BYDUREON FDA ACTION DATE SET FOR JANUARY 28, 2012

SAN DIEGO, INDIANAPOLIS, and WALTHAM, Mass., Aug. 10, 2011 /PRNewswire/ –
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY)
and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug
Administration (FDA) has acknowledged the companies’ BYDUREON(TM) (exenatide
extended-release for injectable suspension) resubmission. The FDA has
categorized it as a Class 2 resubmission requiring up to six months for review
and assigned a new Prescription Drug User Fee Act (PDUFA) action date of January
28, 2012. BYDUREON is an investigational medication for type 2 diabetes.

“If approved, we believe BYDUREON will be an important new option for type 2
diabetes patients, as the first once-weekly treatment available in the U.S.,”
said Christian Weyer, M.D., senior vice president, research and development,
Amylin Pharmaceuticals. “We will continue to work with the FDA through this
stage of the review process.”

BYDUREON is the proposed brand name for exenatide extended-release for
injectable suspension. It is 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 more than 70 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 New Drug Application (NDA) for BYDUREON was submitted in May 2009. It is
based on safety and efficacy data from the DURATION clinical trial program and
the BYETTA NDA, as well as post-marketing experience with BYETTA. The FDA issued
complete response letters to the companies in March 2010 and October 2010.

BYDUREON received marketing authorization in the European Union in June 2011. It
is available in the UK and will launch in other major European countries as soon
as possible.

About Diabetes

Diabetes affects nearly 26 million people in the U.S. and an estimated 347
million adults worldwide.(i)(ii) Approximately 90-95 percent of those affected
have type 2 diabetes. In the U.S., diabetes costs more than $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 was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be
approved by the FDA for the treatment of type 2 diabetes. BYETTA exhibits many
of the same effects as the human incretin hormone 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 currently recommended to be taken with insulin. BYETTA is
not for people with type 1 diabetes or people with diabetic ketoacidosis. BYETTA
has not been studied in people who have pancreatitis.

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 the U.S. in April 2005 and in Europe in November 2006 and has been used by
more than 1.8 million patients since its introduction. See important safety
information below. Additional information about BYETTA is available 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. Patients
should be observed for signs and symptoms of pancreatitis after initiation or
dose escalation of BYETTA. 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. Antibodies may develop with use
of BYETTA. Patients who develop high titers to exenatide could have worsening or
failure to achieve adequate glycemic control. Consider alternative therapy if
this occurs. Severe allergic reactions can happen with BYETTA. There have been
no clinical studies establishing conclusive evidence of macrovascular risk
reduction with BYETTA or any other antidiabetic drug.

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 safetyinformation about BYETTA, please see the full
Prescribing Information (www.byetta.com/pi) and Medication Guide
(www.byetta.com/mg).

About Amylin, Lilly and Alkermes

Amylin and Lilly partnered to develop and market BYDUREON, which is based on
proprietary technology for long-acting medications developed by Alkermes, Inc.
BYDUREON is approved in the EU and is under regulatory review in the U.S.

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 and has a commercial
manufacturing facility in Ohio.

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, 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 and oral products for the
treatment of prevalent, chronic diseases, such as central nervous system
disorders, addiction and diabetes. Headquartered in Waltham, Mass., 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 or royalties 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 in the United States, 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(TM) and BYETTA®are trademarks of Amylin Pharmaceuticals, Inc.

P-LLY

(i) Diabetes Statistics. American Diabetes Association. Available at:
http://www.diabetes.org/diabetes-basics/diabetes-statistics/. Accessed August 8,
2011.

(ii) Danaei G, et al. National, regional, and global trends in fasting plasma
glucose and diabetes prevalence since 1980: systematic analysis of health
examination surveys and epidemiological studies with 370 country-years and 2.7
million participants. Lancet. 2011;DOI:10.1016/S0140-6736(11)60679-X.

(iii) 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 August 8, 2011.

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

(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.; Eli Lilly and Company; Alkermes, Inc.