 |
 |
 |
| |
De: PR Newswire
Brasil
Para: THERESA CATHARINA DE GÓES CAMPOS
Assunto: Novartis MeNZB(TM) Vaccine Campaign
Data Show 80 Percent Efficacy Rate During
Epidemic Meningococcal B Disease Outbreak in New
Zealand
09 de agosto de 2006 08:44 HORALOCAL
Novartis MeNZB(TM) Vaccine Campaign Data Show 80
Percent
Efficacy Rate During Epidemic Meningococcal B
Disease Outbreak in New
Zealand
- Meningococcal B disease rates are five times
higher in children who
have not been immunized than in those who have
received MeNZB
- Partnership with New Zealand Ministry of
Health and Norwegian
Institute of Public Health supported rapid
vaccine development to
combat epidemic
- MeNZB data should contribute to broader
understanding and
development of additional meningococcal disease
vaccines and programs
- Novartis advances meningococcal vaccines
development with programs
for multivalent (ACWY) vaccine and broad
coverage meningococcal B
vaccine
BASEL, Switzerland, Aug. 9 /PRNewswire/ --
Novartis announced the
successful conclusion of a two-year nationwide
mass vaccination
campaign in New Zealand based on the company's
MeNZB(TM) vaccine,
which was developed specifically for the effort.
Working closely with the New Zealand Ministry of
Health and drawing
upon earlier work at the Norwegian Institute of
Public Health,
Novartis scientists developed and manufactured
the MeNZB vaccine to
combat an epidemic caused by a specific strain
of meningococcal B
disease that gripped New Zealand for more than a
decade.
Data from the campaign showed that MeNZB has an
80 percent efficacy
rate in preventing cases of meningococcal B
disease. Before the
epidemic began in 1991, New Zealand saw an
average of 50 cases of
meningococcal disease from all meningococcus
strains each year.
During the epidemic, that number grew to
approximately 400 cases each
year, with 80 of every 100 cases caused by the
epidemic strain.
Over the course of the epidemic, meningococcal
disease has struck
more than 5,900 New Zealanders, killing 239 and
leaving more than
1,000 permanently disabled. A staggered roll-out
of the vaccine
targeted highest-risk populations first, such as
indigenous Maori and
Pacific communities in the country's northern
region, and reduced
cases of the epidemic strain in these groups by
90 percent and 70
percent, respectively, over the campaign.
"Outstanding cooperation and dedication from
both the New Zealand
government and the Novartis team enabled us to
start making a
difference for threatened populations quickly,"
said Rino Rappuoli,
Global Head of research for Novartis Vaccines. "Our
commitment is to
stop the morbidity and mortality numbers from
increasing, in New
Zealand and in other regions, by developing
vaccines that will
eradicate all forms of meningococcal disease."
Experts on meningococcal disease met in late
July 2006 to discuss the
results of the campaign and concluded that the
MeNZB vaccine had been
effective. The group included prominent
independent scientists and
clinicians from several countries as well as
leaders from the New
Zealand Ministry of Health and Novartis. This
peer review followed
rigorous examination by an independent safety
monitoring board during
the campaign itself.
"Novartis Vaccines developed and manufactured a
life-saving vaccine
on an accelerated timetable to support a New
Zealand government
initiative in controlling a devastating epidemic,"
said Jane
O'Hallahan, director of the New Zealand Ministry
of Health
Meningococcal B Immunisation Programme.
The MeNZB campaign ran from July 2004 through
June 2006 following
clinical studies and manufacturing scale-up that
were completed in
approximately three years. The three-dose
vaccination campaign
reached approximately one million people, from
infants to age 20. An
estimated 87 percent of those in the target
population have started
their doses, while 80 percent have completed all
three doses.
Vaccination of the under age five population
will continue until 2009
or until disease rates warrant concluding
immunization activities.
Children who are not immunized now have a five
times higher risk of
contracting the disease than those who have
received MeNZB.
