Medison Pharma Announces Agreement with Regeneron Pharmaceuticals to Commercialize Libtayo® (cemiplimab) in Multiple Countries
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Insights
The exclusive multi-national agreement between Medison Pharma and Regeneron Ireland DAC for the commercialization of Libtayo (cemiplimab) in select European markets and additional markets worldwide represents a strategic move to expand the therapy's global footprint. This collaboration could potentially increase market penetration and drive revenue growth for Regeneron, given that Libtayo is a first-in-class PD-1 inhibitor with approval for multiple indications. The partnership leverages Medison's multi-regional commercial platform, which may streamline the process of bringing Libtayo to new markets, thereby reducing time-to-market and operational complexities.
For investors and stakeholders, this agreement could signal a positive outlook on Regeneron's future earnings and market share, particularly within the oncology segment. However, the actual impact on the stock market would depend on the execution of the commercialization strategy and the competitive landscape of PD-1 inhibitors. It is essential to monitor the uptake of Libtayo in the new markets and the effectiveness of Medison's platform in overcoming regulatory and market access challenges.
Libtayo's efficacy in treating various advanced cancers, including non-small cell lung cancer and certain skin cancers, positions it as a valuable option in the oncology therapeutic area. The collaboration between Medison and Regeneron could enhance patient access to this immunotherapy, potentially improving treatment outcomes for patients with limited options. From a medical research perspective, the expansion of Libtayo's availability is likely to contribute to a larger body of real-world evidence, which can further validate its efficacy and safety profile across diverse patient populations.
Furthermore, the agreement could stimulate additional clinical research and trials in the newly accessible markets, potentially leading to label expansions and an increased therapeutic range for Libtayo. This would not only benefit patients but could also have a substantial impact on Regeneron's market positioning and long-term growth prospects in the biopharmaceutical sector.
The healthcare economics implications of the agreement between Medison and Regeneron extend beyond immediate financial metrics. By facilitating access to Libtayo in multiple regions, the partnership may influence healthcare spending patterns, particularly in the oncology segment. The cost-effectiveness of Libtayo, compared to other PD-1 inhibitors and cancer treatments, will be a crucial factor in determining its adoption and impact on healthcare budgets.
It is important to consider the potential reduction in long-term healthcare costs if Libtayo proves to reduce hospitalizations and improve the quality of life for patients with advanced cancers. On the other hand, the high cost of biologic therapies, such as PD-1 inhibitors, may pose affordability challenges for healthcare systems, especially in markets with limited healthcare funding. The economic analysis of Libtayo's market expansion should, therefore, weigh the potential benefits in patient outcomes against the financial burden on healthcare payers.
- Libtayo (cemiplimab) is a leading PD-1 inhibitor that has shown efficacy in the treatment of certain patients with cutaneous squamous cell carcinoma, advanced basal cell carcinoma, advanced non-small cell lung cancer and advanced cervical cancer, and is approved by regulatory authorities in more than two dozen countries for various indications
- Medison and Regeneron will work together to continue patient access to this important therapy in select markets
Libtayo was invented in laboratories at Regeneron, which acquired exclusive worldwide development, commercialization, and manufacturing rights to the medicine from Sanofi in July 2022. Medison and Regeneron will work together with all stakeholders and regulatory authorities to facilitate a seamless transition of commercialization activities to Medison during the first half of 2024.
Libtayo, which was invented using Regeneron's proprietary VelocImmune® technology, is currently approved by regulatory authorities in more than two dozen countries, including by the European Medicines Agency (EMA). In select markets, it is approved as monotherapy treatment for certain patients with advanced basal cell carcinoma (BCC), as monotherapy treatment for certain patients with advanced cutaneous squamous cell carcinoma (CSCC), as both monotherapy or in combination with chemotherapy for certain patients with advanced non-small cell lung cancer (NSCLC) and/or as monotherapy treatment for certain patients with recurrent or metastatic cervical cancer. Libtayo is a leading and first-in-class PD-1 inhibitor approved for the treatment of two non-melanoma skin cancers and is considered standard of care in these indications.
"Our multi-regional commercial platform is a great fit for Regeneron's go-to-market plan and another great opportunity for Medison to facilitate access to highly innovative therapies for people suffering from rare and severe diseases," said Meir Jakobsohn, Founder and Executive Chairman of Medison. "Regeneron's selection of Medison is yet another testimony of the unique value that our multi-regional solution can generate for innovative biotech companies wishing to focus on selected markets."
"We are proud to partner with Regeneron," said Gil Gurfinkel, CEO of Medison. "Our one-of-a-kind centralized, unified commercial platform, with single alliance management across multiple markets and regions, is of great value to more and more leading biotech companies. Our platform enables biotech companies to transform numerous complex and fragmented markets and regions into a unified territory."
About Libtayo
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary VelocImmune® technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. In the U.S. and other countries Libtayo is indicated in certain patients with advanced BCC, advanced CSCC and advanced NSCLC, as well as in advanced cervical cancer in the European Union, Canada and
The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
Select Approved Indications for Libtayo
Libtayo is a cancer medicine used in adults to treat:
- a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) when the cancer is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body). It is used in patients who cannot have surgery or treatment with radiation to cure their disease;
- a type of skin cancer called basal cell carcinoma (BCC) when the cancer is locally advanced or metastatic. It is used in patients who cannot tolerate treatment with a type of medicine called a 'hedgehog pathway inhibitor (HHI)' or whose disease has worsened after such treatment;
- a type of lung cancer called non-small cell lung cancer (NSCLC) when the cancer is locally advanced and cannot be treated with chemotherapy (medicines to treat cancer) and radiation therapy, or when the cancer is metastatic. It is used either alone in patients whose tumours have a protein called PD-L1 in more than
50% of cells and no mutations in the genes EGFR, ALK and ROS1 involved in the development of NSCLC, or together with platinum-based chemotherapy in patients whose tumours have PD-L1 in at least1% of the cells and no mutations in the EGFR, ALK and ROS1 genes; - cervical cancer that has come back (recurrent) or is metastatic. It is used in patients whose disease has progressed during or after treatment with platinum-based chemotherapy.
It is not known if Libtayo is safe and effective in children.
About Medison Pharma
Medison is a global pharma company focused on providing access to highly innovative therapies to patients in international markets. Medison is the first to create an international commercialization platform for highly innovative therapies, helping to save and improve lives by making the best available novel treatments accessible to patients in international markets. Medison has a track record of multi-territorial partnerships with leading pharmaceutical and biotech companies seeking to expand their global reach. To learn more visit www.medisonpharma.com
For additional information, please contact:
Medison Pharma
Inbal Chen, Corporate Communications
M: +972 54 440 0784
E: inbalc@medisonpharma.com
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