Amylin Pharmaceuticals, Inc. announced that the United States District Court for the Southern District of California issued a temporary restraining order (TRO) against Eli Lilly and Company relating to its litigation with respect to the Amylin/Lilly diabetes collaboration agreement.
The US District Court restrained Lilly from proceeding with its plans to use the same sales force to sell both exenatide and Boehringer Ingelheim GmbH's competitive linagliptin. The court also enjoined Lilly from disclosing any confidential information about exenatide to any of its sales representatives or employees participating in the marketing, promotion or sale of linagliptin.
The complete order is being filed on Amylin's Current Report on Form 8-K with the Securities and Exchange Commission.
In 2002, Amylin entered an alliance with Lilly for the global development and commercialization of exenatide, a medicine indicated as a first line treatment for type 2 diabetes that is currently marketed as Byetta (exenatide) injection. Exenatide is also the active ingredient in Bydureon (exenatide extended-release for injectable suspension), a once-weekly version currently under review by the FDA.
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 programme. 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.
Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines.