July 15, 2008
RNAi Patent Revoked by EPO
Last Friday, the European Patent Office revoked (in its entirety) European Patent No. EP 1 230 375, owned by Cancer Research Therapeutics Ltd. of Cambridge, UK and exclusively licensed to Alnylam Pharmaceuticals, Inc. The patent was opposed by several companies involved in commercializing RNA interference (RNAi), including Sanofi-Aventis Deutschland GmbH, Sirna Therapeutics, Nucleonics, Inc., Quark Biotech, and Silence Therapeutics AG.
The details can be read here. and here.
The details can be read here. and here.
Court Report
Source: http://patentdocs.typepad.com/
As reported by Sherri Oslick in their site i.e. patent docs, following are the details of new cases filed. More details can be obtained from http://patentdocs.typepad.com/
Abbott Laboratories v. Dr. Reddy's Laboratories, Inc. et al.
3:08-cv-03390; filed July 8, 2008 in the District Court of New Jersey
View the complaint here.
Enzo Life Sciences, Inc. v. Eiken Kagaku Kabushiki Kaisha
1:08-cv-00692; filed July 3, 2008 in the Eastern District of Virginia
View the complaint here.
Celgene Corp. et al. v. Barr Laboratories, Inc. et al.
2:08-cv-03357; filed July 2, 2008 in the District Court of New Jersey
View the complaint here. As reported here and here, Celgene has previously asserted other patents against Barr based on the same ANDA filing.
As reported by Sherri Oslick in their site i.e. patent docs, following are the details of new cases filed. More details can be obtained from http://patentdocs.typepad.com/
Abbott Laboratories v. Dr. Reddy's Laboratories, Inc. et al.
3:08-cv-03390; filed July 8, 2008 in the District Court of New Jersey
View the complaint here.
Enzo Life Sciences, Inc. v. Eiken Kagaku Kabushiki Kaisha
1:08-cv-00692; filed July 3, 2008 in the Eastern District of Virginia
View the complaint here.
Celgene Corp. et al. v. Barr Laboratories, Inc. et al.
2:08-cv-03357; filed July 2, 2008 in the District Court of New Jersey
View the complaint here. As reported here and here, Celgene has previously asserted other patents against Barr based on the same ANDA filing.
DCGI, industry agree to withdraw 138 FDCs from market
The year-long impasse over regulating marketing of fixed dose combinations in the market between the industry and the authorities is being finally settled after a fruitful meeting between the DCGI Dr Surinder Singh and the pharma associations.
A consensus has been reached in the case of 138 combination drugs. At the meeting, described by the industry as one of the best ever with the authorities, it was agreed that 138 combinations out of the total 294 FDCs will be withdrawn from the market. The remaining 156 FDCs will be examined based on the scientific data and a final decision will be taken in course of time, sources said.
The details can be read here.
A consensus has been reached in the case of 138 combination drugs. At the meeting, described by the industry as one of the best ever with the authorities, it was agreed that 138 combinations out of the total 294 FDCs will be withdrawn from the market. The remaining 156 FDCs will be examined based on the scientific data and a final decision will be taken in course of time, sources said.
The details can be read here.
Sun Pharma extends tender offer for Taro Pharma
Sun Pharmaceutical Industries today announced its subsidiary, Alkaloida Chemical Company Exclusive Group Ltd. (Alkaloida), has extended the expiration date of the Tender Offer for purchase of all outstanding ordinary shares of Taro Pharmaceutical Industries Ltd. (Taro). The Offer has been extended to 5:00 pm, New York City time, on Tuesday, September 2, 2008.
The details can be read here.
The details can be read here.
Jerini Receives European Commission Approval for Firazyr (Icatibant) in the Treatment of HAE
Shire Limited , the global specialty biopharmaceutical company, notes that Jerini AG has announced today that the European Commission has granted the company marketing authorization for its lead compound FIRAZYR(R) (Icatibant) in the treatment of acute attacks of hereditary angioedema (HAE). HAE is a debilitating and potentially life-threatening genetic disease characterized by spontaneous and recurring attacks of edema.
The details can be read here.
