Healthcare Industry News:  Taiho Pharmaceutical Co 

Biopharmaceuticals Oncology Regulatory

 News Release - March 24, 2014

Taiho's Lonsurf(R) (trifluridine and tipiracil hydrochloride) Tablets Approved In Japan for Treatment of Advanced Metastatic Colorectal Cancer

TOKYO, March 24, 2014 -- (Healthcare Sales & Marketing Network) -- Taiho Pharmaceutical Co., Ltd. (Tokyo, President: Masayuki Kobayashi) announced on March 24 that it has obtained approval in Japan from the Ministry of Health, Labour and Welfare to manufacture and market the oral combination anticancer drug "Lonsurf(R) combination tablet T15, T20" (nonproprietary names: trifluridine and tipiracil hydrochloride; development code: TAS-102), for the treatment of patients with unresectable advanced or recurrent colorectal cancer (only if refractory to standard therapies).

Japan is the first country in the world to grant marketing authorization for Lonsurf. The approval is based primarily on the results of a randomized, double blind placebo controlled Phase II clinical trial conducted in Japan (J003-10040030). Taiho is conducting a global Phase III clinical trial (RECOURSE) on patients with metastatic colorectal cancer refractory to standard chemotherapies.

Lonsurf is a combination drug of trifluridine (FTD) and tipiracil hydrochloride (TPI). FTD is an antineoplastic nucleoside analog, which is incorporated directly into DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD-degrading enzyme thymidine phosphorylase.

Taiho is proud to make Lonsurf available to physicians in Japan as a new treatment option for patients with metastatic colorectal cancer refractory to standard therapies.

About Taiho Pharmaceutical Co., Ltd.

Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is an R&D-driven speciality pharma focusing on the three fields of oncology, allergies and immunology, and urology. Its corporate philosophy takes the form of a pledge: "We strive to improve human health and contribute to a society enriched by smiles." In the field of oncology in particular, Taiho is known as a leading company in Japan and around the world for developing innovative medicines for the treatment of cancer. In areas other than oncology, as well, the company creates quality products that effectively treat medical conditions and can help improve people's quality of life. Always putting customers first, Taiho also aims to offer over-the-counter medicinal products that support people's efforts to lead fulfilling and rewarding lives.

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About Otsuka Holdings Co., Ltd.

The Otsuka Group is a global organization of 158 healthcare companies with nearly 42,000 employees. Otsuka Holdings Co., Ltd. is the Group's holding company. The Group operates in 26 countries and regions, conducting diversified businesses in four segments all connected by a focus on health: pharmaceuticals, nutraceuticals, consumer products, and others.

The Group's corporate philosophy of "Otsuka-people creating new products for better health worldwide," is supported by the corporate ethic of "JISSHO (Proof through Execution) and SOZOSEI (Creativity)." The Otsuka Group thus seeks to foster a culture and vitality appropriate to an enterprise involved with human health and to create innovative products that contribute to the health and wellness of people worldwide.

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Source: Taiho Pharmaceutical

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