Baxter Biopharma Solutions Announces Sterile Manufacturing Agreement For Novavax Covid-19 Vaccine

Press Release
  • Agreement will help increase commercial production and promote access in United Kingdom and European markets

    Manufacturing to take place at Baxter's state-of-the-art Halle/Westfallen, Germany facility

     

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DEERFIELD, Ill., JANUARY 11, 2021 – Baxter International Inc. (NYSE: BAX), a global leader in sterile medication production and delivery, today announced that Baxter BioPharma Solutions has entered into an agreement to provide sterile manufacturing services for NVX-CoV2373, Novavax’ COVID-19 recombinant nanoparticle vaccine candidate with Matrix-M™ adjuvant. Baxter BioPharma Solutions is a premier contract manufacturing organisation that specialises in parenteral (injectable) pharmaceuticals, including vaccines. The agreement is expected to advance commercial-scale manufacturing essential for the vaccine’s production and distribution in the United Kingdom and European markets. Novavax’ COVID-19 vaccine candidate is currently in phase 3 trials and has not yet been authorised or approved for use.


“The quest to develop vaccines for COVID-19 has reinforced the opportunity for industry partners to work together and contribute their unique capabilities and expertise for the benefit of all,” said Marie Keeley, vice president, Baxter BioPharma Solutions. “We welcome the opportunity to work with an innovative company like Novavax and look forward to helping bring their vaccine candidate to the market.”


According to Novavax, NVX-CoV2373 contains a full-length, prefusion spike protein made using Novavax’ recombinant nanoparticle technology and the company’s proprietary saponin-based Matrix-M™ adjuvant. The purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike (S) protein and is produced in insect cells. It can neither cause COVID-19 disease nor can it replicate, is stable at 2°C to 8°C and is manufactured in a ready-to-use liquid formulation that permits distribution using standard vaccine supply chain channels.
“Our priority is to bring a safe, effective COVID-19 vaccine to people around the world,” said Rick Crowley, executive vice president, chief operations officer, Novavax. “Partners like Baxter BioPharma Solutions are enabling Novavax to quickly establish a commercial supply chain network to ensure access for global populations, and ultimately help bring about an end to the global COVID-19 pandemic.”


Baxter’s manufacturing services for NVX-CoV2373 will take place at its state-of-the-art facility in Halle/Westfalen, Germany. The site has broad sterile manufacturing capabilities and areas of focus, offers current good manufacturing practices (cGMP) manufacturing with dedicated production areas and is designed to deliver products with optimum efficiency and speed to market. Baxter’s recently expanded Halle/Westfalen facility has been in operation for more than 60 years. Additional details of the agreement were not disclosed.

About Baxter's BioPharma Solutions Business
Baxter’s BioPharma Solutions business supports leading pharmaceutical companies in meeting their commercialisation objectives by providing scientific expertise, sterile manufacturing solutions, parenteral delivery systems and customised support services needed to meet the unique challenges that parenteral products face. For more information, please visit www.baxterbiopharmasolutions.com.


About Baxter
Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxterhealthcare.co.uk.


This release includes forward-looking statements regarding Baxter’s production of the Novavax COVID-19 vaccine, including expectations with regard to the approval of the vaccine, its manufacture at Baxter sites, its availability to the public and the timing and volume thereof. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; inability to create additional production capacity in a timely manner or the occurrence of other manufacturing or supply difficulties (including as a result of a natural disaster, public health crises and epidemics/pandemics, regulatory actions or otherwise); changes in law and regulations; and other risks identified in Baxter's most recent filings on Forms 10-K and 10-Q and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.


Baxter is a registered trademark and BioPharma Solutions is a trademark of Baxter International Inc. Matrix-M is a trademark of Novavax, Inc.
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