CORAL SPRINGS, Florida, April 29, 2015 /PRNewswire/ --
According to a recent article published on the Wall Street Journal, the debate over prescription drug pricing has grown increasingly contentious, particularly as drug makers issue more new medicines with high price tags. But despite the tumult, the cost for orphan drugs - medicines that are designated by the FDA & EU to treat a rare disease and may cost as much as $400,000 annually - is apparently not fazing some insurers. Biotech Companies in focus today are: Amarantus Bioscience Holdings, Inc. (OTCQB: AMBS), Catalyst Pharmaceutical Partners' (NASDAQ: CPRX), Biogen Inc. (NASDAQ: BIIB), Hemispherx Biopharma, Inc. (NYSE: HEB) and Biocept, Inc. (NASDAQ: BIOC).
Amarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company focused on developing therapeutic and diagnostic products for neurological disorders and orphan indications, announced that the European Commission, acting on the positive recommendation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has granted orphan drug status for MANF (mesencephalic-astrocyte-derived neurotrophic factor) for the treatment of retinitis pigmentosa (RP). RP refers to a group of inherited diseases causing retinal degeneration often leading to blindness. The Company previously announced in December of 2014 that it also received orphan drug designation for MANF for the treatment of RP from the U.S. Food and Drug Administration (FDA). "We are extremely pleased to have received European orphan drug status for our promising investigational product, MANF in RP," said Gerald E. Commissiong, President & CEO of Amarantus BioScience Holdings, Inc. "This EU orphan designation, combined with our recent U.S. orphan designation, positions MANF for an accelerated global regulatory product development pathway to address the significant unmet need in this important ophthalmologic indication.".
To read the full AMBS press release, please click here: http://www.financialnewsmedia.com/profiles/ambs.html
Orphan drug designation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union (EU), and where no satisfactory treatment is available. In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure.
In other Biotech News & Happenings: Catalyst Pharmaceutical Partners' (NASDAQ: CPRX) plan to seek approval and market a drug for a rare muscle-wasting disease is in jeopardy following the surprise disclosure Thursday of positive clinical trial results from a similar, competitive drug. Privately held Jacobus Pharmaceuticals presented a poster Thursday at the American Academy of Neurology annual meeting showing "unequivocal evidence" that 3,4 Dap, the company's experimental drug, is an effective treatment for patients with Lambert-Eaton Myasthenic Syndrome (LEMS). Read the full story at http://www.thestreet.com/story/13125612/1/catalyst-pharma-competitor-surprises-with-positive-orphan-disease-drug-study-results.html?puc=yahoo&cm_ven=YAHOO
George Scangos, Biogen CEO (NASDAQ: BIIB), discusses progress in clinical trials for Alzheimer's treatments, and the outlook for its multiple sclerosis Tecfidera drug. See the video discussion at http://finance.yahoo.com/video/biogen-takes-alzheimers-202900299.html
Hemispherx Biopharma, Inc. (NYSE: HEB) recently announced that the European subsidiary, "Hemispherx Biopharma Europe N.V./S.A" gained a positive opinion from the COMP (Committee on Medical Products) regarding its Orphan Medicinal Product Application for Ampligen(R), an experimental therapeutic, to treat Ebola Virus Disease (EVD). Orphan designation by the European Medicines Agency (EMA) is granted to promote the clinical development of drugs that target rare life-threatening conditions and which are expected to provide significant therapeutic advantage over any existing treatments and includes some tropical diseases primarily found in developing nations as is the case for EVD. Hemispherx submitted in vitro and in vivo data in appropriate preclinical models relevant to the EVD indication to the European Union (EU) Committee for Orphan Medicinal Products. In addition to the efficacy data, clinical safety information was also included in the comprehensive application.
Biocept, Inc. (NASDAQ: BIOC), a molecular oncology diagnostics company specializing in biomarker analysis of circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs), announced recently that it has entered into a clinical collaboration with University of California, San Diego Moores Cancer Center to determine the clinical utility of detecting biomarkers present in CTCs and ctDNA in blood samples for non-small cell lung cancer patients using Biocept's OncoCEE(TM) LU platform and CEE-Selector(TM) technology.
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