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Novavax and FUJIFILM Diosynth Biotechnologies Initiate Large Scale Manufacturing of COVID-19 Vaccine Candidate
GAITHERSBURG, Md. and MORRISVILLE, N.C., July 23, 2020 /PRNewswire/ -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing
About this update from Novavax, Inc.
[{"type":"text","content":"GAITHERSBURG, Md. and MORRISVILLE, N.C., July 23, 2020 /PRNewswire/ -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, and FUJIFILM Diosynth Biotechnologies (FDB), a world leading contract development and manufacturing organization (CDMO) for biologics, viral vaccines and gene therapies, announced today an agreement to manufacture bulk drug substance for NVX-CoV2373, Novavax' COVID-19 vaccine candidate. FDB's site in Morrisville, North Carolina has begun production of the first batch of NVX-CoV2373. \n\n \n \n \n \n \n \n\n \nThis arrangement falls under Novavax' recent $1.6 billion award by the federal government as part of Operation Warp Speed (OWS), a U.S. government program that aims to begin delivering millions of doses of a safe, effective vaccine for COVID-19 to the U.S. population. The OWS funding is being used by Novavax to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX–CoV2373 beginning as early as late 2020. NVX-CoV2373 consists of a stable, prefusion protein made using Novavax' proprietary nanoparticle technology and includes Novavax' proprietary Matrix–M™ adjuvant. The batches produced at the FDB site in North Carolina will be utilized in a future pivotal Phase 3 clinical trial of up to 30,000 subjects which is expected to begin in the fall of 2020 and which will determine the safety and efficacy of NVX-CoV2373.\n\"We are grateful to partner with the team at FUJIFILM Diosynth Biotechnologies to ensure the large-scale manufacture of our COVID-19 vaccine candidate,\" said Stanley C. Erck, President and Chief Executive Officer of Novavax. \"We are committed to working together with unprecedented speed to deliver a vaccine to protect our nation's population.\"\n\"We are delighted to bring our leading technical expertise in baculovirus systems and our proven manufacturing excellence to support Novavax' response to this global crisis,\" said Martin Meeson, Chief Executive Officer of FUJIFILM Diosynth Biotechnologies. \"As a critical partner to Novavax, our focus is to advance the delivery of a vaccine that can have a profound impact.\"\nNovavax' Phase 1/2 clinical trial of NVX-CoV2373 in 130 healthy participants 18 to 59 years...