Judge vacates Amylin injunction against Eli Lilly; latter updates Humalog label

It was a good news day for US drug major Eli Lilly (NYSE: LLY) yesterday, as the firm received approval for new labeling for its Humalog (insulin lispro injection [rDNA origin]), and the US District Court for the Southern District of California ruled in Lilly's favor, vacating a temporary restraining order and denying a request by Amylin Pharmaceuticals (Nasdaq: AMLN) for a preliminary injunction that sought to impose restrictions on the Lilly Diabetes sales force and other relief. Amylin recently filed litigation involving the two companies' diabetes collaboration agreement (The Pharma Letter May 27).

Amylin alleged that Lilly was engaging in improper, unlawful and anticompetitive behavior in the manner in which it plans to implement its recently announced global alliance agreement with independent German drug major Boehringer Ingelheim to jointly develop and commercialize the latter’s diabetes drug candidate linagliptin product (The Pharma Letter January 12), which will compete directly with Amylin's exenatide products. The US Food and Drug Administration recently approved linagliptin, which carries the trade name Tradjenta (TPL May 4), and the temporary injunction stalled launch of the new product.

"We are pleased with the Court's decision to vacate the temporary restraining order and deny Amylin's request for a preliminary injunction," said Robert Armitage, senior vice president and general counsel for Lilly. "We have complied with our contractual obligations under our agreements with Amylin, and done so in a manner fully consistent with all applicable laws. We believe that Amylin's allegations against Lilly are entirely without merit and we fully expect to prevail in this litigation," he added.