Discovery Laboratories, Inc. on May 1, 2008 received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. Discovery Labs' Manufacturing, Quality and Regulatory management have performed an assessment of the remaining conditions set forth in the Approvable Letter that must be satisfied to gain U.S. marketing approval for Surfaxin.
The details can be read here.
Monday, May 5, 2008
Ipsen: Adenuric(R) (Febuxostat) Receives Marketing Authorisation in the European Union
May 5, 2008 - Regulatory News: Ipsen (Paris:IPN) today announced that the European Commission granted marketing authorisation for Adenuric(R) (febuxostat) for the treatment of chronic hyperuricaemia in gout. Adenuric(R) thus pioneers the first major treatment alternative for gout, a severe debilitating disease, for more than 40 years.
"Recent surveys confirm that management of gout is often suboptimal, with less than half of patients receiving appropriate lifestyle advice or urate lowering treatment" said Michael Doherty, Professor of Rheumatology at the University of Nottingham (UK) and Co-chair of the 2006 EULAR Task Force for the Recommendations on Diagnosis and Management of Gout. "Recent European (EULAR) Recommendations emphasise the aim of "cure" by lowering serum urate levels below the saturation point for crystal formation. For some patients, the existing urate lowering therapies have limitations in terms of suitability or side effects. The availability of a new effective therapy that allows the therapeutic target to be achieved will improve the physicians armamentarium and ultimately benefit the population of patients with gout."
The details can be read here.
"Recent surveys confirm that management of gout is often suboptimal, with less than half of patients receiving appropriate lifestyle advice or urate lowering treatment" said Michael Doherty, Professor of Rheumatology at the University of Nottingham (UK) and Co-chair of the 2006 EULAR Task Force for the Recommendations on Diagnosis and Management of Gout. "Recent European (EULAR) Recommendations emphasise the aim of "cure" by lowering serum urate levels below the saturation point for crystal formation. For some patients, the existing urate lowering therapies have limitations in terms of suitability or side effects. The availability of a new effective therapy that allows the therapeutic target to be achieved will improve the physicians armamentarium and ultimately benefit the population of patients with gout."
The details can be read here.
Sunday, May 4, 2008
Watson files ANDA for generic Fentora
Watson Pharmaceuticals, Inc, a leading specialty pharmaceutical company, said its subsidiary Watson Laboratories, Inc. has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market its Fentanyl Buccal tablets C-II product prior to the expiration of patents owned by Cephalon, Inc.
Watson's Fentanyl Buccal tablets C-II product is a generic version of Cephalon's Fentora C-II (fentanyl buccal tablet) which is indicated only for the treatment of breakthrough pain in opioid tolerant patients with cancer.
In its Notice Letter to Cephalon, Watson contends that US. Patent Numbers 6,200,604 and 6,974,590 are invalid, unenforceable and/or will not be infringed by Watson's manufacture, use or sale of the product described in its ANDA. Based on available information, Watson believes it may be the first applicant to file an ANDA for Fentora containing a paragraph IV certification under the provisions of the Hatch-Waxman Act and, should its product be approved, may be entitled to 180 days of generic market exclusivity.
Watson's Fentanyl Buccal tablets C-II product is a generic version of Cephalon's Fentora C-II (fentanyl buccal tablet) which is indicated only for the treatment of breakthrough pain in opioid tolerant patients with cancer.
In its Notice Letter to Cephalon, Watson contends that US. Patent Numbers 6,200,604 and 6,974,590 are invalid, unenforceable and/or will not be infringed by Watson's manufacture, use or sale of the product described in its ANDA. Based on available information, Watson believes it may be the first applicant to file an ANDA for Fentora containing a paragraph IV certification under the provisions of the Hatch-Waxman Act and, should its product be approved, may be entitled to 180 days of generic market exclusivity.
AstraZeneca Files Marketing Application in Europe for EGFR Inhibitor Gefitinib (Iressa) in Locally Advanced Pre-Treated Non-Small Cell Lung Cancer
May 2, 2008-AstraZeneca today announced the submission of a marketing authorisation application to the European Medicines Agency (EMEA) for its oral anti-cancer drug, gefitinib (IRESSA™) as a treatment for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have been pre-treated with platinum-containing chemotherapy.
The whole story can be read here.
The whole story can be read here.
FDA MedWatch- Enbrel (etanercept)-Prescribing Information Revised To Include A Boxed Warning Regarding The Risk Of Infection, Including Tuberculosis
May 2, 2008-Amgen and Wyeth Pharmaceuticals informed healthcare professionals of revisions to prescribing information for Enbrel. The revisions include a BOXED WARNING about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel. Infections have included bacterial sepsis and tuberculosis. The ADVERSE REACTIONS section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with Enbrel. Healthcare professionals should screen patients for latent tuberculosis infection before beginning Enbrel. Patients should be educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with the drug. Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, Enbrel should be discontinued.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter regarding this issue here
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter regarding this issue here
Thursday, May 1, 2008
Dr. Reddy's acquires BASF's contract manufacturing business
Dr. Reddy's Laboratories has signed a definitive agreement to acquire BASF's pharmaceutical contract manufacturing business and related facility in Shreveport, Louisiana, USA for an undisclosed amount.
