Actelion and Nippon Shinyaku enter into a license agreement on novel PAH compound

24-Apr-2008

Actelion Ltd and Nippon Shinyaku announced that the two companies have signed a license agreement on a novel orally available PGI2 receptor agonist NS-304 originally discovered and synthesized by Nippon Shinyaku for the treatment of pulmonary arterial hypertension (PAH), based on the previous binding letter of intent.

The agreement was signed in a formal ceremony at Nippon Shinyaku Headquarters in Kyoto by Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion and Shigenobu Maekawa, President of Nippon Shinyaku. Also present at the ceremony was Satoshi Tanaka, Dr. med. Sci., President and Representative Director of Actelion Pharmaceuticals Japan Ltd.

Under the terms of this license agreement, Nippon Shinyaku will receive from Actelion an upfront payment and additional milestone payments based on development stage and sales achievement. Nippon Shinyaku will also receive royalties on sales. In addition, this agreement enables Nippon Shinyaku to explore the possibility of co-development in Japan of a compound which is being developed by Actelion globally.

In order to promptly bring NS-304 to the market of PAH and other possible indications, Actelion will take over the phase IIa clinical study being conducted by Nippon Shinyaku in Europe and be responsible for global development and commercialization of NS-304 outside Japan. The two companies will co-develop and co-commercialize NS-304 in Japan.

NS-304, originally discovered and synthesized by Nippon Shinyaku, is an orally available long acting prostaglandin I2 receptor agonist), which stimulates PGI2 receptor in blood vessels and exerts vasodilating effects. NS-304 has major potential as a novel treatment of PAH. Nippon Shinyaku has recently completed phase I evaluation in the United Kingdom. A phase II program in PAH patients was initiated in Europe at the end of 2007.

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