Bristol-Myers Squibb and AstraZeneca Submit New Drug Application in the United States...

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Wed Jul 23, 2008 8:00am EDT

Bristol-Myers Squibb and AstraZeneca Submit New Drug Application in the United States and Marketing Authorization Application in Europe for ONGLYZA(TM) (saxagliptin) for the Treatment of Type 2 Diabetes

PRINCETON, N.J. & LONDON--(Business Wire)--
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE:
AZN) today announced the submission of a New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA) on June 30th and
validation of a Marketing Authorization Application (MAA) to the
European Medicines Agency (EMEA) for ONGLYZA(TM) (saxagliptin).
Saxagliptin, a dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor, is an
investigational drug under joint development by Bristol-Myers Squibb
and AstraZeneca for the treatment of type 2 diabetes. The companies
have proposed the name ONGLYZA which, if approved by the FDA and the
EMEA, will serve as the trade name for saxagliptin.

   The NDA and MAA submissions for saxagliptin are based on data from
a comprehensive clinical trial program conducted in addition to
standard therapies, as well as in treatment naive patients as a
monotherapy. The clinical trial program included studies that
evaluated the drug at up to 80 times therapeutic clinical doses. The
six core Phase III trials assessing the safety and efficacy of
saxagliptin involved more than 4,000 patients, including 3,000 who
were treated with saxagliptin.

   About ONGLYZA

   ONGLYZA, a DPP-4 inhibitor, is an investigational drug under joint
development by Bristol-Myers Squibb and AstraZeneca for the treatment
of type 2 diabetes. Saxagliptin is being studied in clinical trials as
a once-daily therapy to determine its efficacy and safety. Saxagliptin
was specifically designed to be a selective, reversible inhibitor of
the DPP-4 enzyme, with dual routes of clearance. Phase III data for
saxagliptin have previously been presented in combination with
metformin, the most commonly prescribed oral anti-diabetic, as well as
when used as monotherapy in treatment-naive individuals. Additional
Phase III data for saxagliptin, including when added to a
sulfonylurea, a thiazolidinedione and as initial combination therapy
with metformin, are planned for disclosure later this year.

   About DPP-4 Inhibitors

   DPP-4 inhibitors are a class of compounds that work by affecting
the action of natural hormones in the body called incretins. Incretins
decrease elevated blood sugar levels (glucose) by increasing the
body's utilization of sugar, mainly through increasing insulin
production in the pancreas, and by reducing the liver's production of
glucose.

   About Type 2 Diabetes

   Diabetes (diabetes mellitus) is a chronic disease in which the
body does not produce or properly use insulin. Insulin is a hormone
that is needed to convert sugar, starches (carbohydrates) and other
nutrients into energy needed for daily life. The cause of diabetes
continues to be investigated, and both genetic and environmental
factors such as obesity and lack of exercise appear to play a role.
Diabetes is associated with long-term complications that affect almost
every part of the body. The disease may lead to blindness, heart and
blood vessel disease, stroke, kidney failure, amputations, and nerve
damage.

   Bristol-Myers Squibb and AstraZeneca Collaboration

   Bristol-Myers Squibb and AstraZeneca entered into a collaboration
in January 2007 to enable the companies to research, develop and
commercialize two investigational drugs for type 2 diabetes -
saxagliptin and dapagliflozin. The Bristol-Myers Squibb/AstraZeneca
Diabetes collaboration is dedicated to global patient care, improving
patient outcomes and creating a new vision for the treatment of type 2
diabetes.

   About Bristol-Myers Squibb

   Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to extend and enhance human life. For more information,
visit www.bms.com.

   About AstraZeneca

   AstraZeneca is a major international healthcare business engaged
in research, development, manufacturing and marketing of prescription
pharmaceuticals and supplier for healthcare services. AstraZeneca is
one of the world's leading pharmaceutical companies with healthcare
sales of US $29.55 billion and is a leader in gastrointestinal,
cardiovascular, neuroscience, respiratory, oncology and infection
product sales. AstraZeneca is listed in the Dow Jones Sustainability
Index (Global) as well as the FTSE4Good Index. For more information
visit www.astrazeneca.com

   ONGLYZA(TM) (saxagliptin) is a trademark of the Bristol-Myers
Squibb Company

Media:
Bristol-Myers Squibb
David M. Rosen, 609-252-5675
david.rosen@bms.com
or
AstraZeneca
Jim Minnick, 302-866-5135
jim.minnick@astrazeneca.com
or
Investors:
Bristol-Myers Squibb
John Elicker, 212-546-3775
john.elicker@bms.com
or
AstraZeneca
Mina Blair, 44-20-7304-5084
mina.blair@astrazeneca.com

Copyright Business Wire 2008
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