Transaction ensures Nestlé Health Science will continue to
commercialize the product
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.
- Rodrigues R, Barber GE, Ananthakrishnan AN. A Comprehensive
Study of Costs Associated With Recurrent Clostridium difficile
Infection. Infect Control Hosp Epidemiol. 2016;38:196-202. DOI:
10.1017/ice.2016.246
- U.S. Bureau of Labor Statistics. CPI Inflation Calculator. U.S.
Bureau of Labor Statistics. Published 2022.
https://www.bls.gov/data/inflation_calculator.htm. CPI inflation
adjusted to March 2023.
Media contact:
Jacquelyn.Campo@nestle.com
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SOURCE Nestlé Health Science U.S.