SAN FRANCISCO, March 4, 2016 /PRNewswire/ --
Amarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, today announced that it has appointed Brian E. Harvey, MD PhD to its strategic advisory board. Dr. Harvey will assist the company's management team in developing and executing its strategy to accelerate FDA regulatory approval for its orphan drug portfolio of products.
"I am excited to help Amarantus accelerate regulatory interactions with the FDA for its diverse orphan drug portfolio of products," said Dr. Harvey. "ESS and Eltoprazine are moving into mid and late stage development across several niche indications where the standard of care has not seen any significant innovation in over 50 years. ESS is a product candidate that demands careful, focused clinical and regulatory execution in order to bring this life-saving treatment to market as expeditiously as possible. With respect to Eltoprazine and its recent Orphan designation, Amarantus has an opportunity to redefine the regulatory pathway to approval for Eltoprazine with its recent orphan drug designation, and we intend to engage the regulatory authorities in discussions as it relates to this pathway forward."
"We are very pleased to have attracted Dr. Harvey to our Strategic Advisory Committee to further enhance our already strong regulatory science infrastructure as we prepare to engage the FDA in discussions regarding the pathway forward for the late-stage development of ESS and Eltoprazine," said Gerald E. Commissiong, President & CEO. "As we are rapidly approaching the initiation of the ESS clinical development program with the US Army for the treatment of severe burns, we foresee the burn community strongly advocating for an accelerated approval process to bring this life-saving treatment to market. We want to ensure that we have the experience and infrastructure at the ready to manage various potential scenarios as it relates to ESS."
About Dr. Harvey's Experience
Dr. Harvey recently served as Vice President of U.S Regulatory Strategy at Pfizer, where he led U.S. FDA regulatory interactions across all Pfizer business units, and was a Member of the CEO's Senior Leadership Council (SLC). He led the Pfizer efforts on the PhRMA Regulatory Affairs Coordinating Committee (RACC). In addition, he was responsible for the Oversight of U.S. Regulatory Policy & Intelligence functions, and the U.S. Advertising & Promotion activities. He played an early role in PDUFA VI Preparation, the PhRMA Steering Committee and the 21st Century Cures initiatives.
Prior to his time at Pfizer, Dr. Harvey served as Vice President of Regulatory Policy at Sanofi, where he was the Liaison with U.S. Food and Drug Administration (FDA), served on the International Biologics and Biotechnology Taskforce and Biologics Key Issues Team, was on the Biotechnology Industry Organization (BIO) Regulatory Affairs Committee (RAC). He was the Signatory authority for Sanofi written comments to the FDA docket and was a Member of the Sanofi Policy Development Committee.
Prior to Sanofi, Dr. Harvey spent 11 years with the FDA in increasing positions of responsibility across various divisions including Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH). From 2000 to 2001, Dr. Harvey served as an American Political Science Association (APSA) Congressional Fellow on behalf of the FDA. Dr. Harvey received his PhD, then MD from the University of Connecticut.
His Internal Medicine Internship and Residency at Beth Israel Hospital/Harvard was followed by a 3 year Gastroenterology Fellowship at Johns Hopkins Hospital prior to joining FDA.
About Amarantus BioScience Holdings, Inc.
Amarantus BioScience Holdings (AMBS) is a biotechnology company developing treatments and diagnostics for diseases in the areas of neurology, regenerative medicine and orphan diseases. AMBS' Therapeutics division has development rights to eltoprazine, a Phase 2b-ready small molecule indicated for Parkinson's disease levodopa-induced dyskinesia, adult ADHD and Alzheimer's aggression, and owns the intellectual property rights to a therapeutic protein known as mesencephalic-astrocyte-derived neurotrophic factor (MANF) and is developing MANF-based products as treatments for brain and ophthalmic disorders. More recently, AMBS acquired the rights to the Engineered Skin Substitute program (ESS), a regenerative medicine-based approach for treating severe burns with full thickness autologous skin grown in tissue culture. ESS is entering Phase 2 clinical studies under a CRADA agreement with the US Army. AMBS' Diagnostics division owns the rights to MSPrecise®, a proprietary next-generation DNA sequencing (NGS) assay for the identification of patients with relapsing-remitting multiple sclerosis (RRMS) at first clinical presentation, has an exclusive worldwide license to the Lymphocyte Proliferation test (LymPro Test®) for Alzheimer's disease, which was developed by Prof. Thomas Arendt, Ph.D., from the University of Leipzig, and owns intellectual property for the diagnosis of Parkinson's disease (NuroPro). AMBS also owns the discovery of neurotrophic factors (PhenoGuard™) that led to MANF's discovery.
Certain statements, other than purely historical information, including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the assumptions upon which those statements are based, are forward-looking statements. These forward-looking statements generally are identified by the words "believes," "project," "expects," "anticipates," "estimates," "intends," "strategy," "plan," "may," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements. Our ability to predict results or the actual effect of future plans or strategies is inherently uncertain. Factors which could have a material adverse effect on our operations and future prospects on a consolidated basis include, but are not limited to: changes in economic conditions, legislative/regulatory changes, availability of capital, interest rates, competition, and generally accepted accounting principles. These risks and uncertainties should also be considered in evaluating forward-looking statements and undue reliance should not be placed on such statements.
Investor and Media Contact:
Ascendant Partners, LLC
SOURCE Amarantus BioScience Holdings, Inc.