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Regeneron Acquires Sanofi's Stake in the Regeneron and Sanofi Collaboration on Libtayo.

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MANews-(C)2009-2022

US-based biotechnology company Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) plans to purchase French healthcare group Sanofi's (NASDAQ: SNY) stake in the Regeneron and Sanofi collaboration on Libtayo (cemiplimab), providing Regeneron with exclusive worldwide development, commercialization and manufacturing rights to the medicine, the company said.

The transaction is subject to merger control clearance outside the United States and is expected to close in 3Q22.

Once the transaction has closed, Regeneron will record 100% of global net sales and expenses for the Libtayo program.

Libtayo, which was invented using Regeneron's proprietary VelocImmune technology, is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells.

It is currently approved by regulatory authorities in more than two dozen countries, including by the US Food and Drug Administration as cemiplimab-rwlc monotherapy treatment for certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer (NSCLC).

Libtayo is a leading and first-in-class PD-1 inhibitor for the treatment of approved non-melanoma skin cancers and is considered a standard of care.

Regulatory reviews are also underway for Libtayo in combination with chemotherapy as a first-line treatment in advanced NSCLC in multiple markets, including the US and European Union, where approvals would provide promising opportunities to extend the medicine's reach.

It is also currently being studied with 18 investigational agents in 22 clinical trials for a variety of difficult-to-treat cancers.

These combinations include numerous assets from Regeneron, including its antibody targeting the LAG-3 checkpoint receptor, and several assets from its collaborators.

Regeneron and Sanofi entered into the Immuno-oncology License and Collaboration Agreement in 2015.

Under that deal, the...

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