Amylin Injunction Request Denied in Byetta Lawsuit Against Eli Lilly

A federal judge has refused to block Eli Lilly from promoting a new diabetes drug, Tradjenta, which Amylin Pharmaceuticals claims is a violation of a contract the two drug makers have to promote their own diabetes treatment, Byetta. 

Amylin Pharmaceuticals’ request for a preliminary injunction against Eli Lilly was denied last week in the U.S. District Court for the Southern District of California.

In the Byetta lawsuit, Amylin attorneys claimed that Eli Lilly plans to use the same sales force that promotes Byetta to promote Tradjenta, another type 2 diabetes drug Lilly has agreed to distribute for Boehringer Ingelheim. Amylin wants to stop the deal between the two companies, claiming that it represented a breach of contract between Amylin and Lilly over Byetta distribution.

According to allegations raised in their lawsuit over the Byetta marketing agreement, Amylin alleges that Tradjenta would be a direct competitor for Byetta, and that Eli Lilly would have a conflict of interests in choosing which drug is promoted better.

Eli Lilly has called Amylin’s claims groundless, and has pointed out that Tradjenta is s tablet and Byetta is an injection. Eli Lilly officials say that even though they are both for the treatment of type 2 diabetes, injection drugs and pills are not considered competing products.

Amylin issued a press release on June 8, saying that the company was disappointed in the court’s decision to deny the requested injunction, but planned to proceed with its lawsuit against Eli Lilly.

“It is important to note that the Court’s decision did not make any findings on the merits of our claims, but merely declines to award injunctive relief, based on the conclusion that monetary damages would be sufficient,” the press release states. ” We intend to vigorously pursue the litigation to enforce our legal and contractual rights.”

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, the once-promising diabetes drug has been hit with mounting concerns over potential side effects of Byetta, after the drug has been linked to reports of kidney failure and pancreatitis. A number of former users of the medication are also pursuing Byetta injury lawsuits against Eli Lilly and Amylin over the failure to adequately research the potential side effects of the medication or warn about the risk of health problems from Byetta.

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.

Last year, Amylin and Lilly faced delays in approval for a new once-weekly version of Byetta, after the FDA indicated the companies need to answer certain questions about the manufacturing processes and how they intend to mitigate the potential health risks for users.