has signed an agreement with Nestl茅 Health Science to co-market the former鈥檚 investigational treatment, SER-109, for recurrent (CDI) in the US and Canada.
An oral microbiome therapeutic, SER-109 has purified Firmicutes spores, which have a modulatory role in the聽C. difficile鈥檚聽life cycle and disease development.
Seres noted that the drug could become the first US Food and Drug Administration (FDA)-cleared microbiome therapeutic if approved.
As per the deal, Nestl茅 Health Science will use its international 鈥� commercial network and expertise, as well as oversee the drug鈥檚 marketing.
Seres will get upfront payments of $175m for the licence as well as further payment of $125m on receiving FDA approval for SER-109.
The deal also comprises sales target milestones payments of up to $225m.
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By GlobalDataSeres will handle the drug’s development and pre-marketing expenses in the US. It will receive 50% of the commercial profits on marketing the therapeutic.
The latest deal expands an already existing partnership between Seres and Nestl茅 Health Science.
Currently, Nestl茅 holds commercial rights of Seres鈥� investigational therapies for CDI and inflammatory bowel disease outside of the US and Canada.
Seres Therapeutics CEO Eric Shaff said: 鈥淣estl茅 Health Science has been a terrific collaborator in our quest to develop a new treatment option for patients suffering from recurrent聽C. difficile聽infection, and their support over the past few years has been critical in advancing SER-109 to address this unmet need.
鈥淎s we prepare for potential approval and commercialisation, we are eager to embark side-by-side on our next phase with a company that believes as fervently as we do in the potential of this transformative approach to reduce the recurrence of CDI.鈥�
In August last year, Seres reported that the drug met the primary goal in the Phase III ECOSPOR III study, with a statistically significant decrease in the CDI recurrence rate at eight weeks.
Data from ECOSPOR III is anticipated to support a biologics license application of SER-109.
Currently, SER-109 is being analysed in an open-label study, which is set to conclude enrolment in the third quarter of this year.
In 2015, Seres obtained orphan drug status from the FDA for SER-109 to prevent recurrent CDI in adults.
