– Novavax secures additional manufacturing capacity until 2022
– SK bioscience obtains long-term license to supply NVX-CoV2373 to Korean market
GAITHERSBURG, MD., 23 December 2021 / PRNewswire / – Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to the development and commercialization of next-generation vaccines against serious infectious diseases, and SK bioscience, Co. Limited, a marketing subsidiary of vaccines of Korea-based SK Group, today announced the extension of the company collaboration and licensing agreements for NVX-CoV2373, Novavax’s COVID-19 vaccine based on recombinant protein nanoparticles.
The companies have agreed that SK bioscience will reserve significant additional manufacturing capacity to produce antigen, a key component of NVX-CoV2373, until 2022, with the possibility of extending the agreement. The agreement between the companies also builds on a previously announced Advance Purchase Agreement (APA) between SK Bioscience and the Korean government to deliver 40 million doses of NVX-CoV2373 to the Republic of Korea. SK bioscience could supply additional quantities of NVX-CoV2373 to the Korean market in 2022. In addition, SK bioscience has acquired the non-exclusive rights to sell doses of Novavax vaccine to governments of Thailand and Vietnam.
“SK Bioscience and the Korean government continue to be important partners of Novavax in our efforts to ensure widespread access to our COVID-19 vaccine to citizens of South Korea and beyond, “said Stanley C. erck, President and Chief Executive Officer, Novavax. “This strategic partnership helps to further expand our global network for manufacturing and marketing high-quality products and will constitute a significant portion of our expected 2 billion annual doses in total global manufacturing capacity in 2022.”
“SK bioscience shares Novavax’s sense of urgency to deliver a safe and effective protein-based COVID-19 vaccine to help protect not only South Koreans, but the world’s population as well,” said Jaeyong Ahn, CEO of SK bioscience. “We are committed to supporting the production of NVX-CoV2373 in South Korea and to doing our part in the fight against COVID-19 in partnership with Novavax. “
In collaboration with Novavax, SK bioscience initiated the continuous submission process for NVX-CoV2373 with that of South Korea Ministry of Food and Pharmaceutical Security (MFDS) in April. An application for an organic product license was submitted to the MFDS in November. Additional information regarding Novavax’s previous license agreement with SK bioscience can be found here.
NVX-CoV2373 is a protein-based vaccine designed from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’s recombinant nanoparticle technology to generate an antigen derived from the coronavirus spike (S) protein and is formulated with Matrix-M ™ adjuvant patented saponin from Novavax to improve the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains a purified protein antigen and cannot replicate or cause COVID-19.
Novavax’s COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination schedule requires two doses of 0.5 ml (5 mcg of antigen and 50 mcg of Matrix-M adjuvant) administered intramuscularly 21 days apart. The vaccine is stored between 2 ° and 8 ° Celsius, which allows the use of existing vaccine supply and cold chain channels. The currently assigned shelf life for the vaccine is 9 months.
Novavax has established partnerships for the manufacture, marketing and distribution of NVX-CoV2373 around the world.
About the Phase 3 trials of NVX-CoV2373
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials.
A UK trial with 14,039 participants was designed as a randomized, placebo-controlled, observer-blind study and achieved an overall efficacy of 89.7%. The primary endpoint was based on the first onset of symptomatic COVID-19 (mild, moderate or severe) confirmed by PCR with onset at least 7 days after the second study vaccination in serologically negative adult participants (SARS -CoV-2) at the start. . The full results of the trial have been published in the New England Journal of Medicine (NEJM).
PREVENT-19, a trial in the United States and Mexico, with 25,452 participants, achieved an overall efficacy of 90.4%. It was designed as a randomized, placebo-controlled, blinded 2: 1 study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373. The primary endpoint of PREVENT-19 was the first occurrence of symptomatic COVID-19 (mild, moderate, or severe) confirmed by PCR with onset at least 7 days after the second dose in serologically negative adult participants (SARS-CoV -2) at baseline. The criterion for statistical success included a lower limit of 95% CI> 30%. The key secondary endpoint is prevention of COVID-19 confirmed by PCR, moderate or severe symptomatic. Both endpoints were assessed at least 7 days after the second study vaccination in volunteers who had not previously been infected with SARS-CoV-2. It was generally well tolerated and elicited a strong antibody response in both studies. The full trial results have been published in NEJM.
About Matrix-M ™ Adjuvant
Novavax’s patented saponin-based Matrix-M ™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating entry of antigen-presenting cells into the injection site and improving antigen presentation in the injection site. local lymph nodes, thereby strengthening the immune response.
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to meet urgent global health needs. NVX-CoV2373, the company’s COVID-19 vaccine, has received conditional marketing authorization from the European Commission, an emergency use list from the World Health Organization, an authorization for use emergency in Indonesia and Philippines, and has been subject to regulatory clearance in several markets around the world. NanoFlu ™, the company’s quadrivalent nanoparticle influenza vaccine, has met all of the primary goals of its pivotal Phase 3 clinical trial in the elderly. Novavax is currently evaluating a COVID-NanoFlu combination vaccine in a Phase 1/2 clinical trial, which combines the company’s NVX-CoV2373 and NanoFlu vaccine candidates. These vaccine candidates incorporate Novavax’s proprietary saponin-based Matrix-M ™ adjuvant to enhance immune response and stimulate high levels of neutralizing antibodies.
For more information, visit www.novavax.com and connect with us on Twitter, LinkedIn, Instagram and Facebook.
The following statements regarding the future of Novavax, its operating plans and prospects, its partnerships, the ongoing development of NVX-CoV2373, the scope, timing and results of future regulatory filings and actions, potential impact of Novavax and NVX-CoV2373 in treating vaccine access, pandemic control and protection of populations, and the expected global manufacturing capacity of Novavax are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties which could cause actual results to differ materially from those expressed or implied by these statements. These risks and uncertainties include the challenges of meeting, alone or with partners, various safety, efficacy and product characterization requirements, including those related to process qualification and test validation, necessary to meet applicable regulatory authorities; difficulty in obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on Novavax’s ability to follow planned regulatory pathways; challenges in meeting contractual requirements under agreements with multiple commercial, government and other entities; and the other risk factors identified in the “Risk factors” and “Management’s analysis and analysis of the financial position and operating results” sections of Novavax’s annual report on form 10-K for the year ended December 31, 2020 and subsequent quarterly reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place significant reliance on any forward-looking statements contained in this press release. We encourage you to read our SEC filings, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements contained in this press release speak only as of the date of this document, and we assume no obligation to update or revise any such statements. Our business is subject to substantial risks and uncertainties, including those mentioned above. Investors, potential investors and others should carefully consider these risks and uncertainties.
Erika Schultz | 240-268-2022
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SOURCE Novavax, Inc.