| KAI Pharmaceuticals, Inc. and Sankyo Company, Ltd. Enter Global Alliance |
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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 South San Francisco, CA., January 09, 2006–Tokyo, Japan, and South San Francisco, CA (January 9, 2006) – 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.
About KAI Pharmaceuticals
About DAIICHI SANKYO COMPANY, LIMITED 1Prasugrel is an ADP-receptor antagonist in Phase III clinical trials, being co-developed with Eli Lilly and Company.
Forward-Looking Statements |