SAN DIEGO, March 9, 2011 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the Nasdaq Global Market (Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number: 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 drug addiction or drug dependence or withdrawal syndrome. Ibudilast, aka MN-166 or AV411, is the company's lead drug candidate for certain neurological conditions, including neuropathic pain, drug addiction and progressive multiple sclerosis. The patent, once issued, covers the use of ibudilast for therapeutic administration alone or in combination with other drugs for the treatment of opioid addiction, dependence, or withdrawal syndrome. Ibudilast is a non-opioid inhibitor of macrophage migration inhibitory factor (MIF) and phosphodiesterases-4 and -10 (PDEs-4, -10) and has been shown to reduce glial cell activation. Such a cellular action has been experimentally linked to certain neurochemical and behavioral changes associated with addiction to drugs like opioids and methamphetamine. The patent application is based upon research by Linda Watkins, Ph.D., and colleagues at University of Colorado, Boulder, and Kirk Johnson, Ph.D., Chief Scientific Officer, at MediciNova. As mentioned above, the allowed claims include a method of treating an opioid withdrawal syndrome, which is sometimes observed in patients who stop or reduce their use of opioids like morphine and oxycodone (i.e., Vicodin®), and the reduction of associated glial cell activation. The allowed claims also cover the use of ibudilast in combination with buprenorphine, itself an opioid, which is approved (i.e., Suboxone®) for treating opioid dependence. 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 drug addiction, especially on the heels of our recent announcement of encouraging preliminary clinical trial results in morphine withdrawal and analgesia." Dr. Iwaki added that "Positive progress in our MN-166 program along with our ongoing phase 2 asthma exacerbation trial with another of our lead drug candidates, MN-221, speaks to our pipeline quality."
About IbudilastIbudilast has been used in asthma and post-stroke disorders in Japan for nearly 20 yrs and has also been utilized at higher doses with encouraging outcomes in company-sponsored clinical trials in multiple sclerosis and neuropathic pain. Collaborative trial planning between drug addiction investigators at organizations like Columbia/NYSPI and UCLA has led to NIDA-supported pre-clinical and clinical investigations for both opioid and methamphetamine addiction. Abuse of these drugs continues to be a significant public health concern and pharmacological treatment is an as yet unmet clinical need. As there are no non-opioid drugs approved for treatment of dependence to opioids or methamphetamine, ibudilast is one of the few known new-approach treatments being investigated clinically. A Phase 1b trial in methamphetamine addicts involving multi-day ibudilast dosing up to 100 mg/day (50 mg twice daily) with overlapping periods of methamphetamine infusion for safety, tolerability, and preliminary efficacy testing has initiated with UCLA investigators. About MediciNova MediciNova, Inc. is a publicly traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of serious diseases 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), for the treatment of multiple sclerosis, chronic pain, spinal cord injury, or drug addiction. 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. The MediciNova, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3135 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 MediciNova's clinical trials supporting safety and efficacy of product candidates and the potential of such product candidates as treatments for disease, including the potential use of ibudilast for the treatment of drug addiction, dependence or withdrawal syndrome, as well as statements regarding the protection afforded by intellectual property rights in the company's product candidates. 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 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, 2009 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.
CONTACT: MediciNova, Inc. Mark Johnson, Investor Relations (858) 373-1500 firstname.lastname@example.org