Acambis submits Biologics License from FDA for investigational smallpox vaccine

By E. Janene Geiss

Philadelphia, Jan. 18 - Acambis plc said Wednesday that it has submitted the first portion of a Biologics License Application with the Food and Drug Administration for its investigational smallpox vaccine, ACAM2000.

As part of an agreement with the FDA, Acambis said it is submitting the BLA on a "rolling" basis, according to a company news release.

The BLA will include safety, tolerability and immunogenicity data obtained from clinical trials of ACAM2000 conducted in more than 3,800 subjects. The ACAM2000 program was given fast track status by the FDA in December 2004, officials said.

"The start of the BLA submission for ACAM2000 is the culmination of years of hard work by Acambis to provide the U.S. government with a licensable smallpox vaccine manufactured, tested, released and evaluated in accordance with current good manufacturing, laboratory and clinical practice standards, chief executive officer Gordon Cameron said in the release.

Given the vaccine's fast track product designation, the company said it hopes to receive the FDA's decision before the end of the year.

Acambis, based in Cambridge, England, and Cambridge, Mass., is a leading developer of vaccines to prevent and treat infectious diseases.

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