FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Private Issuer
Pursuant to Rule 13s - 16 or 15d - 16 of
the Securities Exchange Act of 1934
For the month of January 2006
Acambis plc
(Translation of registrant's name into English)
Peterhouse Technology Park
100 Fulbourn Road
Cambridge CB1 9PT
England
(address of principal executive offices)
(Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F
Forms 20-F X Form 40-F
Indicate by check mark whether the registrant by furnishing the information
contained in this Form also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934).
Yes No X
(if "Yes" is marked, indicate below the file number assigned to the registrant
in connection with Rule 12g3-2(b): 82- ).
Enclosure:
Acambis submits ACAM2000 BLA
Acambis submits US licence application for ACAM2000 smallpox vaccine
Cambridge, UK and Cambridge, Massachusetts - 18 January 2006 - Acambis plc
(Acambis) (LSE: ACM, NASDAQ: ACAM) announces that it has submitted the first
portion of a Biologics License Application (BLA) with the US Food and Drug
Administration (FDA) to seek US licensure of its investigational smallpox
vaccine, ACAM2000.
As agreed with the FDA, Acambis is submitting the BLA on a "rolling" basis. The
BLA will include 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:
"The start of the BLA submission for ACAM2000 is the culmination of years of
hard work by Acambis to provide the US Government with a licensable smallpox
vaccine manufactured, tested, released and evaluated in accordance with current
Good Manufacturing, Laboratory and Clinical Practice standards. Given ACAM2000's
Fast-Track product designation, we hope to receive the FDA's decision on our
application before the end of the year."
-ends-
Enquiries:
Acambis:
Gordon Cameron, Chief Executive Officer
David Lawrence, Chief Financial Officer
Lyndsay Wright, VP, Communications and Investor Relations
Tel: +44 (0) 1223 275 300
Financial Dynamics:
David Yates/Davina Langdale
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 is establishing a travel vaccines
franchise through its US-based subsidiary Berna Products Corporation, which
markets Vivotif(R), the world's only licensed oral typhoid vaccine, in North
America. Acambis has other potential travel vaccines in development and is also
developing an investigational vaccine against the West Nile virus, which has
spread to 48 US States in the last six years.
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 www.acambis.com.
"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.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant Peptide Therapeutics Group has duly caused this report to be
signed on its behalf by the undersigned, thereunto duly authorized.
Date: 18 January 2006 ACAMBIS PLC
By: /s/ Lyndsay Wright
Name: Lyndsay Wright
Title: VP, Communications and IR.