) in the fields of Clostridium difficile
infections (CDI) and Inflammatory Bowel Disease (IBD). The agreement follows Nestlé Health Science’s initial equity investments in U.S.-based Seres Therapeutics announced in January and July 2015.
Under the terms of the agreement, Nestlé Health Science will make an upfront payment of $120 million. Seres Therapeutics will be eligible to receive development and approval milestone payments totaling up to $660 million, and tiered single to double-digit royalties. The full potential value of the up-front payment, milestones, and royalties payable by Nestlé Health Science is more than $1.9 billion, assuming all products receive regulatory approval and significant revenue targets are met.
Through this agreement, Nestlé Health Science will support the potential future commercialization of the first ever microbiome therapy expected to be launched worldwide. SER 109 is in Phase 2 trials and targets multiple recurrent Clostridium difficile, a bacterial infection that can affect the digestive system. An additional C. difficile and two inflammatory bowel disease (IBD) pipeline candidates are also part of the collaboration, including SER-287, the microbiome therapeutic currently in Phase 1 clinical development in IBD. Seres’ Ecobiotics are first-in-field therapies, based upon microbial organisms and target the microbiome—the 100 trillion microorganisms that live within the human body. When unhealthy, the microbiome is increasingly understood to be causally related to a range of diseases.
In the CDI field, SER-109 for recurring C. difficile in adults (in Phase 2) has received Breakthrough Therapy and Orphan Drug Status designation from the U.S. Food and Drug Administration (FDA). SER-262, a follow-on compound is expected to enter clinical trials for the indication of primary C. difficile, a less severe and more prevalent condition, is also included in the agreement.
In the IBD field, SER-287 for mild-to-moderate ulcerative colitis (UC) has entered Phase 1b clinical trials as announced by Seres in December 2015. Also included in the pipeline is SER-301, currently in pre-clinical development stage for ulcerative colitis and other chronic gastrointestinal disorders. There is growing evidence suggesting that UC is marked by an imbalance of bacteria in the gut, and that treating that may lead to a meaningful clinical impact.
Seres Therapeutics will be responsible for all development costs associated with Phase 1 and Phase 2 for all four candidates as well as for Phase 3 for SER-109. Nestlé Health Science will participate with 33% in the development costs associated with Phase 3 for three candidates (SER-262, SER-287, SER-301).
Nestlé Health Science has signed an exclusive agreement outside the United States and Canada for Seres Therapeutics’ novel class of microbiome therapeutics (