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Seres Therapeutics Announces Receipt of $125 Million Milestone From Nestlé Health Science Following FDA Approval of VOWST™
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced that the Company has
About this update from Seres Therapeutics, Inc.
[{"type":"text","content":" CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nSeres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced that the Company has received a $125 million milestone payment from Nestlé Health Science related to the U.S. Food and Drug Administration approval of VOWST™ (fecal microbiota spores, live-brpk), an orally administered microbiota-based therapeutic to prevent recurrence of C. difficile Infection (CDI) in adults following antibiotic treatment for recurrent CDI.\n\n\nThe approval milestone follows the July 2021 agreement between Seres and Nestlé Health Science to jointly commercialize VOWST in the U.S. and Canada. Following VOWST commercialization, each company will be entitled to share equally in commercial profits and losses. In addition, Seres is eligible to receive payments of up to $225 million for the achievement of specified net sales milestones.\n\n\nINDICATION AND IMPORTANT SAFETY INFORMATION FOR VOWST\n\n\nINDICATION\n\n\nVOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).\n\n\nLimitation of Use: VOWST is not indicated for treatment of CDI.\n\n\nIMPORTANT SAFETY INFORMATION\n\n\nWARNINGS AND PRECAUTIONS\n\n\nTransmissible infectious agents: Because VOWST is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents. Report any infection that is suspected to have been transmitted by VOWST to Aimmune Therapeutics, Inc. at 1-833-246-2566.\n\n\nPotential presence of food allergens: VOWST may contain food allergens. The potential to cause adverse reactions due to food allergens is unknown.\n\n\nADVERSE REACTIONS\n\n\nThe most common adverse reactions (reported in ≥5% of participants) were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), chills (11.1%), and diarrhea (10.0%).\n\n\nTo report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics at 1-833-AIM-2KNO (1-833-246-2566), or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch.\n\n\nDRUG INTERACTIONS\n\n\nDo not administer antibacterials concurrently with VOWST.\n\n\nPlease see Full Prescribing Information and Patient Information\n\n\nAbout Seres Therapeutics\n\n\nSeres Therapeutics, Inc. (Nasdaq: MCRB) is a commercial-stage company developi...