Paris and London (ots/PRNewswire) - Bristol-Myers Squibb
Company (NYSE: BMY) and AstraZeneca (LSE: AZN) today announced that
their marketing authorisation application for ONGLYZA(TM)
(saxagliptin) received a positive opinion from the Committee for
Medicinal Products for Human Use (CHMP) for the treatment of type 2
diabetes in adults as add-on therapy with metformin, a
thiazolidinedione or a sulphonylurea.

The positive opinion was reached after the CHMP reviewed data
from a comprehensive clinical development programme that included six
core Phase III trials assessing the safety and efficacy of
saxagliptin as a once-daily therapy. These involved 4,148 patients
with type 2 diabetes, including 3,021 patients treated with
saxagliptin.(1-5)

Saxagliptin belongs to the class of dipeptidyl peptidase-4
(DPP-4) inhibitors. These are designed to enhance the body's ability
to decrease blood sugar (glucose) when it is elevated by acting on
the natural hormones, incretins, thereby increasing insulin
production, and by reducing the liver's production of glucose.

This application to the CHMP is for use as a once-daily 5mg dose
in adult patients with type 2 diabetes mellitus to improve glycaemic
control:

- in combination with metformin, when metformin alone, with diet and
exercise, does not provide adequate glycaemic control;
- in combination with a sulphonylurea, when the sulphonylurea alone, with
diet and exercise, does not provide adequate glycaemic control in
patients for whom use of metformin is considered inappropriate; or
- in combination with a thiazolidinedione, when the thiazolidinedione
alone, with diet and exercise, does not provide adequate glycaemic
control in patients for whom use of a thiazolidinedione is considered
appropriate.(1-5)

The CHMP's positive opinion on ONGLYZA will now be reviewed by
the European Commission which has the authority to approve medicines
for the European Union. Bristol-Myers Squibb and AstraZeneca expect
the European Commission to issue its decision on a Marketing
Authorisation for this type 2 diabetes investigational drug in the
European Union in the coming months.

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 utilisation of sugar, mainly through increasing
insulin production in the pancreas and decreasing glucagon secretion.

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.

There are two primary underlying causes associated with type 2
diabetes: the body does not produce enough insulin (insulin
deficiency), or the cells ignore the insulin (insulin resistance).
Symptoms of type 2 diabetes develop gradually, and their onset is not
as sudden as in type 1 diabetes. Symptoms may include fatigue,
frequent urination, increased thirst and hunger, weight loss, blurred
vision, and slow healing of wounds or sores. Some people, however,
have no symptoms.

Type 2 diabetes is most often associated with older age, obesity,
family history of diabetes, previous history of gestational diabetes,
physical inactivity and certain ethnicities. People with type 2
diabetes often are characterised with: insulin resistance, abdominal
obesity, a sedentary lifestyle, having low HDL-C ("good") cholesterol
levels and high triglyceride levels and hypertension. According to
the International Diabetes Federation (IDF), type 2 diabetes accounts
for approximately 85 to 95 percent of all diabetes. The IDF says that
across the world there are 246 million people with both types of
diabetes. Taking a 90 percent figure for type 2 this equates to
roughly 221 million people with type 2 diabetes globally. It is
estimated there are more than 47 million people in Europe with type 2
diabetes.(6)

The International Diabetes Federation (IDF) recommends a
haemoglobin A1C measurement of less than 6.5 percent for most people
with type 2 diabetes.(7)

Haemoglobin A1C is a measurement of a person's average blood
glucose level over a two-to-three month period and is considered an
important marker of long-term glucose control. Other important
markers for type 2 diabetes include fasting plasma glucose, a measure
of a person's blood glucose after at least eight hours of fasting,
and postprandial glucose, a measure of a person's blood glucose after
a meal.

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
commercialise 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.

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 research, development and commercialization of
pharmaceutical products. 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 a Market
Authorisation will be granted by the European Commission or, if
granted, that it will be granted in the time period indicated in this
release. 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, 2008, 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.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged
in the research, development, manufacturing and marketing of
meaningful prescription medicines and supplier for healthcare
services. AstraZeneca is one of the world's leading pharmaceutical
companies with healthcare sales of US$ 31.6 billion and is a leader
in gastrointestinal, cardiovascular, neuroscience, respiratory,
oncology and infectious disease medicines. For more information about
AstraZeneca, please visit: http://www.astrazeneca.com.

AstraZeneca Forward-Looking Statement

The statements contained herein include forward-looking
statements. Although we believe our expectations are based on
reasonable assumptions, any forward-looking statements, by their very
nature, involve risks and uncertainties and may be influenced by
factors that could cause actual outcomes and results to be materially
different from those predicted.

The forward-looking statements reflect knowledge and information
available at the date of the preparation of this press release and
the Company undertakes no obligation to update these forward-looking
statements.

Important factors that could cause actual results to differ
materially from those contained in forward-looking statements,
certain of which are beyond our control, include, among other things,
those risk factors identified in the Company's Annual Report/Form
20-F for 2007. Nothing contained herein should be construed as a
profit forecast.

ONGLYZA is a trademark of the Bristol-Myers Squibb Company.

References

1. Rosenstock J, et al. Glucose-lowering activity of the
dipeptidyl peptidase-4 inhibitor saxagliptin in drug-naïve patients
with type 2 diabetes. Diabetes, Obesity and Metabolism 2008; 10:
376-386

2. De Fronzo, et al. The efficacy and safety of saxagliptin when
added to metformin therapy in patients with inadequately controlled
type 2 diabetes on metformin alone. Diabetes Care 2009: published
ahead of print May 28, 2009, doi:10.2337/dc08-1984

3. Ravichandran S, et al. Saxagliptin Added to a Sulfonylurea is
Safe and More Efficacious Than Up-titrating a Sulfonylurea in
Patients with Type 2 Diabetes. Abstract presented at EASD, 2008

4. Allen E, et al. Saxagliptin Added To A Thiazolidinedione
Improves Glycemic Control In Patients With Inadequately Controlled
Type 2 Diabetes. Abstract presented at EASD, 2008

5. Jadzinsky M, et al. Saxagliptin given in combination with
metformin as initial therapy improves glycaemic control in patients
with type 2 diabetes compared with either monotherapy: a randomized
controlled trial. Diabetes, Obesity and Metabolism 2009; 11: 611-622

6. International Diabetes Federation factsheet "diabetes
prevalence" accessed 19 May, 2009
http://www.idf.org/diabetes-prevalence

7. IDF Global Guideline for type 2 diabetes 2005: Chapter 6:
glucose control levels accessed 19 May, 2009
http://www.idf.org/webdata/docs/IDF%20GGT2D.pdf

ots Originaltext: Bristol-Myers Squibb Company and AstraZeneca
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