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Novavax Advances Corporate Growth Strategy Through Sanofi Partnership, Including Achievement of First $50 Million Milestone

Novavax Advances Corporate Growth Strategy Through Sanofi Partnership, Including Achievement of First $50 Million Milestone

諾瓦瓦克斯醫藥通過與賽諾菲安萬特的合作推進企業增長策略,包括實現首個5000萬美金的里程碑
PR Newswire ·  12/13 21:00
  • Novavax continues to progress Sanofi agreement by achieving first milestone, with additional milestones and ongoing tiered royalties to come, solidifying a strong model for future partnerships
  • Novavax's COVID-19 vaccine included in Sanofi's two combination vaccine candidates for prevention of influenza and COVID-19, for which Phase 1/2 trials were initiated and Fast Track designation recently granted in the U.S.
  • 諾瓦瓦克斯通過實現第一個里程碑,繼續推進與賽諾菲的協議,未來還將有其他里程碑和持續分層的版權,鞏固未來合作伙伴關係的強大模型。
  • 諾瓦瓦克斯的COVID-19疫苗被納入賽諾菲的兩個流感和COVID-19預防組合疫苗候選中,目前已啓動1/2期臨床試驗,並在美國獲得快速通道認證。

GAITHERSBURG, Md., Dec. 13, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M adjuvant, today announced progress in Q4 2024 advancing its corporate growth strategy through its partnership with Sanofi. The Company has achieved a milestone associated with its Phase 2/3 clinical trial for its COVID-19 vaccine in children, triggering the first $50 million milestone payment from Sanofi.

馬里蘭州蓋瑟斯堡,2024年12月13日 /PRNewswire/ -- 諾瓦瓦克斯公司 (納斯達克:NVAX) 是一家全球公司,通過其Matrix-m佐劑推進基於蛋白質的疫苗,今天宣佈在2024年第四季度通過與賽諾菲的合作推進其企業增長策略。公司已在兒童COVID-19疫苗的2/3期臨床試驗中實現了一個里程碑,觸發了來自賽諾菲的第一個5000萬美元的里程碑付款。

"Novavax is steadily advancing our new corporate growth strategy. By achieving this milestone in our collaboration agreement with Sanofi, as well as the upcoming sale of our Czech Republic manufacturing site, we are strengthening our balance sheet as well as delivering significant cost reductions," said John C. Jacobs, President and Chief Executive Officer, Novavax. "In addition, Sanofi recently announced it received U.S. FDA Fast Track designation for two vaccine candidates combining our proven COVID-19 vaccine with its market-leading influenza vaccines. These assets have progressed to Phase 1/2 clinical trials, with the potential for future Novavax milestone payments and royalties, if successful."

諾瓦瓦克斯總統兼首席執行官約翰·C·雅各布斯表示:"諾瓦瓦克斯正在穩步推進我們的新企業增長策略。通過在與賽諾菲的合作協議中實現這一里程碑,以及即將出售我們的捷克製造基地,我們正在增強我們的資產負債表,同時實現可觀的成本降低。" 他補充道,"此外,賽諾菲最近宣佈,它已獲得美國FDA的快速通道認證,適用於兩種結合我們經過驗證的COVID-19疫苗和其市場領先的流感疫苗的疫苗候選產品。這些資產已進入1/2期臨床試驗,如果成功,未來諾瓦瓦克斯可能獲得里程碑付款和版權。"

The $50 million milestone is the first following the initial upfront payment at signing of the agreement with Sanofi in May 2024. Following this payment, there are additional potential milestones of up to $300 million related to Novavax's partnered COVID-19 vaccine that will be recognized in the periods when earned. In addition to milestones for the stand-alone COVID-19 vaccine, the agreement also includes combination products developed by Sanofi including Novavax's COVID-19 vaccine, which present a potential opportunity of up to an additional $350 million for Novavax in future milestones. In addition, both stand-alone COVID-19 sales and potential sales of any Sanofi combination products would net Novavax ongoing tiered royalties. Further, Novavax is eligible to receive up to $200 million for the first four products created by Sanofi utilizing its Matrix-M adjuvant, and up to $210 million in milestone payments for each product including Matrix-M thereafter, plus ongoing royalties for all Sanofi products utilizing Matrix-M.

5000萬美元的里程碑是2024年5月與賽諾菲簽署協議時的首次預付款後的第一個里程碑。在此付款之後,還有多達30000萬美元的其他潛在里程碑,相關於諾瓦瓦克斯的合作COVID-19疫苗,將在實現時確認。除了獨立COVID-19疫苗的里程碑外,該協議還包括由賽諾菲開發的組合產品,包括諾瓦瓦克斯的COVID-19疫苗,爲諾瓦瓦克斯提供未來里程碑高達另外35000萬美元的潛在機會。此外,所有獨立的COVID-19銷售及任何賽諾菲組合產品的潛在銷售將爲諾瓦瓦克斯帶來持續的分層版權。此外,諾瓦瓦克斯有資格獲得賽諾菲利用其Matrix-m佐劑開發的前四種產品高達20000萬美元的回報,以及每種使用Matrix-m的產品後續21000萬美元的里程碑付款,以及所有使用Matrix-m的賽諾菲產品的持續版權。

Novavax's corporate growth strategy includes efforts to pursue additional partnerships for its late-stage and early-stage Research and Development assets and Matrix-M adjuvant alone. This growth strategy should position the Company for ongoing value creation as additional partnerships are secured under a similar contractual framework.

