DOW JONES NEWSWIRES Three partners on a long-acting version of diabetes drug Byetta--Amylin Pharmaceuticals Inc. (AMLN), Eli Lilly & Co. (LLY) and Alkermes Inc. (ALKS)--said U.S. regulators requested heart-rate testing for the treatment. Amylin and Eli Lily shares were down in after-hours trading, falling 1.2% to $20.25 and 1.2% to $37 respectively. Alkermes was flat after closing Tuesday down 3.3% at $14.50. In a response letter, the Food and Drug Administration requested a thorough QT study for Bydureon. Such studies aim to determine potential heart arrhythmia side effects of a drug. The FDA had expected to issue a decision on Bydureon Friday, after after asking for more details on the treatment in March. The FDA request focused on product labeling, along with risk mitigation and manufacturing information and didn't request additional studies. Bydureon, which uses Alkermes technology, is a once-a-week version of twice-daily Byetta, which is already sold by Amylin and Eli Lilly. Although investors would welcome an approval, analysts are unsure how it would impact each company. Most estimates of the drug's eventual annual sales exceed $1 billion. Eli Lilly's size means the effect would be less, but Alkermes is relying on Bydureon as a key bet in a limited pipeline of drugs. -By Joan E. Solsman, Dow Jones Newswires; 212-416-2291; joan.solsman@dowjones.com
