Amylin Pharmaceuticals has succeeded in getting a temporary restraining order against Eli Lilly related to litigation involving the two companies' diabetes collaboration. Amylin reported on May 16 that it had filed a case against Lilly, stating that Lilly’s diabetes partnership with Boehringer Ingelheim (BI) conflicted with its own alliance with Lilly.
The U.S. District Court for the Southern District of California is restricting Lilly from proceeding with its plans to use the same sales force to sell both Amylin’s exenatide and BI’s linagliptin. The court also enjoined Lilly from disclosing any confidential information about exenatide to any of its sales representatives or employees participating in the marketing, promotion, or sale of linagliptin.
In 2002, Amylin inked a deal with Lilly for the global development and commercialization of exenatide, an injectable medicine indicated as a first-line treatment of type 2 diabetes. It is currently marketed as Byetta. The agreement also covered the long-acting exenatide formulation Bydureon. Last month this once-weekly version was recommended for approval in Europe by the EMA’s CHMP advisory committee. In the U.S., however, FDA has responded with two complete response letters, and the companies have said they hope to have data for the agency by year end.
While the setback with Bydureon first came in March 2010, in January of this year Lilly entered an arrangement with BI for the development and commercialization of the latter’s type 2 diabetes drug candidate, linagliptin. The medication was given the go-ahead by the FDA on May 3 and is under regulatory review in Europe and Japan.
Commenting on the court case, Enrique Conterno, president of Lilly Diabetes, says, "The focus of our business remains on the patients we serve. We seek to offer a broad range of treatment options, including important new therapies, to people with diabetes and their healthcare providers."
In Lilly’s full-year financial statement, the company reported that worldwide Byetta sales decreased 11% to $710.2 million. Specifically, U.S. sales dropped 16% to $559.3 million, while sales outside the U.S. went up 17% to $150.9 million.
By the first quarter of this year, Lilly reported a sales reduction both in the U.S. and outside, citing competitive pressures. Worldwide sales of Byetta were $165.4 million in the first quarter of 2011, down 12% from Q1 FY ’10. U.S. sales fell 15% to $128.0 million compared to the same period last year, while sales outside the U.S. decreased 2% to $37.4 million.
Lilly earns 50% of Byetta's gross margin in the U.S., 100% of sales outside the U.S., and 100% of sales of Byetta pen delivery devices to Amylin. Under the deal with BI, Lilly will earn 50% of the gross margin of linagliptin as well as other products covered in their alliance.
Besides linagliptin, BI and Lilly’s diabetes pact includes BI’s BI10773 and Lilly’s two basal insulin analogues LY2605541 and LY2963016. BI also has an option to co-develop and co-commercialize Lilly’s Phase II-stage anti-TGF-beta mAb. Both firms have the opportunity to earn milestone fees: BI could get an additional €625 million (about $884 million) and Lilly could receive up to $650 million.
Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor and is designed to be a once-daily oral treatment. BI10773 is a sodium-dependent glucose co-transporter-2 (SGLT-2) inhibitor that started in Phase III trials during 2010 as an oral medication. LY2605541 is reportedly a structurally novel basal insulin analogue, while LY2963016 is a new insulin glargine product.
Byetta and Bydureon are GLP-1 receptor agonists. In March 2010, FDA sent Amylin and Lilly a complete response letter raising concerns about product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes.
Then in October 2010, the companies received another complete response letter asking for a thorough QT (tQT) study with exposures of exenatide higher than typical therapeutic levels of Bydureon. Additionally, the agency has asked for results of the Duration-5 study to evaluate the efficacy and thus safety and effectiveness labeling details for the commercial formulation of Bydureon.