VaxGen, Inc., a biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has granted a Fast Track designation to the company's anthrax vaccine candidate, rPA102. The Fast Track designation means that FDA will take such actions that are appropriate to expedite the development and review of a license application for rPA102, when and if it is submitted to the FDA.
Under the FDA Modernization Act of 1997, the FDA's Fast Track Program is designed to expedite the development and review of a new drug that is intended for the treatment or prevention of a serious or life-threatening condition, and demonstrates the potential of a drug candidate to address unmet medical needs for such a condition.
"The Fast-Track designation is designed to provide us with frequent and ongoing communication with the FDA, allows for the possibility of filing portions of the license application ahead of others, and gives priority review status to the license application for our anthrax vaccine candidate," said Carmen Betancourt, VaxGen's senior vice president of Regulatory and Quality Affairs.
VaxGen is developing rPA102 under two contracts valued at more than $100 million from a division of the National Institutes of Health. The latest contract, valued at $80.3 million and awarded on September 30, 2003, is intended to fund animal safety studies, Phase II clinical trials, the scale up and validation of the vaccine manufacturing process and production of 3 million doses of finished product. The latest contract has been funded in whole with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, under Contract No. N01-AI-30053.