U.S. FDA Acknowledges Receipt of Resubmission of the New Drug Application for Investigational Compound Dapagliflozin for the

  U.S. FDA Acknowledges Receipt of Resubmission of the New Drug Application
  for Investigational Compound Dapagliflozin for the Treatment of Type 2
  Diabetes

Business Wire

WILMINGTON, Del. & PRINCETON, N.J. -- July 25, 2013

AstraZeneca(NYSE: AZN) and Bristol-Myers Squibb Company(NYSE: BMY) today
announced that the U.S. Food and Drug Administration (FDA) has acknowledged
receipt of the New Drug Application (NDA) resubmission for investigational
drug dapagliflozin for the treatment of adults with type 2 diabetes. The FDA
assigned a new Prescription Drug User Fee Act (PDUFA) goal date of Jan. 11,
2014.

The dapagliflozin Phase 2/3 clinical development program included more than
12,000 adult patients with diabetes (more than 8,000 patients received
dapagliflozin) in 26 clinical trials. In response to the FDA’s January 2012
complete response letter requesting additional data to allow a better
assessment of the benefit-risk profile of dapagliflozin, the NDA resubmission
includes several new studies and additional long-term data (up to four years’
duration) from previously submitted studies, resulting in an overall increase
in patient-years exposure to dapagliflozin of more than 50 percent.

Dapagliflozin, an investigational compound, is a selective and reversible
inhibitor of sodium-glucose cotransporter 2 (SGLT2), which works independently
of insulin. It is currently approved for the treatment of type 2 diabetes in
the European Union, Australia, Brazil, Mexico and New Zealand.

About SGLT2 Inhibition

The kidney plays an important role in maintaining normal glucose balance by
filtering and reabsorbing glucose from circulation. SGLT2, a sodium-glucose
cotransporter found predominantly in the kidney, is responsible for
approximately 90 percent of glucose reabsorption. In patients with type 2
diabetes, the capacity of the kidney to reabsorb glucose is increased by
approximately 20 percent, further exacerbating the hyperglycemia associated
with the disease. Selective inhibition of SGLT2 reduces the reabsorption of
excess glucose and enables its removal via the urine.

About Diabetes

In 2012, diabetes was estimated to affect more than 370 million people
worldwide. The prevalence of diabetes is projected to reach more than 550
million by 2030. Type 2 diabetes accounts for approximately 90% to 95% of all
cases of diagnosed diabetes in adults. Type 2 diabetes is a chronic disease
characterized by insulin resistance and dysfunction of beta cells in the
pancreas, leading to elevated glucose levels. Over time, this sustained
hyperglycemia contributes to further progression of the disease. Significant
unmet needs still exist, as many patients remain inadequately controlled on
their current glucose-lowering regimen.

AstraZeneca/Bristol-Myers Squibb Diabetes Alliance

Dedicated to addressing the global burden of diabetes by advancing
individualized patient care, AstraZeneca and Bristol-Myers Squibb are working
in collaboration to research, develop and commercialize a versatile portfolio
of innovative treatment options for diabetes and related metabolic disorders
that aim to provide treatment effects beyond glucose control. Find out more
about the Alliance and our commitment to meeting the needs of health care
professionals and people with diabetes at www.astrazeneca.com or www.bms.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that
focuses on the discovery, development and commercialization of prescription
medicines, primarily for the treatment of cardiovascular, metabolic,
respiratory, inflammation, autoimmune, oncology, infection and neuroscience
diseases. AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more information
please visit: www.astrazeneca.com.

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. For more information about Bristol-Myers Squibb, visit
www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

AstraZeneca Cautionary Statement Regarding Forward-Looking Statements

In order, among other things, to utilize the 'safe harbor' provisions of the
US Private Securities Litigation Reform Act 1995, we are providing the
following cautionary statement: This press release contains certain
forward-looking statements with respect to the operations, performance and
financial condition of the Group. 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 preparation of this press release and AstraZeneca
undertakes no obligation to update these forward-looking statements. We
identify the forward-looking statements by using the words 'anticipates',
'believes', 'expects', 'intends' and similar expressions in such 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: the loss or expiration of patents,
marketing exclusivity or trademarks, or the risk of failure to obtain patent
protection; the risk of substantial adverse litigation/government
investigation claims and insufficient insurance coverage; exchange rate
fluctuations; the risk that R&D will not yield new products that achieve
commercial success; the risk that strategic alliances and acquisitions will be
unsuccessful; the impact of competition, price controls and price reductions;
taxation risks; the risk of substantial product liability claims; the impact
of any delay in the manufacturing, distribution and sale of any of our
products; the impact of any failure by third parties to supply materials or
services; the risk of failure to manage a crisis; the risk of delay to new
product launches; the difficulties of obtaining and maintaining regulatory
approvals for products; the risk of failure to observe ongoing regulatory
oversight; the risk that new products do not perform as we expect; the risk of
environmental liabilities; the risks associated with conducting business in
emerging markets; the risk of reputational damage; the risk of product
counterfeiting; the risk of failure to successfully implement planned cost
reduction measures through productivity initiatives and restructuring
programs; the risk that regulatory approval processes for biosimilars could
have an adverse effect on future commercial prospects; the impact of failing
to attract and retain key personnel and to successfully engage with our
employees; and the impact of increasing implementation and enforcement of more
stringent anti-bribery and anti-corruption legislation. Nothing in this press
release should be construed as a profit forecast.

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 regulatory approval in the U.S.
or, if approved, that it will become commercially successful. There is also no
guarantee that the FDA will make a regulatory decision within the time frame
described in this release. 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, 2012, 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.

Contact:

Media:
AstraZeneca
Kristin Rogers, 302-885-8922
kristin.rogers@astrazeneca.com
or
Bristol-Myers Squibb
Ken Dominski, 609-252-5251
ken.dominski@bms.com
or
Investors:
AstraZeneca
Karl Hard, 44-20-7604-8123
karl.j.hard@astrazeneca.com
or
Bristol-Myers Squibb
John Elicker, 609-252-4611
john.elicker@bms.com
 
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