News Releases

July 18, 2008
Taiho Pharmaceutical Co., Ltd.

Results of a randomized comparative phase 3 study of
S-1 in advanced/recurrent gastric cancer become available

Taiho Pharmaceuticals Co. Ltd (Taiho) announced today the results of the phase III study conducted by Taiho Pharma USA Inc., which evaluated the efficacy and safety of S-1 in a multicenter trial, which enrolled over a thousand patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients were randomly allocated to receive either the oral S-1 anticancer agent or 5-FU, in combination with cisplatin. The study did not meet its primary end point of superior overall survival, although the survival curve of S-1/cisplatin group was above that of 5FU/cisplatin group and clinical safety profile was generally in favor of the S-1/cisplatin group.
Taiho will pursue further developments of S-1 outside of Japan by more in-depth analysis of the data.

About S-1

S-1 is an oral fluorouracil anticancer product that combines 3 pharmacological agents in a certain ratio: tegafur which is a pro-drug of 5 fluoro-uracil; gimeracil (5-chloro-2,4 dihydropyridine (CDHP)) which inhibits dihydropyrimidine dehydrogenase (DPD) enzyme activity; and oteracil (potassium oxonate (Oxo)) a gastrointestinal side effects corrector.
S-1 has been commercialized in Japan by Taiho Pharmaceuticals since 1999 for the treatment of gastric, colorectal, head and neck, non-small cell lung, metastatic breast, pancreas and biliary tract cancers.

Information in this news release was current as of the original release date.

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