Sanofi confirmed yesterday that its type 2 diabetes therapy Suliqua™ received marketing authorization in the EU. Approval in Europe follows FDA approval of the drug combination, branded Soliqua™ 100/33 in the U.S., in November 2016. Soliqua was launched in the U.S. earlier this month.

Suliqua is a titratable, fixed-ratio combination of basal insulin glargine and the glucagon-like peptide 1 (GLP-1) receptor agonist lixisenatide. EU clearance covers use of Suliqua, in combination with metformin, in adult type 2 diabetes patients, to improve glycemic control when metformin monotherapy or metformin combination therapies have not been effective. Regulatory approval in Europe was based on data from the Phase III LixiLan-O and LixiLan-L trials, which involved more than 1900 patients.

Suliqua will be delivered in two prefilled SoloSTAR® pens, to offer different dosing options. The 10-40 SoloSTAR prefilled pen will deliver 10 to 40 dose steps of insulin glargine 100 Units/mL in combination with 5 to 20 μg of lixisenatide. The 30-60 SoloSTAR prefilled pen will deliver 30 to 60 dose steps of insulin glargine 100 Units/mL in combination with 10 to 20 μg of lixisenatide.

“Suliqua is an innovative new combination therapy that has the potential to address significant unmet needs for people living with type 2 diabetes in Europe,” said Elias Zerhouni, M.D., president, global R&D, Sanofi. “The approval of Suliqua represents the successful culmination of a concerted effort by Sanofi scientists to bring two injectable treatments together in a single and precisely titratable dose.”

EU approval of Suliqua triggers a $10 million milestone payment to Danish firm Zealand Pharma, which originally developed lixisenatide. Under terms of an agreement between Sanofi and Zealand, which covers lixisenatide and combination products that include the drug, Zealand could receive additional milestone payments of up to $100 million, plus low double-digit sales royalties.

“The product will be marketed by Sanofi and the first launch is planned for Q2 2017,” commented Britt Meelby Jensen president and CEO at Zealand. “Following the recent launch of Soliqua 100/33 in the U.S., this is another important milestone for us, which will provide significant revenue to Zealand in many years to come.”

Just last month Sanofi confirmed that 20% of staff at its U.S. Diabetes and Cardiovascular operation would be axed in response to competition for its insulin glargine product, Lantus®. The French drugs giant reported global net sales by its diabetes franchise of €1805 million ($1928 million) in the third quarter of 2016, down 1.5%, which reflected a drop in U.S. sales of Lantus. Third-quarter U.S. diabetes sales were down 5.4% to €1013 million ($1081 million), while in the Europe, where sales of the insulin glargine product Toujeo® offset lower sales of Lantus, total net sales were down 0.6%, at €325 million ($347 million). Global diabetes drug sales in the first 9 months of 2016 were €5396 million ($5761 million), down 5%.


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