Regulatory Nestlé to Market Recently Approved Therapy Vowst by the...

Nestlé to Market Recently Approved Therapy Vowst by the FDA


The FDA has approved Seres Therapeutics’ microbiome capsule, Vowst, to prevent the recurrence of Clostridioides difficile infection, which is considered a potentially dangerous disorder. Nestlé Health Science already has a sales team that looks after several health items such as Fiber Choice and Zenpep. The former is a probiotic and fiber supplement, whereas the latter is a food digestion medicine for patients suffering from low pancreatic enzymes. The same team will market Vowst after its approval from the FDA.

Purified Firmicutes spores, a form of “good” microbiome, are introduced by Vowst to outcompete C. difficile and thereby restore gut health.

The concept was inspired by fecal transplants, which have long been done in clinical settings with limited FDA regulation. Vowst, while also derived from microbiota spores in donor excrement, is a standardized treatment that has received FDA scrutiny. Furthermore, it is the first FDA-approved oral microbiota treatment.

According to CDC statistics, Seres anticipates around 156,000 recurrent C. difficile infections in the United States in 2023. Vowst outperformed the placebo in lowering the incidence of recurrent C. difficile infections in a phase 3 experiment called ECOSPOR III. Following the treatment course of almost two months, recurrence occurred in 12% of Vowst patients and 40% of placebo participants.

The company’s first offering in the market is Vowst. However, under a profit-sharing agreement made in 2021, the Flagship Pioneering portfolio firm will receive marketing assistance from food giant Nestlé.

However, several questions have been raised regarding the company’s commitment to pharmaceuticals in the recent review of the company’s strategies. Nestlé acquired Zenpep as a divestiture from the AbbVie-Allergan merger in 2020 and then spent $2.1 billion to buy Palforzia maker Aimmune Therapeutics as a pharma venture. Nestlé has a long relationship with Seres as the two signed a strategic agreement on microbiome-based medicines outside of North America in 2016. In mid-2021, the firms will launch Vowst in the USA and Canada.

The CEO of Seres, Eric Shaff, believes that Seres and Nestlé are still dedicated to each other. A Nestlé spokeswoman spoke to the media that the strategic evaluation of Palforzia does not extend to the whole Aimmune segment. The company’s nutritional pharma focus is on GI and metabolic problems, and Vowst is in line with the main aim.

According to Shaff, Seres and Nestlé have formed a joint board to oversee Vowst’s deployment. Seres is primarily in charge of manufacturing and has led the charge on medical affairs and regulatory filings, while Nestlé supplies its commercial infrastructure, including sales representatives and reimbursement capabilities. Shaff stated that the production, negotiations, and medical education were decided well before the clearance.

Another microbiome-based medicine is competing with the two businesses. Ferring Pharmaceuticals received FDA clearance for Rebyota, a one-time, enema-delivered microbiome treatment for C. difficile, in late 2022. Vowst, on the other hand, is given orally once every day for three days.

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