Lilly Provides Statement in Response to Amylin Lawsuit

INDIANAPOLIS, May 16, 2011 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) has
provided the following statement in response to a lawsuit and motion for
temporary restraining order filed by Amylin Pharmaceuticals, Inc. against Lilly.
The action was filed in the United States District Court for the Southern
District of California.

“We believe the lawsuit is without merit and will vigorously defend our
position,” said Enrique Conterno, president of Lilly Diabetes. “Lilly has been
and remains fully committed to fulfilling its obligations under its exenatide
collaboration agreement with Amylin, as well as to complying with all laws and
regulations. We look forward to building on the alliance’s success achieved to
date.”

“Our mission as a company is to bring needed therapeutic solutions to patients,”
added Conterno. “Significant unmet need exists among patients with diabetes, and
the condition’s prevalence and complications from it are projected to rise
sharply as we look to the future. Lilly has a strong heritage of bringing new
diabetes innovations to the market and we know that patients and health care
professionals want choices to treat this complex disease throughout its
progression.”

Since the alliance’s inception, Lilly has devoted significant talent, resources,
and know-how to the collaboration’s efforts and has been instrumental in the
success of the marketed medicine BYETTA® (exenatide injection) and in the
development of BYDUREON(TM) (exenatide extended-release for injectable
suspension), which received a positive opinion from the European Committee for
Medicinal Products for Human Use (CHMP) in April. The alliance plans to submit a
response to the U.S. Food and Drug Administration’s complete response letter in
the second half of 2011.

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

About Eli Lilly and Company

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, Ind., Lilly provides answers -
through medicines and information ? for some of the world’s most urgent medical
needs. Additional information about Lilly is available at www.lilly.com.

This press release contains forward-looking statements about exenatide and our
alliance with Amylin, and it reflects Lilly’s current beliefs. There are
substantial risks and uncertainties in the process of drug development and
commercialization. There is no guarantee that future study results and patient
experience will be consistent with study findings to date or that Bydureon will
be approved. There is also no guarantee that Byetta will continue to be, or that
Bydureon will prove to be, commercially successful. We cannot predict the
outcome of any litigation with Amylin or its effect on our collaboration. For
further discussion of risks and uncertainties, please see Lilly’s latest Forms
10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Lilly
undertakes no duty to update forward-looking statements.

C-LLY

SOURCE Eli Lilly and Company