13.05.2008 13:00:00
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Bristol-Myers Squibb and KAI Pharmaceuticals Enter Global Alliance to Develop and Commercialize KAI-9803 for Cardiovascular Disease
Bristol-Myers Squibb Company (NYSE:BMY) and KAI Pharmaceuticals, Inc., a
privately held biotechnology company, today announced an exclusive
agreement for the global development and commercialization of KAI-9803,
KAI’s proprietary, first-in-class inhibitor of
the delta protein kinase C pathway (delta PKC).
KAI-9803 is designed to reduce the size of the heart attack and to
improve clinical outcomes during treatment of acute myocardial
infarction (AMI). KAI-9803 is expected to enter Phase 2b clinical
testing by the end of 2008 in patients with ST elevation myocardial
infarction (STEMI).
Under the terms of the collaboration, KAI will receive an upfront cash
payment of $25 million. Bristol-Myers Squibb will fund all future
development, including the Phase 2b clinical trial to be conducted by
KAI. In addition, at KAI’s option,
Bristol-Myers Squibb will purchase $10 million of KAI stock at the time
of a qualified initial public offering, or under other specified future
conditions. KAI may receive from Bristol-Myers Squibb up to $192 million
in milestone payments based on the achievement of pre-specified
development and regulatory milestones for KAI-9803. KAI could be
eligible for additional milestones if other compounds are developed. KAI
will have an option to co-promote KAI-9803 in the United States and will
receive royalty payments on product net sales worldwide. The closing of
the transaction is subject to customary regulatory approvals.
"Bristol-Myers Squibb has deep expertise in
helping patients in their battle against cardiovascular disease,”
said Brian Daniels, M.D., Senior Vice President, Global Development &
Medical Affairs. "KAI-9803 provides us with
the opportunity to develop and market a truly innovative therapy that
leverages our core capabilities in this area of high unmet medical need.
This licensing agreement is an example of our company’s
strategy to integrate external innovation that enriches our pipeline and
contributes to our transformation to a next-generation biopharma leader.”
KAI CEO, Steven James, commented, "This is a
major milestone for KAI-9803, our most advanced of three clinical
programs, and a strategically important collaboration for KAI.
Bristol-Myers Squibb is a great partner for us with its impressive
history of developing and commercializing breakthrough medicines in
cardiovascular disease. We believe this deal is testimony to the value
and potential of KAI-9803 and our broad proprietary technology around
protein kinase C modulation.” About KAI-9803
KAI-9803 is an isozyme-selective inhibitor of the delta protein kinase C
pathway designed to reduce the size of the heart attack and to improve
clinical outcomes during treatment of acute myocardial infarction (AMI).
During a heart attack, blood flow to the heart is compromised resulting
in myocardial and endothelial cell necrosis and apoptosis. Selective
inhibition of the delta PKC isozyme by KAI-9803 may reduce the injury to
myocardial and endothelial cells during a heart attack and reduce the
risk of death or heart failure. KAI-9803 has received Fast Track
designation from the FDA for this indication.
In KAI’s Phase 1/2 clinical study in patients
undergoing balloon angioplasty for the treatment of acute myocardial
infarction, patients receiving intracoronary injections of KAI-9803
experienced less damage to heart muscle compared to patients receiving a
placebo. KAI has also demonstrated the feasibility of administering
KAI-9803 intravenously in both preclinical and clinical studies. The
Company intends to begin enrolling patients with ST segment elevation
myocardial infarction in a Phase 2b clinical trial of KAI-9803
administered by intravenous infusion in late 2008.
About KAI Pharmaceuticals
KAI Pharmaceuticals is a privately held, venture-backed drug discovery
and development company with clinical-stage programs addressing
significant and unmet patient needs in cardiovascular disease, metabolic
bone disease and pain. The company has applied its core expertise in the
biology of protein kinase C (PKC) to discover highly potent and
selective inhibitors and activators for validated PKC isozymes. KAI is
based in South San Francisco, California, and can be found online at www.kaipharma.com.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission
is to extend and enhance human life. For more information visit www.bms.com 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
pharmaceutical 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 clinical trials will begin on the timeframe described
in this release, that the clinical studies described in this release
will support a regulatory filing or that the product will receive
regulatory approval. There can be no assurance that if approved,
the product described in this release will be commercially successful.
Nor is there any assurance that the transaction described in this
release will receive the necessary regulatory approvals to close.
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, 2007, 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.
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