Seres Therapeutics and Nestlé Health Science announce license agreement to co-commercialize SER-109 – Business Wire

CAMBRIDGE, Mass. & LAUSANNE, Switzerland – (BUSINESS WIRE) – Seres Therapeutics, Inc. (Nasdaq: MCRB), a leader in microbiome therapeutics, today announced that it has entered into an agreement with Nestlé Health Science to co-commercialize SER-109, the oral test microbiome for relapsing relapses Clostridioides difficile Seres (CDI) infections that struck the US states (US) and Canada. If approved, SER-109 would be the first FDA-approved microbiome therapeutic.

Under the terms of the agreement, Nestlé Health Science will leverage its global pharmaceuticals business within Aimmune Therapeutics and act as a lead commercialization partner. Seres will receive US $ 175 million upfront royalties and an additional US $ 125 million following FDA approval of SER-109. The agreement also includes revenue target milestones that, if met, could reach up to $ 225 million. Seres will be responsible for US pre-commercial development and costs. Once marketed, Seres is entitled to an amount equal to 50% of the commercial profit.

The agreement to jointly commercialize SER-109 in the US and Canada is an extension of an existing strategic collaboration between the companies. Nestlé Health Science already owns the commercial rights to Seres ‘diagnostic treatments for CDI and inflammatory bowel disease outside the United States and Canada, and with this expansion, Nestlé Health Science will become Seres’ global partner in SER-109.

CDI, a leading cause of hospital infections in the United States, is linked to debilitating diarrhea and kills more than 20,000 Americans each year. SER-109 consists of purified Firmicutes spores based on their modulatory role in the C. difficile life cycle and disease pathogenesis. The bacterial consortium in SER-109 quickly repopulates the gut microbiome to induce changes in composition and function that are critical to a sustained clinical response.

“Nestlé Health Science has been an excellent collaboration in our quest to develop a new treatment option for patients with recurrent C. difficile infection, and your support over the past few years has been instrumental in moving SER-109 forward to meet this unmet need . “Eric Shaff, CEO of Seres Therapeutics, said. “We carried out a competition process to select a cooperation partner for SER-109. As we prepare for potential approval and commercialization, we want to begin our next phase side by side with a company as passionate as we are. ”This transformative approach has the potential to reduce the recurrence of CDI.

“We are excited to expand our existing relationship with Seres Therapeutics at this crucial time as SER-109 shows promise for patients trapped in the debilitating cycle of recurrent C. difficile infection,” added Greg Behar, CEO of Nestlé Health Science , add. “Nestlé Health Science is focused on the rapidly evolving areas of gut health, food allergies and metabolic health in our global pharmaceuticals business Aimmune Therapeutics. We look forward to leveraging Aimmune’s existing, fully integrated commercial infrastructure and ability to bring this critical drug to market after approval. ”

Nestlé Health Science continues to invest heavily in innovation while leveraging leading science. His pharmaceutical division, Aimmune Therapeutics, has a strong presence in gastroenterology, which enables him to lead the commercialization of SER-109 while maintaining a strategic role and actively participating in the launch.

SER-109 Clinical and Regulatory Milestones 109

In August 2020, Seres announced that SER-109 had reached the primary endpoint of the pivotal phase 3 study ECOSPOR III, which showed a statistically highly significant reduction in the CDI recurrence rate compared to placebo after 8 weeks with an absolute reduction of 27% . and a relative risk reduction of 68%. In a separate measure, approximately 88% of patients achieved sustained clinical response by week 8. The company expects that the efficacy results of ECOSPOR III should support a BLA filing as a single pivotal study once the SER-109 safety database has treated at least 300 patients for 24 weeks, based on feedback from the FDA. The SER-109 open label study is ongoing and continues to contribute to the SER-109 safety database. Target registration is expected to be completed in the third quarter of 2021.

Responsibility for overseeing activities in support of SER-109 is directed by a joint steering committee made up of an equal number of members from each company. In addition to ex-North America, Seres is responsible for the production and delivery of SER-109 for all regions considered in the cooperation. Seres will lead the pre-launch activities in the medical affairs area and Aimmune Therapeutics will lead the commercialization and post-launch activities in the medical affairs area.

Conference call information

Seres management team will host a conference call today, July 1, 2021 at 8:30 a.m. ET. To participate in the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and provide conference ID number 5382249. To attend the live webcast, please visit the Investors and News section of the Seres website at www.serestherapeutics.com.

The webcast replay will be available on the Seres website approximately two hours after the event and will be archived for a minimum of 21 days.

About Seres Therapeutics

Seres Therapeutics, Inc., (Nasdaq: MCRB) is a leading microbiome therapeutics company developing a new class of multifunctional bacterial consortia designed to functionally interact with host cells and tissues to treat disease. Seres’ SER-109 program achieved the very first positive clinical pivot results for a targeted microbiome drug candidate and received FDA approval as a Breakthrough Therapy and Orphan Drug. The SER-109 program is advanced for the treatment of recurrent C. difficile infections and has the potential to become an FDA-cleared first-class microbiome therapeutic. Seres’ SER-287 program has received fast-track and pediatric orphan drug designs from the FDA and is being evaluated in a Phase 2b study in patients with active mild to moderate ulcerative colitis. Seres is investigating SER-301 in a phase 1b study in patients with ulcerative colitis and SER-155 in a phase 1b study for the treatment of gastrointestinal infections, bacteremia and graft-versus-host reactions. More information is available at www.serestherapeutics.com.

About Nestlé Health Science and Aimmune Therapeutics

Nestlé Health Science, a leader in nutrition science, is a global business unit of Nestlé. We are committed to redefining health management, offering a comprehensive portfolio of science-based consumer health, medical nutrition, pharmaceutical therapies, and vitamin and nutritional supplement brands. Our extensive research network forms the basis for products that enable a healthier life through nutrition. Headquartered in Switzerland, we employ more than 7,000 people worldwide and products are available in more than 140 countries. www.nestlehealthscience.com

Aimmune Therapeutics, Inc., a Nestlé Health Science company, is a biopharmaceutical company that develops and markets treatments for potentially life-threatening gastrointestinal, metabolic and food allergies. www.aimmune.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release that are not historical facts should be considered forward-looking statements, including our development plans; the timing and results of the SER-109 safety data; the ability of our clinical trials to support the approval of SER-109; the size of the market for SER-109; our ability to meet the goals and receive milestone payments from Nestlé Health Science; Nestlé Health Science’s commitment to share the responsibility and cost of commercializing SER-109; and the potential benefits of working with Nestlé Health Science.

These forward-looking statements are based on management’s current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that could cause our actual results, performance or achievements to differ materially from those in the forward-looking statements as of the future Any expression or statement implies including, but not limited to, the following: We have suffered significant losses, are not currently profitable, and may never be profitable; our need for additional funding; our limited operational history; the impact of the COVID-19 pandemic; our unproven approach to therapeutic intervention; the lengthy, expensive, and insecure process of clinical drug development; our reliance on third parties and employees to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; and our ability to retain key people and guide our growth. These and other important factors discussed under the heading “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 4, 2021, and our other filings with the SEC, may result in actual results The forward-looking statements in this press release could differ materially. Such forward-looking statements represent the estimates of management as of the date of this press release. Even if we elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events lead us to change our minds. At no time after the date of this press release should these forward-looking statements be taken as a representation of our views.

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