Teysuno(TM) (S-1) Receives CHMP Positive Opinion for Approval as First-Line Therapy for Advanced Gastric Cancer

By Taiho Pharmaceutical Co. Ltd., PRNE
Thursday, December 16, 2010

Recommendation Marks Taiho's First Regulatory Milestone Outside of Japan and Asia

TOKYO, December 17, 2010 - Taiho Pharmaceutical Co., Ltd., and its parent company, Otsuka Holdings
Co., Ltd., announced today that the Committee for Medicinal Products for
Human Use (CHMP), a division of the European Medicines Agency (EMA), has
issued an opinion recommending approval of Teysuno(TM) (S-1), a novel oral
anti-cancer agent, intended for the treatment of advanced gastric cancer in
adults when given in combination with cisplatin. The Committee will now
recommend that the European Commission (EC) grant marketing authorization for
Teysuno, a decision that is normally issued within 67 days from adoption of a
CHMP opinion.

"We are pleased with the CHMP's positive opinion on Teysuno. It is an
important step toward a new treatment option for European adults living with
gastric cancer," said Toru Usami, President, Taiho Pharmaceutical Co., Ltd.
"The CHMP recommendation also represents the first regulatory milestone for
Taiho outside of Japan and Asia. Teysuno is the first of what we hope will be
many promising anti-cancer agents to be developed globally and made
commercially available by Taiho."

A member of the fluoropyrimidine class of chemotherapeutic agents,
Teysuno is a combination of three pharmacological compounds: tegafur, an
antimetabolite agent that, after absorption, is converted into the
anti-cancer agent fluorouracil (5-FU); gimeracil (5-chloro-2,
4-dihydroxypyridine, or CDHP), which decreases the degradation of 5-FU by the
body; and oteracil (Oxo), which decreases 5-FU activation in the
gastrointestinal tract. The Committee's recommendation 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.

"In the FLAGS study, a Teysuno containing regimen was as effective as the
comparator with a favorable safety profile," commented Fabio M. Benedetti,
M.D., Chief Medical Officer of Taiho Pharma U.S.A., Inc. "Availability of
Teysuno in Europe will provide physicians with another option in the
management of this very difficult to treat disease."

The CHMP, on the basis of quality, safety and efficacy data submitted,
considers there to be a favourable benefit-to-risk balance for Teysuno and
therefore recommends granting marketing authorization for the product. The
CHMP recommendation requires formal approval by the EC for marketing of
Teysuno in all European Union (EU) Member States, which is expected in early

Taiho is currently in discussions with potential marketing partners for
Teysuno to ensure its timely and effective introduction to the European
oncology community.

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.(1) It is the second most common cause
of cancer-related death, accounting for an estimated 700,000 to 800,000
deaths annually.(1,2) Nearly 70% of new cases occur in developing countries;
42% of new cases occur in China alone.(1,2)

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.(3) 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
.(2) 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.(1,2)

About Teysuno

Teysuno was designated an orphan medicinal product by the EMA in 2007 in
recognition of its development specifically to treat the rare condition of
gastric cancer. Since its initial approval in Japan in 1999, Teysuno has
become a standard of care there for the treatment of gastric cancer. Teysuno
is also approved for patients with gastric cancer in South Korea, China,
Singapore and Taiwan. Teysuno was subsequently approved in Japan for six
additional indications: for the treatment of colorectal, head and neck,
non-small cell lung, metastatic breast, pancreatic and biliary tract cancers.
To date, Teysuno has been used by more than 870,000 patients in Japan and

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

(1) Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics,
2002. CA Cancer J Clin 2005;55:74-108.

(2) Garcia M, Jemal A, Ward EM, et al. Global Cancer Facts & Figures
2007. Atlanta, GA: American Cancer Society, 2007.

(3) Ferlay J, Autier P, Boniol M, Heanue M, Colombet M, Boyle P.
Estimates of the cancer incidence and mortality in Europe in 2006. Ann Oncol

Media, Megan Faulkner of JFK Communications, Inc., +1-609-514-5117, Megan.Faulkner at JFKHealth.com

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