Amylin Pharmaceuticals and Eli Lilly have decided to terminate their alliance for exenatide (Byetta) and resolve the outstanding litigation between the companies. As part of the agreement, the companies will transition full responsibility for the global development and commercialization of exenatide to Amylin, starting in the U.S. on Nov. 30, and progressing to all markets by the end of 2013.
After nearly a decade-long partnership for diabetes care, the companies "determined it was in the best interest of all constituents to amicably terminate the collaboration. Both companies are committed to ensuring a seamless transition of global product responsibility to Amylin while maintaining continuity of patient care."
"Amylin is excited to assume full responsibility for developing and commercializing exenatide," said Daniel M. Bradbury, president and CEO of Amylin. "We anticipate working with one or more partners outside the U.S."
Under the terms of the new global agreement, Amylin will make a one-time, upfront payment to Lilly of $250 million. Amylin also will 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 FDA approval prior to June 30, 2014, Amylin's revenue sharing obligations will terminate, and Amylin will thereafter pay Lilly 8 percent of net sales of exenatide products.
Amylin also will 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 also have 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 Nov. 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.
The Amylin and Lilly alliance resulted in several products in the diabetes market, including the 2005 launch of the first-in-class GLP-1 receptor agonist, Byetta, and submission of the first once-weekly GLP-1 receptor agonist, Bydureon, an investigational medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose.
Bydureon received marketing authorization in the European Union in June and is currently under review in the U.S., with a Prescription Drug User Fee Action date of Jan. 28, 2012.
Amylin said it will continue to evolve the GLP-1 market with the exenatide franchise through the development of a pen device for Bydureon and the exenatide monthly suspension program.