Libtayo Archives - Medical Design Sourcing

Regeneron purchases exclusive rights to Libtayo from Sanofi for $900M

Sanofi (Nasdaq:SNY) has agreed to sell Regeneron (Nasdaq:REGN) exclusive international rights of Libtayo (cemiplimab) for $900 million. Sanofi will also receive an 11% royalty on global sales of the drug.

Libtayo is a monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells.

Sanofi could also receive $100 million if the drug hits regulatory milestones in the next two years. The Paris-headquartered company could get an additional $100 million for meeting sales-related milestones in the same time window.

FDA approved the drug for advanced cutaneous squamous cell carcinoma in 2018. In 2021, Libtayo picked up indications for advanced basal cell carcinoma and first-line advanced non-small cell lung cancer with PD-L1 expression of at least 50%.

Sanofi and Regeneron entered into an international immuno-oncology alliance in 2015, agreeing then to split operating profits for Libtayo in the U.S. Sanofi agreed then to commercialize the dr…

Bio-Rad debuts anti-cemiplimab antibodies

Bio-Rad Laboratories, Inc. (NYSE:BIO) has launched a line of antibodies specific to cemiplimab (Libtayo).

The antibodies inhibit the binding of the drug to its target, human programmed death receptor-1 (PD-1).

Hercules, California–based Bio-Rad Lab, said the ready-made antibodies could be used to develop selective and sensitive assays for bioanalysis and drug monitoring of cemiplimab.

Cemiplimab, developed by Regeneron and Sanofi-Aventis U.S., acts as a checkpoint inhibitor by binding to PD-1 on T cells.

It blocks the interaction with its ligands, PD-L1 and PD-L2, to activate T cells to attack cancer cells.

Bio-Rad reports that the anti-cemiplimab antibodies with varying degrees of affinity provide flexibility for bioanalytical ligand binding assays.

“These critical antibody reagents support researchers developing bioanalytical assays for checkpoint inhibitor drugs by providing sequence-defined, well-characterized reagents with stabl…

Regeneron and Sanofi withdraw FDA application for Libtayo in advanced cervical cancer

Regeneron Pharmaceuticals (NSDQ:REGN) and Sanofi (NSDQ:SNY) have voluntarily withdrawn the supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for advanced cervical cancer.

A press release noted that the agency and the sponsors were unable to “align on certain post-marketing studies” that would have been required to greelight the sBLA.

FDA first approved the drug in 2018 for advanced cutaneous squamous cell carcinoma.

Regeneron/Sanofi

The agency approved indications of Libtayo as a first immunotherapy for patients with advanced basal cell carcinoma in 2021 and as a first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50%.

Regeneron and Sanofi are continuing discussions with regulators outside of the U.S. regarding Libtayo’s potential as a second-line advanced cervical cancer therapy.

REGN shares increased 2…