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KAI, BMS Join Forces in $227M Heart Drug Deal
(BioWorld Today Via Acquire Media NewsEdge) KAI Pharmaceuticals Inc. is partnering with Bristol-Myers Squibb Co. to develop and commercialize KAI's heart drug KAI-9803 in a deal potentially worth more than $227 million.
Under the collaboration, Princeton, N.J.-based BMS will pay South San Francisco-based KAI an up-front payment of $25 million. KAI could bank an additional $192 million if certain development and regulatory milestones are met and could garner additional milestones if other compounds are developed under the partnership.
The biotech also will receive an undisclosed amount of worldwide royalties on sales for KAI-9803, a drug given intravenously in the emergency room to patients experiencing heart attacks to protect the heart cells and muscle and prevent death.
KAI has the option to co-promote the product in the U.S. under the agreement.
In addition, BMS also has agreed to buy $10 million of KAI stock at the time of a qualified initial public offering or under other specified future conditions.
KAI-9803, which has been granted fast-track status by the FDA, is expected to enter Phase IIb clinical testing in patients with ST elevation myocardial infarction by the end of this year, said KAI CEO Steve James. The deal calls for BMS to fully fund the Phase IIb study, he told BioWorld Today. James estimated that the study would cost about $40 million to conduct.
Results of a Phase I/II clinical study showed that patients undergoing balloon angioplasty for the treatment of acute myocardial infarction who received intracoronary injections of KAI-9803 experienced less damage to the heart muscle compared with patients receiving a placebo, he said.
The data from the Phase I/II trial, known as Delta-MI, showed a favorable safety profile with no significant adverse events in any of the 102 patients in the trial who received KAI-9803, James said.
KAI subsequently developed an intravenous formulation of KAI-9803 and repeated the Phase I trials, he said, noting that it is the IV formulation that the firm is developing with BMS.
KAI-9803, an isozyme-selective protein kinase C inhibitor, "reduces the injury to myocardial tissue and endothelial cells, which therefore reduces the risk of death or heart failure," James said.
During a heart attack, blood flow to the heart is compromised resulting in myocardial and endothelial cell necrosis and apoptosis.
While restoring blood flow, either through the use of thrombolytic drugs or surgical intervention such as angioplasty or implanting a stent, improves clinical outcomes in heart attack patients, it can cause significant injury to heart tissues, referred to as reperfusion injury, explained Brian Daniels, senior vice president of global development and medical affairs for BMS.
Currently there are no "appropriate therapeutics" available to treat reperfusion injury, which Daniels called "a high unmet medical need."
However, he told BioWorld Today, KAI's product is promising.
"The science at KAI in the protein kinase C field is really spectacular," he said. "They have dissected out tissue specificities that I think really will allow us to test this hypothesis clinically."
KAI, Daniels added, has "advanced the science significantly, both in the understanding of how to selectively target certain protein kinase C isoenzymes so it is tissue specific and also how to deliver those to the cells at the time it is needed."
Having a product like KAI-9803 that can "positively advance the standard of care" not only will benefit cardiac patients and their physicians, but also will benefit health care payers because of better long-term outcomes, he said.
Daniels called his firm's deal with KAI part of BMS's "string of pearls" strategy.
"It totally aligns to our strategy of looking at a diverse range of options to bring in additional investigational compounds to Bristol-Myers Squibb," he said.
While BMS has a long history of developing and commercializing cardiovascular medications, such as Pravachol (pravastatin sodium) and Plavix (clopidogrel bisulfate), "you can't do everything inside the four walls of your company," Daniels said.
"A good biopharma company who really wants to be 21st century is constantly looking for additional opportunities to enrich their pipeline," he said.
The importance of the deal with BMS for KAI, James said, is that "it provides us flexibility in terms of the timing and types of future partnering activities" on the firm's other PKC development programs.
Not having to fund the Phase IIb trial for KAI-9803 and the $25 million up-front payment from BMS, along with the KAI's $30 million in cash it has on hand, "gives us the reserves to fund the rest of our operating plan into 2011," he said.
KAI's pipeline also includes its selective epsilon PKC inhibitor KAI-1455, which is being developed to treat secondary hyperparathyroidism, and KAI-1678, which is being investigated as a therapy for inflammatory and neuropathic pain. n
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