Acambis has delivered 182.5 million doses of ACAM2000 to the US Government for its emergency-use Strategic National Stockpile and has orders from several other governments around the world for its investigational smallpox vaccine.
The company is currently proceeding toward the submission of a biologics license application (BLA) for the vaccine based upon data obtained in all ACAM2000 trials conducted, including clinical data from more than 2,900 subjects vaccinated in its phase III clinical trials.
Under the FDA Modernization Act of 1997, designation as a fast track product for a new drug or biological product means that FDA will take such actions as are appropriate to expedite the marketing application and approval for the product.
Acambis is working with Baxter Healthcare Corporation, part of Baxter International Inc, to manufacture its investigational ACAM2000 for the US and other governments, under the FDA’s investigational new drug (IND) application for ACAM2000.