Amylin and Lilly to re-file Bydureon with US FDA sooner than expected with new tQT data

Amylin Pharmaceuticals (Nasdaq: AMLN), Eli Lilly (NYSE: LLY) and Alkermes (Nasdaq: ALKS) have announced results from a thorough QT (tQT) study that assessed the potential of their type 2 diabetes drug candidate Bydureon (exenatide extended release) to increase the QT interval across a wide range of plasma concentrations.

The study was conducted to satisfy a requirement by the US Food and Drug Administration in support of the New Drug Application for Bydureon which the agency failed to approve last year on cardiac safety concerns (The Pharma Letter October 20, 2010) and then, in a second complete response letter relating to the NDA, called for additional data. . The companies now plan to submit results of the tQT study to the FDA in the third quarter of 2011 as part of their reply to the complete response letter for the Bydureon, which is sooner than the end-2011 date previously expected.

Bydureon is a long-acting version of Byetta, a twice daily drug from Lilly and Amylin that was approved in 2005, but sales of which have been falling (to just $559 billion last year) as patients have switched to new diabetes drugs. The drug was approved by European regulators last month (TPL June 22). Analysts at Credit Suisse have put a net present value for Bydureon of $24.52 a share for Amylin and $2.76/share for Eli Lilly. However, the drug will have to make its marks in a highly competitive market (TPLs passim).