Lilly and Amylin To Collaborate on Potential Breakthrough Diabetes Treatment
Friday September 20, 8:01 am ET INDIANAPOLIS & SAN DIEGO--(BUSINESS WIRE)--Sept. 20, 2002--(NYSE:LLY - News) If Approved, Phase III Compound, AC2993, Would Represent the First of the Next-Generation Therapies for People With Type 2 Diabetes
Eli Lilly and Company (NYSE:LLY - News) and Amylin Pharmaceuticals, Inc. (Nasdaq:AMLN - News), announced today that they have signed a global agreement to collaborate on the development and commercialization of Amylin's compound AC2993 (synthetic exendin-4), a potential new treatment for type 2 diabetes that, if approved, could represent the first of a new class of compounds which have similar actions to GLP-1 (glucagon-like peptide-1). AC2993 is currently in Phase III clinical trials with a submission to the U.S. Food and Drug Administration anticipated as early as 2004.
"Lilly has been bringing major new therapies to people with diabetes for nearly 80 years. This collaboration with Amylin, an innovator in the development of next-generation diabetes therapies, confirms our continued commitment to the treatment of diabetes and its complications," said John C. Lechleiter, Ph.D., executive vice president of pharmaceutical products and corporate development for Lilly. "AC2993, if successful, would represent a significant advance in the treatment of type 2 diabetes as this potent compound may enable many people with type 2 diabetes to effectively control blood-glucose levels while reducing or eliminating the risk of hypoglycemia and weight gain."
"Amylin is committed to discovering, developing and commercializing innovative new medicines to improve the lives of people with diabetes. This collaboration with Lilly is a significant step for Amylin and should accelerate our ability to achieve this goal," said Joseph C. Cook, Jr., chairman and chief executive officer for Amylin. "Lilly's leadership in the development and commercialization of innovative diabetes therapies makes them an ideal partner to maximize the global potential of AC2993."
Under terms of the agreement, Lilly will make initial nonrefundable payments to Amylin totaling $80 million. Lilly will also purchase $30 million of Amylin common stock at a price of $18.69 per share. In addition, in the future, Lilly will pay Amylin up to $85 million upon the achievement of certain development and product profile milestones of AC2993, including long-acting release formulations of the product candidate. These milestones may be convertible into Amylin equity at Lilly's option under certain circumstances. Lilly will also make additional future payments to Amylin of up to $130 million contingent upon global commercialization of AC2993, including long-acting release formulations of the product candidate.
Lilly and Amylin will share U.S. development and commercialization costs equally. Lilly's obligation to actively share in development funding is estimated to begin following the completion of the majority of work on the three pivotal Phase III clinical trials currently under way. Amylin estimates the development costs through the completion of these Phase III studies to be about $100 million. Development costs outside the U.S. will be shared 80 percent by Lilly and 20 percent by Amylin. Lilly is responsible for all commercialization costs outside the U.S. Following the successful completion of the ongoing Phase III trials and contingent upon certain other events, Lilly will make available a $110 million convertible loan to fund a portion of Amylin's development and commercialization costs.
The companies will equally copromote the product in the U.S., while Lilly will market the product exclusively in countries outside the U.S. Operating profits from sales of the product in the U.S. will be shared equally. Outside the U.S., operating profits will be shared at approximately 80 percent to Lilly and 20 percent to Amylin. Additionally, the companies have agreed that, for a limited period of time prior to the commercialization of AC2993, Amylin will copromote Humatrope®, Lilly's recombinant human growth hormone product, in the U.S.
AC2993 (synthetic exendin-4) is being studied for its potential to address important unmet medical needs of many people with type 2 diabetes. Clinical trials suggest that AC2993 decreases blood glucose toward normal levels. This control of blood glucose is expected based on known exendin-4 actions that are similar to those of GLP-1. These actions include glucose-dependent stimulation of insulin secretion, suppression of glucagon secretion, reduction of appetite and delay of food absorption. These actions promote stimulation of insulin secretion in the presence of elevated blood-glucose concentrations but not during periods of normal or low blood-glucose concentrations, thereby reducing or eliminating the risk of hypoglycemia. AC2993 has also been shown in clinical studies to reduce both postmeal and fasting blood-glucose levels. If approved, AC2993 is expected to be administered as a fixed-dose injection. A long-acting release formulation of AC2993 is in early development with a goal of a once-a-month injection utilizing sustained-release drug delivery technology from Alkermes, Inc. .. |
