Forxiga™ (dapagliflozin), First-In-Class SGLT2 That Works Independently of Insulin, Now Approved in European Union for

  Forxiga™ (dapagliflozin), First-In-Class SGLT2 That Works Independently of
  Insulin, Now Approved in European Union for Treatment of Type 2 Diabetes

  *Forxiga, a once-daily oral agent, provides physicians with a new option to
    improve glycaemic control as monotherapy in metformin-intolerant patients
    or combination therapy
  *Reduction of weight and blood pressure are additional benefits seen with
    Forxiga in clinical studies
  *Forxiga’s novel mode of action works independently of insulin to remove
    excess glucose from the body
  *EU approval is supported by an extensive clinical development programme
    across multiple treatment settings

Business Wire

PARIS & LONDON -- November 14, 2012

Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today
announced that the European Commission has approved Forxiga™ ^ 
(dapagliflozin) tablets for the treatment of type 2 diabetes in the European
Union (EU). Forxiga is a selective and reversible inhibitor of sodium-glucose
cotransporter 2 (SGLT2) that works independently of insulin to help remove
excess glucose from the body, a unique mode of action not seen in any other
currently available treatments for type 2 diabetes. This is the first medicine
in the new SGLT2 class to gain regulatory approval for the treatment of type 2
diabetes, a disease in which high unmet medical need exists.

Forxiga tablets are indicated as a once-daily oral medication to improve
glycaemic control in adult patients with type 2 diabetes. Forxiga is intended
to be used as an adjunct to diet and exercise in combination with other
glucose-lowering medicinal products, including insulin, or as a monotherapy in
metformin-intolerant patients.

“Many Europeans with type 2 diabetes are not reaching treatment goals,
increasing their risk of developing complications, so there is a critical need
for new treatments. Forxiga provides physicians with a completely new option
to help improve glycaemic control that complements commonly used
glucose-lowering treatments like metformin and insulin with additional
benefits of weight loss and blood pressure lowering,” said John Wilding, DM,
FRCP, Professor of Medicine and Honorary Consultant Physician, Head of
Diabetes and Endocrinology Clinical Research Unit, University Hospital Aintree
(UK). “The approval of Forxiga represents a significant advance in the
treatment of type 2 diabetes.”

Forxiga™ ^  (dapagliflozin)  works in the kidney to selectively inhibit SGLT2,
resulting in the removal of excess glucose and its associated calories in the
urine. Through the removal of excess glucose, Forxiga helps to reduce blood
sugar levels. In clinical studies, Forxiga also showed reductions in weight
and blood pressure. Bristol-Myers Squibb and AstraZeneca are currently seeking
regulatory approval for Forxiga in several other countries.

“Diabetes is a progressive disease that requires a combination of treatment
approaches over time,” said Lamberto Andreotti, chief executive officer,
Bristol-Myers Squibb. “Forxiga is the first of a new class of type 2 diabetes
medication that works independently of insulin and represents a new treatment
option for patients and physicians across Europe.”

“We are excited about the approval of Forxiga in Europe, and the significant
advancement it represents for the many millions of European patients with type
2 diabetes who need new options to manage this progressive disease,” said
Pascal Soriot, chief executive officer, AstraZeneca. “Forxiga is an important
addition to the growing range of Bristol-Myers Squibb and AstraZeneca diabetes
treatments and further demonstrates our commitment to addressing the unmet
needs of adults with type 2 diabetes.”

Clinical Trial Programme

The approval of Forxiga in the EU is based on the results of a broad clinical
development programme that included 11 double-blind, randomised,
placebo-controlled Phase III clinical trials assessing the safety and efficacy
of Forxiga as a once-daily oral therapy. These 11 trials involved 5,693
patients worldwide with type 2 diabetes, including 3,939 patients treated
withForxiga. A higher proportion of patients with type 2 diabetes treated with
Forxiga compared to placebo achieved the goal of HbA1c < 7%. The extensive
clinical development programme also demonstrated that Forxiga had a positive
benefit-risk profile, with a low risk of hypoglycaemia, across a wide range of
patient populations. Researchers also found additional benefits, such as
reductions in body weight and systolic blood pressure in double-blind,
randomised, placebo-controlled clinical trials.

