Sanofi files for EU approval of Lyxumia, a type-2 diabetes agent partnered with Zealand Pharma

Danish drug discovery firm Zealand Pharma (Nasdaq OMX: ZEAL.CO), says that its partner, French drug major Sanofi (Euronext: SAN) has submitted a marketing authorization application for Lyxumia (lixisenatide) in Europe. Lixisenatide is a once-daily GLP-1 receptor agonist discovered by Zealand Pharma and licensed to Sanofi, which is completing Phase III development of the drug as a new treatment for Type-2 diabetes.

Under the agreement with Sanofi, Zealand Pharma is eligible to receive remaining milestone payments of up to $235 million covering lixisenatide once-daily formulation, depot formulation and any combination product including lixisenatide. There will be no milestone payment associated with the European submission but there will be a payment relating to the completion of the full GetGoal Phase III program, which is expected in the first quarter of 2012. Zealand Pharma is also eligible to low double-digit royalties on worldwide sales of lixisenatide and of any combination product including lixisenatide.

The MAA includes documentation from the extensive international GetGoal Phase III program, comprising data from nine studies and more than 4,300 patients. The GetGoal program provides data to support lixisenatide’s intended use for the treatment of adults with Type-2 diabetes mellitus to achieve glycemic control in patients not adequately controlled on oral anti-diabetics and/or basal insulin; as add-on treatment to metformin; a sulfonylurea or a combination of metformin and a sulfonylurea; or in combination with basal insulin.