Tag: Clinical

MediciNova to Receive $2.5 Million Payment From Kissei Pharmaceutical Co. Ltd. to Expand Clinical Development of the MN-221 Program

MediciNova Management to Host a Business Update Conference Call Monday, October 17, at 4:30pm (EDT)

MediciNova Inc., a biopharmaceutical company publicly traded on the NASDAQ Global Market MNOV 0.00% and the Jasdaq Market of the Osaka Securities Exchange (4875), today announced that Kissei Pharmaceutical Co. Ltd., a pharmaceutical company traded on the Tokyo Stock Exchange (4547), will pay MediciNova $2.5 million, within 30 days, to support further clinical development of MN-221 for the treatment of acute exacerbations of asthma or chronic obstructive pulmonary disease (COPD).

MediciNova is developing MN-221 for acute exacerbations of asthma and COPD in the United States. Under the terms of the 2004 license agreement, MediciNova and Kissei share all data and associated know-how of the MN-221 development program.

“This financial support allows MediciNova to expand the clinical development of the MN-221 program in asthma as well as to further clinical development in COPD,” said Yuichi Iwaki M.D., Ph.D., chief executive officer of MediciNova, Inc.

Conference Call/Webcast Information

MediciNova will host a conference call and audio webcast to give a brief business update presentation followed by a question and answer session with members of management. Management on the call will include Dr. Yuichi Iwaki, the President and Chief Executive Officer, Michael Coffee, the Chief Business Officer, and Dr. Kirk Johnson, the Chief Scientific Officer. The call is scheduled for Monday, October 17th, at 4:30 P.M. (EDT).

To participate in this call, dial 866-730-5769 (domestic), 857-350-1593 (international), passcode: 80015480, shortly before 4:30 P.M. (EDT). For a limited period following the call, a replay of the call will be available, beginning at 7:30 P.M. (EDT); the replay can be accessed by calling 888-286-8010 (domestic), 617-801-6888 (international), passcode: 80745214. The audio webcast will be available on MediciNova’s investor relations website ( http://investors.medicinova.com ) for approximately 60 days following the call.

About MN-221

MN-221 is a novel, highly selective, beta(2)-adrenergic receptor agonist in development as an intravenous treatment for acute exacerbations of asthma and chronic obstructive pulmonary disease (COPD) exacerbations. Preclinical testing in vitro and in vivo shows MN-221 to be more selective for the beta(2)-adrenergic receptor than other beta(2)-adrenergic receptor agonists commonly used for acute exacerbations of asthma. This improved selectivity, coupled with its partial agonist activity at beta(1)-adrenergic receptors, may yield bronchodilation without harmful cardiovascular side effects that are commonly observed with other agents. MediciNova has completed several Phase 1 and 2a trials, and is currently conducting a Phase 2b study in patients with acute exacerbations of asthma. MN-221 demonstrated significant improvements in FEV1 in all asthma trials as well as a 45% decrease in the hospitalization rate when added to current standard of care in a Phase 2a study of acute asthma patients in the emergency room. MediciNova also completed a Phase 1b clinical study of MN-221 in patients with stable, moderate to severe COPD in which MN-221 demonstrated clinically significant improvements in FEV1 with no clinically relevant safety concerns.

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 assets having claims 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 development under U.S. and Investigator INDs and MediciNova is engaged in strategic partnering discussions to support further development of the MN-221 and ibudilast programs. Additionally, MediciNova will seek to monetize its other pipeline candidates. For more information on MediciNova, Inc., please visit www.medicinova.com .

About Kissei Pharmaceutical Co., Ltd.

Kissei Pharmaceutical Co., Ltd. was founded in 1946 and has grown into one of Japan’s leading pharmaceutical companies. Kissei’s management vision is to be an R&D-oriented pharmaceutical company that contributes to the health of people around the world through developing and offering innovative drugs. Kissei is actively pursuing collaborations with many companies to strengthen its R&D pipeline and also promoting global expansion by licensing out the original agents as an important management strategy.

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 the expectation that Kissei will make the $2.5 million payment and statements regarding development and partnering strategy. 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 relating to receiving the $2.5 million payment from Kissei, risks 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.

This news release was distributed by GlobeNewswire, www.globenewswire.com

SOURCE: MediciNova, Inc.

CONTACT: MediciNova, Inc.
Mark Johnson, Investor Relations
(858) 373-1300
info@medicinova.com

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