FORXIGA® (dapagliflozin) Receives Positive CHMP Opinion in the European Union for the Treatment of Type 2 Diabetes

Paris And London (ots/PRNewswire) -

Bristol-Myers Squibb Company [http://www.bms.com ] and
AstraZeneca [http://www.astrazeneca.com/Home ] today announced that
the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has recommended approval of
FORXIGA(R) (dapagliflozin) tablets for the treatment of type 2
diabetes, as an adjunct to diet and exercise, in combination with
other glucose-lowering medicinal products including insulin, and as a
monotherapy in metformin intolerant patients.

Dapagliflozin is an investigational selective and reversible
inhibitor of sodium-glucose co-transporter 2 (SGLT2), which works
independently of insulin. This is the first in the new SGLT2 class to
receive a positive CHMP opinion for the treatment of type 2 diabetes,
a disease where high unmet medical need exists.

The positive opinion was reached after the CHMP reviewed data
from a comprehensive clinical development programme that included 11
core Phase III trials assessing the safety and efficacy of
dapagliflozin as a once-daily oral therapy. These trials involved
5,693 patients with type 2 diabetes, including 3,939 patients treated
with dapagliflozin.

Dapagliflozin 10 mg is intended as a once-daily oral dose in
adult patients with type 2 diabetes to improve glycaemic control:

- As a monotherapy, when diet and exercise alone do not provide adequate
glycaemic control in patients for whom use of metformin is considered inappropriate
due to intolerance;
- In combination with other glucose-lowering medicinal products including
insulin, when these, together with diet and exercise, do not provide adequate
glycaemic control.

"We are pleased the CHMP has given a positive assessment of the
benefit/risk profile of this novel product in a new class for the
treatment of type 2 diabetes, an area of high unmet medical need,"
said Lamberto Andreotti, chief executive officer, Bristol-Myers
Squibb.

The CHMP's positive opinion on dapagliflozin will now be reviewed
by the European Commission, which has the authority to approve
medicines for the European Union.

About SGLT2 inhibition

The kidney plays an important role in glucose balance, normally
filtering ~180g of glucose each day, with virtually all glucose being
reabsorbed back into circulation. SGLT2 is a major sodium-glucose
co-transporter in the kidney and is an insulin-independent pathway
for the re-absorption of glucose back into the blood. Selective
inhibition of SGLT2 facilitates the excretion of glucose and
associated calories in the urine, thereby lowering blood glucose
levels.

About Type 2 Diabetes

At the end of 2011, diabetes was estimated to have affected
nearly 53 million people aged 20-79 in Europe, and this figure is
projected to rise to more than 64 million by 2030. Type 2 diabetes
accounts for approximately 85 to 95% of all cases of diagnosed
diabetes in adults.Type 2 diabetes is a chronic disease characterised
by insulin resistance and/or dysfunction of beta cells in the
pancreas, which decreases insulin sensitivity and secretion, leading
to elevated blood glucose levels. Over time, this sustained
hyperglycaemia contributes to worsening insulin resistance and
further beta cell dysfunction. Significant unmet need exists as many
patients remain uncontrolled on their current glucose-lowering
regimen.

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 select investigational drugs for type 2 diabetes. 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 discover, develop and deliver innovative medicines that
help patients prevail over serious diseases.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical
business with a primary focus on the discovery, development and
commercialisation of prescription medicines for gastrointestinal,
cardiovascular, neuroscience, respiratory and inflammation, oncology
and infectious disease. AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients
worldwide.

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 product development. 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
dapagliflozin will receive European Commission regulatory approval
or, if approved, that it will become a commercially successful
product. Forward-looking statements in this 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, 2011, in our Quarterly
Reports on Form 10-Q and our 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.

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 and Form 20-F Information
2011. Nothing contained herein should be construed as a profit
forecast.

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

Contact:
Contacts: Media: Carmel Hogan, Bristol-Myers Squibb,
+33-6-74-10-76-58, carmel.hogan@bms.com; Phil McNamara, Bristol-Myers
Squibb, +1-609-252-6022, phil.mcnamara@bms.com; Michele Meixell,
AstraZeneca, +1-302-885-6351, michele.meixell@astrazeneca.com;
Investors:
John Elicker, Bristol-Myers Squibb, +1-609-252-4611,
john.elicker@bms.com;
Karl Hard, AstraZeneca, +44-207-604-8123, karl.j.hard@astrazeneca.com