Chronic Obstructive Pulmonary Disease, or COPD, is a serious lung disease that, over time, makes it increasingly difficult for a patient to breathe. According to CDC, in the United States, tobacco use is the primary cause of COPD, but other factors like asthma, exposure to air pollutants, genetic factors, and respiratory infections also play a role.
Statistics indicate that COPD claims lives of more than 137,000 Americans annually and is the third leading cause of death in the country. Exacerbations, which refer to worsening of the disease symptoms, occur in patients with asthma and COPD and remain an unmet need. Working on a treatment for acute exacerbations of asthma and COPD is biopharmaceutical company MediciNova Inc. (MNOV).
For readers who are new to MediciNova, here's a brief overview of the company's pipeline and upcoming events...
The company's pipeline includes product candidates acquired through license agreements primarily with mid-sized Japanese pharmaceutical companies. MediciNova is currently focusing on two core product candidates - MN-221 for the treatment of acute exacerbations of asthma and COPD and MN-166 for the treatment of multiple sclerosis. In addition, there are six other compounds in clinical testing for various indications.
MN-221, which is being developed for the treatment of exacerbations of asthma/COPD, is licensed from Kissei Pharmaceutical Co. MN-221 is an intravenous drug which is beta (2)-adrenergic receptor agonist.
MediciNova has completed several Phase 1 and 2a trials with MN-221 in patients with acute exacerbations of asthma and a Phase 1b clinical study of MN-221 in patients with stable, moderate to severe COPD.
A phase IIb study with MN-221 in patients with acute exacerbations of asthma is also underway and it will continue enrolling patients through December 2011, involving 15 sites across the US and 200 patients.
In October of this year, MediciNova initiated a Phase 1b clinical trial with MN-221 in patients with stable, moderate-to-severe COPD involving multiple administrations of intravenous MN-221 over several days in typical patients with concomitant illnesses. The trial is scheduled to commence enrollment by the end of 2011.
In addition to exacerbations of asthma/COPD, MN-221 is also being tested as a treatment for preterm labor, which is under phase I testing.
The other core candidate drug of MediciNova is Ibudilast, an oral treatment being evaluated for progressive multiple sclerosis, neuropathic pain and drug addiction, all of which are under phase II testing. The company is exploring collaborative paths for the phase II development of Ibudilast. Ibudilast, which is licensed from Kyorin Pharmaceutical, has been marketed in Japan and Korea since 1989 to treat cerebrovascular disorders and bronchial asthma.
The company received a final approval from the Ministry of Commerce of the People's Republic of China for the formation of a joint venture company to develop and commercialize MN-221 in China in September of this year.
MediciNova's non-core candidate drugs include,
* MN-001 for bronchial asthma and MN-001 for interstitial cystitis licensed from Kyorin Pharmaceutical* MN-305 for anxiety disorders and MN-246 for urinary incontinence licensed from Mitsubishi Mitsubishi Tanabe Pharma Corp.* MN-029 for cancer licensed from Angiogene Pharmaceuticals Ltd.
The company has limited the development efforts of all the above non-core candidate drugs, including MN-221 for the treatment of preterm labor.
MediciNova also has two compounds in preclinical development namely, MN-447 for the treatment of thrombotic disorders and MN-462 for the treatment of thrombotic disorders. These two compounds are licensed from Meiji Seika Kaisha.
A quick look at MediciNova's balance sheet...
MediciNova, which is dual listed on the Nasdaq Global Market and the Jasdaq Market of the Osaka Securities Exchange in Japan, is a development stage company. The accumulated deficit as on September 30, 2011 was $281.8 million.
At September 30, 2011, the company had $8.7 million in cash and cash equivalents. In addition, MediciNova received $10 million in cash from Kissei Pharmaceutical Co., Ltd. this quarter as a result of a private stock sale and a clinical development agreement for certain clinical trials related to MN-221.
MNOV has been trading in the range of $1.86 to $5.90 in the last one year. The stock closed Tuesday's trading at $2.05.
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