Amylin Pharmaceuticals files suit against Eli Lilly
Lilly denies alleged anticompetitive activity and breach of strategic alliance agreements
Biopharmaceutical company Amylin Pharmaceuticals has filed a lawsuit and motion for temporary restraining order against Eli Lilly and Company in the US District Court for the Southern District of California, alleging that Lilly is engaging in anticompetitive activity and breaching its strategic alliance agreements with Amylin to maximise commercialisation of exenatide.
In 2002, Amylin entered an alliance with Lilly for the global development and commercialisation of exenatide, a first line treatment for type 2 diabetes that is currently marketed as BYETTA 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.
Amylin alleges that Lilly is engaging in improper, unlawful and anticompetitive behaviour in the manner in which it plans to implement its recently announced global alliance agreement with Boehringer Ingelheim to jointly develop and commercialise Boehringer's linagliptin product, which will compete directly with Amylin's exenatide products. The principal relief Amylin seeks is to prevent Lilly from proceeding with its plans to use the same sales force to sell both exenatide and linagliptin.
‘Amylin selected Lilly as a partner to promote development and maximise 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,’ the company said in a statement. ‘Amylin is committed to exenatide… Notwithstanding this litigation, we intend to continue to collaborate with Lilly in the development and commercialisation of exenatide products.’
Lilly believes that the lawsuit is without merit and says it will vigorously defend its position. ‘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. We look forward to building on the alliance's success achieved to date.’
In a statement the company added that 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 and in the development of BYDUREON, which received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) in April.
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, the company said. ‘We greatly value our collaborative alliance with Amylin and are extremely proud of our work in bringing BYETTA to market and in developing BYDUREON.’
