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 August, 2005
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:
Research Update
EMBARGO: NOT FOR PUBLICATION OR BROADCAST BEFORE 7.00 AM GMT ON TUESDAY, 16
AUGUST 2005
Acambis welcomes start of US Government process for purchasing a stockpile of
MVA smallpox vaccine
Cambridge, UK and Cambridge, Massachusetts - 16 August 2005 - Acambis plc
(Acambis) (LSE: ACM, NASDAQ: ACAM) announces today that the Department of Health
and Human Services has issued its Request for Proposals ("RFP") for the
manufacture and delivery of doses of MVA attenuated smallpox vaccine. This
follows the issuance of a draft RFP on 13 May 2005, upon which Acambis provided
comments.
MVA vaccines are a weakened form of smallpox vaccine. Acambis' investigational
vaccine, MVA3000, is being developed for use in people for whom the traditional
smallpox vaccine is contraindicated, such as patients with disorders of the
immune system or skin conditions such as eczema. The US Government plans to
procure a stockpile of MVA as part of its defence against the threat of smallpox
virus being used as a bioterrorist weapon.
The RFP seeks to procure 20 million doses of MVA within 24 months of a contract
being awarded. It also requires advanced clinical testing up to and including
obtaining a product license for MVA. The RFP includes options for the government
to purchase up to 60 million additional doses of MVA and "warm-base"
manufacturing over the longer term. The deadline for submission of proposals is
29 September 2005 and the US Government has indicated that contract award(s)
will be made in February 2006.
Acambis is co-developing MVA3000 with Baxter Healthcare SA ("Baxter"), which is
providing process development and manufacturing services. Acambis has previously
been awarded two MVA manufacturing and development contracts by the US National
Institute of Allergy and Infectious Disease ("NIAID"), part of the US National
Institutes of Health. The first, worth $9.2m, was awarded in February 2003, and
was followed with a second contract in September 2004, worth $76.3m with an
option for an additional $55.5m for the manufacture, fill, finish and release of
2.5 million doses of MVA3000.
Last month, Acambis announced that it had commenced a Phase II safety and
immunogenicity trial of MVA3000 in 700 healthy adult subjects, half of whom have
been previously vaccinated against smallpox. Previously, Acambis had published
results from a Phase I safety and immunogenicity trial of MVA3000, which found
that 97% of subjects vaccinated at the highest dose level seroconverted to
vaccinia virus-specific antibodies (determined by enzyme-linked immunosorbent
assay) and 82% seroconverted to vaccinia neutralising antibodies (determined by
plaque-reduction neutralisation testing) after two doses. No subjects
experienced unexpected or serious adverse events.
Acambis' Chief Executive Officer Gordon Cameron commented:
"We welcome the issuance of this RFP and are confident that our partnership with
Baxter enables us to compete successfully for award of the contract. As the
world's leading smallpox vaccine supplier, we have a track record in this area
that is second to none and our clinical results for MVA3000 have been exactly in
line with our expectations. The combination of Acambis' US clinical development
and regulatory experience and Baxter's ability to manufacture to commercial
scale ensures that we are in a very strong position to meet all of the US
Government's requirements for a stockpile of MVA vaccine."
Enquiries:
Acambis:
Gordon Cameron, Chief Executive Officer
Tel: +1 (617) 761 4200
David Lawrence, Chief Financial Officer
Lyndsay Wright, VP, Communications and Investor Relations
Tel: +44 (0) 1223 275 300
Financial Dynamics:
David Yates/Lucy Briggs
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 47 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.
About Acambis' NIAID contracts
Acambis has been awarded two contracts by the NIAID for the manufacture and
development of its MVA smallpox vaccine, MVA3000. The first contract, awarded in
February 2003, was for $9.2m. The second, awarded in September 2004, is
potentially worth up to $131m, with a $76m core component requiring clinical
testing and manufacture of 500,000 doses of MVA3000, and an optional element
worth $55m for the manufacture of a further 2.5 million doses of MVA3000.
"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 the 2004 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: 16 August, 2005 ACAMBIS PLC
By: /s/ Lyndsay Wright
Name: Lyndsay Wright
Title: Director of Communications