EC’s approval for Sanofi’s Suliqua triggers $10 million payment to Zealand Pharma

Zealand Pharma has announced a $10 million milestone payment following Sanofi’s announcement of European Commission marketing authorization in Europe for Suliqua for the treatment of adults with type 2 diabetes.

Suliqua is authorized for use in combination with metformin to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin, Zealand explained in its press release.

Britt Meelby Jensen, President and Chief Executive Officer of Zealand said that the product will be marketed by Sanofi and the first launch is planned for Q2 2017.

The approval is based on data from two phase III studies, LixiLan-O and LixiLan-L, which enrolled more than 1,900 adults with type 2 diabetes worldwide to evaluate the efficacy and safety of the fixed-ratio combination when used in patient populations insufficiently controlled after OADs or after basal insulin therapy.

Acording to agreement, which covers lixisenatide and any combination product that includes lixisenatide, Sanofi is responsible for all development and commercialization, including financing hereof.

Zealand is eligible to receive remaining milestone payments of up to USD 100 million as well as low double-digit percentages on global sales in royalty income.

To remind, Sanofi announced on Thuesday that The European Commission has approved Suliqua in combination with metformin, type 2 diabetes treatment, for European adult patients.