Amylin Pharmaceuticals won approval Friday for its long-delayed diabetes mellitus drug Bydureon, a next-generation treatment that requires fewer injections than the company's 7-year old product, Byetta.
Bydureon is a once-a-week version of Byetta, which is taken twice a day to help diabetes patients control their blood sugar. Amylin executives say the new drug's convenient regimen will give it a competitive advantage in the marketplace. However, after multiple delays it enters a market crowded with diabetes treatments, including one in the same class that has shown superior results.
The Food and Drug Administration approval comes after two previous rejections in 2010, when the agency asked Amylin to conduct a new study of the drug's effects on the heart. News of the costly requirement sent company shares tumbling more than 50 percent and contributed to the breakup of Amylin's long-standing partnership with Eli Lilly and Co. The companies ended their collaboration in November, with Amylin paying $250 million and agreeing to take over full responsibility for both Byetta and Bydureon.
Analysts generally expect Bydureon to generate $940 million in sales annually by 2016, though Deutsche Bank analyst Robyn Karnauskas says the drug must post $1.2 billion annually to turn a profit.
