INDIANAPOLIS (dpa-AFX) - Amylin Pharmaceuticals, Inc. (AMLN) and Alkermes plc (ALKS) said Friday that the U.S. Food and Drug Administration has approved Bydureon, the first once-weekly treatment for type 2 diabetes. The approval was based on safety and efficacy data from the DURATION clinical trial program, in which treatment with Bydureon resulted in improvements in glycemic control with just one dose per week. The approval was also based on clinical experience with another type 2 diabetes drug Byetta, a twice-daily injection that Amylin developed with Eli Lilly & Co. (LLY) in a partnership that ended last year. Byetta has been available in the U.S. since June 2005 and is used in nearly 80 countries worldwide. Bydureon, which is a once-weekly injection and uses exenatide as its active ingredient, was approved for sale by European regulators in June. Bydureon, which uses Alkermes' proprietary technology for long-acting medications to provide a controlled release of exenatide, will be available in pharmacies across the U.S. in February. Amylin will have to fulfill a number of post-marketing requirements to further assess the impact of Bydureon on medullary thyroid cancer and cardiovascular disease. The FDA approval process for Bydureon was not an easy one. The drug was rejected on two previous occasions and the agency required extra testing to alleviate safety concerns. In the meantime, Amylin agreed to terminate its decade long diabetes-drug development partnership with Eli Lilly, and resolve the outstanding litigation between them. Under the settlement, Amylin, which gained full ownership for development and commercialization of exenatide, will make a one-time, upfront payment to Lilly of $250 million and also make future revenue sharing payments to Lilly in an amount equal to 15% of global net sales of exenatide products, for aggregate payments of $1.2 billion plus accrued interest. Amylin shares closed Friday's regular trading session at $12.14, up 20 cents or 1.68%, and gained an additional $1.82 or 14.99% in after hours trading. Alkermes shares closed Friday's regular trading session at $19.10, down 18 cents, but gained 90 cents or 4.71% in after hours trading.
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