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 February 2007
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:
1 Holding(s) in Company dated 01 February 2007
2 Holding(s) in Company dated 08 February 2007
3 Holding(s) in Company dated 13 February 2007
4 Holding(s) in Company dated 16 February 2007
5 Holding(s) in Company dated 19 February 2007
6 Holding(s) in Company dated 23 February 2007
7 Notice of Results dated 28 February 2007
8 Phase 3 efficacy data dated 1 March 2007
Enclosure 1
SCHEDULE 10
NOTIFICATION OF MAJOR INTERESTS IN SHARES
1. Name of company
Acambis plc
2. Name of shareholder having a major interest
Legal & General Group plc
3. Please state whether notification indicates that it is in respect of holding
of the shareholder named in 2 above or in respect of a non-beneficial interest
or in the case of an individual holder if it is a holding of that person's
spouse or children under the age of 18
As above
4. Name of the registered holder(s) and, if more than one holder, the number of
shares held by each of them
Legal & General Group Plc (Direct and Indirect) (Group)
7,315,855-6.79% = Total Position)
Legal & General Investment Management (Holdings) Limited
(LGIMH) (Direct and Indirect) (7,315,855-6.79%)
Legal & General Investment Management Limited (Indirect)
(LGIM) (7,315,855 - 6.79% = Total Position)
Legal & General Group Plc (Direct) (L&G) (6,393,925-5.93% = LGAS, LGPL & PMC)
Legal & General Investment Legal & General Insurance
Management (Holdings) Limited Holdings Limited (Direct)
(Direct) (LGIMHD)(3,342,882-3.10%
= PMC)
Legal & General Assurance Legal & General Assurance Society Limited
(Pensions Management)Limited (LGAS & LGPL)
(PMC) (3,342,882-3.10%)
Legal & General
Pensions Limited (Direct)(LPGL)
5. Number of shares / amount of stock acquired
Not disclosed
6. Percentage of issued class
Not disclosed
7. Number of shares / amount of stock disposed
N/A
8. Percentage of issued class
N/A
9. Class of security
Ordinary shares of 10p each
10. Date of transaction
Not disclosed
11. Date company informed
31 January 2007
12. Total holding following this notification
7,315,855 shares
13. Total percentage holding of issued class following this notification
6.79%
14. Any additional information
N/a
5. Name of contact and telephone number for queries
Elizabeth Brown, Company Secretary
+44 (0) 1223 275 300
16. Name and signature of authorised company official responsible for making
this notification
Elizabeth Brown
Date of notification
1 February 2007
The FSA does not give any express or implied warranty as to the accuracy of this
document or material and does not accept any liability for error or omission.
The FSA is not liable for any damages (including, without limitation, damages
for loss of business or loss of profits) arising in contract, tort or otherwise
from the use of or inability to use this document, or any material contained in
it, or from any action or decision taken as a result of using this document or
any such material.
Enclosure 2
Holding in Company
Cambridge, UK and Cambridge, Massachusetts - 8 February 2007 - Acambis plc
("Acambis") (LSE: ACM) announces an interest in its shares by The Goldman Sachs
Group, Inc.
On 7 February 2007, Acambis received notification that, as of the close of
business on 31 January 2007, The Goldman Sachs Group, Inc., ("GS Inc") of 85
Broad Street, New York, NY 10004, USA, was interested in a total of 16,225,116
ordinary shares of 10p each, representing a 15.07% holding of Acambis' issued
share capital.
Of these 16,225,116 shares:
a) The interest in 14,738,501 shares arose from a beneficial interest held
by Goldman Sachs International, a wholly-owned indirect subsidiary of GS Inc.
These shares are, or will be, registered at CREST in account CREPTEMP; and
b) The interest in 1,126,115 shares arose from an interest held by Goldman,
Sachs & Co., a wholly-owned direct subsidiary of GS Inc, acting as custodian for
its customers. These shares are, or will be, registered in the name of Goldman
Sachs Securities (Nominees), Limited; and
c) The interest in 360,500 shares arose from an interest held by GS&Co,
acting as custodian of 180,250 ADRs; these ADRs are, or will be, held at The
Depositary Trust Company, New York.
