London, Nov. 2, 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
 BYETTA Approved for Expanded Use as First-Line Treatment for Type 2 Diabetes  
       Prescribing Information Also Includes Updated Safety Information        
SAN DIEGO and INDIANAPOLIS - October 30, 2009 - Amylin Pharmaceuticals, Inc.,
(Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced that the
U.S. Food and Drug Administration (FDA) 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 expanded indication gives physicians the option to prescribe BYETTA as a
first-line treatment, increasing the number of patients who may benefit from
the medication and providing an opportunity to treat patients with BYETTA
earlier in the disease," said Orville G. Kolterman, M.D., senior vice president
of research and development, Amylin Pharmaceuticals. "Type 2 diabetes is a
complex disease, so it is essential that healthcare professionals and their
patients have a wide array of treatments that can effectively control blood
glucose levels."
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. Results of this study were published in Clinical Therapeutics in
August 2008.
Among treatment-emergent adverse events, nausea was reported with the greatest
incidence (5 mcg, 3 percent; 10 mcg, 13 percent). Hypoglycemia was reported in
5 percent of patients taking 5 mcg and 4 percent of patients taking 10 mcg,
with no severe hypoglycemic events.
In addition to the monotherapy indication, the FDA approved changes to the
BYETTA Prescribing Information to incorporate updated safety information,
including pancreatitis-related language added to the Warnings and Precautions
section. This update addresses the alert issued by the FDA in August 2008. The
new label also expands upon existing language regarding use of BYETTA in
patients with renal impairment. In addition, the label has been amended to
match the format the FDA currently uses for Prescribing Information. This label
update is being communicated to physicians via a "Dear Healthcare Professional"
letter, which will be available at www.BYETTA.com.
"Patient safety is our foremost concern at Amylin and Lilly, and the BYETTA
Prescribing Information represents an important way to communicate the
information that healthcare professionals and patients need in order to use the
medication safely and effectively," Kolterman continued. "Thus, the updated
label offers the most current information about the benefit-risk profile of
BYETTA as a foundational therapeutic choice for people with type 2 diabetes."
BYETTA has been used by more than one million patients since market
introduction in 2005.