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Phase 2b Study Initiated of Diabetes Drug CS-917

Tokyo and San Diego, CA – (January 5, 2005) – Sankyo Co., Ltd. and Metabasis Therapeutics, Inc. today announced the recent initiation of a Phase IIb clinical trial of CS-917 in patients with type 2 diabetes. Sankyo licensed CS-917 from Metabasis and is responsible for the global development of the compound.

The randomized, placebo controlled, double blind Phase IIb study is designed to evaluate the effectiveness of CS-917 in lowering blood glucose levels in patients with type 2 diabetes. Efficacy of CS-917 will be evaluated by measuring levels of hemogloblin A1c (HbA1c), an accurate long-term index of a patient’s average blood glucose control. Results of the Phase IIb study will be used to select the appropriate dosage of CS-917 for use in Phase III clinical trials.

“With the number of diabetes cases rising worldwide, it has never been more important to find new ways to help patients control their blood glucose levels,” said Tomas Bocanegra, M.D., Vice President of Clinical Development at Sankyo’s U.S. subsidiary, Sankyo Pharma Inc. “We hope to provide a new, important treatment option for the millions of patients affected by type 2 diabetes.”

CS-917, the first in a new class of investigational drugs called fructose 1-6 bisphosphatase inhibitors (FBPase), appears to inhibit a metabolic pathway in the liver called gluconeogenesis, which is responsible for the excessive production of glucose by patients with type 2 diabetes. Previous Phase IIa studies have demonstrated promising results in lowering blood glucose levels.

“We are very pleased with the progress we are making with CS-917,” said Dr. Paul Laikind, Chairman, CEO and President of Metabasis. “Two previously completed studies provided important proof of concept for the program and the study now underway, if successful, will allow us to move the compound into Phase III trials.”

According to the American Diabetes Association (ADA), approximately 18.2 million people have diabetes, with 90 to 95 percent affected by type 2 diabetes, a disorder in which the cells do not use insulin properly. The number of new cases of diabetes also is rising rapidly. The World Health Organization (WHO) estimates that at least 171 million people worldwide have diabetes, and that this figure is likely to double by 2030 to reach 366 million.

Source: Sankyo Co., Ltd. and Metabasis Therapeutics, Inc.

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