GERMANY— Merck KGaA has regained global rights to anti-PD-L1 antibody Bavencio (avelumab) as its agreement with Pfizer has ended.

The news comes just a few weeks after Pfizer announced plans to buy antibody-drug conjugate (ADC) company Seagen Inc. at US$43 billion.

The two companies had partnered in 2014 to co-develop and co-commercialize the therapy. Under the agreement, Pfizer paid US$850 million upfront, with Merck eligible to receive regulatory and commercial milestone payments up to approximately US$2 billion.

According to Merck, the current profit share will be replaced by a 15% royalty to Pfizer on net sales of Bavencio.

Effective June 30, the German drugmaker will take full control of the global commercialization of Bavencio.

Merck KGaA and Pfizer will maintain their individual ongoing clinical trials for Bavencio, while Merck KGaA will oversee all future research and development activities.

The manufacturing and supply chain responsibilities will also solely rest with Merck KGaA, thus guaranteeing uninterrupted and dependable patient access to Bavencio.

The therapy is approved in several indications and sales reached €611 million (US$659 million) in 2022.

 “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,” said Peter Guenter, CEO of Merck’s healthcare division.

Despite being approved in several indications, including advanced urothelial carcinoma, Bavencio has faced strong competition from other PD-L1 inhibitors such as Keytruda, Opdivo, Tecentriq, and Imfinzi, leading to the drug’s failure to meet expectations.

Although Pfizer may have been satisfied with the partnership in the past, the recent acquisition of Seagen for US$43 billion has raised concerns about potential antitrust issues.

Jefferies analysts have noted that while Seagen’s Padcev and Bavencio are complementary rather than overlapping, the US Federal Trade Commission may require the divestment of one of the drugs due to concerns about bundled discounts, which could be seen as anti-competitive.

In another development, Pfizer announced that it has signed an agreement with China to collaborate on improving the country’s health coverage.

According to the company’s CEO, Albert Bourla, Pfizer is “aligned very much with the China ‘Healthy 2030’ [initiative] and we are trying to contribute as much as we can.”

The “Healthy China 2030” plan was launched by China in 2016 to enhance public health services, the medical industry, and food and drug safety.

Pfizer’s memorandum of understanding with the Health China Research Center will focus on supporting public health research and enhancing the health of rural populations.

While no further details, including dollar amounts, were disclosed, this initiative is expected to address the gaps in China’s developing public health system that have been highlighted by the COVID-19 pandemic.

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