Business & Finance
Zealand Pharma announces EU approval of Suliqua triggering USD10m milestone payment
18 January 2017 -

Biotechnology company Zealand Pharma (Zealand) (CPH:ZEAL) announced on Wednesday that a USD10m milestone payment has been triggered following Sanofi's announcement of European Commission (EC) marketing authorisation in Europe for Suliqua.

Suliqua is a once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. The company said Suliqua is authorised for use in combination with metformin to improve glycaemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.

This product will be marketed by Sanofi and the first launch is planned for Q2 2017.

According to the company, this EC approval is based on data from two phase III studies, LixiLan-O and LixiLan–L, which enrolled over 1,900 adults with type 2 diabetes worldwide to evaluate the efficacy and safety of the fixedratio combination when used in patient populations insufficiently controlled after OADs or after basal insulin therapy.

Suliqua is the brand name in Europe for the once-daily titratable fixed-ratio combination of basal insulin glargine 100 units/ml and the GLP-1 analogue lixisenatide. Suliqua will be delivered in two pre-filled SoloSTAR pens, providing different dosing options that may help answer individual market and patient insulin needs.

Also, this marketing authorisation in Europe for Suliqua is applicable to the 28 member states of the EU, as well as Iceland, Liechtenstein and Norway, and follows the November 2016 positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The fixed-ratio combination was approved by the US Food and Drug Administration (FDA) in November 2016, as Soliqua 100/33, and has been available in the US since 4 January 2017.

Launches of Suliqua in individual EU countries are anticipated from Q2 2017 onward.

Under the terms of the license agreement between Sanofi and Zealand, which covers lixisenatide and any combination product that includes lixisenatide, Sanofi is responsible for all development and commercialisation, including financing hereof.

This EU approval of Suliqua triggers a milestone payment of USD10m to Zealand. Under the agreement, Zealand is eligible to receive remaining milestone payments of up to USD100m as well as low double-digit percentages on global sales in royalty income.

Zealand Pharma is focused on the discovery, design and development of innovative peptide-based medicines. Zealand has a portfolio of medicines and product candidates under license collaborations with Sanofi, Boehringer Ingelheim and Helsinn, as well as a pipeline of proprietary product candidates that primarily target specialty diseases with significant unmet needs.

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