West Coast Editor

On the heels of a 1-for-10 reverse stock split that could help get the firm listed for trading in the U.S., broad-pipelined MediciNova Inc. - which went public in Japan early last year - filed a shelf registration with the SEC for the sale of up to $100 million in shares.

Founded as a subsidiary of Tanabe Seiyaku Ltd., of Osaka, MediciNova's initial public offering raised $115 million on the Hercules market of the Osaka Securities Exchange, shortly after pulling down $44 million in a Series C round, with about 70 percent of the money coming from Japanese investors. (See BioWorld Today, Sept. 7, 2004, and Feb. 10, 2005.)

San Diego-based MediciNova's drug candidates include MN-305 for the treatment of generalized anxiety disorder, for which the firm completed a Phase II/III trial during the second quarter.

Tokyo-based Mitsubishi Pharma Corp., which holds a license to the serotonin 5-HT1A agonist worldwide except Japan and some Asian countries, has completed an early Phase II trial.

Undergoing a pivotal-design Phase II/III trial is MN-001, which has been shown to block inflammatory mechanisms activated by mast cell degranulation. Enrollment finished in August, and the company expects to offer data in early 2007. The drug is expected to enter a Phase III program in bronchial asthma by the end of this year.

MN-166 targets multiple sclerosis in a Phase II trial for which enrollment concluded early this year, with results expected in the first quarter of next year. The oral drug, when tested in vitro, inhibited leukotrienes, phosphodiesterases and nitric oxide synthase.

MediciNova got MN-001 and MN-166 from Kyorin Pharmaceutical Co. Ltd., of Tokyo, which holds licenses worldwide, except Japan, China, Taiwan and South Korea.

Due to enter Phase II trials this quarter is MN-221 for status asthmaticus, a severe, long-lasting and potentially fatal asthma episode that fails to respond to bronchodilator or corticosteroid therapy. MN-221 is a beta-2-adrenergic receptor agonist licensed from Kissei Pharmaceutical Co. Ltd., of Tokyo, which also is undergoing Phase IIa testing as a potential treatment for pre-term labor.

Further back in the pipeline is MN-029, a small-molecule vascular disrupting drug that targets solid tumors. One Phase I trial has finished and another is under way. Phase II/III studies in ovarian and non-small-cell lung cancers are expected to start by the end of this year. MN-029 came from Oxford, UK-based Angiogene Pharmaceuticals Ltd., which holds a worldwide license.

MN-246, an oral beta-3-adrenergic receptor agonist licensed by MediciNova from Mitsubishi, is undergoing a Phase I trial for urinary incontinence. Mitsubishi's license applies worldwide, except Japan, and certain countries in Asia.

No Comments