- Collaboration to Focus on Antisense Inhibitors of PCSK9 -
PRINCETON, N.J. and CARLSBAD, Calif., May 9 /PRNewswire-FirstCall/ --
Bristol-Myers Squibb Company (NYSE: BMY) and Isis Pharmaceuticals, Inc.
(Nasdaq: ISIS) today announced a collaboration to discover, develop and
commercialize novel antisense drugs targeting proprotein convertase
subtilisin kexin 9 (PCSK9) for the prevention and treatment of
cardiovascular disease. PCSK9 helps regulate the amount of cholesterol in
the bloodstream.
As part of the collaboration, Isis licensed to Bristol-Myers Squibb
exclusive access to its PCSK9 research program. This program has recently
produced new data shedding light on the mechanism by which PCSK9
contributes to high levels of low density lipoprotein (LDL) cholesterol.
With its second- generation antisense PCSK9 compounds, Isis has shown in
mice that reducing PCSK9 leads to increased levels of LDL receptor and
consequently to lower LDL- cholesterol in the bloodstream. Decreasing
LDL-cholesterol is thought to play a key role in reducing the risk of
coronary artery disease.
While Bristol-Myers Squibb will fund all activities under the
collaboration, both companies will be responsible for preclinical
development. Bristol-Myers Squibb will be responsible for clinical
development, regulatory, and commercialization activities. In addition,
Bristol-Myers Squibb will work with Isis to leverage Isis' extensive
oligonucleotide medicinal chemistry expertise for identification of
follow-on PCSK9 antisense drugs with advanced antisense chemistries that
may offer even greater potency and oral bioavailability.
Bristol-Myers Squibb will pay Isis a $15 million upfront licensing fee,
and will provide Isis with at least $9 million in research funding over a
period of three years. Isis will also receive up to $168 million for the
achievement of pre-specified development and regulatory milestones for the
first drug in the collaboration, as well as additional milestones
associated with development of follow-on compounds. Bristol-Myers Squibb
will also pay Isis royalties on sales of products resulting from the
collaboration.
"There is a clear need for new treatment options for many patients at
high risk for cardiovascular disease due to high LDL-cholesterol levels,"
said Francis Cuss, M.D., senior vice president, Discovery and Exploratory
Clinical Research, Bristol-Myers Squibb. "PCSK9 is an attractive,
genetically validated target in the field of cardiovascular disease, and
Isis' antisense technology offers us a strong therapeutic platform for
potentially bringing new cardiovascular medicines rapidly to market."
"This collaboration is an important step in the continued validation of
Isis' cardiovascular program," said Lynne Parshall, J.D., executive vice
president and chief financial officer, Isis Pharmaceuticals. "We look
forward to combining our expertise in antisense technology with the strong
scientific and clinical expertise of Bristol-Myers Squibb, with its
cardiovascular and metabolic disease focus, to advance the PCSK9 compounds
through development to patients as quickly as possible."
About PCSK9
PCSK9 is a member of a large family of proteases that degrade specific
cellular components, but the particular cellular substrate of PCSK9 is not
known. PCSK9 helps regulate the amount of cholesterol in the bloodstream,
and human cases of alterations in PCSK9 that have prompted interest in this
target. People with too much PCSK9 have severely high LDL-cholesterol, and
people with mutations that reduce the levels of PCSK9 have low
LDL-cholesterol and reduced risk of coronary artery disease, with normal
liver function.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical and related health care
products company whose mission is to extend and enhance human life. Visit
Bristol-Myers Squibb on the World Wide Web at http://www.bms.com.
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 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 any products developed from the compounds 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. Bristol-Myers Squibb's collaboration with Isis for the discovery
and development of drugs for cardiovascular disease and high cholesterol
including PCSK9-targeted antisense drugs involves substantial risks and
uncertainties. 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, 2006, its Quarterly Reports on Form 10-Q and its
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 Isis Pharmaceuticals, Inc.
Isis is exploiting its expertise in RNA to discover and develop novel
drugs for its product pipeline and for its partners. The Company has
successfully commercialized the world's first antisense drug and has 17
drugs in development. Isis' drug development programs are focused on
treating cardiovascular and metabolic diseases. Isis' partners are
developing drugs for cancer, and inflammatory and other diseases. Ibis
Biosciences, Inc., Isis' wholly owned subsidiary, is developing and
commercializing the Ibis T5000 Biosensor System, a revolutionary system to
identify infectious organisms. As an innovator in RNA-based drug discovery
and development, Isis is the owner or exclusive licensee of over 1,500
issued patents worldwide. Additional information about Isis is available at
http://www.isispharm.com.
Isis Pharmaceuticals, Inc. Forward-Looking Statement
This press release includes forward-looking statements regarding Isis'
collaboration with Bristol-Myers Squibb, and discovery and development of
drugs for cardiovascular disease and high cholesterol including
PCSK9-targeted antisense compounds. Any statement describing Isis' goals,
expectations, financial or other projections, intentions or beliefs is a
forward-looking statement and should be considered an at-risk statement,
including those statements that are described as Isis' goals. Such
statements are subject to certain risks and uncertainties, particularly
those inherent in the process of discovering, developing and
commercializing drugs that are safe and effective for use as human
therapeutics, and in the endeavor of building a business around such
products. Isis' forward-looking statements also involve assumptions that,
if they never materialize or prove correct, could cause its results to
differ materially from those expressed or implied by such forward- looking
statements. Although Isis' forward-looking statements reflect the good
faith judgment of its management, these statements are based only on facts
and factors currently known by Isis. As a result, you are cautioned not to
rely on these forward-looking statements. These and other risks concerning
Isis' programs are described in additional detail in Isis' annual report on
Form 10- K for the year ended December 31, 2006, which is on file with the
SEC. Copies of this and other documents are available from the Company.
SOURCE Bristol-Myers Squibb Company
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Related links:
http://www.bms.com
http://www.isispharm.com
CONTACT:
Eric Miller, Communications, +1-609-252-7981,
eric.miller@bms.com, or John Elicker, Investor Relations,
+1-212-546-3775, john.elicker@bms.com, both of Bristol-Myers
Squibb Company; or Kate Corcoran, Ph.D., of Isis Pharmaceuticals,
+1-760-603-2712, kcorcoran@isisph.com
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