Novavax Inks Deal with Fujifilm’s Contract Manufacturing Business to Produce Vaccine Product for Clinical Trials

Novavax Inks Deal with Fujifilm’s Contract Manufacturing Business to Produce Vaccine Product for Clinical Trials

Novavax Inc. deal making continues as the COVID-19 vaccine maker recently signed a contract to work with one of the world’s leading contract manufacturers, Fujifilm Diosynth Biotechnologies. All of this, of course, is made possible by the recent $1.6 billion financial commitment by the U.S. government via Operation Warp Speed. Novavax now must work furiously on all fronts to run clinical trials, expand its manufacturing capacity and build a commercial infrastructure. It inked a deal with the Tokyo-based Fujifilm, so the company can commence immediate “at-risk” manufacturing: meaning start producing the vaccine for patient administration during Phase 3 clinical trials that would involve up to 30,000 participants. Of course, any Phase 2 or 3 study advancement is contingent on positive results of its Phase 1 clinical trial.  The data from that study should be shared during the first week of August. In the meantime, President Donald Trump visited the Novavax manufacturing facility in Morrisville, North Carolina.

These batches are planned for the company’s Phase 3 clinical trial which targets up to 30,000 participants in the United States. The study is expected to commence this fall. In the meantime, Novavax hopes to announce its Phase 1 clinical trial data the first week in August prior to the Phase 2 study launch. In a journey that takes several years, the Operation Warp Speed program has initiated unprecedented federal government involvement in drug development in a bid to accelerate vaccines and therapies targeting COVID-19. President Donald Trump has been on record that a safe and effective vaccine will be available by January 2021.

More Deals Necessary

CEO Stanley Erck commenting on the paramount importance of Operation Warp Speed and the responsibility associated with the large funding associated with his company’s vaccine development states, “We are committed to working together with unprecedented speed to deliver a vaccine to protect our nation’s population.” The company currently has a contract for 100 million doses but they will need 500 million according to their CEO. Mr. Erck conveyed that the company will need yet another contract in place for a product purchase in 2021 in addition to partners for distribution of the drug worldwide as he commented, “we also have an interest in making our vaccine available globally.” The CEO repots that they are in discussions with various prospective partners.

Large Sums Already Raised

In addition to the recent $1.6 billion U.S. federal government injection of capital, the company has secured $60 million from the Department of Defense, $388 million from the Coalition for Epidemic preparedness Innovations and selling its own equity to the public raising $200 million.  

Making Executive Moves

Sara Gilgore, writing for the Washington Business Journal, reports that the company has hired Frank Czworka, a Medimmune executive, as senior vice president of global sales; former GlaxoSmithKline executive Brian Webb has become vice president of manufacturing while Dr. Filip Dubovsky, formerly with AstraZeneca and Medimmune, joined as senior vice president and chief medical officer. Biotech investor David Mott joined the Novavax board.

Who is Fujifilm Diosynth Biotechnologies?

Fujifilm Diosynth Biotechnologies is a leading global contract development and manufacturing organization (CDMO). They offer a complete range of solutions for pharmaceutical manufacturing: from pre-clinical investigations and process development to commercial cGMP production. The TrialSite has reported that Fujifilm has “doubled down” on investment in contract manufacturing for the white hot world of drug development, recently spending $928 million into its Danish operation (formerly Biogen). There is a race for CDMO’s to grow while biopharma companies offload their expensive manufacturing to agile firms that seek market share via technology advancements, process innovation and more compelling economic models.