Company Finalizing Development Plans for MN-221 While Enhancing MN-166 Program
SAN DIEGO, Jan. 3, 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), provides a development update on its two lead programs, MN-221 and MN-166.
End-of-phase 2 guidance from the FDA and the newly extended patent protection (to expire no earlier than 2030) for use of MN-221 in the treatment of acute exacerbations of asthma (AEA) provide a clear development path for MN-221. Additional manufacturing and clinical development, which will be partner-dependent, will be undertaken prior to initiation of a pivotal trial program.
MediciNova will leverage its MN-166 neurological program with grant-aided Phase 2 studies to advance MN-166 towards regulatory approval, initially in drug dependence. A phase 2 trial in methamphetamine dependence is scheduled to start in first half 2013 and could lead to MN-166 becoming the first FDA-approved product for treatment of methamphetamine dependence.
"During the past several months MediciNova has been refining the development strategy for our lead product candidates," Dr. Yuichi Iwaki, President and CEO of MediciNova commented. "With the guidance of the FDA, we are planning further MN-221 development towards our ultimate goal of obtaining regulatory approval of MN-221 for the treatment of AEA. With MN-166, we are very encouraged to now have grant funding supporting Phase 2 clinical trials in drug dependence scheduled to provide significant data readouts over the next two years."
MN-221 Development Plan
MediciNova plans to conduct the MN-221 program according to the feedback from FDA following the end-of-phase 2 meeting in October 2012. The FDA identified the risk/benefit profile of MN-221 as a focal point for further development and advised that a clinical outcome, such as a reduction in hospitalizations, would need to be a pivotal trial primary endpoint. Previously completed Phase 2 studies have evaluated the potential for MN-221 to reduce hospitalizations due to AEA.
MediciNova believes the appropriate clinical development for MN-221 will involve conducting dose regimen and AEA trial design optimization studies prior to commencing pivotal trials. Currently, MediciNova is working with licensor and API supplier, Kissei Pharmaceutical Co., Ltd. to address the manufacturing requirements before further clinical development is commenced. MediciNova has determined that any additional future MN-221 clinical trial development will be partner-dependent from a funding perspective.
"We believe the recently-allowed patent for MN-221 for use in the treatment of AEA can significantly increase the length of marketing exclusivity and hence the potential value of MN-221," said Dr. Kazuko Matsuda, patent inventor and Chief Medical Officer of MediciNova. "We look forward to keeping our shareholders updated on our MN-221 progress."
MN-166 Development Plan
The company has been very successful in facilitating investigator-led, development funding to advance the diverse MN-166 (ibudilast) program. The recent grants from the National Institute on Drug Abuse (NIDA) have accelerated the development of MN-166 in drug dependence. Currently ongoing are a Phase 2a clinical trial in opioid dependence led by investigators at Columbia University and the New York State Psychiatric Institute and a Phase 1b clinical trial in methamphetamine dependence that will lead to an already-funded Phase 2 trial in methamphetamine dependence, led by investigators at UCLA. The Phase 2 trial is expected to begin in the first half of 2013. These clinical trials are conducted by some of the country's leading experts in opioid and methamphetamine addiction. MediciNova's method-of-use patent for MN-166 in drug addiction expires no earlier than 2030 in the US.
"We are excited about the positive developments of the MN-166 program and the continuing grant support. Going forward, MediciNova will focus our resources on accelerating and optimizing MN-166 development in collaboration with the investigators conducting multiple grant-funded, proof-of-concept clinical trials," said Dr. Iwaki. "In addition to the potential to address a large unmet medical need in opioid dependence, MN-166 also has the potential to become the first approved product for the treatment of methamphetamine dependence."
In addition to drug dependence, MediciNova is pursuing grant funding opportunities in progressive multiple sclerosis (MS). MediciNova's method-of-use patents for MN-166 for the treatment of progressive MS expire no earlier than 2029.
In the approved and pending grant-funded MN-166 trials, one of MediciNova's commitments is to provide delayed-release ibudilast final product. We have expanded our drug supply collaboration with Taisho Pharmaceutical Industries, Ltd.* to include both drug supply and the development of higher dosage strength ibudilast capsules.
* Taisho Pharmaceutical Industries, Ltd. is owned by Teva Pharmaceuticals.
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 are 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 the potential period of product exclusivity assuming our product candidates obtained marketing approval 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, 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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