The deal is likely to be completed within the first quarter of fiscal year 2008-09, subject to customary closing conditions. The transaction will be funded using Dr. Reddy's internal cash reserves or other committed credit facilities, the Hyderabad-based company said in a press statement.
This business involves the contract manufacturing of generic prescription and over-the-counter products for branded and generic companies in the US. It recorded revenues of US $43 million for the year ended December 31, 2007.
The details can be read here.
The deal is likely to be completed within the first quarter of fiscal year 2008-09, subject to customary closing conditions. The transaction will be funded using Dr. Reddy's internal cash reserves or other committed credit facilities, the Hyderabad-based company said in a press statement.
This business involves the contract manufacturing of generic prescription and over-the-counter products for branded and generic companies in the US. It recorded revenues of US $43 million for the year ended December 31, 2007.
The details can be read here.
Momenta Pharmaceuticals Receives Regulatory Guidance On M-Enoxaparin ANDA
Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the Food and Drug Administration (FDA) has provided guidance regarding the Abbreviated New Drug Application (ANDA) for M-Enoxaparin. Momenta is developing M-Enoxaparin, a technology-enabled generic version of Lovenox(r), in collaboration with Sandoz, the generics division of Novartis AG.
Earlier this year, Momenta and Sandoz submitted a proposal to FDA for addressing the potential immunogenicity of M-Enoxaparin, in response to FDA's letter of November, 2007. On April 28, 2008, FDA responded to the proposal and provided additional guidance which indicated their general concurrence with the Company's approach and proposal. FDA also requested additional data from in vitro and in vivo animal tests, the testing of additional samples for tests previously proposed, and additional information regarding certain of the methods proposed. The agency has not requested human clinical trials at this time.
"We are pleased that the FDA has clarified our path forward for M-Enoxaparin by providing written direction regarding their expectations for our application," commented Craig A. Wheeler, Chief Executive Officer of Momenta. "We are still evaluating the FDA's guidance, but, based on our preliminary assessment, we hope to submit the amendment containing the requested additional data in the third quarter."
Earlier this year, Momenta and Sandoz submitted a proposal to FDA for addressing the potential immunogenicity of M-Enoxaparin, in response to FDA's letter of November, 2007. On April 28, 2008, FDA responded to the proposal and provided additional guidance which indicated their general concurrence with the Company's approach and proposal. FDA also requested additional data from in vitro and in vivo animal tests, the testing of additional samples for tests previously proposed, and additional information regarding certain of the methods proposed. The agency has not requested human clinical trials at this time.
"We are pleased that the FDA has clarified our path forward for M-Enoxaparin by providing written direction regarding their expectations for our application," commented Craig A. Wheeler, Chief Executive Officer of Momenta. "We are still evaluating the FDA's guidance, but, based on our preliminary assessment, we hope to submit the amendment containing the requested additional data in the third quarter."
Pro-Pharmaceuticals Updates NDA Filing for DAVANAT
May 1, 2008 - Pro-Pharmaceuticals, Inc., a Company developing targeted therapeutic compounds to treat cancer and fibrosis, today announced the receipt of the manufacturing and certification data for DAVANAT(R) from SAFC(R), the custom manufacturing services division of Sigma-Aldrich(TM) (Nasdaq: SIAL). The manufacturing and validation data is under final independent audit and is needed for registration of a pharmaceutical ingredient. The Company plans to submit the Drug Master File (DMF) shortly to the U.S. Food and Drug Administration (FDA). The DMF submission is an important step in the Company's plan to file a New Drug Application (NDA) for DAVANAT(R) later this year.
The FDA responded in a letter last year to questions from the Company to discuss the submission of an NDA for DAVANAT(R) to treat cancer patients. The FDA recommended that the Company provide the chemistry, manufacturing and controls (CMC) information necessary to support an NDA submission.
The FDA responded in a letter last year to questions from the Company to discuss the submission of an NDA for DAVANAT(R) to treat cancer patients. The FDA recommended that the Company provide the chemistry, manufacturing and controls (CMC) information necessary to support an NDA submission.
FDA Approves Advair 250/50 for Reduction of Exacerbations in Patients With COPD
April 30, 2008 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration today approved Advair Diskus 250/50 (fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder) for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) who have a history of exacerbations. With this approval, Advair becomes the only treatment FDA has approved to reduce COPD exacerbations. Treatment guidelines for COPD state that the reduction of exacerbations is a key goal in managing the disease.