The details can be read here.
Bapineuzumab To Become the First-to-Market Disease-Modifying Alzheimer's Drug After Flurizan's Discontinuation
Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that with Myriad Genetics/Lundbeck's decision to discontinue the development of Flurizan, the most likely first-to-market disease-modifying Alzheimer's disease treatment becomes Elan/Wyeth's bapineuzumab, an anti-beta-amyloid monoclonal antibody, expected to launch in 2011. The recent Phase III failure of Flurizan underscores the risk involved with developing an agent for Alzheimer's disease.
The details can be read here.
The details can be read here.
Monday, July 14, 2008
AstraZeneca files patent suit over Crestor
An AstraZeneca PLC unit sued generic drug maker Teva Pharmaceuticals USA alleging infringement of a patent for the anti-cholesterol drug Crestor. AstraZeneca, the U.K.'s second-largest drug maker, said Teva wrongly has applied to the U.S. Food and Drug Administration to market a copy of Crestor before the 2001 patent expires in 2016, according to papers filed Friday in federal court in Delaware. The case is AstraZeneca Pharmaceuticals LP, v. Teva Pharmaceuticals USA, 08CV426, U.S. District Court, Wilmington.
Par Pharma to commence shipment of 12.5 & 25mg meclizine HCl tabs
Par Pharmaceutical Companies, Inc, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets, announced that it will commence shipment of 12.5mg and 25mg meclizine HCl tablets immediately. At this time, Par believes it is the exclusive supplier of the AB-rated generic product.
Par marketed meclizine prior to an explosion at the facility of its API supplier in February 2008. Par has since qualified a new API source and received the appropriate approval of its supplemental new drug application to manufacture and market meclizine HCl utilizing its new API supplier.
Meclizine is an oral antiemetic indicated for the prevention and treatment of nausea, vomiting, and dizziness associated with motion sickness. It is contraindicated in individuals who have shown a previous hypersensitivity to it.
source: www.pharmabiz.com
Par marketed meclizine prior to an explosion at the facility of its API supplier in February 2008. Par has since qualified a new API source and received the appropriate approval of its supplemental new drug application to manufacture and market meclizine HCl utilizing its new API supplier.
Meclizine is an oral antiemetic indicated for the prevention and treatment of nausea, vomiting, and dizziness associated with motion sickness. It is contraindicated in individuals who have shown a previous hypersensitivity to it.
source: www.pharmabiz.com
Patient enrolment in ofatumumab combo phase II study completed
Genmab A/S has completed recruitment of 56 patients in the phase II study of ofatumumab (HuMax-CD20) in combination with fludarabine and cyclophosphamide (FC) to treat chronic lymphocytic leukaemia (CLL) in previously untreated patients. "We are pleased to complete patient enrolment in the first front line study of ofatumumab and hope to see a positive outcome for the CLL patients in this trial," said Lisa N. Drakeman, Ph.D., chief executive officer of Genmab.
The details can be read here.
The details can be read here.
Jubilant Organosys ties up with Amgen Inc for drug discovery partnership
Jubilant Organosys, through its subsidiary Jubilant Biosys Ltd, has signed a drug discovery partnership agreement with Amgen Inc, to develop a portfolio of novel drugs in new target areas of interest across multiple therapeutic areas.
Under the agreement, Jubilant will develop early pre-clinical candidates emanating from Amgen's early discovery efforts for an initial term of three years. Amgen will have responsibility for the subsequent pre-clinical and clinical development and commercialization. Amgen will retain/own the drugs developed under the collaboration with worldwide commercialization rights. Jubilant Biosys will partner in early-preclinical development effort from its state-of-the-art Jubilant Research Centre, Bangalore, while Amgen will pursue later stage pre-clinical and clinical development and commercialization of the drugs in global markets.
The details can be read here.
Under the agreement, Jubilant will develop early pre-clinical candidates emanating from Amgen's early discovery efforts for an initial term of three years. Amgen will have responsibility for the subsequent pre-clinical and clinical development and commercialization. Amgen will retain/own the drugs developed under the collaboration with worldwide commercialization rights. Jubilant Biosys will partner in early-preclinical development effort from its state-of-the-art Jubilant Research Centre, Bangalore, while Amgen will pursue later stage pre-clinical and clinical development and commercialization of the drugs in global markets.
