Soliqua®  100/33/ Suliqua®

Branded products in diabetes care commercialized by Sanofi under an exclusive worldwide license.

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Soliqua®  100/33/ Suliqua®

Soliqua®  100/33 in the U.S.

On 21 November, Sanofi received U.S. Food and Drug Administration (FDA) approval for Soliqua®  100/33. Launched and available in U.S. retail pharmacies in January 2017.

Soliqua®  100/33 is a combination of lixisenatide.and insulin glargine
(Lantus®) and a GLP-1 receptor agonist, in a once-daily injection marketed
in the US by Sanofi. This product has been approved in the EU as Suliqua®
for type 2 patients. Soliqua®  100/33 has been approved in the U.S. indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (with a daily dose range from 15 to 60 Units) or lixisenatide. Soliqua®  100/33 is marketed in the U.S. by Sanofi.

Soliqua®  100/33 is delivered in the U.S. in a single pre-filled pen for once-daily
dosing using SoloSTAR® technology, the most frequently used disposable insulin
injection pen in the world.

Suliqua® in the EU

Suliqua®  was approved in the EU in january 2017 for type 2 patients 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. Suliqua®  will be marketed in the
EU by Sanofi.

Suliqua®  will be delivered in two prefilled SoloSTAR® pens, providing different
dosing options that may help answer individual market and patient insulin
needs.

License collaboration with Sanofi

• The contract with Sanofi includes the GLP-1 receptor agonist lixisenatide and any combination product
• Zealand pays 13,5% of its incoming revenue on all lixisenatide products to third parties
• The patent expires on different dates in different countries, but in most cases it is in 2025 (No WO 01/04156. The US No is US RE45,313 and the EU No is EP 1196444).