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Firm Pursues U.S. Development of Japanese Drugs

MEDICINOVA INC.

CEO: Yuichi Iwaki.

Revenue: No revenues for 2011 and 2010.

Net loss: Net loss of $17.7 million 2011; net loss of $20.2 million in 2010.

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No. of local employees: 13.

Headquarters: UTC area of San Diego.

Year founded: 2000.

Stock symbol and exchange: MNOV on Nasdaq Global Market. Code number 4875 on Jasdaq Market of the Osaka Securities Exchange.

Company description: A publicly-traded biopharmaceutical company focused on acquiring and developing novel therapeutics from Japanese biopharma companies for unmet medical needs in the United States and elsewhere.

Key factors for success: Utilizing the company’s strong ties within the Japanese pharmaceutical industry, MediciNova acquires therapeutic candidates with proven safety data from mid-size Japanese companies. MediciNova is developing these therapeutic candidates for medical needs in the U.S. and other global markets.

It’s rare for the Japanese to develop drug compounds outside their country due to differences in regulatory standards, guidelines and culture. San Diego-based MediciNova Inc. is changing that by partnering with several Japan-based pharmas, among them Kyorin, Kissei, Meiji Seika and Mitsubishi Tanabe, to bridge the divide between Japanese and Western medicine and bring new treatments to the U.S. and elsewhere.

Under the direction of President and CEO Yuichi Iwaki, publicly traded MediciNova’s staff of 16, including three employees in Tokyo, are developing eight compounds that aim to treat a variety of ailments from asthma to pre-term labor to solid tumor cancers and generalized anxiety disorder.

One of the more noteworthy programs that is almost ready to move to proof of concept trials is compound MN-166, which MediciNova licensed as ibudilast, from Kyorin Pharmaceutical Co. Ltd. in October 2004. Ibudilast has been marketed in Japan and Korea to treat post-stroke dizziness and asthma. Iwaki said it’s been prescribed to 3.5 million patients in the last 20 years. Now, MediciNova is repurposing the drug to treat patients with multiple sclerosis, a brain or spine damaging disease that progresses over 20 to 40 years, Iwaki said.

“There is no effective drug available, although, there are injectable drugs to slow the progression of multiple sclerosis, but it doesn’t work for every patient,” he said.

Iwaki says there’s limited market potential for MS treatments in Japan where only 10,000 to 20,000 patients could benefit from the drug, but the U.S. and European markets are wide open with potentially 400,000 patients in each of those nations.

Having completed a limited study in 300 patients in Eastern Europe with results that showed efficacy in treating multiple sclerosis, MediciNova is moving forward with developing the MN-166 compound and hopes to achieve similar results as it moves to further clinical trials, Iwaki said.

In recent news, MediciNova received a Notice of Allowance from the Australian Government Patent Office for a pending patent application that covers the use of ibudilast, or MN-166, for the treatment of forms of chronic neuropathic pain.

Kirk Johnson, chief scientific officer of MediciNova, said the notice is one of the final steps in achieving patent protection and means the compound is progressing in terms of global patent protection, which is also being pursued in Japan, Europe, Canada and Mexico.

A Phase II investigator-sponsored trial of ibudilast in the treatment of chronic medication overuse headache pain is also ongoing in Australia.

Addiction Treatment

But MediciNova’s involvement with MN-166 doesn’t end there. Iwaki said MediciNova is supplying the compound for two government-sponsored studies to determine MN-166’s efficacy in treating patients who are addicted to morphine, heroin or methamphetamine. These multimillion-dollar studies funded by the National Institute on Drug Abuse, a part of the National Institutes of Health, have been conducted at Columbia University for the past three years and at UCLA since last October.

In a statement, MediciNova says ibudilast has been shown in preclinical models of opioid withdrawal to significantly reduce withdrawal symptoms.

Sandra Comer, professor of clinical psychiatry and substance abuse at Columbia University, said results from a recent opioid addiction study were sent to the FDA earlier in April. In that study, three groups of 10 participants were given a placebo or a low dose or high dose of morphine. During the third week of the study, the morphine maintenance was switched to a placebo under double-blind conditions and withdrawal symptoms were measured. Using MediciNova’s compound, no statistically significant results were achieved but certain withdrawal symptoms were reduced in the participants, Comer said.

In its pursuit of developing and commercializing products for the treatment of acute and chronic diseases with unmet medical needs, MediciNova is also advancing its lead program, MN-221 for acute asthma attacks and chronic obstructive pulmonary disease, or COPD. In partnership with Kissei Pharmaceutical Co Ltd., MediciNova is developing an intravenous infusion for the treatment of asthma that bypasses constricted airways to deliver the drug directly to the lungs.

Iwaki says there’s great potential for serving people since nearly 2 million patients visit the emergency room each year because of asthma attacks, and only about half of those patients respond to the current therapy.

Some 4,000 to 4,500 patients have lost their lives due to asthma exacerbations each year for the past 15 years, Iwaki says.

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