Program, which originally focused on Zealand’s Lixisenatide, will evaluate the addition of Lantus.
Zealand Pharma reports that its global licensing agreement with sanofi-aventis has been amended to provide for the development and commercialization of Lixisenatide in combination with Lantus®, sanofi-aventis’ recombinant human insulin analog. The original arrangement covered Lixisenatide alone and comprised nineclinical studies within the GetGoal Phase III program, which began in May 2008.
Lixisenatide, discovered at Zealand, is a GLP-1 (glucagon-like-peptide-1) receptor agonist for the treatment of type 2 diabetes. It uses Zealand’s SIP™ (structure inducing probe) peptide-modification technology. Lantus is sanofi-aventis’ number one brand with 2009 sales of more than €3 billion, according to Zealand. Phase III investigations for the Lantus plus Lixisenatide regimen is expected to commence later this year.
In April sanofi-aventis reported positive Phase III results from the first trial within the GetGoal program. NDA filing of Lixisenatide is expected to take place in the second quarter of 2011 in Europe and the second quarter of 2012 in the U.S.
The companies restructured the financial terms of the agreement to provide Zealand with payments for the achievement of development, regulatory, and sales milestones for the Lantus + Lixisenatide combination product. Royalties to Zealand for Lixisenatide and the Lantus + Lixisenatide combination product as well as other nondisclosed provisions of the agreement were also revised, although details were not disclosed.