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
- 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.
- 诺瓦瓦克斯通过实现第一个里程碑,继续推进与赛诺菲的协议,未来还将有其他里程碑和持续分层的版权,巩固未来合作伙伴关系的强大模型。
- 诺瓦瓦克斯的COVID-19疫苗被纳入赛诺菲的两个流感和COVID-19预防组合疫苗候选中,目前已启动1/2期临床试验,并在美国获得快速通道认证。
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.
马里兰州盖瑟斯堡,2024年12月13日 /PRNewswire/ -- 诺瓦瓦克斯公司 (纳斯达克:NVAX) 是一家全球公司,通过其Matrix-m佐剂推进基于蛋白质的疫苗,今天宣布在2024年第四季度通过与赛诺菲的合作推进其企业增长策略。公司已在儿童COVID-19疫苗的2/3期临床试验中实现了一个里程碑,触发了来自赛诺菲的第一个5000万美元的里程碑付款。
"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."
诺瓦瓦克斯总统兼首席执行官约翰·C·雅各布斯表示:"诺瓦瓦克斯正在稳步推进我们的新企业增长策略。通过在与赛诺菲的合作协议中实现这一里程碑,以及即将出售我们的捷克制造基地,我们正在增强我们的资产负债表,同时实现可观的成本降低。" 他补充道,"此外,赛诺菲最近宣布,它已获得美国FDA的快速通道认证,适用于两种结合我们经过验证的COVID-19疫苗和其市场领先的流感疫苗的疫苗候选产品。这些资产已进入1/2期临床试验,如果成功,未来诺瓦瓦克斯可能获得里程碑付款和版权。"
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.
5000万美元的里程碑是2024年5月与赛诺菲签署协议时的首次预付款后的第一个里程碑。在此付款之后,还有多达30000万美元的其他潜在里程碑,相关于诺瓦瓦克斯的合作COVID-19疫苗,将在实现时确认。除了独立COVID-19疫苗的里程碑外,该协议还包括由赛诺菲开发的组合产品,包括诺瓦瓦克斯的COVID-19疫苗,为诺瓦瓦克斯提供未来里程碑高达另外35000万美元的潜在机会。此外,所有独立的COVID-19销售及任何赛诺菲组合产品的潜在销售将为诺瓦瓦克斯带来持续的分层版权。此外,诺瓦瓦克斯有资格获得赛诺菲利用其Matrix-m佐剂开发的前四种产品高达20000万美元的回报,以及每种使用Matrix-m的产品后续21000万美元的里程碑付款,以及所有使用Matrix-m的赛诺菲产品的持续版权。
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.
诺瓦瓦克斯的企业增长策略包括为其后期和早期的研究与开发控件以及单独的Matrix-m佐剂寻求额外合作伙伴的努力。这一增长策略应使公司在通过类似的合同框架获得额外合作伙伴的情况下,持续创造价值。
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.
关于诺瓦瓦克斯
诺瓦瓦克斯公司(纳斯达克:NVAX)通过发现、开发和商业化创新疫苗来促进改善健康,以帮助抵御严重传染病。诺瓦瓦克斯是一家总部位于美国马里兰州盖瑟斯堡的全球公司,提供一种差异化的疫苗平台,结合了重组蛋白方法、创新的纳米颗粒科技以及诺瓦瓦克斯专利的Matrix-m佐剂,以增强免疫反应。公司产品组合包括其COVID-19疫苗,管线包括COVID-19-流感组合疫苗和单独的流感疫苗候选产品。此外,诺瓦瓦克斯的佐剂被纳入牛津大学和印度血清研究所的R21/Matrix-m疟疾疫苗中。请访问novavax.com和LinkedIn获取更多信息。
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.
前瞻性声明
此处所述关于诺瓦瓦克斯的未来、其运营计划和前景、可能实现的额外里程碑或获得版权、以及努力寻求额外合作伙伴的声明均为前瞻性声明。诺瓦瓦克斯提醒,前瞻性声明受多种风险和不确定性影响,这些因素可能导致实际结果与这些声明所表达或暗示的结果存在重大差异。这些风险和不确定性包括但不限于,诺瓦瓦克斯是否能够成功并及时地制造、市场推广、分发或交付其更新的2024-2025年配方COVID-19疫苗,以及其未获得FDA对于2024-2025年疫苗季节的BLA的影响;与赛诺菲的合作伙伴关系及寻求额外合作机会的挑战;单独或与合作伙伴一起满足各种安全性、有效性和产品特征要求所面临的挑战,包括与过程合格和检测验证相关的要求,以满足相关监管机构的要求;获取稀缺原材料和供应品的难度;人力资本和制造能力等资源限制对诺瓦瓦克斯推进计划中的监管途径的能力的影响;获得基于JN.1蛋白的COVID-19疫苗或未来COVID-19变异株变更的监管授权的挑战或延误;临床试验中的挑战或延误;制造、分发或出口延迟或挑战;诺瓦瓦克斯对印度血清研究所有限公司在共同配方和灌装上的独特依赖,以及其运营中的任何延迟或中断对客户订单交付的影响;以及诺瓦瓦克斯在2023年12月31日结束的年度报告及随后提交给证券交易委员会(SEC)的10-Q表中的“风险因素”和“管理层对财务状况及运营结果的讨论与分析”部分所识别的其他风险因素。我们提醒投资者不要过于依赖本新闻稿中包含的前瞻性声明。建议您阅读我们向SEC提交的文件,地址为www.sec.gov,并获取有关这些及其他风险和不确定性的讨论。本新闻稿中的前瞻性声明仅适用本文件的日期,我们没有更新或修订任何声明的义务。我们的业务面临重大风险和不确定性,包括上述提到的风险。投资者、潜在投资者和其他人士应对这些风险和不确定性给予仔细考虑。
Contacts:
Investors
Luis Sanay, CFA
240-268-2022
ir@novavax.com
联系方式:
投资者
路易斯·萨奈,CFA
240-268-2022
ir@novavax.com
Media
Giovanna Chandler
240-720-7804
media@novavax.com
媒体
乔万娜·钱德勒
240-720-7804
media@novavax.com
SOURCE Novavax, Inc.
来源 诺瓦瓦克斯医药,Inc.