TOKYO, November 19 /PRNewswire/ -- Taiho Pharmaceutical Company, Ltd. today announced that the Company's Marketing Authorisation Application (MAA) for S-1, proposed for the treatment of advanced gastric cancer when combined with cisplatin, was validated by the European Medicines Agency (EMEA). S-1 was designated as an orphan medicinal product for the treatment of gastric cancer by the EMEA on 20 December 2007.

Gastric cancer is an area of significant unmet medical need in Europe and around the world, said Peter Harper, M.D., medical oncologist, The London Oncology Clinic. It is exciting to see this progress, especially with an oral drug that has the potential to provide a safer and more convenient treatment alternative for patients and their attending physicians who are dealing with this devastating disease.(1)

In Europe, gastric cancer is the seventh most common cancer and the sixth most common cause of cancer death.(2) The incidence of gastric cancer is higher among men than women, with a male-to-female ratio of 2.3:1.0,(3) and most cases are diagnosed between the ages of 50 and 70 years. Despite the numerous drug combinations that have been studied in clinical trials and commonly used in the treatment of advanced gastric cancer, there still is no chemotherapy regimen considered as a standard of care.

Taiho is committed to making S-1 broadly available to patients afflicted with this terrible disease in the European Union and beyond, and to the ongoing development of S-1 in a broad array of solid malignancies. To accelerate the achievement of this mission Taiho is seeking to collaborate with a leading oncology company that shares its enthusiasm for this novel agent.

About S-1

S-1 is a novel oral anti-cancer drug that combines three pharmacological agents: (1) tegafur, which, after absorption, is converted into the anti-cancer agent 5-FU; (2) gimeracil (CDHP), a dihydropyrimidine dehydrogenase (DPD) inhibitor to prevent degradation of 5-FU; and (3) oteracil (Oxo), an orotate phosphoribosyltransferase (OPRT) inhibitor that reduces the incidence of 5-FU-induced GI toxicity. This combination was designed to provide more efficacious and safer oral delivery of 5-FU by improving upon the performance of the established oral 5-FU prodrug, tegafur. S-1 provides sustained 5-FU plasma concentrations with reduced toxicities due to the addition of the other components to tegafur in S-1.

S-1 was approved in Japan in 1999 and has since become the standard of care for the first line treatment of gastric cancer. S-1 was subsequently approved for six additional indications: for the treatment of head and neck, colorectal, non-small cell lung, inoperable or recurrent breast, pancreatic and biliary tract cancers. To date, S-1 has been approved in 4 countries and used by over 750,000 patients around the world.

About Taiho

Taiho Pharmaceutical Co., Ltd. (Taiho) is a company engaged in discovery, development, manufacturing and marketing of pharmaceutical products, with its headquarters in Tokyo, Japan. Taiho is one of the leading companies focused on oncology. For more information about Taiho, please visit the company's Web site at

(1) Ajani JA, Rodriguez W, Bodoky G, et al.: Multicenter Phase 3 Comparison of Cisplatin/S-1 (CS) with Cisplatin/ 5-FU (CF) as First-Line Therapy in Patients with Advanced Gastric Cancer (FLAGS). ASCO Gastrointestinal Cancers Symposium 2009, Abstr. 8.

(2) Ferlay J, Autier P, Boniol M, Heanue M, Colombet M, Boyle P. Estimates of the cancer incidence and mortality in Europe in 2006. Annals of Oncology; 18: 581-592, 2007.

(3) Blanke CD, Coia LR, Schwarz RE. Chapter 13: Gastric Cancer. Cancer Management: A Multidisciplinary Approach, 10th Edition, 2007.

SOURCE: Taiho Pharmaceutical Company, Ltd.

CONTACT: John F. Kouten of JFK Communications for Taiho PharmaceuticalCo., Ltd., +1-609-514-5117