Seres Lands $175 Million Licensing Agreement
- Posted by ISPE Boston
- On July 14, 2021
Cambridge-based microbiome therapeutics company Seres Therapeutics has entered into an agreement with Nestlé Health Science to jointly commercialize SER-109, Seres’ investigational oral microbiome therapeutic for recurrent Clostridioides difficile infection (CDI), in the U.S. and Canada. If approved, SER-109 would become the first-ever FDA-approved microbiome therapeutic.
Under the terms of the agreement, Nestlé Health Science will utilize its global pharmaceutical business Aimmune Therapeutics and will assume the role of lead commercialization party. Seres will receive license payments of $175 million up front, and an additional $125 million upon FDA approval of SER-109. The agreement also includes sales target milestones which, if achieved, could total up to $225 million. Seres will be responsible for development and pre-commercialization costs in the U.S. Upon commercialization, Seres will be entitled to an amount equal to 50% of the commercial profits.
The agreement represents the expansion of an existing strategic collaboration between the companies. Nestlé Health Science already has commercial rights to Seres’ investigational treatments for CDI and inflammatory bowel disease outside of the U.S. and Canada, and with this expansion, Nestlé Health Science becomes Seres’ global collaborator in SER-109.
Seres’ SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA and has potential to become a first-in-class FDA-approved microbiome therapeutic. Seres’ SER-287 program has obtained Fast Track and pediatric Orphan Drug Designations and is being evaluated in a Phase 2b study in patients with active mild-to-moderate ulcerative colitis. Seres is evaluating SER-301 in a Phase 1b study in patients with ulcerative colitis and SER-155 in a Phase 1b study to address gastrointestinal infections, bacteremia and graft-versus-host disease. (Source: Seres Therapeutics Website, 01 July, 2021)