After a rough couple of years, things are looking up for Seres Therapeutics. The microbiome company’s partner Nestlé Health Sciences is handing over another $175 million upfront to help market its lead microbiome treatment in North America.
Under the deal, the duo will jointly commercialize SER-109, Seres’ microbiome treatment for C. difficile infection (CDI) in the U.S. and Canada, according to a statement. Seres will collect another $125 million if and when the FDA approves the treatment and, if the partners hit certain sales goals, Seres could pocket up to $225 million more. The partners will share profits equally.
The application for SER-109 is based on a phase 3 study that found the treatment beat placebo at staving off recurrent C. difficile infections. Of the patients who received SER-109, 11.1% has recurrent infections, compared to 41.3% of patients who got placebo, according to data unveiled in August 2020.
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Nestlé and Seres first teamed up in January 2016 when the microbiome player handed over the commercial rights for two C. difficile programs and two inflammatory bowel disease programs in exchange for $120 million upfront. The total deal value could exceed $1.9 billion, the companies said at the time.
Six months later, SER-109 hit a roadblock when it failed to beat placebo at preventing recurrent C. difficile infection in a phase 2 study. The company pressed on, unveiling a new potentially pivotal study in March 2017 it hoped would avoid the pitfalls of the previous effort.
That trial was eventually a success, but it hasn’t all been smooth sailing for Seres. Along the way, the company promoted CFO Eric Shaff to CEO. One of his first moves was to narrow the company’s focus to its “highest-priority” programs and cut back about 30% of staff.
Besides pushing its late-stage programs in C. difficile infection and ulcerative colitis, Shaff also led the company’s foray into immuno-oncology. But the COVID-19 pandemic affected its melanoma trial, leading the company to stop enrolling patients and deprioritize the program.
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“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,” Shaff said in the statement.
However, the latest deal with Nestlé was not a foregone conclusion.
"We conducted a competitive process to select a collaborator for SER-109,” Shaff said. “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.”