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.
- Novavax通过实现第一个里程碑继续推进赛诺菲协议,未来还会有更多里程碑和持续的分级特许权使用费,为未来的合作伙伴关系巩固了强大的模式
- Novavax 的 COVID-19 疫苗包含在赛诺菲的两种用于预防流感和 COVID-19 的候选组合疫苗中,这两种疫苗的1/2期试验已经启动,美国最近批准了快速通道。
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/ — 使用其Matrix-M佐剂推进蛋白质疫苗的跨国公司Novavax, Inc.(纳斯达克股票代码:NVAX)今天宣布,通过与赛诺菲的合作,在2024年第四季度取得进展,推进其企业增长战略。该公司已经实现了与儿童 COVID-19 疫苗2/3期临床试验相关的里程碑,这触发了赛诺菲的首笔5000万美元里程碑式付款。
"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."
“Novavax正在稳步推进我们的新企业增长战略。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共和国制造基地,我们正在加强资产负债表,并大幅降低成本。” Novavax总裁兼首席执行官约翰·雅各布斯说。“此外,赛诺菲最近宣布,两款候选疫苗将我们经过验证的 COVID-19 疫苗与市场领先的流感疫苗相结合,获得了美国食品药品管理局的快速通道认证。这些资产已进入1/2期临床试验,如果成功,未来有可能获得Novavax里程碑式的付款和特许权使用费。”
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继2024年5月与赛诺菲签署协议时首次支付预付款。在这笔付款之后,还有其他与Novavax合作的 COVID-19 疫苗相关的高达3亿美元的潜在里程碑,这些里程碑将在获利期内得到认可。除了独立 COVID-19 疫苗的里程碑外,该协议还包括赛诺菲开发的组合产品,包括诺瓦瓦克斯的 COVID-19 疫苗,这为Novavax在未来的里程碑中提供了高达3.5亿美元的潜在机会。此外,COVID-19 的独立销售和任何赛诺菲组合产品的潜在销售都将净化 Novavax 持续的分级特许权使用费。此外,Novavax有资格获得高达2亿美元的里程碑式付款,用于购买赛诺菲使用其Matrix-M辅助剂开发的前四款产品,以及包括Matrix-M在内的每种产品的最高2.1亿美元的里程碑式付款,外加所有使用Matrix-M的赛诺菲产品的持续特许权使用费。
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.
Novavax的企业增长战略包括努力为其后期和早期的研发资产以及单独的Matrix-M辅助资产寻求更多的合作伙伴关系。这种增长战略应使公司能够持续创造价值,因为在类似的合同框架下可以确保更多的合作伙伴关系。
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 Novavax
Novavax, Inc.(纳斯达克股票代码:NVAX)通过发现、开发和商业化有助于预防严重传染病的创新疫苗来促进健康改善。总部位于美国马里兰州盖瑟斯堡的跨国公司Novavax提供差异化疫苗平台,该平台结合了重组蛋白方法、创新的纳米颗粒技术和Novavax的专利Matrix-M佐剂,以增强免疫反应。该公司的产品组合包括其 COVID-19 疫苗,其产品线包括其 COVID-19 流感组合和独立流感候选疫苗。此外,Novavax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 了解更多信息。
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.
前瞻性陈述
此处有关Novavax的未来、其运营计划和前景、可能实现更多里程碑或获得特许权使用费以及努力建立更多合作伙伴关系的陈述均为前瞻性陈述。Novavax警告说,这些前瞻性陈述存在许多风险和不确定性,可能导致实际结果与此类陈述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:Novavax 成功及时制造、销售、分销或交付其更新的 2024-2025 年 COVID-19 疫苗配方的能力,以及其未获得 FDA 2024-2025 疫苗接种季节的 BLA 的影响;与 Novavax 与赛诺菲的合作以及寻求更多合作机会相关的挑战;单独或与合作伙伴一起满足各种安全性、有效性和产品特性要求的挑战,包括这些要求与流程有关资格认证和分析验证,满足相关监管机构的要求;难以获得稀缺的原材料和供应;Novavax 采用计划监管途径的能力受到资源限制,包括人力资本和制造能力;在获得基于JN.1蛋白质的 COVID-19 疫苗或未来 COVID-19 变种菌株变更的监管授权方面面临的挑战或延迟;制造、分销或出口延迟或挑战;Novavax 完全依赖于Serum Institute of India Pvt. Ltd.,负责共同制定和填写以及运营延迟或中断对客户订单交付的影响;以及Novavax截至2023年12月31日止年度的10-k表年度报告以及随后向美国证券交易所提交的10-Q表季度报告中 “风险因素” 和 “管理层对财务状况和经营业绩的讨论和分析” 部分中确定的其他风险因素委员会 (SEC)。我们提醒投资者不要过分依赖本新闻稿中包含的前瞻性陈述。我们鼓励您阅读我们向美国证券交易委员会提交的文件,这些文件可在www.sec.gov上查阅,并讨论这些风险和其他风险和不确定性。本新闻稿中的前瞻性陈述仅代表截至本文件发布之日,我们没有义务更新或修改任何陈述。我们的业务面临重大风险和不确定性,包括上述风险和不确定性。投资者、潜在投资者和其他人应仔细考虑这些风险和不确定性。
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Investors
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SOURCE Novavax, Inc.
来源 Novavax, Inc.