Amylin Pharmaceuticals Inc. is suing Eli Lilly and Company for engaging in uncompetitive behaviour and violating a strategic alliance between the two companies regarding the development and commercialization of diabetes drug exenatide. Amylin says Lilly has teamed up with Boehringer Ingelheim to develop a competing diabetes medication.

Amylin and Lilly entered an alliance in 2002 for the worldwide commercialization and development of exenatide, currently marketed as Byetta (exenatide) injection, indicated as a first line treatment for type 2 diabetes.

Bydureon (exenatide extended-release for injectable suspension), a once-weekly version which is currently being reviewed by the FDA, also has the active ingredient exenatide.

San Diego-based Amylin accuses Indianapolis-based Lilly of “engaging in improper, unlawful and anticompetitive behaviour” by forming a global alliance with Boehringer Ingelheim GmbH of Germany, to commercialize and develop that company’s linagliptin product – a direct competitor of Amylin’s exenatide-containing medications.

Amylin’s main concern is to stop Lilly from using its same sales people from selling both competing products simultaneously.

In a communiqué, Amylin wrote:

“Amylin selected Lilly as a partner to promote development and maximize sales of Amylin’s exenatide products. 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.”

Enrique Conterno, president of Lilly Diabetes, said:

“We believe the lawsuit is without merit and will vigorously defend our position. 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.”

Written by Christian Nordqvist