The details can be read here.
FDA MedWatch- Avastin (bevacizumab) and Sunitinib Malate- Reports of Microangiopathic Hemolytic Anemia In Patients Treated With This Combination
Genentech, Inc. informed healthcare professionals of reports of several cases of microangiopathic hemolytic anemia (MAHA) in patients with solid tumors receiving Avastin in combination with sunitinib malate. Avastin is not approved for use in combination with sunitinib malate and this combination is not recommended. Twenty-five patients were enrolled in a Phase I dose-escalation study combining Avastin and sunitinib malate. The study consisted of 3 cohorts using a fixed dose of Avastin at 10mg/kg/IV every 2 weeks and escalating doses of sunitinib that included 25, 37.5, and 50 mg orally daily given in a 4 weeks on/ 2 weeks off schedule. Five of 12 patients at the highest sunitinib dose level exhibited laboratory findings consistent with MAHA. Two of these cases were considered severe with evidence of thrombocytopenia, anemia, reticulocytosis, reductions in serum haptoglobin, schistocytes on peripheral smear, modest increases in serum creatinine levels, and severe hypertension, reversible posterior leukoencephalopathy syndrome, and proteinuria. The findings in these two cases were reversible within three weeks upon discontinuation of both drugs without additional interventions. Healthcare professionals should report cases of MAHA or any serious adverse events suspected to be associated with the use of Avastin.
source: www.pharmalive.com
source: www.pharmalive.com
FDA Updates Label for Avandia to Include Clinical Findings Demonstrating Sustained Glycemic Control for Up to Five Years
GlaxoSmithKline announces today that the U.S. Food and Drug Administration (FDA) updated the prescribing information for AVANDIA(R) (rosiglitazone maleate) to include clinical findings from A Diabetes Outcome Progression Trial (ADOPT), a 4- to- 6 year head-to-head study of AVANDIA versus metformin and glyburide monotherapy in recently diagnosed type 2 diabetes patients. The percentage of patients with inadequate glucose control at five years was 34 percent with glyburide, 21 percent with metformin and only 15 percent with AVANDIA. The difference between AVANDIA and the comparators was statistically significant.
The details can be read here.
The details can be read here.
FDA Accepts Genta's NDA Amendment as Complete Response for Genasense Treatment of Chronic Lymphocytic Leukemia
Genta Incorporated announced that the Food and Drug Administration (FDA) has accepted the Company's amendment to its New Drug Application (NDA) for Genasense(R) (oblimersen sodium) Injection as a "complete response". The NDA proposed the use of Genasense plus chemotherapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The recent submission was based on new information from the Company's completed, randomized Phase 3 trial that showed, among other findings, a significant increase in overall survival for patients who achieved a complete or partial response when treated with Genasense plus chemotherapy compared with patients treated with chemotherapy alone.
The details can be read here.
The details can be read here.
Abraxis BioScience Announces Approval to Market Abraxane for Metastatic Breast Cancer in China
July 14, 2008 - Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, today announced it has received approval from the China State Food and Drug Administration to market Abraxane(R) Paclitaxel for Injection (Albumin Bound) for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. The Phase III clinical trials in the U.S. and China on which this approval was based demonstrated that ABRAXANE doubled the response rate, significantly prolonged time to tumor progression, and in the U.S. trial, significantly improved overall survival versus Taxol(R) in the approved indication.
The details can be read here.
The details can be read here.
Roxane Laboratories, Inc. Announces the Approval of Morphine Sulfate Tablets and Oral Solution
Roxane Laboratories, Inc. announced today the approval of its New Drug Application (NDA) for Morphine Sulfate Tablets and Oral Solution CII by the U.S. Food and Drug Administration. Roxane Laboratories' Morphine Sulfate CII is available in 15mg, 30mg tablet strengths and 10mg/5mL, 20mg/5mL oral solution strengths. Roxane Laboratories' Morphine Sulfate tablets and oral solutions CII are currently available for immediate shipment to wholesalers and pharmacies nationwide.
