MediciNova, Inc. Extends MN-166 Patent Position in Europe
"Along with our recent EPO allowance for the use of ibudilast in progressive multiple sclerosis, these drug addiction and pain patent allowances solidify our exclusivity in that region for all the core development areas of the MN-166 program," noted Kirk Johnson, PhD, Chief Scientific Officer and co-inventor.
A patent maturing from the allowed application for drug addiction is expected to expire no earlier than 2026 and is a counterpart of an issued U.S. patent expiring no earlier than 2030. The patent application related to the use of ibudilast in acute pain conditions resulted from collaborative pre-clinical studies with renown pain researchers at the University of Colorado, Boulder, including Linda R. Watkins, PhD, Professor of Psychology and the Center for Neuroscience. It includes claims covering the use of ibudilast or phosphodiesterase (PDE) - 4 inhibitors to treat or prevent acute pain in combination with opioids like morphine or oxycodone and expires no earlier than 2028.
"We are very pleased with this advancement in our patent portfolio and its contribution to our European-focused development and overall business plan for MN-166," noted Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova.
About Ibudilast
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 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. Additionally, MediciNova's collaborative clinical development is proceeding well with drug addiction investigators at organizations like Columbia/NYSPI and UCLA and the funding of Phase 2 trials via the National Institute on Drug Abuse (NIDA) for the use of ibudilast to treat both opioid and methamphetamine addiction. A Phase 2a investigator-sponsored trial of ibudilast in the treatment of chronic medication overuse headache (MOH) pain is also ongoing in Australia.
About MediciNova
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) for neurological disorders. MN-221 is involved in clinical trials under U.S. INDs. MN-166 is being developed in Phase 1b/2 trials for pain and drug addiction, largely through Investigator INDs and outside funding. Proof-of-concept Phase 2b trial(s) in Progressive MS are pending. MediciNova is engaged in strategic partnering and consortium funding discussions to support further development of both the MN-221 and ibudilast/MN-166 programs. Additionally, MediciNova will seek to monetize opportunistically its other pipeline candidates. 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 or 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 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 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.
Contact:
INVESTOR CONTACT:
Mark Johnson
Investor Relations
MediciNova, Inc.
(858) 373-1300
johnson@medicinova.com
MEDIA CONTACT:
Stephanie Ashe
Continuum Health Communications
650-245-0425
sashe@continuumhealthcom.com