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MediciNova Announces European Commission Grants Orphan Medicinal Product Designation for MN-166 (ibudilast) for Amyotrophic Lateral SclerosisLA JOLLA, Calif., Dec. 20, 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 Commission has granted Orphan Medicinal Product Designation (OMPD) for MN-166 (ibudilast) for the treatment of amyotrophic lateral sclerosis (ALS). OMPD offers potential benefits including protocol assistance, fee reductions, 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 European Commission. The Committee for Orphan Medical Products (COMP) adopted a positive opinion on November 4, 2016 and recommended granting this designation to the European Commission. The process required a thorough scientific evaluation including establishing “sufficient justification” under the European Medicines Agency’s (EMA) 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 orphan medicinal product designation for MN-166 for ALS in the European Union which complements our recently granted orphan-drug designation for ALS in the U.S. Interim data from the mid-study analysis of our ongoing clinical trial of MN-166 in ALS at Carolinas HealthCare System's Neuromuscular/ALS-MDA Center, 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 About Orphan Medicinal Product Designation About MN-166 (ibudilast) About MediciNova Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-221, MN-001, and MN-029. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-221, MN-001, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2015 and its subsequent periodic reports on Forms 10-Q and 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements. INVESTOR CONTACT: Geoff O'Brien Vice President MediciNova, Inc. [email protected] |