The details can be read here.
The details can be read here.
Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico
Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). Sodium Polystyrene Sulfonate Suspension is used to treat hyperkalemia (an elevated blood level of the electrolyte potassium).
The details can be read here.
The details can be read here.
Allergan Completes Acquisition of Aczone Gel 5%
July 14, 2008 - Allergan, Inc.'s wholly-owned subsidiary, Allergan Sales, LLC, and QLT USA, Inc., a wholly-owned subsidiary of QLT Inc. (NASDAQ:QLTI) (TSX:QLT) today announced the completion of Allergan's acquisition of QLT's Aczone(R) (dapsone) Gel 5% product, a topical treatment for acne vulgaris.
"We are pleased with the opportunity to grow our franchise in medical dermatology where there is a continuous need for new treatment options and strong growth potential," said David E.I. Pyott, Allergan's Chairman of the Board and Chief Executive Officer. "Building upon our more than 10 years of success with TAZORAC(R) (tazarotene), we will now offer dermatologists the only acne treatment with dapsone in a topical formulation to provide to their patients in North America."
The details can be read here.
"We are pleased with the opportunity to grow our franchise in medical dermatology where there is a continuous need for new treatment options and strong growth potential," said David E.I. Pyott, Allergan's Chairman of the Board and Chief Executive Officer. "Building upon our more than 10 years of success with TAZORAC(R) (tazarotene), we will now offer dermatologists the only acne treatment with dapsone in a topical formulation to provide to their patients in North America."
The details can be read here.
Immatics Obtains Important U.S. and European Patents
July 14, 2008 – immatics biotechnologies GmbH today announced that the company has obtained European patent protection for its technology platform XPRESIDENT™. In addition, the company has been granted important U.S. and European patents covering compounds contained in its lead product candidates IMA901 and IMA910.
The details can be read here.
The details can be read here.
Ranbaxy Issues Statement on DOJ Investigation of Drugs Sold in U.S.
July 14, 2008: In view of media reports emanating over the weekend, Ranbaxy would like to clarify its position and put things in the correct perspective.
Ranbaxy strongly denies the allegations contained in the Motion that has been filed (Not Granted) by the US Department of Justice (DOJ), seeking certain documents. No legal proceedings in the sense of a prosecution have been initiated. The Company continues to cooperate with the DOJ in regards to the investigation and has agreed to produce the specific documents sought by the Motion.
Ranbaxy will be filing a response today in the US District Court for The District of Maryland and will strongly defend its position.
The Company would like to state that an investigation has been underway for approximately three years and no charges have been filed against the Company. The FDA has also gathered over 200 random samples of various products marketed by the company in the US. These products have been independently tested by the USFDA and were found to be complying with all the specifications.
Under these circumstances the company finds that the allegations are baseless.
The Company’s business in the US continues as normal. Ranbaxy remains committed to providing high quality generic medicines at affordable prices to its customers and patients in the United States.
Ranbaxy also clarifies that the Company’s deal with Daiichi Sankyo is binding and final and remains on track.
Ranbaxy strongly denies the allegations contained in the Motion that has been filed (Not Granted) by the US Department of Justice (DOJ), seeking certain documents. No legal proceedings in the sense of a prosecution have been initiated. The Company continues to cooperate with the DOJ in regards to the investigation and has agreed to produce the specific documents sought by the Motion.
Ranbaxy will be filing a response today in the US District Court for The District of Maryland and will strongly defend its position.
The Company would like to state that an investigation has been underway for approximately three years and no charges have been filed against the Company. The FDA has also gathered over 200 random samples of various products marketed by the company in the US. These products have been independently tested by the USFDA and were found to be complying with all the specifications.
Under these circumstances the company finds that the allegations are baseless.
The Company’s business in the US continues as normal. Ranbaxy remains committed to providing high quality generic medicines at affordable prices to its customers and patients in the United States.
Ranbaxy also clarifies that the Company’s deal with Daiichi Sankyo is binding and final and remains on track.
