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Nestlé Health Science agrees to acquire global rights to VOWST®, product it launched in June 2023

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Seres Therapeutics announced that Nestlé Health Science will acquire global rights to VOWST, a microbiota-based therapeutic.

This agreement follows a non-binding memorandum of understanding and will give Nestlé full control over the development, commercialization, and manufacturing of VOWST globally.

VOWST, FDA-approved in June 2023, is the first oral microbiota-based treatment to prevent recurrence of Clostridioides difficile infection (CDI) in adults after antibacterial treatment.

The deal requires negotiation of definitive agreements, Seres shareholder approval, and other customary conditions.

Positive
  • Nestlé Health Science acquires global rights, ensuring continued commercialization of VOWST.
  • Full control over VOWST’s development, commercialization, and manufacturing granted to Nestlé.
  • VOWST addresses a significant unmet need in the market, potentially boosting sales growth.
  • VOWST is the first FDA-approved oral microbiota-based treatment for recurrent CDI, enhancing its market appeal.
Negative
  • The transaction is subject to negotiation of definitive agreements and Seres shareholder approval, introducing uncertainty.
  • VOWST's safety concerns include the potential transmission of infectious agents and unknown reactions to food allergens.
  • Common adverse reactions to VOWST include abdominal distension (31.1%), fatigue (22.2%), and constipation (14.4%).

Insights

In analyzing the agreement between Nestlé Health Science and Seres Therapeutics for VOWST, it’s important to understand the financial implications. Nestlé Health Science acquiring full commercialization rights of VOWST is significant. This move suggests that Nestlé has observed strong market potential and performance for VOWST since its launch.

From a financial perspective, the fact that Nestlé is investing in these rights indicates a long-term commitment to VOWST’s market presence. The product's unique position as the first FDA-approved oral microbiota-based therapeutic for preventing recurrent CDI adds to its value. This transaction can potentially influence Nestlé's revenue positively by expanding its portfolio in the pharmaceutical market.

For Seres Therapeutics, this transaction provides immediate capital and might reduce operational burdens associated with VOWST. However, it could also mean losing long-term revenue streams tied to the product. Investors should weigh these trade-offs carefully in considering Seres’ future growth.

From a medical standpoint, the acquisition of VOWST by Nestlé Health Science is important. VOWST addresses a significant unmet need in the market by preventing recurrence of Clostridioides difficile infection (CDI) in adults post-antibiotic treatment. Given the high recurrence rates and severe health implications of CDI, a reliable preventive measure like VOWST can have substantial health benefits for patients.

Nestlé’s focus on gastrointestinal disorders aligns with VOWST’s therapeutic use, potentially enabling more targeted and effective commercial strategies. Long-term benefits could include improved patient outcomes and reduced healthcare costs associated with recurrent CDI.

However, the potential presence of food allergens and the risk of transmitting infectious agents as indicated in the safety warnings are factors that need careful management to maintain patient safety and product reliability. Investors should monitor how Nestlé handles these safety concerns and the implications for product adoption and growth.

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. 

  1. 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.

Media contact:
Jacquelyn.Campo@nestle.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/nestle-health-science-agrees-to-acquire-global-rights-to-vowst-product-it-launched-in-june-2023-302165294.html

SOURCE Nestlé Health Science U.S.

FAQ

What is the significance of Nestlé Health Science acquiring rights to VOWST?

Nestlé Health Science will have full control over the development, commercialization, and manufacturing of VOWST, ensuring its continued availability and potential sales growth.

When was VOWST FDA-approved?

VOWST was FDA-approved in June 2023.

What is VOWST used for?

VOWST is used to prevent the recurrence of Clostridioides difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI.

What are the most common adverse reactions to VOWST?

Common adverse reactions include abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), chills (11.1%), and diarrhea (10.0%).

What conditions must be met for the Nestlé-Seres transaction to be finalized?

The transaction requires the negotiation of definitive agreements, Seres shareholder approval, and other customary conditions.

Seres Therapeutics, Inc.

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