Bavarian Nordic has won a five-year, up-to-$33 million subcontract from Crucell Holland, a unit of Johnson & Johnson’s Janssen Pharmaceutical., focused on manufacturing and storage of the companies’ Ebola prime-boost vaccine regimen candidate.
The subcontract consists of $9 million upfront and options for an additional up-to-$24 million tied to implementing process development activities for formulation of a final drug product with a longer shelf life.
The subcontract is part of a larger contract (No. HHSO100201500008C) awarded to Janssen by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to support the advanced development and manufacturing of the Ebola prime-boost vaccine regimen. The regimen consists of Bavarian Nordic's MVA-BN® Filo and Ad26.ZEBOV from Janssen.
The base subcontract covers studies to improve the manufacturing process and establish long-term storage of MVA-BN Filo bulk vaccine.
Janssen has initiated multiple clinical studies of the prime-boost Ebola vaccine regimen in Europe and Africa, as part of an accelerated development program. To date, Bavarian Nordic has produced and delivered the bulk equivalent of over one million doses of its vaccine.
“It is encouraging that the U.S. government—through BARDA, with whom we have worked for over a decade—recognizes the potential of this vaccine to build international preparedness for current and future Ebola outbreaks,” Bavarian Nordic president and CEO Paul Chaplin said in a statement.
Bavarian Nordic said the deal with Janssen will not change its projected 2015 financial results. In releasing results for the first half of this year on August 25, the company reiterated that it expects to generate annual revenue “at the level of DKK 1,000 million ($151.6 million) and finish at breakeven before interest and taxes.
The company said revenue will primarily be generated from deliveries of bulk material totaling approximately 2 million doses of MVA-BN Filovirus vaccine under the Janssen license agreement and 0.3 million doses of IMVAMUNE to the U.S. Strategic National Stockpile, the Public Health Agency of Canada, Canada’s Department of National Defence, and an unnamed Asian country. Additional revenue is expected from ongoing research and development contracts, Bavarian Nordic added.