Medicinova (MNOV) Receives Positive CHMP Opinion on Ibudilast as ALS Treatment

November 10, 2016 6:11 AM EST
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MediciNova, Inc. (Nasdaq: MNOV) 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."

About Amyotrophic Lateral Sclerosis

Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. The nerves lose the ability to trigger specific muscles, which causes the muscles to become weak. As a result, ALS affects voluntary movement and patients in the later stages of the disease may become totally paralyzed. Life expectancy of an ALS patient is usually 2-5 years. According to the ALS Association, there are approximately 20,000 ALS patients in the U.S. and approximately 6,000 people in the U.S. are diagnosed with ALS each year. Publications estimate that there are approximately 29,000 ALS patients in the EU. Riluzole is the only pharmaceutical treatment approved for ALS in the U.S. and EU, but it has limited efficacy.

About Orphan Medicinal Product Designation

Orphan medicinal product designation in the EU refers to pharmaceuticals that have been developed for the treatment of life-threatening or chronically debilitating rare diseases with reported prevalence of fewer than 5 patients per 10,000 population. Orphan medicinal product designation allows a more straightforward clinical development path for the drug and allows the sponsor to receive significant potential economic, scientific, and regulatory benefits, including reduced fees and taxes, access to free protocol assistance and scientific advice by the EMA, and a 10-year period of marketing exclusivity.

About MN-166 (ibudilast)

MN-166 (ibudilast) has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova is developing MN-166 for ALS and other neurological conditions such as progressive MS and drug use disorders. MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. It attenuates activated glia cells, which play a major role in certain neurological conditions. Ibudilast's anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical study results and provide the rationale for its therapeutic utility in neurodegenerative diseases (e.g., ALS and progressive MS), drug use disorders and chronic neuropathic pain. MediciNova has a portfolio of patents which cover the use of MN-166 (ibudilast) to treat various diseases including ALS, progressive MS, and drug use disorders.

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