Siegfried supports Novavax with commercial aseptic fill & finish services for vaccine candidate NVX-CoV2373
Novavax, a US-based innovative biopharmaceutical company, has chosen the Siegfried Group (SIX: SFZN) as a non-exclusive supplier for the aseptic fill & finish of commercial quantities of its investigational protein-based coronavirus vaccine NVX-CoV2373. The manufacturing and supply agreement between Novavax and Siegfried has an initial term until the end of 2021 with an option to extend. The vaccine candidate is currently under review for approval by different health authorities worldwide and will be filled on Siegfried’s manufacturing site in Hameln (Germany) starting around mid-2021.
Siegfried CEO Dr. Wolfgang Wienand: “We are proud to be able to increase our contribution to the fight against the coronavirus pandemic through our collaboration with Novavax. Implementing this initiative at such speed is proof of the good teamwork between the two companies even under high pressure, and confirms our capabilities and flexibility as one of the leading service providers in the CDMO space. I would like to thank Novavax for entrusting us with their most important project. The Siegfried team as a whole and in Hameln is highly motivated and looking forward to working together with Novavax.”
Novavax has begun the rolling submission process with several regulatory agencies worldwide, including the EU’s Medicines Agency (EMA), the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada, among others. The volumes filled by Siegfried are intended for distribution outside the US market. As part of the services, Siegfried will also provide special storage capacity for the vaccine products at its Hameln site.
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 combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
The Siegfried Group is a global life sciences company with sites in Switzerland, Germany, Spain, France, Malta, the USA and China. In 2020, the Siegfried group achieved sales of CHF 845.1 million and employs approximately 3’500 people at eleven sites on three continents. Siegfried Holding AG is publicly listed on SIX Swiss Exchange (SIX: SFZN).
Siegfried is active in manufacturing pharmaceutical APIs (and their intermediates) as well as drug products (tablets, capsules, sterile vials, ampoules, cartridges and ointments) for the pharmaceutical industry and provides development services.