Exenatide Once Weekly New Drug Application Submitted to FDA for Type 2 Diabetes

SAN DIEGO, INDIANAPOLIS, and CAMBRIDGE, Mass., May 5 /PRNewswire-FirstCall/ --
Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN), Eli Lilly and Company (NYSE:
LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that a New Drug
Application (NDA) for exenatide once weekly has been submitted to the U.S.
Food and Drug Administration (FDA). Exenatide once weekly is an
investigational sustained release medication for type 2 diabetes that is
injected subcutaneously and administered only once a week. Exenatide is the
active ingredient in BYETTA(R) (exenatide) injection, which is currently
available in the U.S. and in many countries worldwide for people with type 2
diabetes who are unable to achieve good glycemic control with common oral
therapies.

"The exenatide once weekly submission is an important milestone in the overall
exenatide development program. The clinical data supporting this submission
highlight the potential of exenatide once weekly to significantly advance the
treatment of type 2 diabetes," said Daniel M. Bradbury, president and chief
executive officer of Amylin. "We remain committed to developing and
commercializing a range of treatment options that address the important unmet
needs of people living with diabetes."

Clinical components of the NDA include the DURATION-1 study and the
meta-analysis of primary cardiovascular events across the BYETTA clinical
database. DURATION-1 was designed to test the superiority of exenatide once
weekly, as compared to BYETTA, which is administered twice daily. In this
study, exenatide once weekly treatment resulted in statistically significant
reductions in A1C of 1.9 percentage points from baseline, compared to a
reduction of 1.5 percentage points for BYETTA, and 77 percent of patients
treated with exenatide once weekly achieved an A1C of 7 percent or less
compared to 61 percent of patients treated with BYETTA. Exenatide once weekly
and BYETTA were both associated with an average weight loss of 8 pounds from
baseline. The most commonly reported adverse event was nausea, which was
typically mild and transient and occurred less frequently in the exenatide
once weekly patients. In addition, a meta-analysis across controlled clinical
studies of three months or greater from the BYETTA database showed no
increased risk of cardiovascular events associated with exenatide use. This
analysis applied principles outlined in the FDA's guidance for evaluating
cardiovascular risk in type 2 diabetes agents.

Components of the submission supporting product manufacturing include analyses
to demonstrate comparability of the intended commercial product with that used
during development. These analyses include data from patients in the ongoing
extension of the DURATION-1 study who used exenatide once weekly produced at
Amylin's manufacturing facility in Ohio.

"If approved, exenatide once weekly would be the first and only once-a-week
therapy for the treatment of type 2 diabetes," said David Vondle, exenatide
global brand development leader for Lilly. "A new treatment option to help
patients with type 2 diabetes manage blood sugar, with potential weight loss
and less frequent dosing, could offer an important advance in the treatment
paradigm for patients and physicians who manage this chronic condition."

About Diabetes
Diabetes affects more than 23 million people in the U.S. and an estimated 246
million adults worldwide.(i,ii) Approximately 90-95 percent of those affected
have type 2 diabetes. Diabetes is the fifth leading cause of death by disease
in the U.S. and costs approximately $174 billion per year in direct and
indirect medical expenses.(iii)

According to the Centers for Disease Control and Prevention's National Health
and Nutrition Examination Survey, approximately 60 percent of people with
diabetes do not achieve their target blood sugar levels with their current
treatment regimen.(iv) In addition, 85 percent of type 2 diabetes patients are
overweight and 55 percent are considered obese.(v) Data support that weight
loss (even a modest amount) supports patients in their efforts to achieve and
sustain glycemic control.(vi,vii)

About BYETTA(R) (exenatide) injection
BYETTA is the first and only FDA-approved incretin mimetic 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 approved by the FDA for use by
people with type 2 diabetes who are unsuccessful at controlling their blood
sugar levels. BYETTA is an add-on therapy for people currently using
metformin, a sulfonylurea, or a thiazolidinedione. BYETTA provides sustained
A1C control and low incidence of hypoglycemia when used 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. For full prescribing information,
visit www.BYETTA.com.

Important Safety Information for BYETTA
BYETTA improves glucose (blood sugar) control in adults with type 2 diabetes.
It is used with metformin, a sulfonylurea, or a thiazolidinedione. BYETTA is
not a substitute for insulin in patients whose diabetes requires insulin
treatment. BYETTA is not recommended for use in patients with severe problems
digesting food or those who have severe disease of the stomach or kidney.

When BYETTA is used with a medicine that contains a sulfonylurea, hypoglycemia
(low blood sugar) is a possible side effect. To reduce this possibility, the
dose of sulfonylurea medicine may need to be reduced while using BYETTA. Other
common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness,
headache, feeling jittery, and acid stomach. Nausea is the most common side
effect when first starting BYETTA, but decreases over time in most patients.