GSK to pay Actelion up to $3.3 bln for drug rights
GlaxoSmithKline Ltd could pay Swiss company Actelion Ltd up to 3.3 billion Swiss francs ($3.28 billion) to develop a promising insomnia drug in the largest biotech partnering deal.
Glaxo, Europe's biggest drugmaker, beat many of the world's top pharmaceuticals companies to partner Actelion's sleeping pill almorexant and the deal sent the Swiss biotech's stock soaring nearly 10 percent on Monday.
The details can be read here.
Glaxo, Europe's biggest drugmaker, beat many of the world's top pharmaceuticals companies to partner Actelion's sleeping pill almorexant and the deal sent the Swiss biotech's stock soaring nearly 10 percent on Monday.
The details can be read here.
Indian drug firms fear Ranbaxy saga sullies already poor image
New Delhi: Indian drug makers that have created a niche in the global market with cheap copycat versions of off-patent medicines are concerned about the fallout from a US investigation of Ranbaxy Laboratories Ltd for alleged fraudulent conduct.
The details can be read here.
The details can be read here.
Friday, July 11, 2008
Abbott Labs Strikes Again Over Depakote ER
Abbott Laboratories has filed a patent suit against Indian pharmaceutical company Dr. Reddy's Laboratories Ltd. to bar it from manufacturing a generic version of the anti-seizure drug Depakote ER that allegedly infringes four Abbott patents.
The details can be read here.
The details can be read here.
Corepharma Counterclaim Restored To Carbatrol Suit
A federal judge has allowed Corepharma LLC to seek a declaratory judgment that its application to make a generic version of the anti-seizure drug Carbatrol does not infringe Shire Laboratories Inc.'s patent, even though Shire has agreed not to sue over that patent.
The details can be read here.
The details can be read here.
Dow acquires Rohm and Haas for $78 per share in cash
The US-based Dow, a diversified chemical company, has signed a definitive agreement to acquire all outstanding shares of Rohm and Haas, one of the largest manufacturers of specialty chemicals, for $78 per share in cash. This acquisition would transform Dow into the world's leading specialty chemicals and advanced materials company. The companies are targeting completion of the transaction by early 2009.
The acquisition would be financed through an equity investment by Berkshire Hathaway and the Kuwait Investment Authority in the form of convertible preferred securities for $3 billion and $1 billion, respectively. Citi, Merrill Lynch and Morgan Stanley have committed debt financing.
The whole story can be read here.
The acquisition would be financed through an equity investment by Berkshire Hathaway and the Kuwait Investment Authority in the form of convertible preferred securities for $3 billion and $1 billion, respectively. Citi, Merrill Lynch and Morgan Stanley have committed debt financing.
The whole story can be read here.
Teva Comments on Paragraph IV Filing for Copaxone; Intends to File Lawsuit Against Generic Filer for Patent Infringement
Jul 11, 2008 - Teva Pharmaceutical Industries Ltd. today commented on Momenta Pharmaceuticals, Inc./Sandoz Inc.'s announcement regarding the filing of a Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification for COPAXONE(R) (glatiramer acetate), a leading multiple sclerosis therapy.
Teva expects to receive Momenta/Sandoz's Paragraph IV certification notice referring to Teva's U.S. Patent Nos. 5,981,589, 6,054,430, 6,342,476, 6,362,161, 6,620,847, 6,939,539, and 7,199,098 which cover the chemical composition of COPAXONE(R), pharmaceutical compositions containing it, and methods of using it. These patents are listed in the U.S. Food and Drug Administration's (FDA) Orange Book and expire on May 24, 2014.
Teva is committed to vigorously defending its intellectual property rights against infringement wherever they are challenged. Teva intends to file a lawsuit for patent infringement against Momenta/Sandoz within the 45 day period provided under the Hatch-Waxman legislation. The lawsuit will trigger a stay of the FDA approval of the Momenta/Sandoz ANDA until the earlier of the expiration of a period of 30 months or a district court decision in its favor.
