Amylin and Eli Lilly submit CRL reply on Bydureon to US FDA

US biotech Amylin Pharmaceuticals (Nasdaq: AMLN), drug major Eli Lilly (NYSE: LLY) and partner Alkermes (Nasdaq: ALKS) yesterday submitted their reply to a complete response letter issued in October 2010 by the US Food and Drug Administration regarding their investigation type 2 diabetes drug Bydureon (exenatide extended-release for injectable suspension).

The companies expect to receive an updated Prescription Drug User Fee Act (PDUFA) action date from the FDA within the next two weeks. Since the reply included additional data, it will likely be categorized as a Class 2 resubmission requiring up to six months for review.

Bydureon was approved by European regulators last month (TPL June 22). It is available in the U.K. and will launch in other major European countries as soon as possible, the companies have previously stated. 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 diabetes market (TPLs passim).