Company gets $877.5 million U.S. government contract to supply anthrax vaccine.

2004 DEC 1 - (NewsRx.com & NewsRx.net) -- VaxGen, Inc. (VXGN) announced that the U.S. government has awarded the company an $877.5 million contract to supply 75 million doses of anthrax vaccine for civilian defense.

The contract, the first of its kind under the Project BioShield Act of 2004, is intended to provide enough product to vaccinate 25 million Americans in a multiple-dose regimen against inhalation anthrax, the most deadly form of the disease and the one most likely to be used as a bioterrorist weapon.

The contract calls on VaxGen to provide 25 million doses of its recombinant protective antigen anthrax vaccine to the Strategic National Stockpile (SNS) within 2 years of the award and a total of 75 million doses within 3 years.

The SNS is a national repository of medical products maintained by the Centers for Disease Control and Prevention (CDC). For the remainder of the 5-year contract, VaxGen will be maintaining active manufacturing operations and providing stockpile-related services.

VaxGen expects to recognize revenue from the supply contract upon acceptance of the vaccine by the U.S. government and delivery to the SNS. VaxGen will be working closely with the government to deliver the vaccine beginning in early 2006.

Under the authority of the Project BioShield Act of 2004, the U.S. government intends to begin taking delivery of the vaccine before it is licensed for use by the U.S. Food and Drug Administration (FDA). Vaccine purchased prior to FDA approval could be used in an emergency if authorized by the Secretary of Health and Human Services.

Under the terms of the contract, VaxGen is required to continue developing the vaccine with the goal of receiving FDA approvals for use of the vaccine both before and after exposure to anthrax. The vaccine has already received fast-track designation, meaning that the FDA will take actions that are appropriate to expedite the development and review of a license application for the vaccine, when and if it is submitted to the FDA.