諾瓦瓦克斯的企業增長策略包括爲其後期和早期的研究與開發控件以及單獨的Matrix-m佐劑尋求額外合作伙伴的努力。這一增長策略應使公司在通過類似的合同框架獲得額外合作伙伴的情況下,持續創造價值。

About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance the immune response. The Company's portfolio includes its COVID-19 vaccine and its pipeline includes its COVID-19-Influenza Combination and stand-alone influenza vaccine candidates. In addition, Novavax's adjuvant is included in the University of Oxford and Serum Institute of India's R21/Matrix-M malaria vaccine. Please visit novavax.com and LinkedIn for more information.

關於諾瓦瓦克斯
諾瓦瓦克斯公司(納斯達克:NVAX)通過發現、開發和商業化創新疫苗來促進改善健康,以幫助抵禦嚴重傳染病。諾瓦瓦克斯是一家總部位於美國馬里蘭州蓋瑟斯堡的全球公司,提供一種差異化的疫苗平台,結合了重組蛋白方法、創新的納米顆粒科技以及諾瓦瓦克斯專利的Matrix-m佐劑,以增強免疫反應。公司產品組合包括其COVID-19疫苗,管線包括COVID-19-流感組合疫苗和單獨的流感疫苗候選產品。此外,諾瓦瓦克斯的佐劑被納入牛津大學和印度血清研究所的R21/Matrix-m瘧疾疫苗中。請訪問novavax.com和LinkedIn獲取更多信息。

Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating plans and prospects, the possible achievement of additional milestones or receive royalties, and efforts to pursue additional partnerships, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, Novavax's ability to successfully and timely manufacture, market, distribute, or deliver its updated 2024-2025 formula COVID-19 vaccine and the impact of its not having received a BLA from the FDA for the 2024-2025 vaccination season; challenges related to Novavax's partnership with Sanofi and in pursuing additional partnership opportunities; challenges satisfying, alone or together with partners, various safety, efficacy and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorization for a JN.1 protein-based COVID-19 vaccine or for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and , for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

前瞻性聲明
此處所述關於諾瓦瓦克斯的未來、其運營計劃和前景、可能實現的額外里程碑或獲得版權、以及努力尋求額外合作伙伴的聲明均爲前瞻性聲明。諾瓦瓦克斯提醒,前瞻性聲明受多種風險和不確定性影響,這些因素可能導致實際結果與這些聲明所表達或暗示的結果存在重大差異。這些風險和不確定性包括但不限於,諾瓦瓦克斯是否能夠成功並及時地製造、市場推廣、分發或交付其更新的2024-2025年配方COVID-19疫苗,以及其未獲得FDA對於2024-2025年疫苗季節的BLA的影響;與賽諾菲的合作伙伴關係及尋求額外合作機會的挑戰;單獨或與合作伙伴一起滿足各種安全性、有效性和產品特徵要求所面臨的挑戰,包括與過程合格和檢測驗證相關的要求,以滿足相關監管機構的要求;獲取稀缺原材料和供應品的難度;人力資本和製造能力等資源限制對諾瓦瓦克斯推進計劃中的監管途徑的能力的影響;獲得基於JN.1蛋白的COVID-19疫苗或未來COVID-19變異株變更的監管授權的挑戰或延誤;臨床試驗中的挑戰或延誤;製造、分發或出口延遲或挑戰;諾瓦瓦克斯對印度血清研究所有限公司在共同配方和灌裝上的獨特依賴,以及其運營中的任何延遲或中斷對客戶訂單交付的影響;以及諾瓦瓦克斯在2023年12月31日結束的年度報告及隨後提交給證券交易委員會(SEC)的10-Q表中的「風險因素」和「管理層對財務狀況及運營結果的討論與分析」部分所識別的其他風險因素。我們提醒投資者不要過於依賴本新聞稿中包含的前瞻性聲明。建議您閱讀我們向SEC提交的文件,地址爲www.sec.gov,並獲取有關這些及其他風險和不確定性的討論。本新聞稿中的前瞻性聲明僅適用本文件的日期,我們沒有更新或修訂任何聲明的義務。我們的業務面臨重大風險和不確定性,包括上述提到的風險。投資者、潛在投資者和其他人士應對這些風險和不確定性給予仔細考慮。

Contacts:
Investors
Luis Sanay, CFA
240-268-2022
[email protected]

聯繫方式:
投資者
路易斯·薩奈,CFA
240-268-2022
[email protected]

Media
Giovanna Chandler
240-720-7804
[email protected]

媒體
喬萬娜·錢德勒
240-720-7804
[email protected]

SOURCE Novavax, Inc.

來源 諾瓦瓦克斯醫藥

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