Amylin Pharmaceuticals and Takeda Enter into Worldwide Agreement to Co-Develop and Commercialize Compounds for Obesity

Sun Nov 1, 2009 6:30pm EST
 
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Amylin Pharmaceuticals and Takeda Enter into Worldwide Agreement to Co-Develop
and Commercialize Compounds for Obesity





SAN DIEGO and OSAKA, Japan, Nov. 1, 2009 /PRNewswire-FirstCall/ -- Amylin
Pharmaceuticals, Inc. (Nasdaq: AMLN) and Takeda Pharmaceutical Company Limited
(TSE: 4502) announced today that they have entered into a worldwide exclusive
license, development and commercialization agreement to co-develop and
commercialize pharmaceutical products for the treatment of obesity and related
indications.  

The agreement includes products to be developed from Amylin's pipeline,
including pramlintide/metreleptin and davalintide, which are compounds
currently in phase 2 development for treatment of obesity. The agreement also
includes additional compounds from both companies' obesity research programs.
Amylin will receive a one-time up-front payment of $75 million from Takeda
and, over the term of the agreement and in relation to the compounds under the
agreement, is eligible to receive additional payments upon achieving certain
development, commercialization and sales-based milestones that could exceed $1
billion. The agreement also provides for future tiered, double-digit royalty
payments to Amylin based on global product sales.

Under the terms of the agreement, Amylin will be responsible for executing
development activities for potential products through phase 2 with the aim of
regulatory approval in the U.S. Takeda will lead development activities beyond
phase 2 in the U.S., and all development activities outside the U.S. In most
instances, Amylin will be responsible for 20% of development costs associated
with obtaining approval for products in the U.S. and Takeda will be
responsible for 80% of such U.S. development costs. Takeda will be responsible
for 100% of development costs associated with obtaining approval for products
outside the U.S.

Takeda will lead product commercialization, both in the U.S. and outside the
U.S., and will be responsible for 100% of commercialization costs. Amylin will
have the option to co-commercialize the first two approved products in the
U.S. and any follow-on products containing the identical active ingredients.  

"Takeda is excited to realize this partnership with Amylin focused on the
treatment of obesity and related indications. By leveraging Takeda's global
development and commercial infrastructure we look forward to maximizing the
significant potential of the products under this agreement," said Yasuchika
Hasegawa, president & chief executive officer, Takeda Pharmaceutical Company
Limited.  "Both Amylin and Takeda have extensive experience in the diabetes
and metabolic disease area, and this collaboration should allow us to more
quickly bring promising new treatments to patients in need." 

"This collaboration will leverage Amylin's experience and expertise with
peptide and protein science and Takeda's worldwide development and commercial
expertise," said Daniel M. Bradbury, president and chief executive officer,
Amylin Pharmaceuticals. "Amylin recognizes the enormous potential of this
collaboration to advance more options in obesity treatment more quickly than
either company could do alone. Amylin and Takeda are excited about working
together to address the significant unmet need for the millions of patients
who need better solutions to manage obesity."

About Obesity
Obesity is rapidly becoming a major health problem in all industrialized
nations and many developing countries. It has reached epidemic proportions
globally, with more than 1 billion adults overweight, and at least 300 million
of them obese. Obesity is a chronic disorder that is linked to increased
health risk of several medical conditions including type 2 diabetes,
non-alcoholic fatty liver disease, high blood pressure, heart disease, stroke,
osteoarthritis, sleep disorders and several types of cancers. According to The
Obesity Society, obesity is the second leading cause of preventable death in
the United States. The total direct and indirect cost burden attributed to
treating overweight and obesity and related conditions has grown to nearly
$150 billion in the United States each year.

About Amylin Pharmaceuticals
Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving
lives of patients through the discovery, development and commercialization of
innovative medicines. Amylin has developed and gained approval for two
first-in-class medicines for diabetes, SYMLIN® (pramlintide acetate) injection
and BYETTA® (exenatide) injection. Amylin's research and development
activities leverage the Company's expertise in metabolism to develop potential
therapies to treat diabetes and obesity. Amylin is headquartered in San Diego,
California. Further information on Amylin Pharmaceuticals is available at
www.amylin.com.

About Takeda
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 website, www.takeda.com.

Forward-Looking Statements 
This press release contains forward-looking statements about Takeda and
Amylin, which involve risks and uncertainties. The actual results for each
Company could differ materially from those discussed due to a number of risks
and uncertainties, including that the obesity co-development and
commercialization agreement mentioned in this press release will not achieve
the results we expect; our clinical trials may not start when planned, be
completed in a timely manner and/or confirm previous results; our preclinical
studies may not be predictive; our product candidates, including those covered
by the co-development and commercialization agreement mentioned in this press
release, may not receive regulatory approval; and inherent scientific,
regulatory and other risks in the drug development and commercialization
process. 

With respect to Amylin, these and additional risks and uncertainties are
described more fully in Amylin's most recently filed SEC documents, including
its Form 10-Q. Amylin undertakes no duty to update these forward-looking
statements.



SOURCE  Amylin Pharmaceuticals, Inc.; Takeda Pharmaceutical Company Limited

Anne Erickson, Amylin, +1-858-754-4443, cell, +1-858-349-3195,
Anne.Erickson@amylin.com; or Seizo Masuda, Takeda (Japan), +81-3-3278-2037,
Masuda_Seizo@takeda.co.jp, or Angela Bechan, Takeda (USA), +1-224-554-5467,
ABechan@tpna.com

 

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