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The microbiome ascendant
CAMBRIDGE, Mass.—The microbiome as a target of interest in therapeutics continues to grow. The billions upon billions of microorganisms that inhabit our gastrointestinal (GI) systems is one of the bigger areas of exploration right now in terms of its impact on human health, and that is shown in a deal announced Jan. 11 betweenn Seres Therapeutics and Nestlé Health Sciences for the commercialization of Seres’ microbiome-based Clostridium difficile infection (CDI) and inflammatory bowel disease (IBD) therapies in markets outside of North America.
Reportedly the “most substantial commercial agreement ever in the microbiome space,” in the words a Seres spokesperson, Nestlé is paying Seres $120 million cash up front and as much as $1.9 billion total over the course of the agreement, including milestones and royalties.
The agreement will support the expansion of Seres’ portfolio in markets outside of the United States and Canada and provide “substantial financial support” for Seres’ ongoing research and development. More specifically, the upfront payment to be received under the agreement is expected to help fund the late-stage development of Seres’ lead programs and drive the continued growth of Seres’ pipeline in a variety of conditions where addressing the microbiome could be an effective clinical strategy. Preclinical product candidates currently being investigated at Seres include new indications in infectious, inflammatory and metabolic diseases, including rare genetic diseases and immuno-oncology indications.
“Seres is leading the development of microbiome therapies with the potential to address a wide range of diseases of high unmet medical need, and we are thrilled to collaborate together to ensure that GI-focused products reach the best outcome for patients,” said Greg Behar, CEO of Nestlé Health Science. “By correcting the fundamental microbiome dysbiosis that is the root cause of many diseases, Seres is creating a profoundly new and important way of treating many conditions that are inadequately managed through current approaches. In essence, Seres is leading the creation of an entirely new field within medicine.”
Under the deal terms, Seres keeps full commercial rights to its entire portfolio of product candidates in the United States and Canada—the company plans to build its own commercial organization for that region.
“Nestlé Health Science is an ideal partner for Seres in a wide range of global markets, where its vast reach and long-standing GI focus should help drive the successful adoption of our lead microbiome therapies,” said Dr. Roger J. Pomerantz, president,CEO and chairman of Seres. “With this transformational transaction, we are pleased that significant value was placed not only on our C. difficile candidates, but also on the IBD franchise, which underscores the strong potential of our microbiome platform to address a wide range of challenging diseases across multiple areas in medicine.”
Under the agreement, Seres has granted Nestlé Health Science commercial rights in global markets outside of the United States and Canada to SER-109 and SER-262 for CDI, and SER-287 and SER-301 for IBD. The U.S. Food and Drug Administration has granted SER-109 Orphan Drug and Breakthrough Therapy designations.
Nestlé Health Science agreed to contribute to certain development efforts, including 33 percent of expenses for potential global Phase 3 studies for SER-287, SER-301 and SER-262.
Seres expects to receive a total of $30 million in milestone payments in 2016 associated with the planned initiation of a Phase 1b study for SER-262 in primary CDI and the anticipated start of the Phase 3 trial for SER-109 in recurrent CDI.
The two companies already had a relationship with each other, going back to January 2015 when Nestlé Health Science made an equity investment in Seres, followed by another such investment in July 2015.
Seres Therapeutics is a microbiome therapeutics platform company developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome characterized by an increased presence of pathogenic bacterial species, where the natural state of bacterial diversity is imbalanced.
Nestlé Health Science, a wholly-owned subsidiary of Nestlé, is a health-science company engaged in advancing the role of nutritional therapy to change the course of health for consumers, patients and its partners in healthcare. Nestlé Health Science’s portfolio of nutrition solutions, diagnostics, devices and drugs, targets a number of health areas, such as inborn errors of metabolism, pediatric and acute care, obesity care, healthy aging, gastrointestinal health and brain health. Nestlé Health Science employs around 3,000 people worldwide and is headquartered in Epalinges, Switzerland, near Lausanne.
SOURCE: Seres/ Nestlé news release