Lilly and Sanofi Reach Settlement Agreement in U.S. Insulin Glargine Litigation

Pending final FDA approval, Basaglar can be launched in the U.S. beginning on December 15, 2016

Sep 28, 2015, 09:33 ET from Eli Lilly and Company

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INDIANAPOLIS, Sept. 28, 2015 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) has entered into a settlement agreement to resolve patent litigation with Sanofi regarding its insulin glargine product, Basaglar®. As a part of the agreement, Lilly and its alliance partner, Boehringer Ingelheim, will have the ability to launch Basaglar in the U.S. on December 15, 2016. Under the terms of the agreement, Sanofi has granted Lilly a royalty-bearing license so Lilly can manufacture and sell Basaglar in the Kwikpen® device globally. Further details regarding the settlement are confidential.

The U.S. Food and Drug Administration tentatively approved Basaglar in August 2014. With this resolution, Lilly plans to request final approval of Basaglar from the FDA.

"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," said Michael J. Harrington, senior vice president and general counsel for Lilly. "This enables us to focus our efforts on preparing to successfully market and launch Basaglar in the U.S. in December of 2016."

About Eli Lilly and Company Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels. C-LLY

This release contains forward-looking statements regarding U.S. insulin glargine patent litigation and related settlement. There can be no guarantees as to the outcome of the settlement, nor are there any guarantees that Lilly's insulin glargine product will be commercially successful. These statements are based on management's current expectations, but actual results may differ materially. Other risk factors that may affect the company's results can be found in the company's latest Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission