Maryland biotech Novavax scored a big leg up in its hunt for a COVID-19 vaccine with a major infusion from the Trump administration this month. Now, Novavax is using some of those funds to help supply doses of its shot for a pivotal late-stage trial down the road.
Fujifilm Diosynth Biotechnologies will churn out clinical supply for a phase 3 trial of Novavax's COVID-19 vaccine candidate expected to begin in the fall, according to a manufacturing pact signed Thursday.
Fujifilm has already begun manufacturing bulk drug substance for the shot at its Morrisville, North Carolina, facility, the companies said in a joint release.
The arrangement will be funded through a $1.6 billion grant from the Trump administration Warp Speed initiative, which aims to rapidly develop and distribute workable COVID-19 vaccines to U.S. patients. Novavax plans to use the government funding to finance a phase 3 involving up to 30,000 patients and rapidly scale manufacturing to produce 100 million doses of the shot by the end of 2020.
The Fujifilm pact is the first Novavax has signed to make good on the Trump administration's down payment. Novavax is set to read out phase 1 clinical data for its vaccine within weeks and could roll into phase 2 testing immediately after that.
The road to success for Novavax—a once-troubled biotech without an approved vaccine—could come with a big payday for its executives if its COVID-19 shot moves into the next phase of testing.
Four Novavax executives, including CEO Stanley Erck, would together earn 830,000 stock options if the COVID-19 vaccine, dubbed NVX-CoV2373, simply enters phase 2 human testing by April 2021, according to a proxy filing.
Those options are valued at roughly $100 million at Novavax's pumped-up stock price, which has skyrocketed in recent months as the biotech moves forward with its COVID-19 shot and a four-strain flu hopeful.
Meanwhile, Fujifilm has been busy producing doses of flu drug Avigan as a potential therapy for COVID-19 alongside generics maker Dr. Reddy's Laboratories and Dubai-based Global Response Aid.
Earlier this month, the partners struck a three-way deal to manufacture and sell Avigan, which at the time was already approved for COVID-19 in India and Russia. That agreement covered all countries other than Japan, China and Russia.
For an unidentified lump-sum license fee and royalties on sales, Fujifilm granted Dr. Reddy’s and Global Response Aid access to Avigan’s preclinical and clinical data to help run their own studies. Dr. Reddy’s gained exclusive rights to the drug in India while Fujifilm transferred its manufacturing method exclusively to Dr. Reddy’s.
Back in April, Fujifilm pledged to devote some of its manufacturing capacity in Denmark for a treatment yet to be identified by the Gates-funded COVID-19 Therapeutics Accelerator. As part of the deal, Fujifilm allocated space at its Hillerød, Denmark, facility and said it would "work with a selected pharmaceutical partner in supporting the swift manufacture and dedicated supply for patients with COVID-19 in lower-income countries," the CDMO said in a release.