Lilly Provides Statement in Response to Amylin Lawsuit

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May 16, 2011, 09:53 ET

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^™ (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

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SOURCE Eli Lilly and Company