April 18, 2006 02:01 ET

Acambis PLC - ACAM2000 BLA Completed

Cambridge, UK -- (MARKET WIRE) -- April 18, 2006 --Acambis completes submission of US licence application for ACAM2000 smallpox vaccine

Cambridge, UK and Cambridge, Massachusetts - 18 April 2006 - Acambis plc ("Acambis") (LSE: ACM, NASDAQ: ACAM) announces that it has completed submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) to seek licensure of its investigational smallpox vaccine, ACAM2000.

As agreed with the FDA, Acambis submitted the BLA on a "rolling" basis, starting with the first portion in January 2006. The BLA includes safety, tolerability and immunogenicity data obtained from clinical trials of ACAM2000 conducted in more than 3,800 subjects. The ACAM2000 programme was given "fast-track" status by the FDA in December 2004.

Gordon Cameron, Chief Executive Officer of Acambis, commented:

"I'm very proud of Acambis' achievement in completing the ACAM2000 BLA submission just three-and-a-half years after ACAM2000's Investigational New Drug application was submitted. We look forward to the FDA completing its review of the BLA, which we anticipate will come before the end of 2006, based on ACAM2000's fast-track status."



Acambis plc

Gordon Cameron, Chief Executive Officer

David Lawrence, Chief Financial Officer

Lyndsay Wright, VP, Communications and IR

Tel: +44 (0 1223 275 300

Financial Dynamics

David Yates/Anna Keeble

Tel: +44 (0) 20 7831 3113

About Acambis

Acambis is a leading developer of vaccines to prevent and treat infectious diseases. Recognised internationally as the leading producer of smallpox vaccines, Acambis is developing an investigational smallpox vaccine, ACAM2000, and is manufacturing emergency-use stockpiles of this investigational vaccine for the US Government and other governments around the world. It is also developing an attenuated smallpox vaccine, MVA3000, under contracts with the US National Institutes of Health. Acambis' US-based subsidiary Berna Products Corporation markets Vivotif®, the world's only licensed oral typhoid vaccine, in North America. Acambis' investigational vaccine against Japanese encephalitis, ChimeriVax-JE, is undergoing Phase 3 clinical testing. It also has the most advanced investigational vaccine against the West Nile virus, which has spread to 48 US States in the last six years, and a vaccine against Clostridium difficile bacteria, a leading cause of hospital-acquired infections.

Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US. Its primary listing is on the London Stock Exchange (ACM) and its shares are listed in the form of American Depositary Receipts on NASDAQ (ACAM). More information is available at

"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:

The statements in this news release that are not historical facts are forward-looking statements that involve risks and uncertainties, including the timing and results of clinical trials, product development, manufacturing and commercialisation risks, the risks of satisfying the regulatory approval process in a timely manner, the need for and the availability of additional capital. For a discussion of these and other risks and uncertainties see "Risk management" in the Company's 2004 Annual Report and "Risk factors" in its Form 20-F, in addition to those detailed on the Company's website and in the Company's filings made with the Securities and Exchange Commission from time to time. These forward-looking statements are based on estimates and assumptions made by the management of Acambis and are believed to be reasonable, though are inherently uncertain and difficult to predict. Actual results or experience could differ materially from the forward-looking statements.

                      This information is provided by RNS
            The company news service from the London Stock Exchange