-ends-
Enquiries:
Acambis plc
Elizabeth Brown, Company Secretary: Tel: +44 (0) 1223 275 300
Lyndsay Wright, VP, Communications and Investor Relations: Tel: +44 (0) 1223 275
300
About Acambis
Acambis is a leading biotechnology company targeting infectious diseases with
novel vaccines. Acambis' development-stage pipeline includes vaccines that could
either offer improvements over existing products or target unmet medical needs.
As well as ChimeriVax-JE, Acambis' proprietary ChimeriVax technology, developed
in association with St Louis University, has also been used to develop
ChimeriVax-West Nile, which is undergoing Phase 2 clinical testing, making it
the most advanced investigational vaccine against the West Nile virus. Acambis
also has the only vaccine in development against Clostridium difficile bacteria,
a leading cause of hospital-acquired infections. 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.
Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US, and is
listed on the London Stock Exchange (ACM). 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 2005 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.
Enclosure 3
Holding in Company
Cambridge, UK and Cambridge, Massachusetts - 13 February 2007 - Acambis plc
("Acambis") (LSE: ACM) announces an interest in its shares by The Goldman Sachs
Group, Inc.
On 12 February 2007, Acambis received notification that, as of the close of
business on 8 February 2007, The Goldman Sachs Group, Inc., ("GS Inc") of 85
Broad Street, New York, NY 10004, USA, was interested in a total of 15,724,759
ordinary shares of 10p each, representing a 14.60% holding of Acambis' issued
share capital.
Of these 15,724,759 shares:
a) The interest in 13,942,544 shares arose from a beneficial interest held
by Goldman Sachs International, a wholly-owned indirect subsidiary of GS Inc.
These shares are, or will be, registered at CREST in account CREPTEMP; and
b) The interest in 1,421,715 shares arose from an interest held by Goldman,
Sachs & Co., a wholly-owned direct subsidiary of GS Inc, acting as custodian for
its customers. These shares are, or will be, registered in the name of Goldman
Sachs Securities (Nominees), Limited; and
c) The interest in 360,500 shares arose from an interest held by GS&Co,
acting as custodian of 180,250 ADRs; these ADRs are, or will be, held at The
Depositary Trust Company, New York.
-ends-
Enquiries:
Acambis plc
Elizabeth Brown, Company Secretary: Tel: +44 (0) 1223 275 300
Lyndsay Wright, VP, Communications and Investor Relations: Tel: +44 (0) 1223 275
300
About Acambis
Acambis is a leading biotechnology company targeting infectious diseases with
novel vaccines. Acambis' development-stage pipeline includes vaccines that could
either offer improvements over existing products or target unmet medical needs.
As well as ChimeriVax-JE, Acambis' proprietary ChimeriVax technology, developed
in association with St Louis University, has also been used to develop
ChimeriVax-West Nile, which is undergoing Phase 2 clinical testing, making it
the most advanced investigational vaccine against the West Nile virus. Acambis
also has the only vaccine in development against Clostridium difficile bacteria,
a leading cause of hospital-acquired infections. 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.
Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US, and is
listed on the London Stock Exchange (ACM). 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 2005 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.
Enclosure 4
Holding in Company
Cambridge, UK and Cambridge, Massachusetts - 16 February 2007 - Acambis plc
("Acambis") (LSE: ACM) announces an interest in its shares by The Goldman Sachs
Group, Inc.
On 15 February 2007, Acambis received notification that, as of the close of
business on 13 February 2007, The Goldman Sachs Group, Inc., ("GS Inc") of 85
Broad Street, New York, NY 10004, USA, was interested in a total of 15,004,902
ordinary shares of 10p each, representing a 13.94% holding of Acambis' issued
share capital.
