New Collaborations Lead to Advancements in Human Clinical Trials for Development of Clinical Grade Production for Therapeutic Product Candidates With Proprietary Technologies

CORAL SPRINGS, Florida, May 14, 2015 /PRNewswire/ --


Therapeutic treatment applications for diseases in the areas of neurology, psychiatry, ophthalmology and regenerative medicine and other rare orphan conditions search for new advancements through continued research and human clinical studies.  Specialty Biotech companies in focus today are:  Amarantus BioScience Holdings, Inc. (OTC: AMBS), Discovery Laboratories, Inc. (NASDAQ: DSCO), Fibrocell Science, Inc., (NASDAQ: FCSC), OPKO Health, Inc. (NYSE:OPK) and AbbVie Inc. (NYSE: ABBV).

Amarantus BioScience Holdings, Inc. (OTC: AMBS), a biotechnology company focused on developing therapeutic and diagnostic products for neurological disorders and orphan indications, today announced that it has entered into a manufacturing agreement with Catalent Pharma Solutions (NYSE: CTLT), the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, for clinical-grade production of MANF (mesencephalic-astrocyte-derived neurotrophic factor). Under the agreement, Catalent will provide all cell line engineering, process development and clinical Good Manufacturing Practices (cGMP) biomanufacturing activities necessary for the rapid development of a high performance cell line expressing MANF protein that will thereafter be advanced into scale up for cGMP production.  "We selected Catalent as our development and manufacturing partner because they have the cGMP capabilities, expertise and proprietary technologies required to efficiently synthesize and scale up MANF production for human clinical use," said Gerald E. Commissiong, President & CEO of Amarantus. "Advancing MANF, our first internally-discovered therapeutic product candidate, into human clinical studies will be a major advancement for the Company.  Rapid production of MANF in collaboration with Catalent will enable us to achieve this objective as quickly and in the most cost-effective manner possible. The Company is currently targeting the orphan ocular indication retinitis pigmentosa (RP) for first-in-man studies, expected to start in 2016."

Read the full AMBS Press Release at http://www.financialnewsmedia.com/profiles/ambs.html

The project will utilize Catalent's proprietary GPEx® technology, which creates high-expression, extremely stable cell lines with speed and efficiency, typically capable of getting drug development projects to clinic in one-third the time of traditional approaches. The advantages of applying GPEx® technology span from early feasibility studies, to clinical manufacturing and commercial scale production.

MANF is a naturally-occurring protein that reduces and prevents apoptosis (programmed cell death) in response to injury or disease. Amarantus is developing MANF for the treatment of orphan ocular indications, including retinitis pigmentosa (RP), and recently received orphan drug designation for MANF for the treatment of RP in the United States and in Europe. In addition, MANF proteins have demonstrated proof-of-concept in animal pre-clinical models to treat a wide range of conditions including retinal artery occlusion, glaucoma, Parkinson's disease (PD), diabetes and ischemic heart disease, among others.

In other pharma, biologics & biotech news and happenings around the Healthcare Sector:  Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company focused on developing aerosolized KL4 surfactant therapies for respiratory diseases, announced top-line results from its AEROSURF® Phase 2a clinical trial in premature infants 29 - 34 gestational age with respiratory distress syndrome (RDS) this morning at 7:00 a.m. EDT.  A replay of the conference call will be accessible one hour after completion through May 22, 2015 by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and referencing conference ID number 10065912.

Fibrocell Science, Inc., (NASDAQ: FCSC), an autologous cell and gene therapy company primarily focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, announced that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation for Fibrocell's lead orphan gene-therapy drug candidate, FCX-007, for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). The rare pediatric disease designation augments the Orphan Drug designation granted by the FDA and announced by Fibrocell in June 2014 for FCX-007 to treat dystrophic epidermolysis bullosa (DEB), which includes RDEB.

OPKO Health, Inc. (NYSE:OPK) announced early this month the acquisition of EirGen Pharma, Ltd., a growing, profitable and cash flow positive specialty pharmaceutical company focused on the development and commercial supply of high potency, high barrier to entry, pharmaceutical products for sale in the U.S., Canada, Japan, Australia, most European countries, and more than 40 others around the world.  EirGen, based in Waterford, Ireland, was founded by two former executives of IVAX Pharmaceuticals, Tom Brennan and Patsy Carney. The company, situated in a state of the art high containment research and development, and manufacturing facility, is approved by the FDA, EMEA (European Health Authorities) and the PMDA (Japanese Health Authorities). High potency drugs such as those used for cancer chemotherapy are typically unsuitable for manufacture in normal multi-product facilities due to cross contamination risks.

The addition of an experimental Bristol-Myers Squibb (NYSE: BMY) biotech medicine to standard therapy for patients whose multiple myeloma has relapsed led to longer remissions and cut the risk of death over standard treatment alone, according to data from a late stage study.  The drug, elotuzumab, which is being developed in collaboration with AbbVie (NYSE: ABBV), extended the duration of remissions by about five months on average when used with Celgene's Revlimid and the corticosteroid dexamethasone. It is the first antibody to be used against this type of blood cancer, researchers said.  In the study of 646 patients with recurrent multiple myeloma, those who received the three-drug combination on average went 19.4 months before the cancer began to worsen, compared with 14.9 months for those who received Revlimid and dexamethasone.  Read the full article at http://finance.yahoo.com/news/bristol-abbvie-drug-extends-multiple-210001423.html

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