Amylin Pharmaceuticals and Eli Lilly and Co. have terminated their exenatide alliance, resolving the outstanding litigation between the companies. Amylin will take full responsibility for the worldwide development and commercialization of Byetta (exenatide), starting in the U.S. on November 30, 2011, and extending to all markets by the end of 2013.

“As pioneers in the GLP-1 market, we are proud of the truly innovative diabetes products that our two companies have provided patients,” said Daniel M. Bradbury, president and chief executive officer of Amylin Pharmaceuticals. “Amylin is excited to assume full responsibility for developing and commercializing exenatide. We anticipate working with one or more partners outside the U.S. in order to maximize the global potential of this innovative molecule and achieve greater operational flexibility and efficiency. This clarity of focus will provide us with an enhanced opportunity to increase shareholder value.”

Amylin will make an upfront payment to Lilly of $250 million and will make future revenue sharing payments equal to 15% of global sales until payments reach $1.2 billion. If Amylin’s once-weekly version of exenatide, Bydureon, is not approved by the FDA prior to June 30, 2014, Amylin’s revenue sharing obligations will terminate. Amylin would then pay Lilly 8% of global sales of exenatide products. Amylin will also pay a $150 million milestone contingent upon FDA approval of a once-monthly suspension version of exenatide. The maturity date for Amylin’s $165 million line of credit from Lilly will be extended to 2Q16.

“This marks an amicable end to a very productive 10-year collaboration that will continue to benefit many people worldwide. Lilly and Amylin are proud of the important accomplishments we achieved together,” said Enrique Conterno, president of Lilly Diabetes. “Lilly remains confident that the resubmission package for Bydureon has addressed the requirements outlined by the FDA and looks forward to Amylin achieving the alliance’s long-held goal of making Bydureon available to patients in the U.S. Looking forward, Lilly Diabetes remains committed to providing a comprehensive portfolio of diabetes treatment options for patients through our currently marketed products and robust clinical pipeline.”