Marketing Authorisation Application for S-1 Validated by European Medicines Agency

By Taiho Pharmaceutical Company Ltd., PRNE
Wednesday, November 18, 2009

TOKYO, November 19 - 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 www.taiho.co.jp/english/index.html.

(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.

John F. Kouten of JFK Communications for Taiho Pharmaceutical Co., Ltd., +1-609-514-5117

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