Of these 15,004,902 shares:
a) The interest in 1,421,715 shares arose from an interest held by
Goldman, Sachs & Co., a wholly-owned direct subsidiary of GS Inc, acting as
custodian for its customers. These shares are, or will be, registered in the
name of Goldman Sachs Securities (Nominees), Limited; and
b) The interest in 13,232,687 shares arose from a beneficial interest held
by Goldman Sachs International, a wholly-owned indirect subsidiary of GS Inc.
These shares are, or will be, registered at CREST in account CREPTEMP; and
c) The interest in 350,500 shares arose from an interest held by GS&Co,
acting as custodian of 175,250 ADRs; these ADRs are, or will be, held at The
Depositary Trust Company, New York.
-ends-
Enquiries:
Acambis plc
Elizabeth Brown, Company Secretary: Tel: +44 (0) 1223 275 300
Lyndsay Wright, VP, Communications and Investor Relations: Tel: +44 (0) 1223 275
300
About Acambis
Acambis is a leading biotechnology company targeting infectious diseases with
novel vaccines. Acambis' development-stage pipeline includes vaccines that could
either offer improvements over existing products or target unmet medical needs.
As well as ChimeriVax-JE, Acambis' proprietary ChimeriVax technology, developed
in association with St Louis University, has also been used to develop
ChimeriVax-West Nile, which is undergoing Phase 2 clinical testing, making it
the most advanced investigational vaccine against the West Nile virus. Acambis
also has the only vaccine in development against Clostridium difficile bacteria,
a leading cause of hospital-acquired infections. 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.
Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US, and is
listed on the London Stock Exchange (ACM). 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 2005 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.
Enclosure 5
Holding in Company
Cambridge, UK and Cambridge, Massachusetts - 19 February 2007 - Acambis plc
("Acambis") (LSE: ACM) announces an interest in its shares by The Goldman Sachs
Group, Inc.
On 16 February 2007, Acambis received notification that, as of the close of
business on 14 February 2007, The Goldman Sachs Group, Inc., ("GS Inc") of 85
Broad Street, New York, NY 10004, USA, was interested in a total of 12,900,149
ordinary shares of 10p each, representing a 11.98% holding of Acambis' issued
share capital.
Of these 12,900,149 shares:
a) The interest in 1,421,715 shares arose from an interest held by
Goldman, Sachs & Co., a wholly-owned direct subsidiary of GS Inc, acting as
custodian for its customers. These shares are, or will be, registered in the
name of Goldman Sachs Securities (Nominees), Limited; and
b) The interest in 11,127,934 shares arose from a beneficial interest held
by Goldman Sachs International, a wholly-owned indirect subsidiary of GS Inc.
These shares are, or will be, registered at CREST in account CREPTEMP; and
c) The interest in 350,500 shares arose from an interest held by GS&Co,
acting as custodian of 175,250 ADRs; these ADRs are, or will be, held at The
Depositary Trust Company, New York.
-ends-
Enquiries:
Acambis plc
Elizabeth Brown, Company Secretary: Tel: +44 (0) 1223 275 300
Lyndsay Wright, VP, Communications and Investor Relations: Tel: +44 (0) 1223 275
300
About Acambis
Acambis is a leading biotechnology company targeting infectious diseases with
novel vaccines. Acambis' development-stage pipeline includes vaccines that could
either offer improvements over existing products or target unmet medical needs.
As well as ChimeriVax-JE, Acambis' proprietary ChimeriVax technology, developed
in association with St Louis University, has also been used to develop
ChimeriVax-West Nile, which is undergoing Phase 2 clinical testing, making it
the most advanced investigational vaccine against the West Nile virus. Acambis
also has the only vaccine in development against Clostridium difficile bacteria,
a leading cause of hospital-acquired infections. 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.
Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US, and is
listed on the London Stock Exchange (ACM). 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 2005 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.
