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VaxGen Wins Extension on Anthrax Vaccine

By Renae Merle
Washington Post Staff Writer
Friday, November 17, 2006; Page D07
http://www.washingtonpost.com/wp-dyn/content/article/2006/11/16/AR2006111601522.html

VaxGen Inc., a California biotechnology firm, said yesterday that the government had given it more time to conduct human testing of its anthrax vaccine, postponing a decision on whether the program should be canceled.

The Food and Drug Administration threw the effort into doubt earlier this month after calling a halt to testing in response to questions about the drug's reliability. The decision put the company in potential violation of its contract with the Department of Health and Human Services, which required testing to begin Nov. 13.

VaxGen said HHS has decided to extend the company's deadline for resolving the issue until Dec. 18. At stake is a contract potentially worth $1 billion.

Meeting that deadline will be difficult. The company has yet to hold a formal telephone or in-person meeting with the FDA.

Those meetings should occur no later than the middle of December, said Lance Ignon, VaxGen's vice president of corporate affairs. "HHS, it appears, has provided the necessary time for us to meet with FDA to try to discuss our data and try to find a pathway forward," he said.

VaxGen's anthrax vaccine effort, already years behind schedule, is the largest component of the Bush administration's Project BioShield, a $5.6 billion effort to counter bioterrorism threats. The firm has run into several technical problems, including a previous failed human test, and has struggled to fund its research. The contract calls for the company to be paid after it delivers the vaccine -- which is supposed to be enough for 25 million people, roughly the population in the New York and Washington metropolitan areas combined.

The latest problem centers on the vaccine's stability or the rate at which it would deteriorate while stockpiled. VaxGen has said it was encouraged by the improvements it made to the vaccine's stability, but that FDA still had concerns.