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news.Zealand Pharma, a biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs, has amended its global licensing agreement with Sanofi-aventis, to provide for the development and commercialisation of Lixisenatide (AVE0010/ZP10) in combination with Lantus, Sanofi-aventis' recombinant human insulin analog.
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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 (structure inducing probe) peptide modification technology.
Previously, in April 2010, Sanofi-aventis has 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. Zealand Pharma is expecting to initiate a Phase III clinical program for Lantus + Lixisenatide combination product in 2010.
Both the entities have 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.
David Solomon, president and CEO of Zealand Pharma, said: “This agreement not only strengthens Zealand’s financial position, allowing us to progress our other pipeline programs, but also provides significant excitement globally around a superior treatment for patients suffering with Type-2 Diabetes.
“We look forward to the ongoing clinical development of Lixisenatide and of the Lantus + Lixisenatide combination product. Our focus at Zealand continues to be to build shareholder value through the development of leading peptide-based drugs.”