BYDUREON RECEIVES MARKETING AUTHORIZATION IN EUROPE

INDIANAPOLIS, SAN DIEGO and WALTHAM, Mass., June 21, 2011 /PRNewswire/ — Eli
Lilly and Company (NYSE: LLY), together with Amylin Pharmaceuticals, Inc.
(Nasdaq: AMLN) and Alkermes, Inc. (Nasdaq: ALKS), announced today that the
European Commission has granted marketing authorization to BYDUREON(TM)
(exenatide 2 mg powder and solvent for prolonged release suspension for
injection).

BYDUREON, a glucagon-like peptide-1 (GLP-1) receptor agonist, is the first
once-weekly treatment for type 2 diabetes. It delivers glycemic control in a
single weekly dose and is indicated for the treatment of type 2 diabetes in
adult patients in combination with metformin, a sulfonylurea, a
thiazolidinedione, metformin plus a sulfonylurea or metformin plus a
thiazolidinedione.

“As the global impact of diabetes continues to expand, so does the need for
innovative medicines to help people living with diabetes successfully fit
treatment into their lives,” said Enrique Conterno, president, Lilly Diabetes.
“BYDUREON is the first and only once-weekly treatment for type 2 diabetes and
has demonstrated powerful efficacy in multiple clinical trials.”

The EU Marketing Authorization of BYDUREON is based on review of the submission
package, including data from studies in the DURATION clinical program in which
exenatide resulted in improvements in glycemic control with just one dose per
week. In the data submitted, BYDUREON showed statistically significant
improvements in glycemic control based on reduction of A1C (a measure of average
blood sugar over three months) between 1.5 and 1.9 percent after six months.
Although BYDUREON was not studied as a weight-loss product, most patients taking
BYDUREON lost weight. Further, the BYDUREON submission builds upon six years of
market experience with BYETTA® (exenatide) injection, the twice-daily form of
exenatide that is available in more than 70 countries worldwide. The most common
side effect with BYDUREON in clinical trials was mild-to-moderate nausea, which
affected approximately 20 percent of patients and decreased over time in most
patients. Other common side effects were vomiting, diarrhea and constipation.

In the U.S., the New Drug Application for BYDUREON (exenatide extended-release
for injectable suspension) was submitted to the U.S. Food and Drug
Administration (FDA) in 2009. The FDA issued a complete response letter and
requested further data in late 2010. The companies plan to submit a response in
the second half of 2011. BYDUREON is the proposed trade name.

BYDUREON is delivered using a biodegradable microsphere technology developed by
Alkermes. The medicine offers a continuous release of exenatide with just one
weekly dose.

About Diabetes

Diabetes affects an estimated 285 million adults worldwide and nearly 26 million
people in the U.S.(1),(2) Approximately 90-95 percent of those affected have
type 2 diabetes. Diabetes costs exceed $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 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 postmarketing 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 was approved in the EU in June 2011 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.

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 as soon as anticipated or at
all; the companies’ response to the FDA’s complete response letter may not be
submitted in a timely manner and/or the information provided in such response
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 not receiving regulatory approval; the commercial launch of BYDUREON
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

(1) Diabetes Statistics. American Diabetes Association. Available at
http://www.diabetes.org/diabetes-basics/diabetes-statistics/. Accessed June 14,
2011.

(2) The International Diabetes Federation Diabetes Atlas. Available at:

http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010.

Accessed June 14, 2011.

(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 June 14, 2011.

(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 2008; 31 Suppl 1;
S61-78.

(7) 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.

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SOURCE Amylin Pharmaceuticals, Inc.