Enclosure 6
Holding in Company
Cambridge, UK and Cambridge, Massachusetts - 23 February 2007 - Acambis plc
("Acambis") (LSE: ACM) announces an interest in its shares by The Goldman Sachs
Group, Inc.
On 23 February 2007, Acambis received notification that, as of the close of
business on 21 February 2007, The Goldman Sachs Group, Inc., ("GS Inc") of 85
Broad Street, New York, NY 10004, USA, was interested in a total of 13,069,809
ordinary shares of 10p each, representing a 12.04% holding of Acambis' issued
share capital.
Of these 13,069,809 shares:
a) The interest in 1,421,715 shares arose from an interest held by Goldman,
Sachs & Co., a wholly-owned direct subsidiary of GS Inc, acting as custodian for
its customers. These shares are, or will be, registered in the name of Goldman
Sachs Securities (Nominees), Limited; and
b) The interest in 11,297,594 shares arose from a beneficial interest held by
Goldman Sachs International, a wholly-owned indirect subsidiary of GS Inc. These
shares are, or will be, registered at CREST in account CREPTEMP; and
c) The interest in 350,500 shares arose from an interest held by GS&Co, acting
as custodian of 175,250 ADRs; these ADRs are, or will be, held at The Depositary
Trust Company, New York.
-ends-
Enquiries:
Acambis plc
Elizabeth Brown, Company Secretary:
Tel: +44 (0) 1223 275 300
Lyndsay Wright, VP, Communications and Investor Relations:
Tel: +44 (0) 1223 275 300
About Acambis
Acambis is a leading biotechnology company targeting infectious diseases with
novel vaccines. Acambis' development-stage pipeline includes vaccines that could
either offer improvements over existing products or target unmet medical needs.
As well as ChimeriVax-JE, Acambis' proprietary ChimeriVax technology, developed
in association with St Louis University, has also been used to develop
ChimeriVax-West Nile, which is undergoing Phase 2 clinical testing, making it
the most advanced investigational vaccine against the West Nile virus. Acambis
also has the only vaccine in development against Clostridium difficile bacteria,
a leading cause of hospital-acquired infections. 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.
Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US, and is
listed on the London Stock Exchange (ACM). 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 2005 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.
Enclosure 7
Notice of results
Cambridge, UK and Cambridge, Massachusetts - 28 February 2007 - Acambis plc
("Acambis") (LSE: ACM) will announce its preliminary results for the year ended
31 December 2006 on Thursday, 15 March 2007.
The results announcement will be released at 7.00am GMT. A meeting and a
conference call for analysts will be held at 9.00am GMT.
An instant replay of the conference call will be available from 11.00am on
Thursday, 15 March until 11.00am on Thursday, 22 March 2007. The UK dial-in
number for this replay is +44 (0) 20 8196 1998 and the US dial in number
is 001 866 583 1035. The pin code is 949716.
A webcast of the call will also be available via Acambis' website at
www.acambis.com. The webcast replay will be available for 12 months until 15
March 2008.
-ends-
Enquiries:
Acambis plc
Lyndsay Wright, VP, Communications and Investor Relations
Tel: +44 (0) 1223 275 300
Brunswick
Gill Tempest
Tel: +44 (0) 20 7404 5959
About Acambis
Acambis is a leading biotechnology company targeting infectious diseases with
novel vaccines. Acambis' development-stage pipeline includes vaccines that could
either offer improvements over existing products or target unmet medical needs.
As well as ChimeriVax-JE, Acambis' proprietary ChimeriVax technology, developed
in association with St Louis University, has also been used to develop
ChimeriVax-West Nile, which is undergoing Phase 2 clinical testing, making it
the most advanced investigational vaccine against the West Nile virus. Acambis
also has the only vaccine in development against Clostridium difficile bacteria,
a leading cause of hospital-acquired infections. 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.
Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US, and is
listed on the London Stock Exchange (ACM). 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 2005 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.