Momenta/Sandoz cannot launch a generic version of COPAXONE(R) before it receives final approval of its ANDA from the FDA. COPAXONE(R) is a glatiramoid, a complex mixture of the acetate salts of synthetic polypeptides, non-uniform with respect to molecular weight and sequence. Due to the variability of the composition of the polymers, Teva believes replicating this formulation would be extremely difficult and presents a significant challenge. Moreover, once subcutaneously injected, it is rapidly hydrolyzed locally and no level of the intact drug can be measured in the blood, rendering a bioequivalence study comparing two formulations extremely difficult. Therefore, evidence supporting the effectiveness of a generic copy of glatiramer acetate cannot be derived from bioequivalence studies but from a full-fledged clinical study using clinical outcomes.
Teva expects to receive Momenta/Sandoz's Paragraph IV certification notice referring to Teva's U.S. Patent Nos. 5,981,589, 6,054,430, 6,342,476, 6,362,161, 6,620,847, 6,939,539, and 7,199,098 which cover the chemical composition of COPAXONE(R), pharmaceutical compositions containing it, and methods of using it. These patents are listed in the U.S. Food and Drug Administration's (FDA) Orange Book and expire on May 24, 2014.
Teva is committed to vigorously defending its intellectual property rights against infringement wherever they are challenged. Teva intends to file a lawsuit for patent infringement against Momenta/Sandoz within the 45 day period provided under the Hatch-Waxman legislation. The lawsuit will trigger a stay of the FDA approval of the Momenta/Sandoz ANDA until the earlier of the expiration of a period of 30 months or a district court decision in its favor.
Momenta/Sandoz cannot launch a generic version of COPAXONE(R) before it receives final approval of its ANDA from the FDA. COPAXONE(R) is a glatiramoid, a complex mixture of the acetate salts of synthetic polypeptides, non-uniform with respect to molecular weight and sequence. Due to the variability of the composition of the polymers, Teva believes replicating this formulation would be extremely difficult and presents a significant challenge. Moreover, once subcutaneously injected, it is rapidly hydrolyzed locally and no level of the intact drug can be measured in the blood, rendering a bioequivalence study comparing two formulations extremely difficult. Therefore, evidence supporting the effectiveness of a generic copy of glatiramer acetate cannot be derived from bioequivalence studies but from a full-fledged clinical study using clinical outcomes.
Momenta Pharmaceuticals Announces Filing of Abbreviated New Drug Application with a Paragraph IV Certification for Generic Version of Copaxone
July 11, 2008-- Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for a generic version of Copaxone (glatiramer acetate injection), submitted by Sandoz Inc., Momenta’s development and commercialization partner for this product.
The details can be read here.
The details can be read here.
Akorn-Strides, LLC Announces the First Commercial Product Launch for the Joint Venture, Rifampin for Injection
Jul 11, 2008 - Akorn-Strides, LLC today announced the first commercial product launch for the Joint Venture, Rifampin for Injection USP, 600 mg/vial. Rifampin is used in the treatment of all forms of tuberculosis in conjunction with Isoniazid and Ethambutol.
To date, the company has filed for 18 ANDAs and received nine ANDA approvals. Five additional products are under development and expected to be filed in the next 12 months. The Joint Venture expects to generate immediate revenue from this product launch and from several other new product launches in the second half of 2008. The approximate annual IMS market value of the nine approved products is $192 million.
The details can be read here.
To date, the company has filed for 18 ANDAs and received nine ANDA approvals. Five additional products are under development and expected to be filed in the next 12 months. The Joint Venture expects to generate immediate revenue from this product launch and from several other new product launches in the second half of 2008. The approximate annual IMS market value of the nine approved products is $192 million.
The details can be read here.
Thursday, July 10, 2008
Panacea gets WHO prequalification for pentavalent vaccine
Panacea Biotec, a leading vaccine manufacturing company, has received WHO prequalification for its fully liquid innovative combination pentavalent vaccine, EasyFive against five deadly infectious diseases (DTwP + Hep B+ Hib) of early childhood. This feat comes close on heels of Panacea Biotec's pre-qualification by WHO for two other combination vaccines, EasyFour (DTP + Hib) and Ecovac (DTP + Hep B) in January this year.