The details can be read here.
The details can be read here.
FDA Approves Mixject, a Convenient, Easy-to-Use Drug Delivery System For Watson Pharmaceutical's Trelstar Depot and Trelstar LA
April 30, 2008 -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration has approved MIXJECT(TM), the new delivery system for TRELSTAR(R) (triptorelin pamoate for injectable suspension), a palliative treatment for advanced prostate cancer. MIXJECT(TM), developed and manufactured by Medimop Medical Projects Ltd. a subsidiary of West Pharmaceutical Services, Inc., combines the proven efficacy of TRELSTAR(R) DEPOT 3.75 mg and TRELSTAR(R) LA 11.25 mg with new features that make preparation, administration and disposal easier.
These new features include: a smaller 21-gauge needle for improved patient comfort; reconstitution without the use of a needle; and a shield covering the needle both before and after drug administration. The system is specifically designed to encourage compliance with OSHA (Occupational Safety and Health Administration) regulations within the medical community.
"At Watson, we understand what matters most for the physicians who prescribe our products and for the patients whose lives are impacted by them. Through these types of innovations, we are committed to developing effective, safe and convenient treatments that improve the lives of patients with urological conditions," said Edward Heimers, Jr., Executive Vice President and President of Watson's Brand Division. "The new MIXJECT(TM) drug delivery system was designed with a smaller needle size and updated features that promote OSHA compliance based on the needs and suggestions from our customers in collaboration with our partner, West."
(Source: www.pharmalive.com)
These new features include: a smaller 21-gauge needle for improved patient comfort; reconstitution without the use of a needle; and a shield covering the needle both before and after drug administration. The system is specifically designed to encourage compliance with OSHA (Occupational Safety and Health Administration) regulations within the medical community.
"At Watson, we understand what matters most for the physicians who prescribe our products and for the patients whose lives are impacted by them. Through these types of innovations, we are committed to developing effective, safe and convenient treatments that improve the lives of patients with urological conditions," said Edward Heimers, Jr., Executive Vice President and President of Watson's Brand Division. "The new MIXJECT(TM) drug delivery system was designed with a smaller needle size and updated features that promote OSHA compliance based on the needs and suggestions from our customers in collaboration with our partner, West."
(Source: www.pharmalive.com)
Nabi Biopharmaceuticals Prevails in Opposition Hearing for NicVAX Patent
April 30, 2008 -- Nabi Biopharmaceuticals (Nasdaq:NABI) announced today that the European Patent Office (EPO) upheld the Company's European Patent No. EP 1,135,166 (Hapten Carrier Conjugates for Treating and Preventing Nicotine Addiction) that covers its NicVAX(r) vaccine. The EPO issued this patent to Nabi in late 2004 with an expiration date of January 12, 2019.
In July 2005, Cytos Biotechnology AG filed a Notice of Opposition against Nabi's European patent and the Company filed its response in December 2005. The EPO notified Nabi in September 2007 that the opposition filing was admissible and held a hearing on April 23, 2008. The EPO cancelled some claims in the patent that do not affect the primary claim protecting Nabi Biopharmaceuticals' exclusive use of NicVAX for its intended purpose of treating and preventing nicotine addiction. Nabi plans to appeal these ancillary claim cancellations.
In July 2005, Cytos Biotechnology AG filed a Notice of Opposition against Nabi's European patent and the Company filed its response in December 2005. The EPO notified Nabi in September 2007 that the opposition filing was admissible and held a hearing on April 23, 2008. The EPO cancelled some claims in the patent that do not affect the primary claim protecting Nabi Biopharmaceuticals' exclusive use of NicVAX for its intended purpose of treating and preventing nicotine addiction. Nabi plans to appeal these ancillary claim cancellations.
U.S. Patent and Trademark Office to Confirm Patentability of Lipitor Basic Patent
April 30, 2008 - Pfizer Inc announced today that the U.S. Patent & Trademark Office has issued a communication notifying the company that it will confirm the patentability of the claims of Pfizer's '893 basic patent for Lipitor. The Patent Office had conducted a re-examination of the '893 patent in response to a request by a law firm that represented the generic company Ranbaxy Laboratories Limited. The patent, which expires in March 2010 (including pediatric exclusivity), was previously the subject of litigation against Ranbaxy, in which Pfizer prevailed in both the trial and appeal courts.
The company noted that it is pleased with the decision, which affirms the company's position that the patent was properly granted.
(Source: www.pharmalive.com)
The company noted that it is pleased with the decision, which affirms the company's position that the patent was properly granted.
