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S-1

Otsuka Holdings Co., Ltd.

Drug Names(s): G-SOX, Teysuno (EU), TS-1 (Japan), TS-ONE (Thailand, Hong Kong)

Description: S-1 is a novel oral anticancer drug, composed of tegafur (FT), gimestat (CDHP) and otastat potassium (Oxo) in a molar ratio of 1:0.4:1, based on the biochemical modulation of 5-fluorouracil (5-FU). CDHP inhibits dihydropyrimidine dehydrogenase (DPD), an enzyme which degrades 5-FU, and maintains prolonged 5-FU concentrations in the blood and tumours. Oxo is distributed in the gastrointestinal tract at a high concentration after oral administration and alleviates gastrointestinal toxicity due to 5-FU.

5-Fluorouracil exerts its cytotoxicity mainly following its conversion,by a two-step route, to 5-fluoro-uridine monophosphate (5-FUMP).5-FUMP is further transformed to 5-FdUMP, an irreversibleinhibitor of thymidylate synthase. This binding inhibits the formation of thymidylate from 2’-deoxyuridylate. Thymidylate is the necessary precursor of thymidine triphosphate, which is essential for the synthesis of DNA, so that a deficiency of this compound can inhibit cell division. Second, nuclear transcriptional enzymes can mistakenly incorporate FUTP in place of uridine triphosphate (UTP) during the synthesis of RNA. This metabolic error can interfere with RNA processing and protein synthesis.

Deal Structure: Taiho, a subsidiary of Otsuka, commercializes and develops S-1 in Japan and few other countries in Asia, sanofi-aventis collaborates on the current clinical development and is leading the future clinicaldevelopment and commercialization of the product in the United States, Europe, and othercountries in the world, except certain Asian countries.

Taiho and Sanofi-aventis
In July 2008, Sanofi-aventis announced that it is returning its territory rights to Taiho Pharmaceutical for the development and commercialization of S-1.

Taiho and Nordic Group
In July 2011, Taiho and Nordic Group entered into an agreement to support the ongoing development and commercialization of Teysuno in the EU and other selected European countries.

Under the agreement Nordic acquired an exclusive right to commercialize Teysuno in their territory and will become the Marketing Authorization Holder. Taiho holds an option right to participate in the commercialization of Teysuno.

Partners: Nordic Group BV


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