BRIDGEWATER, N.J., June 6, 2024 /PRNewswire/ -- Seres Therapeutics, Inc. (Nasdaq: MCRB), announced today that it has agreed to a non-binding memorandum of understanding with Nestlé Health Science in which Nestlé Health Science will acquire certain tangible and intangible assets associated with VOWST (fecal microbiota spores, live-brpk) capsules. This transaction, when completed, supersedes any prior agreements between Nestlé and Seres concerning VOWST. Nestlé Health Science has been the lead commercialization party for the product since its launch in June 2023 in the United States. This transaction will allow Nestlé Health Science full control over the further development, commercialization, and manufacturing of VOWST in the US and worldwide.
"VOWST has been extremely successful since we first made it available to patients in June of last year," said Moreno Perugini, President of Medical Nutrition and Pharma, Nestlé Health Science. "We have had a productive collaboration with Seres during the development and FDA approval of VOWST, and we are pleased to continue to provide this important medication to patients."
VOWST is the first and only U.S. Food and Drug Administration (FDA)-approved orally administered microbiota-based therapeutic to prevent recurrence of Clostridioides difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI).
VOWST is not indicated for the treatment of CDI. Please see the full Indication, Limitation of Use, and Important Safety Information below.
Perugini continued, "With the Nestlé Health Science portfolio focused on nutritional science, our pharma business specializes on medical conditions that are specifically related to gastrointestinal disorders. VOWST fits within our expertise and fills a significant unmet need in the market; we are confident that sales will continue to grow and that many more patients will benefit from it."
The transaction is subject to the negotiation of definitive agreements, Seres shareholder approval and other customary conditions.
INDICATION
VOWST (fecal microbiota spores, live-brpk) 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.
Limitation of Use: VOWST is not indicated for treatment of CDI.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Transmissible 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.
Potential presence of food allergens: VOWST may contain food allergens. The potential to cause adverse reactions due to food allergens is unknown.
ADVERSE REACTIONS
The 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%).
To 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.
DRUG INTERACTIONS
Do not administer antibacterials concurrently with VOWST.
Please see Full Prescribing Information and Patient Information
About Recurrent C. difficile Infection (rCDI)
Recurrent C. difficile infection is a gastrointestinal infection caused by C. difficile bacteria. rCDI is linked to dysbiosis of the gastrointestinal microbiome and is associated with increased morbidity and mortality. CDI has been characterized as an Urgent Health Threat by the Centers for Disease Control and Prevention (CDC). rCDI results in a substantial burden on the healthcare system1 with the average rCDI-related annual costs per patient at approximately $43K.2
About Nestlé Health Science
Nestlé Health Science, a leader in the science of nutrition, is a globally managed business unit of Nestlé. We are committed to redefining the management of health, offering an extensive portfolio of science-based consumer health, medical nutrition, pharmaceutical therapies, and vitamin and supplement brands. Our extensive research network provides the foundation for products that empower healthier lives through nutrition. Headquartered in Switzerland, we have more than 12,000 employees in 56 countries.
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