Seres Therapeutics and Nestlé Health Science have signed an agreement to jointly commercialise SER-109, an investigational oral microbiome therapy, in the US and Canada.
SER-109 has been developed to treat patients with recurrent Clostridioides difficile infection (CDI).
It comprises purified Firmicutes spores, which are based on their modulatory role in the life cycle of C. difficile and disease pathogenesis.
Under the agreement, Nestlé will use Aimmune Therapeutics, its global pharmaceutical business, and will take the lead on commercialisation.
Seres will obtain $175m of upfront license payments as well as another $125m if SER-109 receives FDA approval.
The deal also includes sales target milestones of up to $225m. All profits net of allowable expenses will be equally shared by the companies, upon commercialisation.
As per the terms of the agreement, Seres will be responsible for development and pre-commercialisation costs in the US.
Currently, Nestlé holds commercial rights to Seres’ investigational treatments for CDI and inflammatory bowel disease outside of Canada and the US.
Seres CEO Eric Shaff said: “Nestlé Health Science has been a terrific collaborator in our quest to develop a new treatment option for patients suffering from recurrent C. difficile infection, and their support over the past few years has been critical in advancing SER-109 to address this unmet need.
“We conducted a competitive process to select a collaborator for SER-109. As we prepare for potential approval and commercialization, we are eager to embark side-by-side on our next phase with a company that believes as fervently as we do in the potential of this transformative approach to reduce the recurrence of CDI.”
Last year, the company announced that SER-109 met the primary endpoint in the Phase III ECOSPOR III study.
This showed significant reduction in CDI recurrence rate compared to placebo at eight weeks, with 27% reduction and 68% of relative risk reduction.