Novavax Inc. is looking to get its Covid-19 vaccine through clinical trials with help from global contract development and manufacturing organization Fujifilm Diosynth Biotechnologies.
The deal, part of the $1.6 billion the Gaithersburg biotech secured from the federal government’s Operation Warp Speed program, has already given Tokyo-based Fujifilm the green light to start production on its first batch of the drug substance for Novavax’s candidate at its manufacturing facility in Morrisville, North Carolina.
Those batches are earmarked for the company’s phase 3 study, designed to include 30,000 people in the U.S. and expected to start this fall. The company plans to announce its phase 1 trial data the first week of August, before kicking off a phase 2 study. A successful outcome would position Novavax for its phase 3 trial which, if successful, would allow Novavax to seek for approval from the Food and Drug Administration. It’s a journey that typically takes several years and, more often than not, does not result in a commercialized product.
“We are committed to working together with unprecedented speed to deliver a vaccine to protect our nation's population,” said Novavax President and CEO Stanley Erck in a statement.
Operation Warp Speed, an initiative to invest in coronavirus countermeasures and accelerate vaccine development, comes from the Department of Health and Human Services, the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health, the Department of Defense and the Biomedical Advanced Research and Development Authority.
Novavax’s contract under the program aims to get its candidate through late-stage clinical trials. That means establishing large-scale manufacturing and making 100 million doses “in parallel” with those trials, Erck said in an interview earlier this month. “You have to start building manufacturing capacity at large scale.”
And still, the company will need more help, Erck said. “This contract covers 100 million doses, but what we need is 500 million doses.”
Specifically, he said, Novavax needs an additional contract for a product purchase next year, and partners to help the company distribute the product globally, in addition to those already on board. That work will also involve the traditional vaccine distribution network, but “we also have an interest in making our vaccine available globally,” and those discussions have started, Erck said.
The biotech’s stock closed up about 4.2% Monday at $139.60 per share, after reaching a high of $151.20 July 23, the day Novavax announced its agreement with Fujifilm.
Fujifilm joins Novavax’s team on its coronavirus program, alongside Emergent BioSolutions Inc., AGC Biologics and PolyPetide Group.
Novavax’s Operation Warp Speed award is just the latest for its Covid-19 program, after landing $60 million from the Department of Defense, $388 million from the Norway-based Coalition for Epidemic Preparedness Innovations and selling its own stock for a total of $200 million. The company, one of DC Inno’s 2020 Inno on Fire, has also made a series of executive hires amid this work, appointing U.S. Pharmacopeia and MedImmune veteran Frank Czworka to senior vice president of global sales; promoting Brian Webb, formerly of GlaxoSmithKline and Human Genome Sciences, to senior vice president of manufacturing; hiring AstraZeneca and MedImmune alum Dr. Filip Dubovsky as senior vice president and chief medical officer; and tapping biotech investor David Mott for its board.
Editor’s Note: This story first appeared in the Washington Business Journal. See the original post here.
