Amylin, Lilly and Alkermes Submit Reply to FDA Complete Response Letter for BYDUREON

Classification of Submission and New PDUFA Action Date Expected Within 14 Days,
per FDA Guidelines

SAN DIEGO, INDIANAPOLIS & WALTHAM, Mass.--(Business Wire)--
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY)
and Alkermes, Inc. (Nasdaq: ALKS) today announced that the companies have
submitted their reply to a complete response letter issued last month by the
U.S. Food and Drug Administration (FDA) after review of the New Drug Application
(NDA) submission for BYDUREON (exenatide for extended-release injectable
suspension). In accordance with its guidelines, the FDA is expected to classify
the complete response as a Class 1 or Class 2 resubmission, and also provide the
companies with an updated Prescription Drug User Fee Act (PDUFA) target action
date within the next two weeks.

The companies` reply addresses requests from the FDA primarily related to
finalization of the product labeling with accompanying Risk Evaluation and
Mitigation Strategy (REMS) and clarification of existing manufacturing
processes.

The FDA`s complete response letter did not request new pre-clinical or clinical
trials, nor did it contain requests related to the December 2009 observations
from the FDA`s pre-approval inspection at the Ohio manufacturing facility. All
of these observations have been addressed.

"The companies have worked diligently and quickly over the last few weeks to
submit a complete response and are confident we addressed the requests that were
outlined by the FDA," said Orville G. Kolterman, M.D., senior vice president of
research and development, Amylin Pharmaceuticals. "We are committed to making
BYDUREON available to patients as soon as possible and will continue to work
closely with the agency toward our goal."

BYDUREON (pronounced by-DUR-ee-on) is the proposed brand name for exenatide once
weekly. It is an investigational, extended-release medication for type 2
diabetes designed to deliver continuous therapeutic levels of exenatide in a
single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the
active ingredient in BYETTA® (exenatide) injection, which has been available in
the U.S. since June 2005 and is used in approximately 60 countries worldwide to
improve glycemic control in adults with type 2 diabetes. BYDUREON and BYETTA
belong to the glucagon-like peptide-1 (GLP-1) receptor agonist class of
medications.

The NDA for BYDUREON was submitted in May 2009 and was based on data from the
DURATION clinical trial program, as well as more than seven years of clinical
experience with BYETTA. The NDA was accepted by the FDA in July 2009. The agency
issued a complete response letter to the companies in March 2010.

About Diabetes

Diabetes affects more than 24 million people in the U.S. and an estimated 285
million adults worldwide.1,2 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.3

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.4 In addition, 85 percent of type 2 diabetes patients are
overweight and 55 percent are considered obese.5 Data indicate that weight loss
(even a modest amount) supports patients in their efforts to achieve and sustain
glycemic control.6,7

About BYETTA® (exenatide) injection

BYETTA is the first FDA-approved GLP-1 receptor agonist 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 an injectable prescription medicine that may improve blood sugar
(glucose) control in adults with type 2 diabetes mellitus, when used with a diet
and exercise program. BYETTA is not insulin and should not be taken instead of
insulin. BYETTA is not recommended to be taken with insulin. BYETTA is not for
people with type 1 diabetes or people with diabetic ketoacidosis.

BYETTA provides sustained A1C control and low incidence of hypoglycemia when
used alone or in combination 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. See important safety information below. Additional information
about BYETTA is at www.BYETTA.com.

Important Safety Information for BYETTA® (exenatide) injection

Based on post-marketing data, BYETTA has been associated with acute
pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing
pancreatitis. The risk for getting low blood sugar is higher if BYETTA is taken
with another medicine that can cause low blood sugar, such as a sulfonylurea.
BYETTA should not be used in people who have severe kidney problems, and should
be used with caution in people who have had a kidney transplant. Patients should
talk with their healthcare provider if they have severe problems with their
stomach, such as delayed emptying of the stomach (gastroparesis) or problems
with digesting food. Severe allergic reactions can happen with BYETTA.

The most common side effects with BYETTA include nausea, vomiting, diarrhea,
dizziness, headache, feeling jittery, and acid stomach. Nausea most commonly
happens when first starting BYETTA, but may become less over time.

These are not all 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 additional important safety information about BYETTA, please see the full
Prescribing Information (http://pi.lilly.com/us/byetta-pi.pdf) and Medication
Guide (http://pi.lilly.com/us/byetta-ppi.pdf).

About Amylin, Lilly and Alkermes

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

Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving
lives of patients 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 Waltham, Massachusetts,
Alkermes has a research facility in Massachusetts and a commercial manufacturing
facility in Ohio.

This press release contains forward-looking statements about Amylin, Lilly and
Alkermes. 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 BYDUREON may not be approved by the FDA in a timely manner or at all;
the information provided in the companies` response to the FDA`s complete
response letter may not satisfy the FDA; the FDA may request additional
information prior to approval; BYETTA and/or the approval of BYDUREON and the
revenues generated from these products may be affected by competition;
unexpected new data; safety and technical issues; clinical trials not being
completed in a timely manner, not confirming previous results, not being
predictive of real world use or not achieving the intended clinical endpoints;
label expansion requests or NDA filings, such as the NDA filing for BYDUREON
mentioned in this press release, not receiving regulatory approval; the
commercial launch of BYDUREON, if approved, being delayed; or manufacturing and
supply issues. The potential for BYETTA and/or BYDUREON 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.

BYDUREON and BYETTA® are trademarks of Amylin Pharmaceuticals, Inc., and
Medisorb® is a registered trademark of Alkermes, Inc.

1 The International Diabetes Federation Diabetes Atlas. Available at:
http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010.
Accessed April 4, 2010.

2 Diabetes Statistics. American Diabetes Association. Available at
http://www.diabetes.org/diabetes-basics/diabetes-statistics/. Accessed April 4,
2010.

3 Direct and Indirect Costs of Diabetes in the United States. American Diabetes
Association. Available at:
http://www.diabetes.org/how-to-help/action/resources/cost-of-diabetes.html.
Accessed April 4, 2010.

4 Saydah SH, Fradkin J and Cowie CC. Poor control of risk factors for vascular
disease among adults with previously diagnosed diabetes. JAMA. 2004;291:335-42.

5 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.

6 Nutrition Recommendations and Interventions for Diabetes: a position statement
of the American Diabetes Association. Diabetes Care. 2007;30 Suppl 1:S48-65. 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, 781-609-6378
Cell: 617-899-2447
rebecca.peterson@alkermes.com

Copyright Business Wire 2010