Enclosure 8
Acambis' JE vaccine meets and exceeds primary endpoint in pivotal Phase 3
efficacy trial
Cambridge, UK and Cambridge, Massachusetts - 1 March 2007 - Acambis plc
(Acambis) (LSE: ACM) announces that its investigational single-dose vaccine
against Japanese encephalitis (JE), ChimeriVaxTM-JE, has met and exceeded the
primary immunogenicity endpoint in a pivotal Phase 3 efficacy trial.
In the randomised, double-blind, multi-centre Phase 3 study, 820 adult subjects
were vaccinated at a 1:1 ratio with either Acambis' single-dose ChimeriVax-JE or
JE-VAX(R), the licensed three-dose JE vaccine. The trial was designed to compare
the immunogenicity 30 days after immunisation with a single dose of
ChimeriVax-JE or with three doses of JE-VAX. The subjects received either two
doses of placebo (saline) followed by one dose of ChimeriVax-JE or the full
three-dose schedule of JE-VAX.
The primary efficacy endpoint, seroconversion rates based on neutralising
antibodies against the relevant homologous JE virus, was met, demonstrating the
non-inferiority of ChimeriVax-JE to JE-VAX. Of the subjects vaccinated with
ChimeriVax-JE, 99.1% of subjects seroconverted compared with 74.8% of subjects
in the JE-VAX group. The efficacy of ChimeriVax-JE was also shown to be
statistically superior to JE-VAX (p <0.05). In addition, ChimeriVax-JE elicited
a rapid immune response, with 93.6% of those vaccinated with ChimeriVax-JE
generating neutralising antibodies 14 days after vaccination.
The primary safety objective of the study compared the safety and tolerability
of ChimeriVax-JE and JE-VAX. There were no vaccine-related serious adverse
events observed during the 60-day treatment observation period. The overall
incidence of adverse events following vaccination was slightly lower in the
ChimeriVax-JE group than in the JE-VAX group. Additionally, the incidence of
local injection site reactions in the ChimeriVax-JE group was statistically
significantly lower than in the JE-VAX group. The majority of adverse events in
those vaccinated with ChimeriVax-JE were mild or moderate in nature. These data
will be added to those already generated from the Phase 3 safety trial, results
of which were announced in October 2006.
Acambis' Chief Executive Officer Gordon Cameron commented:
"These are remarkable results, surpassing even our high expectations of
ChimeriVax-JE. The data clearly support the benefits of a live, attenuated
vaccine approach - single-dose administration, rapid immunity and high
immunogenicity. When combined with the excellent safety profile shown by the
data from both this trial and the Phase 3 safety trial in 2,000 subjects
completed last year, we believe that ChimeriVax-JE is ideally placed to address
the very real global health need for a safe and effective single-dose JE
vaccine."
These Phase 3 data will support filings for both the endemic and the travel
vaccine markets.
Acambis recently entered into a partnership agreement with sanofi pasteur, the
vaccines business of the sanofi-aventis Group, for the worldwide marketing and
distribution of ChimeriVax-JE, excluding India, the Indian subcontinent and the
US. Sanofi pasteur, a world leader in vaccines, plans to introduce ChimeriVax-JE
in Europe and throughout the Asia Pacific region, with particular focus on the
large endemic countries, including Thailand and China.
In India and the Indian subcontinent, Acambis has partnered with Bharat Biotech
International Limited, a leading Indian biotechnology company, and is currently
conducting a paediatric clinical trial of ChimeriVax-JE in India, where the
target population for a JE vaccine is predominantly children.
