Amylin Pharmaceuticals has more good news to share from its journey to gain approvals of its long-acting diabetes drug, Bydureon. The San Diego-based firm ($AMLN) says that it met the primary endpoints of a key safety study the FDA asked for when it declined to approve the drug last fall--and investors have reacted accordingly, giving the firm's stock boost since the news came late yesterday.
The company, which is developing Bydureon through a strained partnership with Eli Lilly ($LLY), said that a randomized, double-blind study of 75 healthy volunteers showed that exenatide did not prolong corrected QT intervals (prolonged QT is a risk factor of sudden cardiac death). Amylin says that plans to present details from the study at a future scientific meeting and include the data in its response to the FDA's complete response letter from last year for Bydureon later this quarter.
This is another win for Bydureon, a once-weekly version of the diabetes drug exenatide. Last month the EU granted approval of Bydureon for the European market, a positive development for Amylin and Lilly, who have been at odds over Lilly's diabetes pact with German pharma Boehringer Ingelheim. With the most riding on approval of Bydureon, Amylin's stock price shot up more than 10% in afterhours trading on the positive news from the QT study.
"The findings of this tQT study are clear. Exenatide did not lead to QT prolongation, even at very high concentrations in the blood," Christian Weyer, senior vice president of R&D at Amylin, said. "This study was designed in accordance with existing guidelines and in consultation with the FDA. We are confident in these results and will continue to work toward making Bydureon available to patients in the U.S. as soon as possible."
- here's Amylin's release
- check out Xconomy's coverage
- see the AP's report
Editor's Note: This story was corrected to say that exenatide did not prolong QT intervals in the study. The word "not" was inadvertantly omitted when this story was first published.