In a notification, WHO has advised the UN procuring agencies regarding the acceptability of these vaccines worldwide. Panacea Biotec is already a pre-qualified supplier of OPV and hepatitis-B vaccines to UN agendas, a company press release said.
This makes Panacea Biotec as the first Indian company & one of three companies in the world to have been pre-qualified by WHO for a pentavalent vaccine. Pentavalent vaccines are used by UN agencies (UNICEF, PAHO etc.) to vaccinate & save precious lives of millions of children in the developing world.
Panacea Biotec has been playing an important role in immunization through its novel and innovative, world's first fully liquid vaccine with brands such as, 'Easy Four' & 'Easy Five', for over 3 years. It has partnered with WHO & UNICEF' with a mission of supporting the cause of maximising coverage of vaccines under the Expanded Program on Immunization (EPI) for more than a decade.
Developing countries would need a combination vaccine to the tune of around 300 Mb doses annually. The combined demand of all combination paediatric vaccines worldwide was valued at USD 600 million in 2005 and estimated to grow up to USD 1.6 billion by 2012. Pentavalent vaccine market is estimated to cross a mark of $1 billion out of which UN agencies arc likely to procure this vaccine worth more than Rs 1,500 crore (>$ 350Mio), by 2009 itself The WHO prequalification fox Easy Five makes Panacea Biotec a strong contender in this important market segment.
"India is responding to globalization faster than people think. Encouraging innovation from India to develop vaccines for the developing countries is good for the world and will help to reduce the overall costs of healthcare, a cause dose to our heart", said Rajesh Jain speaking on the occasion.
Panacea Biotec inaugurated its ultra modern, green field construction, vaccine production plant at Baddi, HP., with over Rs.100 crore (approx. USD 25 million) investment in September 2007, having capacity of more than I billion doses per annum, to cater to domestic and global.
In a notification, WHO has advised the UN procuring agencies regarding the acceptability of these vaccines worldwide. Panacea Biotec is already a pre-qualified supplier of OPV and hepatitis-B vaccines to UN agendas, a company press release said.
This makes Panacea Biotec as the first Indian company & one of three companies in the world to have been pre-qualified by WHO for a pentavalent vaccine. Pentavalent vaccines are used by UN agencies (UNICEF, PAHO etc.) to vaccinate & save precious lives of millions of children in the developing world.
Panacea Biotec has been playing an important role in immunization through its novel and innovative, world's first fully liquid vaccine with brands such as, 'Easy Four' & 'Easy Five', for over 3 years. It has partnered with WHO & UNICEF' with a mission of supporting the cause of maximising coverage of vaccines under the Expanded Program on Immunization (EPI) for more than a decade.
Developing countries would need a combination vaccine to the tune of around 300 Mb doses annually. The combined demand of all combination paediatric vaccines worldwide was valued at USD 600 million in 2005 and estimated to grow up to USD 1.6 billion by 2012. Pentavalent vaccine market is estimated to cross a mark of $1 billion out of which UN agencies arc likely to procure this vaccine worth more than Rs 1,500 crore (>$ 350Mio), by 2009 itself The WHO prequalification fox Easy Five makes Panacea Biotec a strong contender in this important market segment.
"India is responding to globalization faster than people think. Encouraging innovation from India to develop vaccines for the developing countries is good for the world and will help to reduce the overall costs of healthcare, a cause dose to our heart", said Rajesh Jain speaking on the occasion.
Panacea Biotec inaugurated its ultra modern, green field construction, vaccine production plant at Baddi, HP., with over Rs.100 crore (approx. USD 25 million) investment in September 2007, having capacity of more than I billion doses per annum, to cater to domestic and global.
Patent Granted for ProBioGen's Avian Cell Line AGE1.CR
July 10, 2008 - ProBioGen AG, a leading biotechnology company in cell engineering and production of biopharmaceuticals, has been granted patent protection for AGE1.CR, a proprietary duck cell line developed for the production of human and animal vaccines and proteins.
The granted patent as parent, ProBioGen also claims the use of a duck cell line that is infected with Modified Vaccinia Ankara (MVA) and that replicates MVA.
