Daiichi Sankyo Launches New Phase 3 Trial with CS-8958 for Flu Prevention

For Immediate Release Company name: DAIICHI SANKYO COMPANY, LIMITED Representative: Takashi Shoda, President and Representative Director (Code no.: 4568, First Section, Tokyo, Osaka and Nagoya Stock Exchanges) Please address inquiries to Toshiaki Sai, General Manager, Corporate Communications Department Telephone: +81-3-6225-1126 http://www.daiichisankyo.com/ Daiichi Sankyo Launches New Phase 3 Trial with CS-8958 for Flu Prevention Tokyo, November 05, 2009 - Daiichi Sankyo Co., Ltd. today announced that it has launched a new Phase 3 trial of its anti-influenza agent, CS-8958. The goal is to gain an influenza prevention indication in Japan. The trial is placebo-controlled, double-blind and will evaluate preventive effect and safety of CS-8958 in families of influenza A and B sufferers. Daiichi Sankyo will measure influenza transmission among those receiving CS-8958 or placebo. We expect to observe that inhaled CS-8958 administered once weekly shows the prophylaxis effect. CS-8958, a novel neuraminidase inhibitor discovered by Daiichi Sankyo for the treatment of influenza is co-owned with Biota Holdings Limited, and is a laninamivir prodrug. This inhaled formulation will be single-administered, acting directly on the trachea and lungs to inhibit influenza. Daiichi Sankyo is pressing ahead with the development program of CS-8958 in Japan. We are preparing to submit an application for manufacturing and marketing approval by March 2010 to the Japanese Ministry of Health, Labour and Welfare for CS-8958 to treat adult and pediatric patients. The trial is named SHIELD (a Study of Household Influenza prophylaxis Effect of Long-acting anti-influenza Drug). End

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