SAN DIEGO, Feb. 25, 2013 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on the NASDAQ Global Market (Nasdaq:MNOV) and the Jasdaq Market of the Osaka Securities Exchange (Code Number: 4875), today 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 methamphetamine dependence. Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious diseases and have the potential to fill an unmet medical need. An important feature of the FDA's Fast Track program is that it emphasizes early and 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.
According to the Substance Abuse and Mental Health Services Administration's (SAMHSA) 2011 National Survey on Drug Use and Health, there are approximately 439,000 methamphetamine abusers in the U.S. An independent study conducted by the Rand Corporation estimated the economic burden of methamphetamine use in the U.S. at $23.4 billion in 2005. There are no medications currently approved by the FDA for the treatment of methamphetamine dependence. Herbert D. Kleber M.D., founder and Director of the Division on Substance Abuse, New York State Psychiatric Institute, and Professor of Psychiatry at Columbia University Medical Center, and a prior Deputy Director at the White House Office of National Drug Control Policy noted that "there truly is an unmet need for pharmacotherapy treatment of methamphetamine dependence and the recognition of such need by the FDA is positive for the field."
"We are very pleased that MN-166 has received Fast Track designation and believe this validates its potential to address unmet medical needs in this devastating and life-threatening disease," Dr. Yuichi Iwaki, President and CEO of MediciNova commented. "We look forward to initiating the NIDA-funded Phase 2 outpatient clinical trial of MN-166 for the treatment of methamphetamine addiction with UCLA investigators."
About Fast Track Designation
According to the FDA, in order to be granted Fast Track designation, a drug must (1) be intended for the treatment of a serious or life-threatening condition; and (2) demonstrate the potential to address unmet medical needs for the condition.
A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval;
More frequent written correspondence from the FDA about such things as the design of the proposed clinical trials;
Accelerated Approval, i.e., approval based on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit;
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; and
Priority Review, with an FDA goal for completing review within eight months of submission.
About MN-166 Clinical Development in Addiction
Clinical development of MN-166 is ongoing in both methamphetamine addiction and opioid addiction. These clinical trials are conducted by some of the country's leading experts in opioid and methamphetamine addiction. A Phase 1b clinical trial of MN-166 in methamphetamine dependence is near completion at UCLA. A Phase 2 outpatient clinical trial of MN-166 in methamphetamine dependence, led by investigators at UCLA, has been funded by NIDA. In opioid addiction, a Phase 1b clinical trial of MN-166 in heroin-dependent volunteers was completed at Columbia University/New York State Psychiatric Institute. A NIDA-funded Phase 2a clinical trial of MN-166 in opioid dependence is currently ongoing and led by investigators at Columbia University and the New York State Psychiatric Institute.
About Methamphetamine Addiction
Methamphetamine is a very addictive stimulant that is closely related to amphetamine. It is long lasting and toxic to dopamine nerve terminals in the central nervous system. It is a white, odorless, bitter-tasting powder taken orally or by snorting or injecting, or a rock "crystal" that is heated and smoked.
Methamphetamine increases wakefulness and physical activity, produces rapid heart rate, irregular heartbeat, and increased blood pressure and body temperature. Long-term use can lead to memory loss, aggression, psychotic behavior, heart damage, malnutrition and severe dental problems. All users, but particularly those who inject the drug, risk infectious diseases such as HIV/AIDS and hepatitis.
About MN-166 (ibudilast)
MN-166 has been marketed in Japan and Korea since 1989 to treat cerebrovascular disorders, including post-stroke complications, and bronchial asthma. MediciNova licensed MN-166 (ibudilast), from Kyorin Pharmaceutical in October 2004 for potential utility in relapsing remitting multiple sclerosis. MediciNova scientists and collaborators independently established evidence of ibudilast utility in opioid and methamphetamine addiction as well as chronic neuropathic pain.
MN-166 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 including IL-1ß, TNF-a, and IL-6, and may upregulate the anti-inflammatory cytokine IL-10 and neurotrophic factors. It has additionally been shown to be a toll-like receptor 4 (TLR4) functional antagonist that may contribute to its therapeutic action.
MediciNova's development efforts in progressive MS and chronic neuropathic pain is also founded upon both preclinical and clinical data indicating anti-neuroinflammatory and neuroprotective actions, which may be beneficial in those conditions.
MediciNova's method-of-use patent for MN-166 for the treatment of addiction expires no earlier than 2030 in the U.S. In the approved and pending grant-funded MN-166 trials, one of MediciNova's commitments is to provide delayed-release ibudilast final product. A drug supply collaboration with Taisho Pharmaceutical Industries, Ltd., owned by Teva Pharmaceuticals, has expanded to include development of higher dosage strength ibudilast capsules.
MediciNova, Inc. is a publicly traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet need with a commercial focus on the U.S. market. MediciNova's current strategy is to focus on its two prioritized product candidates, MN-166 (ibudilast) for neurological disorders, and MN-221 for the treatment of acute exacerbations of asthma. MN-166 is being developed in Phase 1 and Phase 2 clinical trials for drug dependence and pain, largely through investigator sponsored trials and outside funding. Proceeding with proof-of-concept Phase 2b trial(s) in Progressive MS is dependent on receipt of funding, which we are pursuing. MediciNova is engaged in strategic partnering and consortium funding discussions to support further development of both the MN-221 and ibudilast/MN-166 programs. For more information on MediciNova, Inc., please visit www.medicinova.com.
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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 our clinical development strategies, including future development, statements regarding the progress of clinical trials, statements regarding expectations for the ibudilast/MN-166 program, including development of ibudilast/MN-166 for certain indications and expectations on future progress in the development of our drug candidates, expected timing of clinical trial results and any implication as to the results of our development, partnering and funding efforts, the implication of patent terms and potential product exclusivity and the implication that the company will have the ability to execute on its priorities. 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," 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-221 and MN-166 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 obtained 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, 2011 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.
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