Lilly, Amylin, and Alkermes hit back with once-weekly exenetide filing.

Published trial data suggests Novo Nordisk’s type 2 diabetes candidate, liraglutide, is better at lowering HbA1c levels than Byetta® (exenatide), the GLP-1 receptor agonist marketed by Eli Lilly and Amylin Pharmaceuticals. Liraglutide has been recommended for approval by the European Medicines Agency’s CHMP, and was submitted for approval in the U.S. and Japan during 2008.

The study, one of a number of LEAD trials evaluating liraglutide, included 464 patients with type 2 diabetes who were not reaching recommended sugar targets on either the maximum tolerated dose of metformin, sylphonylurea, or both. The trial data is reported in The Lancet.

Data from the LEAD™ (liraglutide effect and action in diabetes) 6 study, which directly compared the effects of twice-daily treatment with exenatide and once-daily liraglutide,  showed treatment with the GLP-1 analogue, liraglutide, led to a 1.2% drop in HbA1c levels, while exenatide therapy lowered HbA1c by 0.79% drop in HbA1c. The investigational drug was also significantly better at lowering fasting plasma glucose levels than exenatide.

“Because of the differences in how the body absorbs and eliminates these two compounds, we were very interested to see if there were clinically meaningful differences in the effect in people with diabetes”, comments principal study investigator, John Buse, M.D., chief of endocrinology and director of the Diabetes Care Center at the University of North Carolina School of Medicine. “The clinical benefits that liraglutide provides, from greater glucose lowering to weight loss to better tolerability and improvements in beta-cell function, represent a clinically meaningful treatment advance for patients with type 2 diabetes.

Byetta, the twice-daily formulation of exenatide, was jointly developed and commercialized by Lilly and Amylin Pharmaceuticals. The drug was approved in the U.S. in 2005 and in the EU the following year.   Amylin and Lilly have also collaborated with Alkermes to develop a once-weekly formulation of the drug, which was submitted to the FDA for approval in May 2009.

Amylin reported net sales of Byetta were $678.5 million in 2008, compared with $636 million in 2007. Prescriptions for the drug took a dip during the second half of 2008, following the FDA’s update of a prior pancreatitis alert, but Amylin said this decline stabilized by the end of Q4 2008.  Lilly reported worldwide sales of Byetta were $751.4 million in 2008 up 16% over the previous year, with its revenues increasing 20%, to $396.1 million.

Under terms of the exenatide development and commercialization agreement between Lilly and Amylin, signed in 2002, the companies are sharing the U.S. development and commercialization costs of exenatide formulations and also development costs outside the U.S. Lilly is responsible for commercialization costs in non-U.S. markets. The companies are also equally sharing operating profits from exenatide products sold in the U.S., with Amylin receiving royalties on non-U.S. product sales.

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