AMLN Amylin Pharmaceuticals, Inc. (MM)

Amylin Pharmaceuticals, Inc. (AMLN) is suing its exenatide partner Eli Lilly and Company (LLY) in the US District Court for the Southern District of California. According to Amylin, Eli Lilly has violated its agreement with Amylin for exenatide. Amylin believes that Eli Lilly is engaging in anticompetitive activities thereby breaching its agreement for the maximization of sales of exenatide.

Exenatide Partnership Dates Back to 2002

Amylin and Eli Lilly’s partnership dates back to 2002 when the companies entered into a global development and commercialization agreement for exenatide. Exenatide is currently available under the trade name, Byetta. It is also being developed as a once-weekly treatment (Bydureon) of type II diabetes.

While Eli Lilly co-promotes Byetta in the US with Amylin, the former is primarily responsible for the ex-US development and commercialization of Byetta and any sustained-release formulations like Bydureon.

Concern Stems from Eli Lilly’s Agreement with Boehringer Ingelheim

Amylin’s main complaint is regarding Eli Lilly’s recent global alliance with Boehringer Ingelheim for the development and commercialization of type II diabetes product, Tradjenta (linagliptin). According to Amylin, Tradjenta, which received US Food and Drug Administration (FDA) approval earlier this month, will compete directly with the exenatide family.

Amylin believes the manner in which Eli Lilly intends to implement the Tradjenta agreement shows that Eli Lilly is behaving in an improper, unlawful and anticompetitive manner. Amylin, which is seeking a preliminary and permanent injunction, is looking to stop Eli Lilly from using the same sales force for promoting both Byetta and Tradjenta.

Eli Lilly’s Response

In response to Amylin’s lawsuit, Eli Lilly issued a statement denying the allegation. The company said that it has always contributed significant resources and know-how to the exenatide collaboration and remains committed to the alliance.

The company said that its alliances with Amylin and Boehringer Ingelheim reflect its strategy of providing diabetes patients with more treatment options.

Conclusion

There could be several outcomes to this lawsuit. While a decision could be delivered in favor of either Amylin or Eli Lilly, the companies could also decide to terminate the collaboration. Another outcome could be an amicable settlement between the companies. Meanwhile, investor focus will remain on the results of the thorough QT (tQT) study being conducted for gaining FDA approval of Bydureon. EU approval of Bydureon is expected by late June. 

 
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