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Onglyza(R) (saxagliptin) Receives Marketing Authorisation in Europe for the Treatment of Type 2 Diabetes

Geschrieben am 05-10-2009

Paris and London (ots/PRNewswire) - Bristol-Myers Squibb
Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) (LSE: AZN) announced
today that the European Commission has granted marketing
authorisation for Onglyza in the 27 countries of the European Union.

Onglyza is indicated as a once-daily 5 mg oral tablet 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 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 marketing authorisation is based on data submitted from a
comprehensive clinical development programme that included six core
Phase III registrational trials and a Phase IIIB study comparing
saxagliptin plus metformin with sitagliptin plus metformin. The
registrational trials assessed the safety and efficacy of Onglyza and
involved 4,148 patients with type 2 diabetes, including 3,021
patients treated with Onglyza.(1-5)

Onglyza is the first medicine to be launched in Europe through
the worldwide collaboration of Bristol-Myers Squibb and AstraZeneca
to enable the companies to research, develop and commercialise select
investigational medicines for the treatment of type 2 diabetes.

Béatrice Cazala, Bristol-Myers Squibb's President Europe, and
President, Global Commercialization, said: "The European Commission
decision marks an important milestone in the alliance between
Bristol-Myers Squibb and AstraZeneca. Our legacy in treating type 2
diabetes and cardiovascular disease, together with our knowledge and
expertise, enables us to deliver to patients a medicine that will
offer further choice for the treatment of this serious condition."

Ulf Sather, AstraZeneca's Regional Vice President for Europe,
said: "Diabetes is a growing epidemic currently affecting some 53
million people in Europe with the number of cases expected to
increase. Today's announcement is good news for those affected by
type 2 diabetes and further demonstrates the commitment of
AstraZeneca and Bristol-Myers Squibb to bring much needed options for
the treatment of type 2 diabetes."

Onglyza 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.

The launch of Onglyza is expected to begin in the fourth quarter
of 2009.

About Type 2 Diabetes

Diabetes (diabetes mellitus) is a chronic disease in which the
body does not produce or properly use insulin (a hormone that is
needed for the cells of the body to properly take up glucose). This
leads to elevated blood glucose levels (hyperglycemia) that are
sustained over time. Sustained hyperglycemia, the hallmark of
diabetes, is associated with long-term complications that can affect
almost every part of the body.

The genesis of diabetes continues to be investigated, and both
genetic and environmental factors such as obesity and lack of
exercise appear to play a role. There are two primary underlying
causes associated with type 2 diabetes: the body does not produce
enough insulin (insulin deficiency), and the cells are resistant to
the effect of 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.(7) 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 53 million people in Europe with type 2
diabetes.(8) The International Diabetes Federation (IDF) recommends a
haemoglobin A1C measurement of less than 6.5 percent for most people
with type 2 diabetes.(9)

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 develop and commercialize select investigational
drugs for type 2 diabetes. These therapies address two key pathways
in managing type 2 diabetes and seek to expand the range of current
and future therapeutic options. Our collaboration is dedicated to
global patient care, improving patient outcomes and creating a new
vision for the treatment of patients living with type 2 diabetes.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company
committed to discovering, developing and delivering innovative
medicines that help patients prevail over serious diseases.

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.

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.

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 2008. Nothing contained herein should be construed as a
profit forecast.

ONGLYZA is a registered trademark of 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
Sep;32(9):1649-55. Epub 2009 May 28

(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. Diabetologia. 2008; 51 (Suppl 1):
S342, Abstract 858 (Poster presented at EASD. September 7-11,2008,
Rome, Italy).

(4). Allen E, et al. Saxagliptin added to a thiazolidinedione
improves glycemic control in patients with inadequately controlled
type 2 diabetes. Diabetologia. 2008; 51 (Suppl 1):S342-S343, Abstract
859 (Poster presented at EASD. September 7-11, 2008, Rome, Italy).

(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). Data on file

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

(8).
http://www.eatlas.idf.org/upload/files/Tables%20Chapter%201.1.xls
(accessed 1601 hours September 15th 2009)

(9). 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

Media:
Bristol-Myers Squibb,
Carmel Hogan,
+33-674-107-658,
Carmel.hogan@bms.com
OR
AstraZeneca,
Neil McCrae,
+44-207-304-5045,
Neil.mccrae@astrazeneca.com
OR
Christopher Sampson
+44-207-304-5130
Christopher.sampson@astrazeneca.com
OR
Jim Minnick
+1-302-886-5135,
Jim.minnick@astrazeneca.com
Investors:
Bristol-Myers Squibb,
John Elicker,
+1-609-252-4611,
John.elicker@bms.com
OR
AstraZeneca,
Karl J. Hard,
+44-20-7304-5322,
Karl.j.hard@astrazeneca.com
OR
Jonathan Hunt
+44-777-570-4032,
Jonathan.hunt@astrazeneca.com
OR
Edward Seage
+1-302-886-4065
Edward.seage@astrazeneca.com
OR
Jorgen Winroth
+1-212-579-0506
Jorgen.winroth@astrazeneca.com

ots Originaltext: Bristol-Myers Squibb Company and AstraZeneca
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Media: Bristol-Myers Squibb, Carmel Hogan, +33-674-107-658,
Carmel.hogan@bms.com OR AstraZeneca, Neil McCrae, +44-207-304-5045,
Neil.mccrae@astrazeneca.com OR Christopher Sampson, +44-207-304-5130,
Christopher.sampson@astrazeneca.com OR Jim Minnick, +1-302-886-5135,
Jim.minnick@astrazeneca.com; Investors: Bristol-Myers Squibb, John
Elicker, +1-609-252-4611, John.elicker@bms.com OR AstraZeneca, Karl
J. Hard, +44-20-7304-5322, Karl.j.hard@astrazeneca.com OR Jonathan
Hunt, +44-777-570-4032, Jonathan.hunt@astrazeneca.com OR Edward
Seage, +1-302-886-4065, Edward.seage@astrazeneca.com OR Jorgen
Winroth, +1-212-579-0506, Jorgen.winroth@astrazeneca.com


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