Amylin's Bydureon fails to impress in head-to-head trial

Shares of Amylin Pharmaceuticals dipped after the developer posted disappointing data from a new trial showing that its closely watched GLP-1 diabetes drug Bydureon managed to beat out a competitor but only matched two other standard treatments.

In the study, patients taking Bydureon demonstrated a 1.5 percent drop in blood sugar, or A1C, slightly better than Januvia but only on par with the generic metformin and Takeda's Actos. Analysts weren't impressed, noting that the once-weekly version of Byetta has to distinguish itself in a crowded field in order to compete. Amylin's shares slid about four percent on the news. A spokesperson for the company says that the trial results will not be submitted to the FDA as part of its application for approval.

"Our conclusion is that Duration-4 may do more to reinforce generic metformin as the front-line diabetes drug of choice than to support asking for broad front-line use of Bydureon," noted Robert W. Baird analyst Thomas Russo. Some analysts, though, say they are waiting for upcoming data on the drug's cardiovascular benefits before determining its true market potential.

"The real key to actual expanded use of Bydureon is and still remains the demonstration of a cardiovascular outcomes benefit," Thomas Wei, an analyst with Jefferies & Co., told the San Diego Union-Tribune. "If positive, Bydureon could be the first drug to demonstrate a reduction in cardiovascular events in diabetics, which we suspect would change the way the GLP-1 class is used."

- check out Amylin's release
- read the story from the San Diego Union-Tribune
- here's the report from Reuters