London, Nov. 3, 2009 (PR Newswire UK Disclose) -- 
Media contacts: Amylin - Anne Erickson
Phone: (858) 754-4443
Cell: (858) 349-3195
Email: anne.erickson@amylin.com
Lilly - Kindra Strupp
Phone: (317) 277-5170
Cell: (317) 554-9577
Email: kstrupp@lilly.com
         AmyLIN PHARMACEUTICALS AND eli LILLY And Company statement on         
                  FDA's byetta® (EXENATIDE) injection update                   
SAN DIEGO and INDIANAPOLIS - Nov. 2, 2009 - Amylin Pharmaceuticals, Inc.,
(Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today issued the following
statement in response to the U.S. Food and Drug Administration (FDA) update on
BYETTA® (exenatide) injection.
"The FDA update issued today aligns with the BYETTA label approved last week.
The current label reflects our 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," said
Orville G. Kolterman, M.D., senior vice president of research and development,
Amylin Pharmaceuticals. "Post-marketing reports of serious changes in renal
function have been rare and usually complicated by other factors that could
have contributed to the kidney problems. It is also important to note that
diabetes is the leading cause of kidney failure. Information about use of
BYETTA in patients with impaired renal function was included in the initial
product label in 2005 and was updated in 2007. We remain committed to working
closely with the FDA to ensure that physicians and patients are provided with
accurate information about any potential risks associated with the use of our
products."
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. It also specifies
that because BYETTA may induce nausea and vomiting with transient hypovolemia
(low blood volume), treatment may worsen renal function. This update was
communicated to physicians via a "Dear Healthcare Professional" letter, which
is available at www.BYETTA.com.
BYETTA has extensive post-marketing experience and a well-documented safety
profile. BYETTA has been used by more than one million patients since market
introduction in 2005. It has a proven history with more than 10 million
prescriptions written and 6.5 years of clinical experience.
About Diabetes
Diabetes affects more than 24 million people in the United States and an
estimated 246 million adults worldwide., Approximately 90-95 percent of those
affected have type 2 diabetes.