Acambis plc (Acambis) (LSE:ACM), a leading vaccine company,
announced today that the US Food and Drug Administration (FDA) has
approved its ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) vaccine for
protection against smallpox. The vaccine is intended for active
immunisation against smallpox disease for persons determined to be at
high risk for smallpox infection. ACAM2000 is the first biodefence
vaccine to be approved as part of the US response to the 2001
bioterrorism attacks.
Acambis developed ACAM2000 under contracts with the US Centers for
Disease Control and Prevention (CDC). To date, Acambis has supplied
192.5 million doses of ACAM2000 to the CDC for the US Strategic
National Stockpile (SNS), which was established to provide medicines
to the American public in the event of a public health emergency, such
as a terrorist attack.
Having produced a stockpile of ACAM2000 doses for the SNS, Acambis
and the CDC are now in advanced discussions on a "warm-base
manufacturing" contract for Acambis to provide ACAM2000 production and
licence maintenance activities for the long term.
Ian Garland, Acambis Chief Executive Officer, said:
"The licensure of ACAM2000 is a significant milestone not only for
Acambis but also for the US Government in its efforts to ensure a
state of preparedness against the threat of smallpox. This has been a
highly successful collaboration between Acambis and the CDC, and
Acambis is very proud to have played a role in providing this
countermeasure against a significant bioterrorism threat. We look
forward to finalising an agreement with the CDC that will ensure that
a US-based capability to manufacture ACAM2000 remains at the ready."
ACAM2000 was developed to be a modern smallpox vaccine with a
safety and efficacy profile comparable to the previous US vaccine but
manufactured using advanced production capabilities. Until the
development of ACAM2000, smallpox vaccines were last manufactured in
the US in 1982 and were produced from calf lymph.
ACAM2000, which is a single-dose vaccine, is the primary smallpox
vaccine for use in an emergency and forms the majority of the US
Government's smallpox vaccine stockpile.
The clinical trials data generated on ACAM2000 were reviewed by
the FDA Vaccines and Related Biological Products Advisory Committee in
May 2007, which voted unanimously (11-0) in favour of the vaccine's
safety and efficacy. In addition to being stockpiled for emergency
use, ACAM2000 will be used by the US Department of Defense for
protection of military personnel.
Important safety information
ACAM2000 may not protect all persons exposed to smallpox. ACAM2000
is contraindicated for individuals with severe immunodeficiency who
are not expected to benefit from the vaccine. These individuals may
include persons who are undergoing bone marrow transplantation or
persons with primary or acquired immunodeficiency states who require
isolation.
-- The most serious adverse events associated with smallpox
vaccination are myocarditis, pericarditis, encephalitis,
encephalomyelitis, encephalopathy, progressive vaccinia,
generalised vaccinia, severe vaccinial skin infections, and
erythema multiforme major (including STEVENS-JOHNSON SYNDROME)
and eczema vaccinatum resulting in permanent sequelae or
death, ocular complications, blindness and foetal death have
occurred following either primary vaccination or revaccination
with smallpox vaccines.
-- The most common side effects following smallpox vaccination
include itching, swollen lymph nodes, sore arm, fever,
headache, body ache, mild rash, and fatigue.
Full prescribing information may be obtained by calling Acambis at
+1 866 440 9440 (toll free) or +1 617 866 4500.
About smallpox
Smallpox is a highly contagious disease caused by the variola
virus, a member of the Orthopox virus family. It is one of the most
devastating diseases known to humanity, with a mortality rate as high
as 30%. In 1967, the World Health Organization embarked upon an
intensified vaccination campaign to eliminate smallpox, which
culminated in the successful eradication of the disease globally by
1980.(1)
By the mid-1980s, there were only two known repositories of
variola virus: the Institute of Virus Preparations in Russia and the
US Centers for Disease Control and Prevention (CDC). The events in the
US in September and October 2001 highlighted the risk that the variola
virus might be used as an agent of bioterrorism.(2) Governments around
the world are taking precautionary measures to be ready to deal with a
potential smallpox outbreak.
About ACAM2000
-- ACAM2000 is a live, vaccinia virus smallpox vaccine indicated
for active immunisation against smallpox disease for persons
determined to be at high risk for smallpox infection.
-- It is a single dose vaccine administered percutaneously.
-- It was derived by plaque purification from Dryvax(R), the
licensed calf lymph-produced vaccine that was extensively used
in the smallpox eradication programme.
-- ACAM2000 is manufactured in Vero cells using modern
cell-culture techniques designed to comply with current Good
Manufacturing Practice standards.
-- Acambis has supplied more than 200 million doses of ACAM2000
under an FDA Investigational New Drug application to 15
governments around the world, including the US.
Notes and references
(1) WHO: http://www.who.int/mediacentre/factsheets/smallpox/en/
(2) CDC:
http://www.bt.cdc.gov/agent/smallpox/overview/disease-facts.asp
About Acambis
Acambis is a leading vaccine company developing novel vaccines
that address significant unmet medical needs or substantially improve
standards of care. ChimeriVax(TM)-JE, Acambis' most advanced vaccine
candidate in its non-biodefence pipeline, has completed Phase 3 trials
and is currently undergoing paediatric trials in India. It is
partnered with sanofi pasteur and Bharat Biotech. Acambis' proprietary
ChimeriVax technology, developed in association with St Louis
University, has also been used to develop Acambis' ChimeriVax-West
Nile vaccine candidate, 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. Acambis' influenza programme aims to develop a universal
vaccine against influenza, for which a universal 'A' strain vaccine,
ACAM-FLU-A(TM), is currently being tested in a Phase 1 trial, and also
includes various further vaccine candidates in the research and
pre-clinical stages.
Recognised internationally as the leading producer of smallpox
vaccines, Acambis manufactured its smallpox vaccine, ACAM2000, for
emergency-use stockpiles held by the US Government and 14 others
governments around the world under a US FDA IND application. ACAM2000
is licensed for active immunisation of persons determined to be at
high risk for smallpox infection.
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 the 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, and the
need for and the availability of additional capital. For a discussion
of these and other risks and uncertainties, see the relevant risk
sections in the Company's latest Annual Report, in addition to those
detailed on the Company's website and in the Company's filing made
with the Securities and Exchange Commission prior to Acambis'
deregistration. 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.
