Amylin (AMLN), Lilly (LLY) Terminate Exenatide Alliance, Resolve Litigation
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Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) entered an agreement to terminate their alliance for exenatide and resolve the outstanding litigation between the companies. As part of the agreement, the parties will transition full responsibility for the worldwide development and commercialization of exenatide to Amylin, starting in the United States (U.S.) on November 30, 2011, and progressing to all markets by the end of 2013.
Under the terms of the new global agreement, Amylin will make a one-time, upfront payment to Lilly of $250 million. Amylin will also agree to make future revenue sharing payments to Lilly in an amount equal to 15 percent of global net sales of exenatide products until Amylin has made aggregate payments to Lilly of $1.2 billion plus accrued interest. Amylin will issue a secured note in the amount of $1.2 billion to Lilly under which any revenue sharing payments made to Lilly will reduce amounts outstanding under the note. If Amylin's investigational once weekly version of exenatide, BYDUREON™ (exenatide extended-release for injectable suspension), has not received U.S. Food and Drug Administration (FDA) approval prior to June 30, 2014, Amylin's revenue sharing obligations will terminate, and Amylin shall thereafter pay Lilly 8 percent of global net sales of exenatide products. Amylin will also pay a $150 million milestone to Lilly contingent upon FDA approval of a once monthly suspension version of exenatide that is currently in Phase 2. The companies have also agreed that the maturity date for the $165 million line of credit that Amylin drew from Lilly earlier in the year will be extended from the second quarter of 2014 to the second quarter of 2016.
The transition of commercial operations to Amylin in the U.S. will be complete by November 30, 2011. Outside the U.S., Lilly will transfer responsibility for commercialization of BYETTA® (exenatide) injection and BYDUREON to Amylin on a market-by-market basis in 2012 and 2013. Amylin will work with Lilly on all plans for markets outside the U.S. during the transition period and will guarantee that Lilly does not experience losses on exenatide-related activities during that period, up to a total cap of $60 million.
Under the terms of the new global agreement, Amylin will make a one-time, upfront payment to Lilly of $250 million. Amylin will also agree to make future revenue sharing payments to Lilly in an amount equal to 15 percent of global net sales of exenatide products until Amylin has made aggregate payments to Lilly of $1.2 billion plus accrued interest. Amylin will issue a secured note in the amount of $1.2 billion to Lilly under which any revenue sharing payments made to Lilly will reduce amounts outstanding under the note. If Amylin's investigational once weekly version of exenatide, BYDUREON™ (exenatide extended-release for injectable suspension), has not received U.S. Food and Drug Administration (FDA) approval prior to June 30, 2014, Amylin's revenue sharing obligations will terminate, and Amylin shall thereafter pay Lilly 8 percent of global net sales of exenatide products. Amylin will also pay a $150 million milestone to Lilly contingent upon FDA approval of a once monthly suspension version of exenatide that is currently in Phase 2. The companies have also agreed that the maturity date for the $165 million line of credit that Amylin drew from Lilly earlier in the year will be extended from the second quarter of 2014 to the second quarter of 2016.
The transition of commercial operations to Amylin in the U.S. will be complete by November 30, 2011. Outside the U.S., Lilly will transfer responsibility for commercialization of BYETTA® (exenatide) injection and BYDUREON to Amylin on a market-by-market basis in 2012 and 2013. Amylin will work with Lilly on all plans for markets outside the U.S. during the transition period and will guarantee that Lilly does not experience losses on exenatide-related activities during that period, up to a total cap of $60 million.
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