BioWorld International Correspondent
Crucell NV gained what Chief Financial Officer Leonard Kruimer described as a larger-than-expected contract from the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
The contract is for manufacturing 10 clinical-grade batches of Ebola virus vaccine for use in Phase I and Phase II studies. The full value of the contract, which is set for about two and a half years, stands at €21.4 million (US$27.9 million).
The vaccine is being developed under a Cooperative Research and Development Agreement between Crucell and the NIH, which also includes provisions for the development of vaccines against two other viruses that cause hemorrhagic infection, Marburg and Lassa.
The program is due to move into the clinic in the fourth quarter. Depending on the outcome of the initial studies, the NIH, of Bethesda, Md., might decide not to proceed with all 10 trials, Kruimer said.
"Then you do not get all the revenues from this contract, but you have a product," he said. The vaccine, which Crucell, of Leiden, the Netherlands, will produce using its PER.C6 human cell culture system, will not be eligible for full FDA approval but will be available under U.S. biopreparedness plans for administration to key personnel, including the military, government officials and health care workers, in the event of an outbreak.
"The government has indicated that they would be able to buy 3 million doses," Kruimer said. "You're talking about a market of $100 million, and that's what we're going for."
Additional human and animal studies would be required for full approval. A single dose of the recombinant vaccine, which is based on Crucell's replication-deficient adenovirus vector expressing Ebola viral antigens, bestowed protection on macaque monkeys challenged with a lethal dose of Ebola virus in studies conducted last year by the Vaccine Research Center and the U.S. Army Medical Research Institute of Infectious Disease, located in Frederick, Md.
"We are the only company in the world, which has developed a vaccine which keeps animals alive and disease-free after vaccination," Kruimer said.
Administrations in other countries also have expressed interest in the Ebola program, he said. "We will make sure it works in the United States and then we'll take it from there."