(Source: www.pharmalive.com)
Eisai Gained Favourable Ruling by Court of Appeal, as NICE Process for Developing Guidance on Anti-dementia Medicines Ruled Unfair
May 1, 2008-Eisai Limited, a UK subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) gained a positive ruling on May 1, 2008 (the UK time) from the UK Court of Appeal which found that the process by which the National Institute for Health and Clinical Excellence (NICE) made the current guidance which restrict anti-dementia medicines for newly diagnosed patients with mild Alzheimer's disease breached the principle of procedural fairness.
NICE's current guidance in effect bans the use of anti-dementia medicines for patients with mild Alzheimer's disease. The Court stated that procedural fairness required NICE to release a fully executable version of the cost effectiveness model it used to produce guidance for the treatment of patients with Alzheimer's. The Court also found that refusal by NICE to release the model put consultees at significant disadvantage in challenging its reliability.
When the model is released to Eisai it will be able to review NICE's cost effectiveness calculations and submit any new findings to NICE. Eisai is fully committed to working with NICE to ensure all patients in the UK with mild to moderate Alzheimer's disease will have access to these medicines
(Source: www.pharmalive.com)
NICE's current guidance in effect bans the use of anti-dementia medicines for patients with mild Alzheimer's disease. The Court stated that procedural fairness required NICE to release a fully executable version of the cost effectiveness model it used to produce guidance for the treatment of patients with Alzheimer's. The Court also found that refusal by NICE to release the model put consultees at significant disadvantage in challenging its reliability.
When the model is released to Eisai it will be able to review NICE's cost effectiveness calculations and submit any new findings to NICE. Eisai is fully committed to working with NICE to ensure all patients in the UK with mild to moderate Alzheimer's disease will have access to these medicines
(Source: www.pharmalive.com)
Sepracor Announces Final Settlement of Xopenex Inhalation Solution Patent Infringement Litigation with Breath Limited
May 1, 2008 - Sepracor Inc. (Nasdaq: SEPR) today announced that it has entered into a Settlement and License Agreement with Breath Limited (Breath), an Arrow Group subsidiary, to resolve the patent litigation involving Sepracor's XOPENEX(R) brand levalbuterol HCl Inhalation Solution products (1.25 mg/3 mL, 0.63 mg/3 mL and 0.31 mg/3 mL). The agreement permits Breath to launch generic versions of these XOPENEX Inhalation Solution dosages under terms of an exclusive license commencing on August 20, 2012. Upon launch, Breath would pay Sepracor a double-digit royalty on gross profits generated from the sales of generic versions of these XOPENEX Inhalation Solution dosages. The parties will promptly file a dismissal without prejudice in the United States District Court for the District of Massachusetts that will conclude this litigation.
Sepracor and Breath also contemporaneously entered into a Supply Agreement whereby, effective August 20, 2012, Sepracor will exclusively supply levalbuterol HCl products (1.25 mg/3 mL, 0.63 mg/3 mL and 0.31 mg/3 mL) to Breath, under Sepracor's New Drug Application (NDA), for a period of 180 days and on a non-exclusive basis for a period of time thereafter. In addition to the royalties described above, Breath will pay Sepracor on a cost plus margin basis for supply of the levalbuterol HCl products. Both the exclusive license under the Settlement and License Agreement and the exclusive supply obligations under the Supply Agreement could become effective prior to August 20, 2012 if a third party launches a generic version of those dosages of XOPENEX Inhalation Solution or if the parties otherwise mutually agree.
The details can be read here
Sepracor and Breath also contemporaneously entered into a Supply Agreement whereby, effective August 20, 2012, Sepracor will exclusively supply levalbuterol HCl products (1.25 mg/3 mL, 0.63 mg/3 mL and 0.31 mg/3 mL) to Breath, under Sepracor's New Drug Application (NDA), for a period of 180 days and on a non-exclusive basis for a period of time thereafter. In addition to the royalties described above, Breath will pay Sepracor on a cost plus margin basis for supply of the levalbuterol HCl products. Both the exclusive license under the Settlement and License Agreement and the exclusive supply obligations under the Supply Agreement could become effective prior to August 20, 2012 if a third party launches a generic version of those dosages of XOPENEX Inhalation Solution or if the parties otherwise mutually agree.
The details can be read here
Mylan Announces Final FDA Approval for Trandolapril Tablets
Mylan Inc. today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Trandolapril Tablets, 1 mg, 2 mg and 4 mg.
Trandolapril Tablets are the generic version of Abbott Laboratories' Mavik(R) Tablets. Brand and generic versions of this product had total U.S. sales of approximately $34 million for the 12 months ending Dec. 31, 2007, for the same strengths, according to IMS Health.
Trandolapril Tablets are the generic version of Abbott Laboratories' Mavik(R) Tablets. Brand and generic versions of this product had total U.S. sales of approximately $34 million for the 12 months ending Dec. 31, 2007, for the same strengths, according to IMS Health.
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