The FDA has denied the Bydureon version of Byetta. The FDA did not approve Bydureon’s version of Byetta prompting a Eli Lilly and Amylin response this morning.

The Bydureon Byetta news is resulting in a conference call by Amylin and Lilly started moments ago. Amylin Pharmaceuticals Inc (AMLN.O) and Eli Lilly and Co (LLY.N) wants the FDA to issue a complete response letter regarding NDA for BYDUREON™.

Bydureon is the one weekly version of Byetta.

The conference call started at 5:30 AM PST 8:30 AM EST. It can be watched online at Amylin’s corporate Web site at www.amylin. The manufacturer says the following about BYETTA:

“BYETTA is the first FDA-approved GLP-1 receptor agonist for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain.

“BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program. BYETTA is not insulin and should not be taken instead of insulin. BYETTA is not recommended to be taken with insulin. BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis.

“BYETTA provides sustained A1C control and low incidence of hypoglycemia when used alone or in combination with metformin or a thiazolidinedione, with potential weight loss. BYETTA is not a weight-loss product. BYETTA was approved in April 2005 and has been used by more than one million patients since its introduction. See important safety information below. Additional information about BYETTA is at www.BYETTA.com.”

Orville G. Kolterman with Amylin says today:

“This is a significant step forward in our ability to bring this important therapy to patients. We have a clear path forward and are working diligently to submit our response to the FDA in the next few weeks.”