Amylin accuses Lilly of anticompetitive activity in diabetes drug development, commercialization

SAN DIEGO — Amylin Pharmaceuticals filed suit against Eli Lilly in federal court Monday concerning an agreement between the latter and German drug maker Boehringer Ingelheim to develop drugs for diabetes.

In a complaint filed in the U.S. District Court for the Southern District of California, Amylin said Lilly engaged in unlawful and anticompetitive activity in its development and commercialization agreement with BI for Tradjenta (linagliptin), an orally administered Type 2 diabetes drug that the Food and Drug Administration recently approved.

Since 2002, Lilly and Amylin have had a global development and commercialization agreement concerning the injectable Type 2 diabetes drug Byetta (exenatide). Amylin said that Tradjenta would directly compete with Byetta and Bydureon, a long-acting form of exenatide currently under FDA review and that Lilly had breached its contractual agreement with Amylin to maximize commercialization of exenatide products.

Amylin is seeking to prevent Lilly from using the same sales staff to sell Tradjenta and Byetta and Bydureon.

“Amylin selected Lilly as a partner to promote development and maximize sales of Amylin’s exenatide products,” a statement by Amylin read. “We are disappointed that we could not resolve this matter amicably and that we were forced to bring legal action to protect our rights our products and our shareholders. Amylin is committed to exenatide, a franchise that we believe provides important treatment options for the millions of patients around the world with Type 2 diabetes. Notwithstanding this litigation, we intend to continue to collaborate with Lilly in the development and commercialization of exenatide products.”

Lilly rejected Amylin’s allegations in a statement released soon after, saying that injectables, such as Byetta, usually compete against other injectables rather than against such orally administered drugs as Tradjenta and also said that the contract between Lilly and Amylin allows Lilly to develop and market “a full range of diabetes treatment options for patients.”

“We emphatically reject the allegation that we did not meet our contractual obligations under the Lilly and Amylin alliance,” Lilly Diabetes president Enrique Conterno said. “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.”

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