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MediciNova Receives a Notice of Patent Allowance for a Method of Treating Progressive Multiple Sclerosis
Wednesday, February 01, 2012
San Diego, CA -- MediciNova Inc, a biopharmaceutical company traded on the NASDAQ Global Market and the Jasdaq Market of the Osaka Securities Exchange (4875), today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application, which covers the use of ibudilast for the treatment of progressive forms of multiple sclerosis. Ibudilast (MN-166), is the company's lead drug development candidate for certain neurological conditions, including progressive multiple sclerosis, neuropathic pain, and drug addiction.
A patent maturing from this allowed patent application is expected to expire no earlier than early 2029 and covers a method of treating primary progressive multiple sclerosis (PPMS) or secondary progressive MS (SPMS) by administering ibudilast either alone or in combination with other drugs. The patent application is based upon clinical investigations conducted by MediciNova researchers which showed an apparent disease-modifying benefit in which brain volume loss, or brain atrophy, commonly associated with disease progression, was reduced by oral administration of ibudilast to a group of multiple sclerosis patients including some subjects with progressive multiple sclerosis, in a dose-related fashion over at least a 10-month treatment period.
Multiple sclerosis (MS) is recognized as a chronic disease in which disability progresses over time. Patients suffering from progressive forms of MS tend to have a poor prognosis and have greater levels of disability. Robert J. Fox, M.D., M.S., FAAN, Medical Director of Mellen Center for MS, Cleveland Clinic, noted that, "Despite recent improvements in pharmacotherapy for relapsing remitting multiple sclerosis, treatment options in progressive multiple sclerosis are extremely limited in the absence of relapses. There is great need for safe, effective, and conveniently-administered therapies for progressive MS."
Obtaining long-term protection of market exclusivity for the use of ibudilast in certain neurological conditions has been a key component of MediciNova's development strategy for the MN-166 program. Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, noted that, "We are very pleased to receive notice of this patent allowance for ibudilast in progressive MS. Moreover, we anticipate that this allowance will facilitate further development and business options around this program."
Ibudilast has been used in asthma and post-stroke disorders in Japan for around 20 years. MediciNova has demonstrated the potential utility of ibudilast in the treatment of neurological disorders at higher doses with encouraging outcomes in company-sponsored clinical trials in multiple sclerosis (MS) and neuropathic pain. MediciNova's collaborative trial planning with drug addiction investigators at organizations like Columbia/NYSPI and UCLA has led to National Institute on Drug Abuse (NIDA)-to support clinical investigations of the use of ibudilast to treat both opioid and methamphetamine addiction. A Phase 2 investigator-sponsored trial of ibudilast in the treatment of chronic medication overuse headache (MOH) pain is also ongoing in Australia. MediciNova's priorities include pursuing Phase 2 proof-of-concept trials of ibudilast for the treatment of progressive MS and/or neuropathic pain through non-dilutive funding.
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. Through strategic alliances primarily with Japanese pharmaceutical companies, MediciNova holds rights to a diversified portfolio of clinical and preclinical product candidates, each of which MediciNova believes has a well-characterized and differentiated therapeutic profile, attractive commercial potential, and patent coverage of commercially adequate scope. MediciNova's pipeline includes six clinical-stage compounds for the treatment of acute exacerbations of asthma, chronic obstructive pulmonary disease exacerbations, multiple sclerosis and other neurologic conditions, asthma, interstitial cystitis, solid tumor cancers, Generalized Anxiety Disorder, preterm labor and urinary incontinence and two preclinical-stage compounds for the treatment of thrombotic disorders. MediciNova's current strategy is to focus on its two prioritized product candidates, MN-221, for the treatment of acute exacerbations of asthma and chronic obstructive pulmonary disease exacerbations, and ibudilast (MN-166/AV411). Each drug candidate is involved in clinical trials under U.S. and Investigator INDs. MediciNova is engaged in strategic partnering discussions to support further development of the MN-221 and ibudilast programs. Additionally, MediciNova will seek to monetize opportunistically its other pipeline candidates. For more information on MediciNova, Inc., please visit www.medicinova.com.
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 the potential utility of ibudilast in the treatment of progressive MS and other neurological disorders and the proposed proof of concept trial of ibudilast, including any 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, the risk and certainties of raising additional capital to fund clinical development of Ibidulast, risks and uncertainties inherent in clinical trials, product development and commercialization, such as the uncertainty in results of clinical trials for product candidates, 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 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, cost and design of future clinical trials and research activities, 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 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, 2010 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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