|Amarin Announces FDA Approval of Vascepa(TM); Horizon Pharma Announces FDA Approval of RAYOS|
|By Staff and Wire Reports|
|Thursday, 26 July 2012 17:59|
Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced the U.S. FDA has approved VascepaTM (icosapent ethyl) capsules (formerly known as AMR101) as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (TG greater than or equal to 500mg/dL) hypertriglyceridemia (very high triglycerides). Amarin submitted the New Drug Application (NDA) for the use of Vascepa in this indication in September 2011.
"FDA approval of Vascepa represents the introduction of an important new treatment option for patients with severe hypertriglyceridemia. In Amarin's MARINE clinical trial, Vascepa demonstrated a statistically significant placebo-adjusted reduction in levels of triglycerides without elevation in levels of LDL-C, commonly referred to as 'bad cholesterol,'" stated Joseph Zakrzewski, Chairman and CEO of Amarin. "Amarin continues to anticipate commercial launch of Vascepa early in the first quarter of 2013, and we continue to consider three potential paths for the marketing and sale of the product: an acquisition of Amarin, a strategic collaboration, or self-commercialization, the latter of which could include third-party support. We are now focused on continued commercial preparations for Vascepa which includes, but is not limited to, finalizing the introduction of Vascepa to managed care plans to gain formulary access, building-up inventory levels and coordinating other pre-launch marketing activities."
The efficacy and safety of Vascepa were assessed in Amarin's MARINE clinical trial, a randomized, placebo-controlled, double-blind, parallel-group study of adult patients with very high fasting triglyceride levels, between 500 mg/dL and 2000 mg/dL. At baseline, 25% of patients were on concomitant statin therapy, 28% were diabetics, and 39% of patients had TG levels greater than 750 mg/dL. Patients treated for 12 weeks with the 4 gram dose of Vascepa demonstrated a statistically significant placebo-adjusted median triglyceride reduction of 33% (p<0.001), and did not show an increase in LDL-C levels relative to placebo. Vascepa 4 grams per day also showed statistically significant placebo-adjusted median reductions from baseline in non-HDL-C (total cholesterol less "good cholesterol") of 18%, Total Cholesterol (TC) of 16%, Very Low Density Lipoprotein Cholesterol (VLDL-C) of 29%, and apolipoprotein B (Apo B) of 9%.
The most commonly reported adverse reaction (incidence >2% and greater than placebo) in Vascepa treated patients was arthralgia (joint pain) (2.3% for Vascepa vs. 1.0% for placebo).
Amarin has made significant progress in its efforts to expand the patent protection for Vascepa in the United States to at least 2030 with seven patent applications either issued, allowed or in progressed states of prosecution and over 25 additional U.S. applications pending. Amarin is awaiting a decision from FDA as to whether Vascepa will be granted five-year new chemical entity (NCE) or three-year new product marketing exclusivity under the provisions of the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act. Typically, FDA's determination on the exclusivity of approved products is made public through the posting on FDA's website in the Orange Book. This typically occurs mid-month following the month of an NDA approval.
Horizon Pharma, Inc., (NASDAQ: HZNP) announced the U.S. FDA has approved RAYOS® (prednisone) delayed-release tablets (1 mg, 2 mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD).
The FDA approval was supported by data bridging the pharmacokinetics of RAYOS to immediate-release prednisone and data from the Circadian Administration of Prednisone in RA (CAPRA-1 and 2) trials. The CAPRA-2 trial demonstrated that people with moderate to severe RA treated with RAYOS experienced a statistically significant improvement in ACR20 response criteria compared to placebo. The CAPRA-1 trial supported the overall safety of RAYOS.
AdCare Health Systems, Inc. (NYSE MKT: ADK), a leading long-term care provider, has rescheduled its conference call to discuss results for the second quarter ended June 30, 2012.
ADVENTRX Pharmaceuticals, Inc. (NYSE MKT: ANX) today announced that it is presenting at the 1st Annual Sickle Cell Disease Therapeutics Conference.
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that preclinical data for the Company's targeted cytotoxic luteinizing hormone-releasing hormone (LH-RH) analog, AEZS-108 (formerly AN-152), in urinary bladder cancer, have been published in the online edition of Oncotarget.
Alimera Sciences, Inc., (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced the Federal Ministry of Health of Germany (Bundesministerium fur Gesundheit, BfArM) has granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
Biodel Inc. (Nasdaq: BIOD) announced today that the Small Business Innovation Research (SBIR) program of the National Institutes of Health (NIH) has awarded Biodel a grant for the development of concentrated ultra-rapid-acting insulin formulations for use in an artificial pancreas, also known as a closed loop pump system.
Cardium Therapeutics (NYSE MKT: CXM) today announced the publication of preclinical findings demonstrating that cardiac ischemia plays an important role in adenovector gene delivery (transfection) in mammalian hearts.
CONMED Corporation (NASDAQ: CNMD) today announced financial results for the second quarter ended June 30, 2012.
Cytori Therapeutics (NASDAQ: CYTX) will provide a live webcast of its second quarter financial results and business update on Wednesday, August 8, 2012 at 5:00 PM Eastern Time.
Digirad Corporation (NASDAQ: DRAD) today reported 2012 second quarter revenue of $12.7 million, 2012 six-month revenue of $25.7 million and an ending cash and available-for-sale securities balance of $28.5 million.
iBio, Inc. (NYSE MKT: IBIO), and GE Healthcare, the healthcare business of GE (NYSE: GE), announced today a new global alliance to commercialize plant-based technologies for the manufacture of biopharmaceuticals and vaccines.
MiMedx Group, Inc. (OTCBB: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today its results for the quarter ended June 30, 2012.
MMRGlobal, Inc. (OTCBB: MMRF) (MMR) today announced that the Company has been invited to participate in presentations with government officials, healthcare regulators and telephony providers in the Asia Pacific region, particularly in Australia, New Zealand and Singapore where MMR already holds issued patents for its Personal Health Records eHealth technology with additional claims pending and applied for.
Neuralstem, Inc. (NYSE MKT: CUR) announced that it received a notice of issuance for patent number 12/710,097 titled: "Transplantation of Human Neural Cells for Treatment of Neurodegenerative Conditions."
Stevia Corp. (OTCBB: STEV) ("Stevia Corp." or the "Company"), a farm management company focused on the economic development of stevia, the fastest growing product in the alternative sweetener sector, is pleased to announce its wholly owned subsidiary, Stevia Asia Limited's entry into a cooperative agreement with Technew Technologies for the provision of stevia formulations by their newly formed joint venture, Stevia Technew Limited, as part of an ongoing feed program serving the shrimp farming sector of Guangdong Province, China.
United Therapeutics Corporation (NASDAQ: UTHR) today announced its financial results for the second quarter ended June 30, 2012.
Watson Pharmaceuticals, Inc. (NYSE: WPI) today reported net income for the second quarter 2012 increased 42 percent to $181.4 million or $1.42 per diluted share on a non-GAAP basis, compared to $127.9 million or $1.01 per diluted share in the second quarter 2011.