Zealand Pharma Announces An Extension of The Lixisenatide Global Licensing Agreement with sanofi-aventis for Type-2 Diabetes

08-Jun-2010 - Denmark

Zealand Pharma A/S announced that the global licensing agreement with sanofi-aventis has been amended to provide for the development and commercialization of Lixisenatide (AVE0010/ZP10) in combination with Lantus®, sanofi-aventis' recombinant human insulin analog.

Lixisenatide is a Zealand-invented GLP-1 (glucagon-like-peptide-1) receptor agonist for the treatment of Type-2 Diabetes, and uses Zealand's proprietary SIP(TM) (structure inducing probe) peptide modification technology. In April 2010, sanofi-aventis reported positive Phase III results from the first of nine clinical studies within the Lixisenatide GetGoal Phase III program. Filing of Lixisenatide is expected to take place in H2 2011 in Europe & H2 2012 in the US.

The Phase III clinical program for the Lantus® + Lixisenatide combination product is expected to commence in 2010. Zealand knows of no similar Type-2 Diabetes product that is as advanced in clinical testing.

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. Zealand expects to receive a part of such payments in 2010 as the combination product advances into Phase III. Royalties (low double digits) to Zealand for Lixisenatide and the Lantus® + Lixisenatide combination product as well as other non-disclosed provisions of the agreement have been further amended providing value for both companies.

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