Jun 29 2011
SAN DIEGO, California -– MediciNova Inc, a biopharmaceutical company publicly traded on the Nasdaq Global Market (Nasdaq: MNOV) and the Jasdaq Market of the Osaka Securities Exchange (4875) and Zhejiang Medicine Co., Ltd. (ZMC) traded on the Shanghai Stock Exchange (600216) today announced the execution of a Joint Venture agreement for the formation of a Joint Venture Company to develop and commercialize MediciNova’s MN-221 in China. The completion of the agreement between MNOV and ZMC allows the JV to complete the final approval process with the Ministry of Commerce of the People’s Republic of China.
“We are pleased with the completion of this important step and look forward to the JV advancing toward the development of MN-221 in China” said Yuichi Iwaki M.D., Ph.D., chief executive officer of MediciNova, Inc. Chunbo Li, chairman of Zhejiang Medicine Company commented, “We plan for the JV to file an IND by year end to commence clinical development for MN-221 in China. We are eager to work closely with the Chinese FDA to advance the development of MN-221 to address the growing need for new emergency asthma therapies in China.”
In China, increasing urbanization and adoption of Western lifestyles are predicted to produce a sharp increase in the prevalence of asthma during the next decade. Due to China’s large population, a 2% increase in the prevalence of asthma would result in an additional 20 million people with the disease. The prevalence of asthma symptoms is higher in urban areas than rural areas of China. Asthma prevalence and emergency room visits are expected to grow substantially in the future due to increased diagnosis of asthma from continued migration of people from rural areas to cities with better access to medical care. High air pollution, a known contributor to acute exacerbations of asthma, is
expected to increase as the growing middle class in China buys more automobiles. The growing middle class in China is demanding better health care and access to better pharmaceutical products. The percentage of the Chinese population that can afford to pay for premium-priced pharmaceutical products out of pocket is expected to increase as the middle class continues to grow. All of these factors bode well for a very attractive market opportunity for MN-221 in China.
According to the Global Burden of Asthma report (M. Masoli, D. Fabian, S. Holt, R. Beasley), there were 27.8 million people with asthma in the China/Taiwan/Mongolia region. More than one third of people with asthma in this region require urgent medical care, emergency room visits, or hospitalization for asthma attacks. Mortality data also reflect the burden of severe asthma in the region with China having one of the highest asthma case fatality rates in the world.
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 I 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.
MediciNova acquired an exclusive, worldwide (excluding Japan), sublicensable license to MN-221 from Kissei Pharmaceutical Co., Ltd. The intellectual property acquired from Kissei includes extensive preclinical and clinical safety data.
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.
Zhejiang Medicine Co., Ltd. is a leading pharmaceutical manufacturer in China. The company is profitable and had reported sales of $705 million in 2010. Zhejiang Medicine Co., Ltd. is committed to research and development of new pharmaceutical products for the Chinese market. In April 2010, Zhejiang Medicine Co., Ltd. signed an agreement with Huazhong University of Science & Technology, to augment its research and development effort. With its extensive scientific capabilities, Zhejiang Medicine Co., Ltd. is poised to become a leader in the emerging pharmaceutical development industry in China.
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 expectations for the joint venture, including the timing of beginning clinical development in China and the market opportunity, and our portfolio of clinical and preclinical 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 relating to obtaining governmental approval of the joint venture, completing the license and supply agreement for the joint venture and obtaining regulatory approval to commence clinical development in China, including timing related risks, as well as risks inherent in investing in a joint venture that is not controlled by us, 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.
CONTACT: MediciNova, Inc.
Mark Johnson, Investor Relations