The overall incidence of adverse events in patients treated with Forxiga 10 mg
was similar to placebo. Few adverse events led to discontinuation of treatment
and incidences were balanced across study groups. The most commonly reported
events leading to discontinuation in patients treated with Forxiga 10 mg were
increased blood creatinine (0.4%), urinary tract infections (0.3%), nausea
(0.2%), dizziness (0.2%) and rash (0.2%). Vulvovaginitis and balanitis were
more common with Forxiga™ ^  (dapagliflozin). Most episodes of vulvovaginitis
and balanitis were mild to moderate, responded to standard treatment, and
rarely resulted in discontinuation from Forxiga treatment. The most frequently
reported adverse reaction was hypoglycaemia, which was affected by the type of
background therapy used in each study. Thus, Forxiga treatment led to higher
rates of hypoglycaemia compared to placebo primarily when used in addition to
background insulin or sulphonylurea therapies. However, Forxiga used as
monotherapy or in combination with metformin did not demonstrate a tendency to
cause hypoglycaemia, and the frequency of hypoglycaemia events with Forxiga in
these settings was similar to placebo.

About Forxiga

Forxiga was discovered by Bristol-Myers Squibb and is the latest product to be
approved under the collaboration between Bristol-Myers Squibb and AstraZeneca,
to research, develop and commercialise select investigational drugs for type 2
diabetes.

Forxiga tablets are approved as a once-daily oral medication 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; or
  *In combination with other glucose-lowering medicinal products including
    insulin, when these, together with diet and exercise, do not provide
    adequate glycaemic control.

Forxiga is not indicated as a weight loss product or for the management of
obesity or high blood pressure, and has only been studied for the treatment of
type 2 diabetes.

About Type 2 Diabetes

At the end of 2011, diabetes was estimated to affect 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 at least 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 research, develop and commercialise select investigational drugs for
type 2 diabetes. The Bristol-Myers Squibb/AstraZeneca diabetes collaboration
is dedicated to global patient care and improving patient outcomes in the
treatment of type 2 diabetes. The portfolio of type 2 diabetes products
developed as a part of the Bristol-Myers Squibb and AstraZeneca collaboration
includes the first-in-class SGLT2 inhibitor Forxiga^™ (dapagliflozin), the
DPP4 inhibitor Onglyza^® (saxagliptin), Komboglyze^™ (saxagliptin and
metformin HCl immediate-release fixed dose combination) and Kombiglyze  XR^™
(saxagliptin and metformin HCl extended-release fixed dose combination), which
is only available outside the European Union.

In August 2012, Bristol-Myers Squibb completed the acquisition of Amylin
Pharmaceuticals. Bristol-Myers Squibb and AstraZeneca then expanded their
existing alliance in diabetes to incorporate Amylin’s portfolio of diabetes
products, which includes GLP1s Byetta^® (exenatide injection) and Bydureon^™ 
(exenatide extended-release for injectable suspension), both the first to be
approved in their class and now available in the U.S. and Europe, as well as
the first-in-class Amylin mimetic Symlin^® (pramlintide acetate injection),
which is only available in the U.S. Eli Lilly and Amylin amicably terminated
their joint collaboration in November 2011 for exenatide and began to
transition global responsibility for the exenatide franchise to Amylin,
starting in the U.S. and targeting the transition for all markets by the end
of 2013. Bristol-Myers Squibb and AstraZeneca are now working to transition
markets outside the U.S. in which Lilly markets and sells exenatide into the
expanded Bristol-Myers Squibb and AstraZeneca alliance.

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 Forxiga will become a commercially successful product in the
EU or that it will be approved in other jurisdictions. 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.

Forxiga^™ is a registered trademark of Bristol-Myers Squibb Company.

For background information, please visit the microsite strictly reserved to
media professionals WWW.FORXIGA.EU/MEDIA

Photos/Multimedia Gallery Available:
http://www.businesswire.com/multimedia/home/20121114006517/en/

Multimedia
Available:http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50478626&lang=en

Contact:

Media:
Carmel Hogan, Bristol-Myers Squibb
+33-6-74-10-76-58
carmel.hogan@bms.com
Ken Dominski, Bristol-Myers Squibb
+1-609-252-5251
ken.dominski@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
 
Press spacebar to pause and continue. Press esc to stop.