Lilly accused of anti-competitive practices
pharmafile | May 17, 2011 | News story | | Amylin, Boehringer, diabetes, exenatide, lilly, linagliptin
Amylin Pharmaceuticals is suing Eli Lilly and Company for alleged anticompetitive activity around Lilly’s January agreement with Boehringer Ingelheim to promote linagliptin.
The problem stems from Amylin’s own 2002 alliance with Lilly to develop and commercialise exenatide, currently marketed as the first line injectable type II diabetes treatment Byetta.
Linagliptin – one of the drugs in the Lilly/Boehringer deal – is the active ingredient in Tradjenta, Boehringer’s own once-daily oral type II diabetes drug, which was approved by the FDA this month.
Amylin’s lawsuit, filed in the US District Court for the Southern District of California, seeks to prevent Lilly using the same sales force to sell both GLP-1 receptor agonist Byetta and Tradjenta.
Amylin contends that, by promoting Boehringer’s DPP-4 inhibitor, Lilly is breaching its strategic alliance agreements to maximise commercialisation of exenatide.
But Lilly sees no problem since the delivery systems of the Amylin and Boehringer drugs are completely different and said all it wants to do is give greater choice to doctors and patients.
“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,” insisted Lilly Diabetes president Enrique Conterno.
“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,” he added.
In its own statement, Amylin said: “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 II diabetes.”
Despite dubbing Lilly’s actions “improper, unlawful and anticompetitive”, Amylin does not intend to walk away from its collaboration with the company.
Lilly has likewise said it is committed to fulfilling its obligations under the exenatide agreement and looks forward to working with Amylin.
But Lilly has still dismissed Amylin’s claims out of hand. “We believe the lawsuit is without merit and will vigorously defend our position,” said Conterno. “Our mission as a company is to bring needed therapeutic solutions to patients.”
“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,” he added. “We emphatically reject the allegation that we did not meet our contractual obligations under the Lilly and Amylin alliance.”
Conterno points out that 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”.
Bydureon, a once-weekly version of the drug, has exenatide as its main ingredient and received a positive opinion from the European Committee for Medicinal Products for Human Use in April.
In the US the FDA has issued Lilly and Amylin with a complete response letter on Bydureon, which Lilly said they would respond to in the second half of 2011.
Adam Hill
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