IdB Holding S.p.A. (IdB), a global leader in active ingredients derived from medicinal plants and their applications in pharmaceuticals and health supplements industries and in high potent active pharmaceutical ingredients, and Nestlé Health Science, a global leader in the science of nutrition, today announced that they have entered into a licensing agreement to develop and, subject to regulatory approval by the European Medicines Agency, commercialize VOWST® (fecal microbiota spores, live–brpk) for patients in Europe. VOWST® is an orally administered live biotherapeutic product (LBP) indicated in the United States to prevent recurrent Clostridioides difficile infection (rCDI) in individuals 18 years of age and older following antibacterial treatment for rCDI.
Under the agreement, the parties will work jointly to pursue regulatory approval in Europe, with IdB obtaining rights to commercialize VOWST® across European markets subject to such approval.
The collaboration aims to expand European patients’ access to VOWST® for rCDI, a potentially life‑threatening infection that can be difficult to manage with limited treatment options. It also marks the beginning of planned clinical and regulatory activities to support its potential approval.
“The signing of this partnership marks the first major step in this project, a milestone that signifies trust, collaboration and the exchange of expertise between IdB Holding and Nestlé Health Science – said Gianluigi Frozzi, president of IdB Holding -. This effort begins a new exciting chapter for IdB, which will start a new dedicated company that will endeavor to market VOWST® and bring to European patients new therapies for high unmet medical needs”.
IdB is a privately owned Italian life sciences group headquartered in Milan, with longstanding experience in pharmaceutical development and commercialization across Europe and other markets. The group includes two operating companies: Indena, which has a global presence spanning Italy, France, the United States, Brazil, China, Japan, and India; and Scharper, which operates in Italy.
“This agreement reflects the strength of VOWST® and the confidence we have in its clinical foundation and long‑term potential – said Luis Briz, President of Professional Health, Nestlé Health Science – Collaborating with IdB Holding S.p.A. represents a meaningful step toward bringing this innovative therapy to European patients. We look forward to working together through the regulatory approval process, with a continued focus on patients who may benefit from a potential new preventive treatment option”.
VOWST® is the first and only U.S. Food and Drug Administration (FDA)‑approved orally administered LBP used to prevent recurrent Clostridioides difficile (C.diff) infection in individuals 18 years of age or older after antibiotic treatment for C. diff infection has been completed, with the following indication and safety information.
INDICATION
VOWST® 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).
VOWST® is not intended for treatment of C. diff infection.
IMPORTANT SAFETY INFORMATION
Do not take VOWST® at the same time as antibiotics. VOWST® contains live bacteria and antibiotics can interfere with VOWST®.
Swallow each capsule whole. DO NOT crush, chew, or break the capsule. See Patient Information for complete information about how to take VOWST®.
The most common side effects of VOWST® are:
- bloated abdomen
- fatigue
- constipation
- chills
- diarrhea
These are not all the possible side effects of VOWST®. Call your health care provider for medical advice on side effects. You are encouraged to report negative side effects to the FDA. Call 1-800-FDA-1088 or visit www.fda.gov/MedWatch.
Before taking VOWST®, tell your doctor about all your medical conditions, including if you: have kidney disease because you may not be able to take the magnesium citrate laxative; or have any other medical conditions now or have had before, are pregnant or planning to get pregnant, or are breastfeeding.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and supplements.
Please see Patient Information and Prescribing 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 US 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 in the US at approximately $43K.2
- 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
2. 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.
About IdB Holding S.p.A.
IdB Holding is an Italian company, founded in 1921 and owned by Della Beffa family, which includes two subsidiaries: Indena, with a global presence spanning Italy, France, the USA, Brazil, China, Japan, and India; and Scharper, operating in Italy. IdB Holding’s expertise, combined with an unwavering pursuit of excellence, ensures the delivery of high-quality products in the pharmaceutical and health food sectors. Research and production technologies are central to the Group’s mission to create lasting value for our partners and patients.
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 around the world, with products available in more than 140 countries. For more information, please visit www.nestlehealthscience.us/.