If patients experience the following severe and persistent symptoms (alone or
in combination): abdominal pain, nausea, vomiting, or diarrhea, they should
talk to their healthcare provider because these symptoms could be signs of
serious medical conditions. BYETTA may reduce appetite, the amount of food
eaten, and body weight. No changes in dose are needed for these side effects.
These are not all of the side effects from use of BYETTA. A healthcare
provider should be consulted about any side effect that is bothersome or does
not go away. For full prescribing information, visit www.BYETTA.com.

About Amylin, Lilly and Alkermes
Amylin, Lilly, and Alkermes are working together to develop exenatide once
weekly, a subcutaneous injection of exenatide for the treatment of type 2
diabetes based on Alkermes' proprietary technology for long-acting
medications. Exenatide once weekly is not currently approved by any regulatory
agencies.

Amylin Pharmaceuticals is a biopharmaceutical company committed to improving
lives through the discovery, development and commercialization of innovative
medicines. Amylin's research and development activities leverage the company's
expertise in metabolism to develop potential therapies to treat diabetes and
obesity. Amylin is headquartered in San Diego, California.

Through a long-standing commitment to diabetes care, Lilly provides patients
with breakthrough treatments that enable them to live longer, healthier and
fuller lives. Since 1923, Lilly has been the industry leader in pioneering
therapies to help healthcare professionals improve the lives of people with
diabetes, and research continues on innovative medicines to address the unmet
needs of patients.

Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Indiana, Lilly provides answers - through medicines and
information - for some of the world's most urgent medical needs.

Alkermes, Inc. is a fully integrated biotechnology company committed to
developing innovative medicines to improve patients' lives. Alkermes' robust
pipeline includes extended-release injectable, pulmonary and oral products for
the treatment of prevalent, chronic diseases, such as central nervous system
disorders, addiction and diabetes. Headquartered in Cambridge, Massachusetts,
Alkermes has research facilities in Massachusetts and a commercial
manufacturing facility in Ohio.

This press release contains forward-looking statements about Amylin, Lilly and
Alkermes and the investigational drug, exenatide once weekly. Actual results
could differ materially from those discussed or implied in this press release
due to a number of risks and uncertainties, including the risk that BYETTA
and/or the approval of exenatide once weekly and the revenues generated from
BYETTA and/or exenatide once weekly may be affected by competition; unexpected
new data; safety and technical issues; pre-clinical trial results; clinical
trials, including the clinical trials mentioned in this press release, not
being completed in a timely manner, not confirming previous results, or not
achieving the intended clinical endpoints; the DURATION-1 study extension
results potentially not being accepted to support comparability; label
expansion requests or NDA filings, including the NDA filing mentioned in this
press release, not being submitted and/or accepted in a timely manner;
regulatory approval being delayed or not received; or manufacturing and supply
issues. The potential for BYETTA and/or exenatide once weekly may also be
affected by government and commercial reimbursement and pricing decisions, the
pace of market acceptance, or scientific, regulatory and other issues and
risks inherent in the development and commercialization of pharmaceutical
products including those inherent in the collaboration with and dependence
upon Amylin, Lilly and/or Alkermes. These and additional risks and
uncertainties are described more fully in Amylin's, Lilly's and Alkermes' most
recent SEC filings including their Quarterly Reports on Form 10-Q and Annual
Reports on Form 10-K. Amylin, Lilly and Alkermes undertake no duty to update
these forward-looking statements.

P-LLY

(i) "All About Diabetes." American Diabetes Association. Available at:
http://www.diabetes.org/about-diabetes.jsp. Accessed March 28, 2009.

(ii) The International Diabetes Federation Diabetes Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
Accessed March 28, 2009.

(iii) "Direct and Indirect Costs of Diabetes in the United States." American
Diabetes Association. Available at:
http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp.
Accessed March 28, 2009.

(iv) Saydah SH, Fradkin J and Cowie CC. "Poor control of risk factors for
vascular disease among adults with previously diagnosed diabetes." JAMA:
291(3), January 21, 2004.

(v) Bays HE, Chapman RH, Grandy S. The relationship of body mass index to
diabetes mellitus, hypertension and dyslipidaemia: comparison of data from two
national surveys. Int J Clin Pract. 2007;61:737-47.

(vi) Nutrition Recommendations and Interventions for Diabetes: a position
statement of the American Diabetes Association. Diabetes Care. 2008;31 Suppl
1:S61-78.

(vii) Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in
type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll
Nutr. 2003;22:331-9.

SOURCE Amylin Pharmaceuticals, Inc.

Anne Erickson of Amylin Pharmaceuticals, Inc., +1-858-754-4443, or cell,
+1-858-349-3195, anne.erickson@amylin.com; or Kindra Strupp of Lilly,
+1-317-277-5170, or cell, +1-317-554-9577, kstrupp@lilly.com; or Rebecca
Peterson of Alkermes, +1-617-583-6378, or cell, +1-617-899-2447,
rebecca.peterson@alkermes.com