Lawsuit Over Byetta Marketing Agreement Filed by Amylin Against Eli Lilly

Amylin Pharmaceuticals is suing Eli Lilly, saying that the drug company violated an agreement over the marketing of their joint diabetes drug Byetta by allying with another drug company to sell a competing product. 

The Byetta lawsuit was filed in the U.S. District Court for the Southern District of California, accusing Eli Lilly of violating federal laws and engaging in anti-competitive practices by partnering with Boehringer Ingelheim to develop and market Tradjenta, which was recently approved by the FDA for the treatment of diabetes.

Amylin and Eli Lilly had a similar agreement for Byetta, and were also working together to get a longer acting version of the drug, which will be marketed as Bydureon, onto the market in the United States.

According to allegations raised in their lawsuit over the Byetta marketing agreement, Amylin alleges that Tradjenta would be a direct competitor for Byetta, and Eli Lilly would be able to use the same marketing people on both drugs, giving it the ability to choose which drug is promoted better.

Eli Lilly released a press release on Monday, denying that Tradjenta would compete with Byetta, and indicated that the company committed no crime in allying itself with Boehringer Ingelheim. 

Byetta (exenatide) is used to control blood sugar levels and is part of a class of medications known as incretin mimetics, which imitate natural hormones that lower blood glucose levels. In recent years, FDA adverse event reports have raised concerns about a link between Byetta and a risk of kidney failure and pancreatitis.

Concerns about pancreatitis from Byetta first surfaced in 2007, when the FDA issued an alert indicating that the drug had been linked to at least 30 reports of acute pancreatitis. In August 2008, the FDA notified doctors about six more cases of severe pancreatitis with Byetta, including two deaths. Following the FDA announcement, the drug makers disclosed that they were aware of at least four other pancreatitis deaths among Byetta users.

In November 2009, the FDA issued warnings about a potential risk of Byetta kidney problems after receiving reports of users developing kidney insufficiency, including at least 62 cases of kidney failure from Byetta.

Amylin and Eli Lilly currently face a number of potential Byetta lawsuits over failure to adequately research the potential side effects of the medication or warn about the risk of pancreatitis and kidney failure from Byetta.