Bristol-Myers Squibb and KAI Pharmaceuticals, a privately held biotechnology company, have announced an exclusive agreement for the global development and commercialization of KAI-9803, a 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. KAI-9803 is expected to enter Phase 2b clinical testing by the end of 2008 in patients with ST elevation myocardial infarction. Under the terms of the deal, 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 US and will receive royalty payments on product net sales worldwide.
Novartis was hit with a DDMAC warning letter May 1, citing a Trileptal-branded magnet distributed to doctors for omitting the full indication and risk information. DDMAC said the magnet misbrands the seizure medication and “may encourage the use of Trileptal in circumstances other than those for which the drug has been shown to be safe and effective and suggest that Trileptal is safer and more effective than has been demonstrated.”