MediciNova Announces European Medicines Agency Recommends Orphan Medicinal Product Designation For MN-166 (ibudilast) For Amyotrophic Lateral Sclerosis

LA JOLLA, Calif., Nov. 10, 2016 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending orphan medicinal product (orphan-drug) designation for MN-166 (ibudilast) for the treatment of amyotrophic lateral sclerosis (ALS).  Orphan-drug designation offers potential benefits including protocol assistance, fee waivers, and 10-year market exclusivity once the medicine is on the market in Europe.

This is the first orphan medicinal product designation that MediciNova has received from the EMA.  The process required a thorough scientific evaluation including establishing "sufficient justification" under the EMA's COMP criteria and that MN-166 (ibudilast) "will be of significant benefit to those affected by the condition…"

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased to receive a positive opinion recommending orphan-drug designation for MN-166 for ALS in the European Union, a recommendation that complements our recently granted orphan-drug designation in the U.S.  This is an important milestone for the development of a promising new therapeutic treatment for ALS, a life-threatening, rare disease for which riluzole is the only currently-approved treatment option in the EU and U.S.  Currently, we have two ongoing clinical trials to evaluate MN-166 in ALS in collaboration with researchers at Carolinas HealthCare System's (CHS) Neuromuscular/ALS-MDA Center and Massachusetts General Hospital.  MN-166 (ibudilast) demonstrated positive trends in the interim efficacy data from the mid-study analysis of the CHS Neuromuscular/ALS-MDA Center study.  This interim data, along with previously reported positive ALS preclinical study data, was submitted to EMA COMP to address the scientific rationale for orphan medicinal product designation to establish the medical basis for the use of MN-166 (ibudilast) for ALS."

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