- Partnership Aligned with Bristol-Myers Squibb Company Strategy -
- Deal a Significant Step in Strengthening AstraZeneca's Late Stage
Pipeline -
PRINCETON, N.J., Jan. 11 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb
Company (NYSE: BMY) and AstraZeneca ("companies") today announced a
collaboration to develop and commercialize two investigational compounds
being studied for the treatment of Type 2 diabetes. Both compounds were
discovered by Bristol-Myers Squibb.
Saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is currently
in Phase III development. Upon successful completion of the development
program, the companies plan to file for U.S. regulatory approval of
saxagliptin during the first half of 2008. Dapagliflozin (previously
referred to as BMS-512148), a sodium-glucose cotransporter-2 (SGLT2)
inhibitor, is currently in Phase IIb development. The collaboration on
these compounds is worldwide, except for Japan. Should either party develop
additional DPP-4 or SGLT2 compounds, the other company can elect to add
those compounds to the collaboration.
Terms of the agreements include an upfront payment of $100 million by
AstraZeneca to Bristol-Myers Squibb. The companies have agreed upon initial
development plans for the two compounds. From 2007 through 2009, the
majority of development costs will be funded by AstraZeneca. Any additional
development costs will be shared equally.
Bristol-Myers Squibb may also receive additional payments of up to $650
million based on development and regulatory milestones for the two
compounds. In addition, potential sales milestones up to $300 million per
product are also possible. The companies will jointly develop the clinical
and marketing strategy of the compounds, and post-launch will share
commercialization expenses and profits/losses equally on a global basis,
excluding Japan. Bristol-Myers Squibb will manufacture both products and
book sales.
"This collaboration provides Bristol-Myers Squibb the opportunity to
maximize our primary care assets, and it is aligned with our corporate
strategy to concentrate R&D efforts on serious diseases such as diabetes
while maintaining commercial focus on specialists and high prescribing
primary care physicians," said Jim Cornelius, chief executive officer,
Bristol-Myers Squibb. "Bristol-Myers Squibb has a strong legacy in treating
Type 2 diabetes and cardiovascular disease, and we look forward to
leveraging the combined expertise of our company and AstraZeneca to further
develop and commercialize these compounds."
David Brennan, chief executive officer of AstraZeneca, said, "Diabetes
is a disease reaching almost epidemic proportions in many regions
throughout the world and is a particular area of scientific interest for
AstraZeneca. This deal represents a significant step in delivering our
externalization strategy as it gives us access to two strategically
important late-stage compounds in an area of high unmet medical need. We
believe that Bristol-Myers Squibb's recognized contributions to diabetes
research will complement our existing strengths. Additionally, our combined
expertise will develop new areas of opportunity for both companies and the
potential to bring real medical benefit to the wider community."
About Diabetes
Diabetes is a disease in which the body does not produce or properly
use insulin. Insulin is a hormone needed to carry glucose (sugar) from the
blood into cells, where it is converted to energy the cells need to perform
properly. When insulin is not present or does not function correctly, the
result is high levels of glucose in the blood. Over time, high blood
glucose levels can lead to complications in the eyes, kidneys, central
nervous system or heart.
Type 2 diabetes is the most common form of diabetes, accounting for
approximately 90-95 percent of diabetes cases. Having Type 2 diabetes
increases the risk of many serious complications, including heart disease
or stroke, high blood pressure, amputation (particularly legs), blindness,
nerve damage, and kidney failure. The risk of stroke and the rate of deaths
due to heart disease are two to four times higher among people with
diabetes, while about 65 percent of deaths among people with diabetes are
due to heart disease and stroke.
The American Diabetes Association (ADA) estimates that more than 20
million people in the United States, or 7 percent of the population, have
diabetes, and that one in three Americans born in 2000 will develop
diabetes sometime during their lifetime. There are currently more than 230
million people living with diabetes worldwide. The objective of treating
diabetes is to control blood glucose to as normal a level as possible. This
can be accomplished by a combination of diet, exercise and medication.
About Saxagliptin and Dapagliflozin
Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, a new class
of diabetes medicines that work by increasing and prolonging the action of
natural hormones in the body called incretins. Incretins decrease blood
sugar by increasing consumption of sugar by the body, mainly through
increasing insulin production in the pancreas, and by reducing production
of sugar by the liver. By enhancing the effect of active incretin hormones
in the body, DPP-4 inhibitors improve timely insulin release and ultimately
decrease high blood sugar levels in patients with Type 2 diabetes.
Dapagliflozin is a sodium glucose cotransporter-2 (SGLT2) inhibitor.
The SGLT2 transporter protein is located only in the kidney, where it
normally reabsorbs glucose from urine while waste products are filtered
out. Patients with Type 2 diabetes continue to reabsorb glucose from the
urine, even though this process contributes to high blood glucose levels,
or hyperglycemia. Dapagliflozin has a novel mechanism of action that blocks
re-absorption of glucose from urine in patients with Type 2 diabetes.
Inhibiting SGLT2 activity decreases re-absorption of glucose by the kidney,
helping to improve glucose control in patients with Type 2 diabetes.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical and related healthcare
products company whose mission is to extend and enhance human life.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of prescription
pharmaceuticals and the supply of healthcare services. It is one of the
world's leading pharmaceutical companies with healthcare sales of $23.95
billion and leading positions in sales of gastrointestinal, cardiovascular,
neuroscience, respiratory, oncology and infection products. AstraZeneca is
listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4
Good Index. AZ has over 40 years experience in cardiovascular medicine,
with a powerful range of products including Atacand, a hypertension
medication, Seloken ZOK, a leader in its class of beta blockers and
CRESTOR, for the treatment of high cholesterol levels.
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 development and commercialization of 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 the products described in this release will receive regulatory
approval, or that if approved, will be commercially successful. Nor is
there any assurance that any or all of the development, regulatory, and
sales milestones provided for in the agreement will be achieved.
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, 2005, 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.
SOURCE Bristol-Myers Squibb Company
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