FDA-Approves Amarin's MARINE and Claim to Proect Vascepa®; Ligand Pharma, Glaxo Confirm PROMACTA FDA Approval Print E-mail
By Staff and Wire Reports   
Monday, 19 November 2012 20:17
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 19, 2012.

Amarin Corporation plc (Nasdaq: AMRN)
announced the US PTO has published notification of Notice of Allowance for U.S. Patent Application Serial Number 13/608,775. This application includes claims intended to protect the Vascepa® (icosapent ethyl) indication approved in July 2012 by the U.S. Food and Drug Administration (FDA) based on Amarin's MARINE clinical trial results. This application is a continuation of Amarin's U.S. Patent Number 8,293,728 (formerly, the '153 application) and broadens the '728 claims by covering the use of Vascepa with and without other lipid lowering agents, such as statins. The '775 application claims gauge drug effects against placebo control.

A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The issued patent would have a term that expires no earlier than in 2030. After issuance, Amarin plans to list this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.


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Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)
partner GlaxoSmithKline (NYSE: GSK) announced the U.S. FDA has approved PROMACTA for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.

PROMACTA is the first supportive care treatment available to patients who are ineligible or poor candidates for interferon-based therapy due to their low blood platelet counts. PROMACTA in combination with interferon-based therapy has been shown to improve a patient's chance of achieving a sustained virologic response (SVR) or viral cure.



Also Monday:



AeroGrow International, Inc. (OTCQB: AERO)
("AeroGrow" or the "Company"), which sells the AeroGarden® line of extraordinary dirt-free indoor gardens, seed kits, and accessory items, announced that it has opened retail merchandising kiosks at high-end malls in Arizona and Colorado.

Amarantus BioSciences, Inc. (OTCQB: AMBS)
, a biotechnology company developing new treatments and diagnostics for Parkinson's disease and Traumatic Brain Injury centered on its proprietary anti-apoptosis therapeutic protein MANF, today announced that President & CEO Gerald Commissiong issued a letter to shareholders as detailed below.

Cardium Therapeutics (NYSE MKT: CXM)
today announced a winning patent decision in Europe and successful resolution of a long-standing competition between Cardium and its licensor the University of California, and Boston Scientific Corporation (NYSE: BSX) and its licensor Arch Development, over rights to key methods for the application of cardiovascular gene therapy to the treatment of coronary heart disease, as is employed in Cardium's Generx® gene therapy candidate currently in late-stage clinical studies.

CDEX Inc. (OTCQB: CEXID)
, a leading developer of chemical detection products using patented technologies for use in healthcare, safety and security markets, today announced the Company's common stock will begin trading under the new symbol "CDEX" (OTCQB: CDEX) effective the first day of trading November 19, 2012.

China Biologic Products, Inc. (Nasdaq: CBPO)
, a leading fully integrated plasma-based biopharmaceutical company in China, today announced that its board of directors has adopted a stockholder rights plan.

China Cord Blood Corporation (NYSE: CO)
("CCBC" or the "Company"), China's leading provider of cord blood collection, laboratory testing, hematopoietic stem cell processing, and stem cell storage services, today announced its preliminary unaudited financial results for the second quarter and first half of fiscal year 2013, which ended September 30, 2012.

CryoLife, Inc. (NYSE: CRY)
, a leading tissue processing and medical device Company focused on cardiac and vascular surgery, announced today that its Board of Directors has approved a quarterly cash dividend for the fourth quarter 2012 of $0.025 per share of common stock outstanding.

Daxor Corporation (NYSE MKT: DXR)
, a medical instrumentation and biotechnology company, today announced the receipt of a signed trial agreement from PCI Nuclear Pharmacy in Arizona.

Dr. Reddy’s Laboratories (NYSE:RDY)
announced today that it has launched Sildenafil Tablets (20 mg), a bioequivalent generic version of REVATIO® (Sildenafil) Tablets in the US market on November 16, 2012, following the approval by the United States Food & Drug Administration (USFDA) of Dr. Reddy’s ANDA for Sildenafil Tablets.

