Merck Regains Worldwide Rights to BAVENCIO After Parting Ways with Pfizer

by Richard Chau
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Merck has announced that it will regain the exclusive worldwide rights to develop, manufacture, and commercialize the anti-programmed death ligand-1 (PD-L1) antibody BAVENCIO (avelumab) after ending the partnership and collaboration with Pfizer for more than 8 years. 

Effective June 30, 2023, Pfizer will receive a 15% royalty on net sales of BAVENCIO instead of the current equal share of all revenue resulting from the collaboration. Merck will also take back control of all research and development activities related to the drug, as Pfizer and Merck continue to operationalize their respective clinical trials. In addition, product manufacturing and supply chain will remain solely with Merck to ensure patients’ continuous and reliable access to the drug.

Related article: Bavencio Meets Primary Endpoint in Bladder Cancer Trial 

Merck Allied With Pfizer for the Success of BAVENCIO

BAVENCIO (avelumab) is a fully human anti-PD-L1 monoclonal antibody which was discovered in-house at Merck. In November 2014, Merck formed a global strategic alliance with Pfizer to jointly develop and commercialize the drug. Under the terms of the agreement, Merck received an upfront payment of $ 850 million together with regulatory and commercial milestone payments of up to $ 2.0 billion. 

Throughout the years of collaboration, BAVENCIO has gained prominence in the field of cancer immunotherapy after gaining several important FDA approvals. In 2017, BAVENCIO received FDA approval for treating metastatic Merkel cell carcinoma (MCC) and urothelial carcinoma (UC) respectively. In 2019, the drug received approval for treating advanced renal cell carcinoma (RCC)  in combination with INLYTA (axitinib). Another major regulatory achievement came with the FDA approval as the first-line maintenance treatment for patients with locally advanced or metastatic UC in June 2020. Apart from the U.S., BAVENCIO is also an authorised drug in the European Union for these indications. As of 2023, the drug is currently approved for patients in 68 countries for at least one use.

According to Merck’s financial report for 2022, BAVENCIO generated €611 million in sales, with organic growth of 57.9% from 2021 numbers of €373 million.

Merck’s Big Move to Strengthening its Oncology Franchise

Both Merck and Pfizer expressed gratitude and appreciation to their former ally for the efforts and contributions they have made to the success of BAVENCIO. And Merck also has indicated that the decision reflects the long-held interest of the company. According to Peter Guenter, Chief Executive Officer of Healthcare at Merck, “With our late-stage pipeline, our broader Oncology portfolio, and now with full ownership of BAVENCIO, we look forward to demonstrating the strength of our Oncology Franchise as we amplify our efforts to deliver important innovation to patients.”

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