Amylin Pharmaceuticals (NASDAQ:AMLN) Awaits TQT Protocol Review

As Amylin Pharmaceuticals (NASDAQ:AMLN) waits for a review of a TQT protocol submission, Barclays feels there will be risks to higher doses being required.

Barclays says, "We are maintaining our rating on shares of AMLN following an update with management and on further consideration of TQT trial requirements. With a TQT protocol submission yet to be reviewed by FDA we believe that the proposed exenatide concentration range falls below conditions of maximal inhibition and may need to be pushed higher to satisfy FDA. In the near term, we see increased risk to Byetta share erosion and with BYDUREON approval unlikely before mid-2012 would advise a wait-and-see approach to AMLN shares."

"...With primary focus on BYDUREON and the recent complete response letter (CRL) it would seem that AMLN has submitted a thorough QT (TQT) study protocol to FDA but has yet to meet with the agency. We believe that AMLN is targeting exenatide blood levels up to 500pg/ml with company suggesting no reason to go beyond 2x therapeutic levels. With Byetta blood levels increased 3.37x in ESRD patients, however, and with higher CMax with BYDUREON we see risk to higher doses being required."

Barclays reiterates an "Equalweight" rating on Amylin Pharmaceuticals, which closed Tuesday at $15.02, gaining $0.42, or 2.88 percent. Barclays has a price target of $12 on the company.