Agenus, Zydus Lifesciences ink partnership including US biologics manufacturing
Massachusetts-based biotech Agenus has announced a partnership with India’s Zydus Lifesciences that includes the transfer of Agenus’ biologics facilities in Berkeley and Emeryville, California to Zydus for an upfront $75 million payment and $50 million in potential payments triggered by production orders.
Zydus, an India-based pharmaceutical company, plans to launch a CDMO leveraging the California facilities as their flagship U.S. sites to provide biologics contract manufacturing services to biopharmaceutical companies around the world.
The deal with Zydus marks a quick exit from the CDMO business by Agenus, which in late 2024 launched a fee-for-service biologics manufacturing business as part of a strategic realignment and to generate revenue while supporting its focus on advancing immunotherapies.
As part of the collaboration announced on Tuesday, Agenus will become Zydus’ first biologics CDMO customer through an exclusive manufacturing agreement for botensilimab and balstilimab (BOT/BAL), Agenus’ immunotherapy combination.
“This collaboration enables Agenus to unlock the value of its manufacturing assets and secure strategic capital to drive BOT/BAL toward global regulatory engagement and commercialization,” according to the announcement. “Agenus will also grant Zydus an exclusive license to develop and commercialize BOT and BAL in India and Sri Lanka.”
In July 2024, the FDA put the kibosh on Agenus’ plans to seek accelerated approval for BOT/BAL for the treatment of adult patients with relapsed/refractory microsatellite stable colorectal cancer (r/r MSS CRC) with no active liver metastases (NLM).
William Blair analyst Matt Phipps in a Wednesday note to investors said Agenus’ “partnership with Zydus provides advantages down the line with the exclusive manufacturing agreement and potential for royalties.” According to Phipps, the next key regulatory update from the company “will be feedback from the FDA” on Agenus’ second attempt at accelerated approval “with a Type B meeting anticipated in the near term.”
Agenus CEO Garo Armen in a statement said the company is teaming with Zydus to accelerate future clinical trials for BOT/BAL and that their agreement is “an expression of confidence” in the future and in the U.S. regulatory environment.
“With a trade agreement between the United States and India seemingly imminent, there is a renewed sense of confidence by trading partners in both countries in the future of Indian-American relations,” Armen said. “The United States is the second largest trading partner with India. For these reasons and the strong collaborative spirit we feel with our new partners at Zydus, we decided to enter into this partnership now.”