The details can be read here.
The granted patent as parent, ProBioGen also claims the use of a duck cell line that is infected with Modified Vaccinia Ankara (MVA) and that replicates MVA.
The details can be read here.
Angiotech Wins Before the UK House of Lords
Angiotech Pharmaceuticals, Inc. , a global specialty pharmaceutical and medical device company, announced that yesterday, the highest court of the United Kingdom, the House of Lords, confirmed in a precedent-setting decision the validity of one of Angiotech's patents related to its paclitaxel stent inventions. As Lord Neuberger of Abbotsbury, commented, "The decision represents a significant development in the United Kingdom patent law".
"We are pleased that the House of Lords entered final judgment in Angiotech's favor and view this outcome as further proof of the continued strength of our paclitaxel stent patent portfolio throughout the world," said Dr. Bill Hunter, President and CEO of Angiotech. "We remain committed to vigorously protecting our proprietary technologies and defending our intellectual property, and reaching supportive conclusion on this decision reaffirms this commitment," added Dr. Hunter.
The patent at issue was granted to Angiotech Pharmaceuticals Inc. by the European Patent Office (the "EPO") on June 25, 1997. At the EPO, five different companies opposed the patent. After over nine years of legal battles their challenge proved unsuccessful and the validity of the patent was maintained. On February 1, 2005, Angiotech commenced suit against Conor Medsystems Inc. ("Conor") in the Netherlands. Conor responded by commencing proceedings in the UK to revoke the patent. Conor argued that, as of July 1993 (the priority date), the claims in the patent lacked inventive step (i.e., were obvious) under UK law.
Both the UK trial court and the UK Court of Appeal decided that the patent was invalid in view of several publications. Within the same time frame several courts in the Netherlands, following the approach of the EPO and concluded that Angiotech's claimed invention was inventive and not obvious in view of the same publications. Angiotech appealed the UK lower court decisions to the House of Lords seeking to resolve these inconsistent outcomes.
In his lead opinion upholding the validity of Angiotech's patent, Lord Hoffmann did not agree with the reasoning that the UK lower courts used in justifying revocation and instead agreed with the opinion of the Dutch Court. The House of Lords' unanimous decision reflects an important development in bringing uniformity to the interpretation of the European Patent Convention among the national courts of Europe and the European Patent Office.
The whole Judgement can be read here.
"We are pleased that the House of Lords entered final judgment in Angiotech's favor and view this outcome as further proof of the continued strength of our paclitaxel stent patent portfolio throughout the world," said Dr. Bill Hunter, President and CEO of Angiotech. "We remain committed to vigorously protecting our proprietary technologies and defending our intellectual property, and reaching supportive conclusion on this decision reaffirms this commitment," added Dr. Hunter.
The patent at issue was granted to Angiotech Pharmaceuticals Inc. by the European Patent Office (the "EPO") on June 25, 1997. At the EPO, five different companies opposed the patent. After over nine years of legal battles their challenge proved unsuccessful and the validity of the patent was maintained. On February 1, 2005, Angiotech commenced suit against Conor Medsystems Inc. ("Conor") in the Netherlands. Conor responded by commencing proceedings in the UK to revoke the patent. Conor argued that, as of July 1993 (the priority date), the claims in the patent lacked inventive step (i.e., were obvious) under UK law.
Both the UK trial court and the UK Court of Appeal decided that the patent was invalid in view of several publications. Within the same time frame several courts in the Netherlands, following the approach of the EPO and concluded that Angiotech's claimed invention was inventive and not obvious in view of the same publications. Angiotech appealed the UK lower court decisions to the House of Lords seeking to resolve these inconsistent outcomes.
In his lead opinion upholding the validity of Angiotech's patent, Lord Hoffmann did not agree with the reasoning that the UK lower courts used in justifying revocation and instead agreed with the opinion of the Dutch Court. The House of Lords' unanimous decision reflects an important development in bringing uniformity to the interpretation of the European Patent Convention among the national courts of Europe and the European Patent Office.
The whole Judgement can be read here.
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