Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment...

Takeda Receives FDA Complete Response Letter for Alogliptin, an
Investigational Treatment for Type 2 Diabetes

DEERFIELD, Ill., June 26, and OSAKA, Japan, June 27, 2009 /PRNewswire/ --
Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda
Global Research & Development Center, Inc., a wholly owned United States
(U.S.) subsidiary received on June 26 (U.S. time) a complete response letter
from the U.S. Food and Drug Administration (FDA) regarding the Company's New
Drug Application (NDA) for alogliptin, a selective dipeptidyl peptidase IV
(DPP-4) inhibitor under investigation for the treatment of type 2 diabetes as
an adjunct to diet and exercise. In recent months, the FDA and Takeda have
been in discussions about conducting an additional cardiovascular study for
alogliptin.

As previously announced on March 6, 2009, the FDA informed Takeda that,
although the alogliptin NDA was filed prior to the release of the December
2008 FDA Guidance titled, "Guidance for Industry: Diabetes Mellitus --
Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2
Diabetes," the FDA did not believe that the amount of existing alogliptin
clinical data was sufficient to meet certain statistical requirements outlined
in that Guidance. The FDA has asked Takeda to conduct an additional
cardiovascular safety trial that satisfies the December 2008 FDA Guidance.

"Takeda will continue to promote key initiatives in order to realize sustained
growth from a medium- to long-term perspective," said Takeda President & CEO,
Yasuchika Hasegawa.

About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its
main focus on pharmaceuticals. As the largest pharmaceutical company in Japan
and one of the global leaders of the industry, Takeda is committed to striving
toward better health for individuals and progress in medicine by developing
superior pharmaceutical products. Additional information about Takeda is
available through its corporate Web site, www.takeda.com.

About Takeda Pharmaceuticals North America, Inc. and Takeda Global Research &
Development Center, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and
Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda
Pharmaceutical Company Limited, the largest pharmaceutical company in Japan.
The respective companies currently market oral diabetes, insomnia,
rheumatology and gastroenterology treatments and seek to bring innovative
products to patients through a pipeline that includes compounds in development
for diabetes, cardiovascular disease, gastroenterology, neurology and other
conditions. To learn more about these Takeda companies, visit www.tpna.com.

SOURCE Takeda Pharmaceutical Company Limited

Seizo Masuda, Takeda Pharmaceutical Company Limited, +81-3-3278-2037; or Julia
Ellwanger, Takeda Global Research & Development, +1-847-582-2461