Nestlé Health Science Agrees to Acquire Global Rights to VOWST, Product It Launched in June 2023
Nestlé Health Science Agrees to Acquire Global Rights to VOWST, Product It Launched in June 2023
Transaction ensures Nestlé Health Science will continue to commercialize the product
交易確保雀巢健康科學繼續推廣該產品。
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.
2024年6月6日，新澤西州布里奇沃特 /美通社/--賽瑞斯治療公司（納斯達克股票代碼：MCRB）今天宣佈，與雀巢健康科學簽署了一份非約束性諒解備忘錄，其中雀巢健康科學將收購與VOWST（腸道菌群孢子，活菌）膠囊相關的某些有形和無形資產。完成該交易後，將取代任何關於VOWST的雀巢和賽瑞斯之前的協議。雀巢健康科學自2023年6月在美國首次推出該產品以來一直是該產品的主要商業化方。此次交易將允許雀巢健康科學全面控制VOWST在美國和全球的進一步發展、商業化和製造業務。
"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."
“自從去年6月我們首次讓患者使用VOWST以來，它已經取得了極大的成功，”雀巢健康科學的醫學營養和製藥總裁Moreno Perugini表示。“在VOWST的開發和FDA批准期間，我們與賽瑞斯進行了富有成效的合作，我們很高興能繼續向患者提供這種重要的藥物。”
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是首個且唯一獲得美國食品和藥物管理局（FDA）批准的口服微生態製劑治療，旨在預防成人經歷抗生素治療後易復發的克氏桿菌感染（rCDI）的再次發生。Clostridioides difficileVOWST旨在預防抗菌治療復發克氏桿菌感染（rCDI）的成人。
VOWST is not indicated for the treatment of CDI. Please see the full Indication, Limitation of Use, and Important Safety Information below.
VOWST不適用於治療CDI。請看下面的完整適應症，使用限制和重要安全信息。
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."
Perugini繼續表示：“以營養科學爲重點的雀巢健康科學產品組合，我們的製藥業務專注於與腸胃疾病特別相關的醫學狀況。VOWST符合我們的專業技能和滿足市場上一個顯著的未滿足需求；我們有信心銷售將繼續增長，並有更多的患者受益於此。”
The transaction is subject to the negotiation of definitive agreements, Seres shareholder approval and other customary conditions.
該交易需根據協議與條件進行談判，賽瑞斯股東批准和其他習慣條件。
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.
適應症
VOWST（腸道菌群孢子，活菌）預防成人使用抗菌藥物治療復發Clostridioides difficile感染（rCDI）的再次發生。Clostridioides difficileVOWST（腸道菌群孢子，活菌）適用於18歲及以上人群，預防成人使用抗菌藥物治療復發Clostridioides difficile感染（rCDI）的再次發生。
Limitation of Use: VOWST is not indicated for treatment of CDI.
使用限制：VOWST不適用於治療CDI。
IMPORTANT SAFETY INFORMATION
重要安全信息
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.
警告及注意事項
可傳播的傳染性因素：由於VOWST是從人類糞便中製造的，因此可能具有傳輸感染性因素的風險。如果疑似通過VOWST傳輸了任何感染，請致電Aimmune Therapeutics，Inc.，電話1-833-246-2566。潛在存在食物過敏原：VOWST可能含有食物過敏原。由於食物過敏原引起不良反應的潛在能力是未知的。
Potential presence of food allergens: VOWST may contain food allergens. The potential to cause adverse reactions due to food allergens is unknown.
最常見的不良反應（在≥5％的參與者中報告）包括腹脹（31.1％），疲勞（22.2％），便秘（14.4％），寒戰（11.1％）和腹瀉（10.0％）。要報告可疑的不良反應，請聯繫Aimmune Therapeutics，電話1-833-AIM-2KNO（1-833-246-2566），或FDA（美國食品和藥物管理局）電話1-800-FDA-1088，或訪問 。
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%).
不良反應
請勿在使用VOWST時與抗菌藥物同時使用。
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 .
如發現可疑的不良反應，請聯繫Aimmune Therapeutics，電話1-833-AIM-2KNO（1-833-246-2566），或聯繫FDA，電話1-800-FDA-1088，或訪問 。
DRUG INTERACTIONS
Do not administer antibacterials concurrently with VOWST.
藥物相互作用
VOWST不適用於同時使用抗菌藥物治療復發Clostridioides difficile感染。
Please see Full Prescribing Information and Patient Information
請查看完整處方信息，包含警告信息。 完整處方信息和頁面。病人信息
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
關於復發C. 梭菌感染（rCDI）
復發C. 梭菌細菌引起的腸道感染。rCDI與腸道微生物不平衡有關，並與增加的發病率和死亡率相關。CDI被美國疾病控制和預防中心（CDC）評估爲緊急的健康威脅。rCDI對醫療保健系統造成了重大負擔，每位患者平均相關費用約爲43,000美元。C. 梭菌業務中的藥品。rCDI總是由其引起，且關聯了腸道微生物的不平衡。1每位患者每年平均相關費用約爲43,000美元。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.
關於雀巢健康科學
雀巢健康科學是雀巢的全球管理業務部門，是營養科學領域的領導者。我們致力於重新定義健康管理，提供基於科學的消費者健康、醫學營養、藥物治療和維生素及補充劑品牌的廣泛組合。我們廣泛的研究網絡爲營養賦能更健康的生活提供了基礎。總部位於瑞士，在56個國家擁有超過12,000名員工。
- 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
- U.S. Bureau of Labor Statistics. CPI Inflation Calculator. U.S. Bureau of Labor Statistics. Published 2022. CPI inflation adjusted to March 2023.
- Rodrigues R，Barber GE，Ananthakrishnan AN。與複發性難辭梭菌感染相關的成本的綜合研究。Infect Control Hosp Epidemiol。2016;38：196-202。DOI：10.1017/ice.2016.246
- 美國勞工統計局。CPI通貨膨脹計算器。美國勞工統計局。2022年發佈。CPI通貨膨脹率調整至2023年3月。
Media contact:
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媒體聯繫人：
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SOURCE Nestlé Health Science U.S.
來源：雀巢健康科學美國。
譯文內容由第三人軟體翻譯。