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January 9, 2006
KAI Pharmaceuticals, Inc. and Sankyo
Company, Limited Enter Global Alliance to Develop and
Commercialize Novel Compounds for Cardiovascular Disease
Kai Pharmaceuticals is developing drugs based on protein
kinase C, an important disease target. Their first program
addresses cardiac ischemia reperfusion injury, a clinical
problem with “holy grail” status in cardiovascular
medicine. Kai’s development and commercialization
deal with Daiichi-Sankyo (one of our limited partners)
around its lead product KAI-9803 will contribute significantly
to definitively demonstrating the safety and efficacy
of this novel therapy.
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KAI Pharmaceuticals, Inc., a privately held biotechnology
company, and DAIICHI SANKYO COMPANY, LIMITED today announced
that Sankyo Company, Limited, a wholly owned subsidiary
of DAIICHI SANKYO, and KAI Pharmaceuticals have entered
an agreement for the global development and commercialization
of KAI-9803, with an initial focus on cardiovascular disease.
KAI-9803, a delta Protein Kinase C (delta PKC) inhibitor,
is a first-in-class agent for the prevention of myocardial
tissue death and associated congestive heart failure in
acute myocardial infarction patients undergoing revascularization
procedures.
KAI-9803 is currently in a Phase I/II clinical trial (“DELTA-MI”)
to assess safety and efficacy in patients with acute myocardial
infarction undergoing reperfusion via balloon angioplasty.
The U.S. Food and Drug Administration has granted KAI-9803
Fast Track status due to the important unmet medical need
the product may address. Currently, approximately one
million people suffer from heart attacks every year in
the United States alone.
“We are extremely pleased to have Sankyo as our
partner in developing KAI-9803. Sankyo’s immense
expertise in the cardiovascular field will greatly benefit
the successful clinical and commercial development of
this compound,” said Steven James, president and
chief executive officer of KAI. “We look forward
to working closely with Sankyo to gain approval of this
drug, which has the potential to help a significant percentage
of heart attack victims.”
"This is truly advanced technology,” said DAIICHI
SANKYO President and CEO Takashi Shoda. “Through
our partnership with KAI, DAIICHI SANKYO has the opportunity
to build on its strong tradition of significant contributions
to the treatment of cardiovascular disease, with products
such as Benicar® and Olmetec® (olmesartan medoxomil)
and Pravachol® (pravastatin), as well as prasugrel1,
currently in Phase III development. Developing and marketing
such a potentially breakthrough compound through this
global commercial licensing agreement helps us fulfill
our goal of improving the health and well-being of people
around the world."
Under the terms of the partnership, Sankyo will make an
initial payment to KAI of $20 million. In addition, KAI
could receive potential development and commercialization
milestones of up to $300 million for two initial indications
for KAI-9803, as well as milestone payments for future
delta PKC inhibitors. Sankyo will fund all future development,
and will have global development and commercialization
rights and pay KAI a double-digit royalty on sales.
KAI will have the option to perform certain clinical studies.
In North America, KAI will have the right to co-promote
products in the acute care/hospital setting. KAI may receive
$20 million from Sankyo in research support over five
years to identify new compounds, routes of administration
and indications directed toward the inhibition of delta
PKC.
KAI-9803 is a small peptide that works by inhibiting the
translocation of delta PKC to its specific intracellular
receptor. Delta PKC activation during reperfusion initiates
the molecular processes for cell death which ultimately
leads to inflammation and damage in the heart or the brain
during a stroke. KAI-9803 is currently being evaluated
in acute heart attack patients undergoing balloon angioplasty
in DELTA-MI, a 150-patient, double-blind, placebo-controlled
Phase I/II clinical trial.
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