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February 13, 2016 8:28 AM ET

Biotechnology

Company Overview of MediciNova Inc.

Company Overview

MediciNova, Inc., a biopharmaceutical company, focuses on acquiring and developing novel and small molecule therapeutics for the treatment of serious diseases with unmet medical needs for the United States market. Its product candidates include MN-166 (Ibudilast), an anti-inflammatory and neuroprotective agent, which has completed Phase II clinical trials for the treatment of neurological disorders; MN-221 (Bedoradrine), a ß2-adrenergic receptor agonist that has completed Phase IIb clinical trails for the treatment of acute exacerbations of asthma; MN-001 (Tipelukast), an orally bioavailable small molecule compound, which has completed a pre-clinical study for the treatment of nonalcoholic s...

4275 Executive Square

Suite 650

La Jolla, CA 92037

United States

Founded in 2000

10 Employees

Phone:

858-373-1500

Fax:

858-404-0048

Key Executives for MediciNova Inc.

Co-Founder, Chief Executive Officer, President and Executive Director
Age: 65
Total Annual Compensation: $504.8K
Head of Japanese Office and Vice President
Age: 47
Total Annual Compensation: $293.6K
Chief Medical Officer
Age: 49
Total Annual Compensation: $293.6K
Compensation as of Fiscal Year 2014.

MediciNova Inc. Key Developments

MediciNova Receives Notice of Allowance for New Patent Covering MN-001 and MN-002 for the Treatment of Advanced Nash with Fibrosis

MediciNova Inc. announced that it has received a notice of allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-001 (tipelukast) and MN-002 (a major metabolite of MN-001) for the treatment of advanced NASH (nonalcoholic steatohepatitis) with fibrosis. Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than September 2034. The allowed claims cover a method of treating advanced NASH with fibrosis, a method of reducing hepatic fibrosis in advanced NASH, and a method of reducing hepatic scarring in advanced NASH using MN-001 or MN-002. The allowed claims cover oral administration, including tablets and capsules, as well as liquid dosage forms.

FDA Grants Rare Pediatric Disease Designation to MediciNova, Inc.'s MN-166 (ibudilast) for Treatment of Krabbe Disease

MediciNova Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to MN-166 (ibudilast) for treatment of Type 1 - Early Infantile Krabbe disease. The FDA has previously granted orphan drug designation to MN-166 (ibudilast) for treatment of Krabbe disease.

MediciNova Inc. Receives Fast Track Designation from the U.S. Food and Drug Administration for MN-166 for the Treatment of Patients with Amyotrophic Lateral Sclerosis

MediciNova Inc. announced that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for MN-166 (ibudilast) for the treatment of patients with amyotrophic lateral sclerosis (ALS). Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious or life-threatening diseases and demonstrate the potential to address unmet medical needs for such diseases. An important feature of the FDA's Fast Track program is that it emphasizes frequent communication between the FDA and the sponsor throughout the entire drug development and review process to improve the efficiency of product development. Accordingly, Fast Track status can potentially lead to a shortened timeline to ultimate drug approval. A drug that receives Fast Track designation may be eligible for: More frequent meetings with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval. Accelerated Approval, i.e., approval based on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality; Priority Review, with an FDA goal for completing review within six months of submission; and Rolling Review, which means that a sponsor can submit completed sections of its New Drug Application (NDA) for review by the FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed.

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