Alkermes plc (ALKS - Free Report) announced the initiation of a new phase III study of pipeline candidate ALKS 8700. ALKS 8700 is a monomethyl fumarate (MMF) prodrug which is being developed for the treatment of multiple sclerosis. The trial is a randomized five week, head-to-head phase III study which will evaluate the gastrointestinal tolerability (GI) of ALKS 8700 462 mg twice daily compared to Biogen Inc.s (BIIB - Free Report) Tecfidera 240 mg twice daily in approximately 420 patients with relapsing-remitting MS (RRMS). Alkermes share price has increased 7% year to date, while the Zacks classified Medical - Biomedical and Genetics industry gained 9.8%. This elective study is part of the ongoing clinical development program for ALKS 8700, named EVOLVE-MS. The data from this study will help in finding ALKS 8700s potential advantages for patients and its future positioning in the fumarate market, which represents a $3 billion opportunity in the U.S. Alkermes intends to submit a New Drug Application (NDA) for ALKS 8700 for the treatment of RRMS to the FDA in 2018. Alkermes key areas of focus include central nervous system (CNS) disorders like schizophrenia, depression, addiction and multiple sclerosis. In fact, one of its drugs Ampyra/Fampyra, … Continue reading
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