• Merck KGaA, Darmstadt, Germany regains exclusive worldwide rights to develop, manufacture and commercialize BAVENCIO from Pfizer
• Deal is the latest example of the company’s focused leadership strategy in oncology and showcases increased commitment to BAVENCIO and the patients helped by this important therapy

Merck KGaA, Darmstadt, Germany, which operates its Healthcare business as EMD Serono in the US and Canada,  announced it has strengthened its Oncology franchise by regaining exclusive worldwide rights to develop, manufacture, and commercialize anti-programmed death ligand-1 (PD-L1) antibody BAVENCIO^® (avelumab) following the termination of its Alliance agreement with Pfizer.

“On behalf of Merck KGaA, Darmstadt, Germany, I’d like to thank Pfizer for their partnership and collaboration over the last nine years, and for the role they have played in the success of BAVENCIO,” said Belén Garijo, Chair of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany. “Our joint efforts have delivered meaningful therapeutic value to patients around the world who are living with cancer. This has been an incredible journey for us, and thanks to Pfizer’s partnership we are now very well positioned to continue to deliver this therapy to patients in need.”

“Our alliance with Merck KGaA, Darmstadt, Germany allowed us to combine our complementary strengths to develop and launch BAVENCIO to help meet the needs of people with cancer globally,” said Dr. Albert Bourla, Pfizer Chairman and Chief Executive Officer. “We are proud of our achievements together, including introducing BAVENCIO as an important treatment option for patients with metastatic Merkel cell carcinoma, locally advanced or metastatic urothelial carcinoma, and in combination with INLYTA for advanced renal cell carcinoma. We thank our colleagues at Merck KGaA, Darmstadt, Germany, for a tremendous partnership and wish them well in their future plans for BAVENCIO.”

Reflecting a long-held interest of Merck KGaA, Darmstadt, Germany, effective June 30, 2023, Merck KGaA, Darmstadt, Germany, through its affiliate Ares Trading S.A., will take full control of the global commercialization of BAVENCIO. The current profit share will be replaced by a 15% royalty to Pfizer on net sales of BAVENCIO. Merck KGaA, Darmstadt, Germany and Pfizer will continue to operationalize their respective ongoing clinical trials for BAVENCIO, and Merck KGaA, Darmstadt, Germany will control all future research and development activities. As it is currently, product manufacturing and supply chain will remain solely with Merck KGaA, Darmstadt, Germany, ensuring continuous and reliable access to BAVENCIO for patients.

“This is an excellent example of our focused leadership strategy in action, as we are now fully accountable to reinforce BAVENCIO’s position as a standard of care in advanced urothelial carcinoma for the benefit of patients in need, and as an important therapeutic option for appropriate patients with renal cell carcinoma and Merkel cell carcinoma,” says Peter Guenter, Chief Executive Officer Healthcare at Merck KGaA, Darmstadt, Germany. “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.”

BAVENCIO was discovered in-house at Merck KGaA, Darmstadt, Germany. The Alliance between Merck KGaA, Darmstadt, Germany and Pfizer was executed in 2014 to co-develop and co-commercialize BAVENCIO with the goal to accelerate development of the human PD-L1 antibody. With this announcement, BAVENCIO will further contribute to Merck KGaA, Darmstadt, Germany’s Big 3 strategy focusing on new Healthcare products, Process Solutions and Life Science Services, as well as Semiconductor Solutions.

BAVENCIO is an anti PD-L1 monoclonal antibody that is widely recognized in international guidelines as the standard of care for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. BAVENCIO in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). BAVENCIO is also authorized for use as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).