Eli Lilly and Company has provided additional perspective in response to Amylin Pharmaceuticals, Inc.'s lawsuit filed in the United States District Court for the Southern District of California. The lawsuit alleges that Lilly is not using commercially reasonable efforts to support the success of Byetta (exenatide injection) and ultimately, Bydureon (exenatide extended-release for injectable suspension).
"We emphatically reject the allegation that we did not meet our contractual obligations under the Lilly and Amylin alliance," 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."
More options for patients — Given that diabetes is a complex and chronic condition, patients and their health care providers need choices throughout the progression of the disease. Our strategy in Lilly Diabetes is to offer a broad range of treatment options.
Our pursuit of this strategy through collaborations with partners such as Amylin and Boehringer Ingelheim allows us to educate physicians more effectively and efficiently about a broad range of treatment options. Contrary to the suggestions in Amylin's complaint, Lilly's actions encourage competition and benefit diabetes patients for whom there is significant unmet need today.
Regarding Byetta and Tradjenta (linagliptin) tablets, our broad market experience teaches us that injectables like Byetta generally compete with other injectable treatments in the class rather than with oral anti-diabetic agents.
No breach of contract — The Lilly and Amylin alliance contract specifically provides for Lilly's ability to develop and market a full range of diabetes treatment options for patients.
Since the alliance's inception in 2002, Lilly has upheld its obligations (including those related to confidentiality) under the various Amylin alliance agreements. Lilly has devoted significant talent, resources, and know-how to the alliance's efforts and has been instrumental in the success of the marketed medicine Byetta and in the development of Bydureon.
We greatly value our collaborative alliance with Amylin and are extremely proud of our work in bringing Byetta to market and in developing Bydureon. Byetta is an important treatment option for health care professionals and their patients with type 2 diabetes.
Lilly's commitment — We are dedicated to patients, health care professionals and all our partners who help us achieve our mission of making medicines that help people live longer, healthier, more active lives.
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 US in April 2005 and in Europe in November 2006 and has been used by more than 1.8 million patients since its introduction.
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.