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UPDATE 2-Amylin says heart trial of diabetes drug met goal
July 7, 2011 / 9:59 PM / 6 years ago

UPDATE 2-Amylin says heart trial of diabetes drug met goal

* To submit data to FDA in third quarter

* Amylin shares rise 10.8 percent in extended trade

* Alkermes shares rise 6 percent (Adds background, updates share prices)

LOS ANGELES, July 7 (Reuters) - A trial of exenatide, the active ingredient in a long-acting diabetes drug being developed by Amylin Pharmaceuticals AMLN.O, Eli Lilly (LLY.N) and Alkermes (ALKS.O), found no link between the drug and changes in heart rhythms, the companies said on Thursday.

The news sent shares of Amylin up nearly 11 percent in after-hours trading. Shares of Alkermes were up 6 percent, while shares of Lilly were flat at $37.85.

U.S. regulators last October asked for data from the trial before deciding whether to approve Bydureon, a once-weekly version of exenatide, as a treatment for Type 2 diabetes.

The companies said the study met its goal, showing that, even at high doses, exenatide did not prolong the QT interval, the time the heart’s electrical system takes to recharge after each beat, in healthy volunteers.

The companies said they plan to submit results of the study to the Food and Drug Administration in the third quarter of this year.

Shares of Amylin were trading at $15.19 after hours, while shares of Alkermes were at $20.40.

Bydureon is a longer-acting version of Byetta, known generically as exenatide, which is also sold by Lilly and Amylin. Both injectable drugs belong to a relatively new GLP-1 class of drugs that stimulate insulin release when glucose levels become too high.

Bydureon was approved by European health regulators last month. It competes with Novo Nordisk’s (NOVOb.CO) Victoza, a GLP-1 agonist which is injected daily.

Bydureon sales for Amylin are expected to reach $1.1 billion a year by 2015, according to analysts polled by Thomson Pharma. (Reporting by Deena Beasley; Editing by Tim Dobbyn)

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