Eli Lilly & Co. (LLY:NYSE)

Eli Lilly & Co. announced that Steven M. Paul, M.D., executive vice president, science and technology, and president, Lilly Research Laboratories, will retire from Lilly effective February 28, 2010. Lilly has also announced that Jan M. Lundberg, Ph.D., executive vice president and head of global discovery research, AstraZeneca, is to become his successor. Paul is committed to working closely with Lundberg to ensure a successful transition. Lundberg plans to join Lilly in Indianapolis as early as January 2010, subject to completion of the U.S. immigration process. Paul joined Lilly as vice president, central nervous system discovery research and decision-phase medical research, in 1993. Paul had planned to retire in 2010. With the successful recruitment of his successor, he will retire at the end of February 2010.

Amylin Pharmaceuticals Inc. and Eli Lilly & Co. issued a statement in response to the U.S. Food and Drug Administration (FDA) update on BYETTA® (exenatide) injection. The FDA update issued aligns with the BYETTA label approved last week. The current label reflects the understanding of post-marketing reports of renal events and provides physicians with updated guidance about appropriate use in patients with renal conditions. There is no evidence from preclinical and clinical studies that BYETTA has any direct toxic effect on the kidney. On October 30, the FDA approved an expanded indication for BYETTA as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes. In addition to the monotherapy indication, the FDA approved changes to the BYETTA Prescribing Information to incorporate updated safety information. The new label expands upon existing language regarding use of BYETTA in patients with renal impairment, which Amylin and Lilly updated in September 2007 to include additional language regarding renal adverse events. It specifies that BYETTA should not be used in patients with severe renal impairment or end-stage renal disease and should be used with caution in patients with renal transplantation.

Amylin Pharmaceuticals Inc. and Eli Lilly & Co. announced that the U.S. Food and Drug Administration has approved an expanded indication for BYETTA® (exenatide) injection. BYETTA is now approved for use as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes. Previously, it was approved for use only in patients who were also taking other common diabetes medications and had not achieved adequate glycemic control. The approval of BYETTA as a monotherapy treatment was based on a clinical study of patients with type 2 diabetes who were unable to achieve glycemic control through diet and exercise alone. Study findings showed that patients treated with 5 mcg or 10 mcg of BYETTA as monotherapy reduced their A1C, a measure of average blood sugar over three months, by 0.7 percentage points and 0.9 percentage points, respectively, and lost 6.0 pounds and 6.4 pounds, respectively.