-ends-
Enquiries:
Acambis plc
Gordon Cameron, Chief Executive Officer
David Lawrence, Chief Financial Officer
Lyndsay Wright, VP, Communications and IR
Tel: +44 (0) 1223 275 300
Brunswick
Jon Coles / Justine McIlroy / Margherita Lupi
Tel: +44 (0) 20 7404 5959
Notes to editors:
About Japanese encephalitis
Japanese encephalitis is a disease caused by a mosquito-borne flavivirus that
affects the membranes around the brain. Most JE virus infections are mild
(fever and headache) or without apparent symptoms but approximately one in 200
infections results in severe disease characterized by rapid onset of high
fever, headache, neck stiffness, disorientation, coma, seizures, spastic
paralysis and death. The case fatality rate can be as high as
60% among those with disease symptoms. Around 30% of those who survive
suffer from lasting damage to the central nervous system. In areas where
the JE virus is common, encephalitis occurs mainly in young children.
According to the WHO, approximately 30,000 to 50,000 people suffer from JE
annually, mainly in Asia. During a recent epidemic in northern India and Nepal,
JE killed more than 1,000 people, most of them children. An estimated three
billion people live in JE-endemic regions, which include Thailand, China,
Japan, India and parts of Australia.
About ChimeriVax-JE
- ChimeriVax-JE is being developed to provide a safe, single-dose JE
vaccine for travellers and those living in JE-endemic regions.
- It is a live, attenuated, injectable vaccine and was developed using
Acambis' proprietary ChimeriVaxTM technology.
- Clinical results show that Acambis' ChimeriVax-JE requires only one dose
for adequate protection against JE versus two or three required with other
JE vaccines.
- In previous trials, subjects vaccinated with ChimeriVax-JE exhibited an
immune response with long-term memory and a rapid rise in protective
antibodies on exposure to the virus.
- Acambis has recently initiated a Phase 2 paediatric trial in India.
- In the phase 3 efficacy trial, the primary endpoint was the
non-inferiority of the seroconversion rate to the homologous vaccine virus
of subjects given ChimeriVax-JE compared with the seroconversion
rate to the Nakayama virus of subjects given JE-VAX. In October 2006,
Acambis announced an overall blinded seroconversion rate to ChimeriVax
JE virus for all subjects combined.
Phase 3 safety trial
Acambis announced results from a pivotal Phase 3 multi-centre safety trial of
ChimeriVax-JE in October 2006. Results showed that the total number of subjects
reporting adverse events was comparable between subjects vaccinated with
ChimeriVax-JE and those who received placebo, and that vaccination with
ChimeriVax-JE was systemically and locally well tolerated. There was one serious
adverse event considered to be vaccine-related. This event, febrile illness,
resolved without complications. The majority of adverse events were mild or
moderate in nature, with headache and fatigue being the most frequently reported
events
About ChimeriVax
ChimeriVax was developed jointly by Acambis and St Louis University and has been
used by Acambis to develop vaccines against Japanese encephalitis, West Nile
and dengue. Acambis has held an exclusive worldwide licence to the technology
platform from St Louis University since 1997. The technology uses a live,
attenuated strain of the yellow fever virus as a backbone into
which elements of the target virus are introduced to create new "chimeric"
viruses as vaccines. These vaccines have the potential to safely and effectively
elicit protective immune responses after only a single dose. Sanofi pasteur has
licensed another ChimeriVax-based vaccine from Acambis, ChimeriVax-Dengue.
About Acambis
Acambis is a leading biotechnology company targeting infectious diseases with
novel vaccines. Acambis' development-stage pipeline includes vaccines that
could either offer improvements over existing products or target unmet medical
needs. As well as ChimeriVax-JE, Acambis' proprietary ChimeriVax technology
has also been used to develop ChimeriVax-West Nile, which is undergoing P
hase 2 clinical testing, making it the most advanced investigational
vaccine against the West Nile virus. Acambis also has the only vaccine in
development against Clostridium difficile, a leading cause of "superbug"
hospital-acquired infections. 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.
Acambis is based in Cambridge, UK and Cambridge, Massachusetts, US, and is
listed on the London Stock Exchange (ACM). 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 2005 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: 28 February 2007 ACAMBIS PLC
By: /s/ Lyndsay Wright
Name: Lyndsay Wright
Title: VP, Communications and IR.