PRINCETON, N.J. and TOKYO, Dec. 27 /PRNewswire-FirstCall/ --
Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co.,
Ltd. today announced Otsuka has been granted exclusive rights in Japan to
develop and commercialize the investigational compound saxagliptin, being
studied for the treatment of Type 2 diabetes. Saxagliptin, discovered by
Bristol-Myers Squibb, is a dipeptidyl peptidase-4 (DPP-4) inhibitor
currently in Phase III development in the United States and Europe.
Terms of the agreement include an upfront payment by Otsuka to
Bristol-Myers Squibb. Bristol-Myers Squibb will receive milestone payments
based on certain regulatory events, as well as sales-based payments
following regulatory approval of saxagliptin in Japan. Bristol-Myers Squibb
also retains rights to co-promote saxagliptin with Otsuka in Japan. Under
the licensing agreement, Otsuka will be responsible for all development
costs in Japan.
"Bristol-Myers Squibb is focused on the research and development of
therapies for serious diseases, and this agreement is part of our ongoing
effort to provide new options to diabetes patients," said Lamberto
Andreotti, executive vice president and president, Worldwide
Pharmaceuticals, Bristol-Myers Squibb. "Our collaboration with Otsuka on
the antipsychotic agent ABILIFY(R) (aripiprazole) has been very successful,
and we are pleased to expand our relationship to include saxagliptin."
"Otsuka has endeavored to contribute to better health worldwide through
innovative pharmaceutical products that address unmet medical needs. Our
antipsychotic agent ABILIFY has provided us with an opportunity to work
closely with Bristol-Myers Squibb, and we are pleased to enhance this
partnership and take on responsibility for the development and
commercialization of saxagliptin in Japan," said Tatsuo Higuchi, President
and Representative Director, Otsuka Pharmaceutical Co., Ltd. "I hope this
compound will provide a new option to patients suffering from diabetes in
Japan."
About Saxagliptin
Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, a new class
of diabetes medicines that work by increasing and prolonging the action of
natural hormones in the body called incretins. Incretins decrease blood
sugar by increasing consumption of sugar by the body, mainly through
increasing insulin production in the pancreas, and by reducing production
of sugar by the liver. By enhancing the effect of active incretin hormones
in the body, DPP-4 inhibitors improve timely insulin release and ultimately
decrease high blood sugar levels in patients with Type 2 diabetes.
About Diabetes
Diabetes is a disease in which the body does not produce or properly
use insulin. Insulin is a hormone needed to carry glucose (sugar) from the
blood into cells, where it is converted to energy the cells need to perform
properly. When insulin is not present or does not function correctly, the
result is high levels of glucose in the blood. Over time, high blood
glucose levels can lead to complications in the eyes, kidneys, central
nervous system or heart.
Type 2 diabetes is the most common form of diabetes, accounting for
approximately 90-95% of diabetes cases. Having Type 2 diabetes increases
risk of many serious complications, including heart disease or stroke, high
blood pressure, amputation (particularly legs), blindness, nerve damage,
and kidney failure. The risk for stroke and the rate of deaths due to heart
disease are two to four times higher among people with diabetes, while
about 65% of deaths among people with diabetes are due to heart disease and
stroke.
The American Diabetes Association (ADA) estimates that more than 20
million people in the United States, or 7% of the population, have
diabetes, and that one in three Americans born in 2000 will develop
diabetes sometime during their lifetime. In Japan, the Ministry of Health,
Labor and Welfare estimates, based on a survey conducted in 2002, that
approximately 7.4 million people are strongly suspected of having diabetes
mellitus, and that the number is increasing every year. There are currently
more than 230 million people living with diabetes worldwide.
The objective in treating diabetes is to control blood glucose to as
normal a level as possible. This can be accomplished by a combination of
diet, exercise and medication.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical and related healthcare
products company whose mission is to extend and enhance human life.
About Otsuka Pharmaceutical Co., Ltd.
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a healthcare
company with the mission statement: "Otsuka -- people creating new products
for better health worldwide." Otsuka researches, develops, manufactures and
markets innovative, original products, focusing its core businesses on
pharmaceutical products for the treatment of disease and consumer products
for the maintenance of everyday health.
The Otsuka Pharmaceutical Group comprises 87 companies and employs
approximately 27,000 people in 17 countries and regions worldwide. Otsuka
and its consolidated subsidiaries earned US$6.8 billion in annual revenues
in fiscal 2005.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term
is defined in the Private Securities Litigation Reform Act of 1995,
regarding the development and commercialization of an investigational
compound. Such forward-looking statements are based on current expectations
and involve inherent risks and uncertainties, including factors that could
delay, divert or change any of them, and could cause actual outcomes and
results to differ materially from current expectations. No forward-looking
statement can be guaranteed. Among other risks, there can be no guarantee
that the product described in this release will receive regulatory
approval, or that if approved, will be commercially successful. Nor is
there any assurance that any of the milestones based on regulatory events
or sales provided for in the agreement will be achieved. Forward-looking
statements in the press release should be evaluated together with the many
uncertainties that affect Bristol-Myers Squibb's business, particularly
those identified in the cautionary factors discussion in Bristol-Myers
Squibb's Annual Report on Form 10-K for the year ended December 31, 2005,
its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K.
Bristol-Myers Squibb undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information, future
events, or otherwise.
SOURCE Bristol-Myers Squibb
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Related links:
http://www.bms.com
CONTACT:
Jeff Macdonald, Corporate Communications,
+1-212-546-4824, Mobile, +1-917-3710-0940,
jeffrey.macdonald@bms.com, or John Elicker, Investor Relations,
+1-212-546-3775, john.elicker@bms.com, both of Bristol-Myers
Squibb Company; or Hideki Shirai of Otsuka Pharmaceutical Co.,
Ltd., +81-3-3292-0021, siraih@otsuka.jp
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