Dyadic International, Inc. (OTC Pink: DYAI)
, a global biotechnology company focused on the discovery, development, manufacture and sale of enzymes and other proteins for the bioenergy, bio-based chemicals, biopharmaceutical and industrial enzyme industries, announced today that it has been issued U.S. Patent No. 8,304,212 entitled "Methods and compositions for degradation of lignocellulosic material"by the United States Patent and Trademark Office ("USPTO").

EnteroMedics Inc. (NASDAQ: ETRM)
, the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that Mark B. Knudson, Ph.D., EnteroMedics' President and Chief Executive Officer, is scheduled to present at the Canaccord Genuity 2012 Medical Technology and Diagnostic Forum on December 4, 2012 at 2:30 pm Eastern Time at the Le Parker Meridien Hotel in New York.

First China Pharmaceutical Group, Inc. (OTCQB: FCPG)
("First China" or the "Company"), a rapidly growing and technologically advanced pharmaceutical distribution company based in Yunnan, China, today announced its unaudited financial results for the three-month period ended Sep. 30, 2012.

GlaxoSmithKline plc (LSE/NYSE: GSK)
announced today that the U.S. Food and Drug Administration (FDA) has approved PROMACTA for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy.

Incyte Corporation (Nasdaq:INCY)
announced today it will present at the 24th Annual Piper Jaffray Healthcare Conference on Tuesday, November 27th at 1:30 p.m. (EST) in New York.

Medistem (PINKSHEETS: MEDS)
announced today appointment of Alexander Gershman, MD, Ph.D to the company's Scientific Advisory Board. Dr. Gershman is an internationally-renowned opinion leader in urological surgery having pioneered numerous minimally invasive procedures using laparoscopic techniques.

MEI Pharma, Inc. (Nasdaq: MEIP)
, an oncology company focused on the clinical development of novel therapies for cancer, announced today that its lead mitochondrial inhibitor drug candidate, ME-344, has been named one of the Top 10 Most Licensable Oncology Products to Watch for 2012 by Elsevier Business Intelligence and Campbell Alliance.

MMRGlobal, Inc. (OTCBB: MMRF)
today announced that through its wholly owned subsidiary, MMR Life Sciences Group, the Company plans on exploiting its pipeline of biotech assets by facilitating a partnership or other joint venture with a privately held biotech company that has completed its Phase 2 clinical trials and is in the process of beginning Phase 3.

NuVasive, Inc. (NASDAQ: NUVA)
, a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that management will participate in the following investor events in November and December 2012.

Orgenesis Inc. (OTCBB:ORGS)
(“Orgenesis” or the “Company”), a development-stage company with a novel therapeutic technology dedicated to converting a patient’s own liver cells into functioning insulin-producing cells as a treatment for diabetes, announced today that it has recently held its first scientific meeting with the Paul-Ehrlich Institute (“PEI”), completing another important step toward initiating advanced stage trials of the Company’s technology.

Pfizer Inc. (NYSE: PFE) today announced that top-line results of a double-blind, Phase 3 study evaluating pregabalin controlled-release (CR) formulation in patients with fibromyalgia indicate that pregabalin CR had a statistically significant positive effect compared to placebo in the primary endpoint, time to loss of therapeutic response (LTR).

Regulus Therapeutics Inc. (NASDAQ: RGLS)
, a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today reported financial results for the quarter ended September 30, 2012 and provided a summary of recent corporate highlights.

Shire plc (LSE: SHP, NASDAQ: SHPGY)
today announced a new initiative – the Shire Rare Disease Impact Report – to research the health, psycho-social, societal and economic impact of rare diseases in patient and medical communities.

Effective January 1, 2013, Sigma-Aldrich Corporation (NASDAQ: SIAL) will align its organization into three market-focused business units that are defined by the customers and markets they serve.



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