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news.Eli Lilly and Company has entered into a settlement agreement to resolve patent litigation with Sanofi over its Basaglar insulin glargine product.
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The deal will allow Lilly and its German partner, Boehringer Ingelheim, to launch the product in the US in late 2016.
Basaglar secured approval from the US Food and Drug Administration in August last year. The product’s launch was however delayed due to the lawsuit filed by Sanofi in early that year, claiming that the product would compete with its Lantus SoloSTAR.
With the latest resolution, Lilly plans to request final approval from the FDA. The settlement requires the company to pay royalties to Sanofi.
The agreement does not include Lantus (vial), Toujeo or combination products. The companies have also agreed to discontinue similar disputes globally.
Lilly senior vice president and general counsel Michael Harrington said: "The settlement agreement ends the legal dispute between Lilly and Sanofi and provides us with certainty as it relates to our U.S. launch timing.
"This enables us to focus our efforts on preparing to successfully market and launch Basaglar in the U.S. in December of 2016."
Basaglar is indicated to enhance glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes.
It has the similar amino acid sequence as the currently marketed insulin glargine product and was approved for use with KwikPen, a pre-filled dosing device.
Basaglar is Eli Lilly and Boehringer Ingelheim’s basal insulin, which is aimed at offering long-lasting blood sugar control in between meals and during the night.
Image: The settlement will allow Lilly to launch Basaglar in the US in late 2016. Photo: courtesy of suphakit73/FreeDigitalPhotos.net.