New Drug Application for Exenatide Once Weekly Accepted for Review by FDA

SAN DIEGO, INDIANAPOLIS & CAMBRIDGE, Mass.--(Business Wire)--
Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY)
and Alkermes, Inc. (Nasdaq: ALKS) today announced that the New Drug Application
(NDA) for exenatide once weekly has been accepted for review by 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® (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.

"Acceptance of the NDA submission for exenatide once weekly is an important
milestone both in the exenatide development program and in the treatment of type
2 diabetes," said Orville G. Kolterman, M.D., senior vice president of research
and development at Amylin Pharmaceuticals. "If approved, this therapy could fill
an important unmet need for treating patients with type 2 diabetes with just one
dose per week."

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 results in 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 indicate that weight
loss (even a modest amount) supports patients in their efforts to achieve and
sustain glycemic control.(vi,vii)

About BYETTA® (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 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 not being completed in a timely manner, not confirming previous results,
or not achieving the intended clinical endpoints; label expansion requests or
NDA filings 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.

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

Copyright Business Wire 2009