Pharma Focus Europe

Medison Pharma and Regeneron Pharmaceuticals Have Signed an Agreement for the Commercialization of Libtayo® (Cemiplimab) in Various Countries

Tuesday, January 09, 2024

Medison Pharma, a global pharmaceutical company dedicated to providing access to innovative therapies internationally, recently announced an exclusive multinational agreement with Regeneron Ireland DAC, a subsidiary of Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN). The collaboration aims to commercialize Libtayo® (cemiplimab), a fully human monoclonal antibody targeting the PD-1 immune checkpoint receptor on T cells, in select European markets and additional global markets. Libtayo, developed by Regeneron, is currently approved in over two dozen countries for various indications.

Regeneron acquired exclusive worldwide development, commercialization, and manufacturing rights to Libtayo from Sanofi in July 2022. Medison and Regeneron plan to collaborate with stakeholders and regulatory authorities for a smooth transition of commercialization activities to Medison in the first half of 2024.

Libtayo, utilizing Regeneron's VelocImmune® technology, is approved for the treatment of advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC), advanced non-small cell lung cancer (NSCLC), and recurrent or metastatic cervical cancer in select markets. It serves as a PD-1 inhibitor, setting the standard of care for two non-melanoma skin cancers.

Meir Jakobsohn, Founder and Executive Chairman of Medison, expressed that their multi-regional commercial platform aligns well with Regeneron's go-to-market strategy, emphasizing the value Medison brings to innovative biotech companies targeting specific markets. Gil Gurfinkel, CEO of Medison, highlighted the uniqueness of their centralized commercial platform, providing a unified approach across multiple markets and regions.

Libtayo's clinical program focuses on challenging-to-treat cancers, with ongoing trials investigating its efficacy as a monotherapy or in combination with various therapeutic approaches for solid tumors and blood cancers. The approved indications for Libtayo include treatment for cutaneous squamous cell carcinoma, basal cell carcinoma, non-small cell lung cancer, and recurrent or metastatic cervical cancer in adults.

The partnership between Medison and Regeneron underscores the strategic collaboration between a global pharmaceutical company and a leading biotechnology firm to enhance access to transformative medicines for patients worldwide.



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