Teysuno(TM) (S-1) Receives European Marketing Authorization as First-Line Therapy for Advanced Gastric Cancer

By Taiho Pharmaceutical Co. Ltd., PRNE
Sunday, March 13, 2011

Authorization Provides a New Treatment Option for European Gastric Cancer Patients

TOKYO, March 14, 2011 - Taiho Pharmaceutical Co., Ltd., and its parent company, Otsuka Holdings
Co., Ltd., announced today that the European Commission (EC) has granted
marketing authorization for Teysuno(TM) (S-1), a novel oral anti-cancer agent
indicated for the treatment of adults with advanced gastric cancer when given
in combination with cisplatin. The authorization is applicable to the 27
Member States and the three European Economic Area (EEA) countries of the
European Union (EU).

"For European patients living with gastric cancer, the availability of
this new treatment option is a timely addition to the therapeutic landscape,"
said Alfredo Carrato, MD, Professor and Director of the Medical Oncology
Department at Ramon y Cajal University Hospital in Madrid, Spain.

A member of the fluoropyrimidine class of anticancer agents, Teysuno(TM)
is a combination of three pharmacological compounds. The main active
substance in Teysuno, tegafur, is a prodrug of a chemical called
5-fluorouracil (5-FU), meaning that it is converted in the body to 5-FU. In
the body, 5-FU interferes with the enzymes involved in making DNA. As a
result, it can prevent the growth of cancer cells or result in cell death.

The two other active substances in Teysuno(TM) allow tegafur to be
effective at lower doses and with fewer side effects. Specifically, gimeracil
prevents the breakdown of 5-FU and oteracil reduces the activity of 5-FU in
normal, non-cancerous tissue in the gut.

The EC's marketing authorization decision was based in part on the
results of the First-Line Advanced Gastric Cancer Study (FLAGS), the largest
international Phase III trial ever conducted in patients with advanced
gastric cancer.

"We are pleased that the European Commission has recognized the
importance of the FLAGS study findings, which showed that Teysuno-based
combination therapy was as effective as a comparator regimen, with an
acceptable safety profile," commented Fabio M. Benedetti, MD, Chief Medical
Officer of Taiho Pharma U.S.A., Inc.

Teysuno(TM) will be launched in Europe during the second half of 2011.

About Gastric Cancer

With an estimated 934,000 new cases per year (8.6% of all new cancer
cases), gastric cancer is the fourth most common cancer worldwide, following
lung, breast, and colorectal cancers. It is the second most common cause
of cancer-related death, accounting for an estimated 700,000 to 800,000
deaths annually. Nearly 70% of new cases occur in developing countries;
42% of new cases occur in China alone.

In Europe, gastric cancer is the seventh most common cancer and the sixth
most common cause of cancer death, with an estimated annual mortality rate of
118,200. In general, gastric cancer incidence rates are about twice as
high among men as in women. The disease is difficult to cure unless it is
diagnosed in its early stages. Unfortunately, because early gastric cancer
causes few symptoms, the disease is not usually diagnosed until it has
reached an advanced stage. In Europe, the five-year survival rate for gastric
cancer is roughly 20% in men and 25% in women. Similarly, in the United
, the five-year survival rate for gastric cancer is 24%, though
survival rates improve to 61% if the disease is detected early. However, less
than one-quarter of gastric cancers are diagnosed at an early stage in the
United States
. In contrast, the five-year survival rate exceeds 50% in
Japan, where early gastric cancer is diagnosed relatively frequently due to
mass screening efforts, which have been practiced since the 1960s.

About Teysuno

Teysuno(TM) was authorized for the treatment of gastric cancer in Japan
in 1999. Teysuno(TM) is also authorized for patients with gastric cancer in
South Korea, China, Singapore and Taiwan. To date, Teysuno(TM) has been used
by more than 870,000 patients in Japan and Asia.

About Taiho Pharmaceutical Co., Ltd.

Taiho Pharmaceutical Co., Ltd. (Taiho) is a company engaged in discovery,
development, manufacturing and marketing of pharmaceutical products, with
headquarters in Tokyo, Japan. Taiho is one of the leading companies focused
on oncology. More information is available at the company's website at

About Otsuka Holdings Co., Ltd.

The Otsuka Group is a global organization of 145 healthcare companies
with nearly 39,000 employees. Otsuka Holdings Co., Ltd., is the Group's
holding company. The main operating companies are Otsuka Pharmaceutical Co.,
Ltd.; Otsuka Pharmaceutical Factory, Inc.; Taiho Pharmaceutical Co., Ltd.;
Otsuka Warehouse Co., Ltd.; and Otsuka Chemical Co., Ltd. The Group operates
in 23 countries and regions, conducting diversified businesses in four
segments all connected by a focus on health: pharmaceuticals, nutraceuticals,
consumer products, and other product areas. 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. For more information, please visit the company's website at

Megan Faulkner, JFK Communications, Inc., +1-609-514-5117, mfaulkner at jfkhealth.com

will not be displayed