"The benefits of this effective public-private
partnership are
immediately visible. We are seeing that children
who are fully
immunized have a good level of protection, while
those who are not
remain at higher risk of contracting
meningococcal disease," said
Diana Martin of the New Zealand Institute of
Environmental Science
and Research, which partnered with the New
Zealand Ministry of Health,
Auckland University and Novartis Vaccines (formerly
Chiron) on the
MeNZB campaign.
Rappuoli added: "We are pleased with being able
to bring this
expertise to New Zealand. Looking forward, we
are hopeful that our
genome-derived vaccine for multiple strains of
meningococcus B, which
represents the first successful application of
genomic information in
vaccines development, will bring much wider
protection worldwide."
Novartis scientists recently published data from
preclinical studies
of a universal group B vaccine candidate in the
Proceedings of the
National Academy of Sciences (Inaugural Article:
A universal vaccine
for serogroup B meningococcus, Giuliani 2006
PNAS 103:10834), which
showed protection against 78-95 percent of group
B strains tested,
depending on the adjuvant used in combination.
It had previously been difficult to develop
vaccines that offered
broad protection against meningitis B, which
accounts for a large
portion of meningococcal disease cases in
developed countries.
Standard vaccine development approaches for
meningitis B led to the
development of a capsular polysaccharide
identical to one present in
the human brain, thus disabling the desired
preventive effect of a
vaccine. Novartis scientists used their "reverse
vaccinology"
technique to discover potential antigens for
development, and
recently completed Phase 1 clinical studies for
a candidate vaccine
for meningitis B.
To address the other four primary serogroups
causing most other
meningococcal disease, Novartis is also
developing a multivalent ACWY
vaccine candidate, which is currently in Phase
III clinical studies.
About meningococcal disease
Meningococcal disease results from infection
caused by the bacterium
Neisseria meningitidis, known as meningococcus.
Meningococcal disease
usually affects the membranes around the brain
and spinal cord or the
bloodstream, causing meningitis or septicemia,
respectively. The
disease is fairly rare, with annual worldwide
incidence of about 1.2
million cases, almost all due to five primary
serogroups: A, B, C,
W-135 and Y. However, infection progresses
rapidly and may be fatal
even if diagnosed properly, making prevention
essential. Cases may
also result in brain damage, blindness, deafness
or limb amputations.
About Novartis' meningococcal disease vaccines
Novartis Vaccines' current products to prevent
meningococcal disease
include Menjugate(R) meningococcal C conjugate
vaccine, which played
a key role in reducing the toll of meningococcal
C disease in the
United Kingdom in the past decade, and MeNZB(TM)
meningoccal B
vaccine, developed specifically for the specific
B strain that caused
an epidemic in New Zealand. Novartis Vaccines
development programs
target disease caused by the five primary
serogroups of meningococcus
with a multivalent ACWY meningococcal vaccine
candidate and a broad
coverage recombinant meningococcal B vaccine
candidate.
Disclaimer
This release contains certain forward-looking
statements, relating to
Novartis' business, which can be identified by
the use of
forward-looking terminology such as "should
contribute,"
"commitment," "will," "looking forward,"
"hopeful," "developing," or
similar expressions, or by express or implied
discussions regarding
potential marketing approvals or future sales of
existing or
potential future vaccine products. Such
statements reflect current
views with respect to future events and are
subject to certain risks,
uncertainties and assumptions. There can be no
guarantee that vaccine
candidates will be approved for any indications
in any market or that
any existing or potential future vaccine
products will reach any
particular sales levels. In particular,
management's expectations
could be affected by, among other things,
unexpected clinical trial
results, including additional analysis of
clinical data, or new
clinical data; unexpected regulatory actions or
delays or government
regulation generally; Novartis' ability to
obtain or maintain patent
or other proprietary intellectual property
protection; competition in
general; increased government, industry, and
general public pricing
pressures; and other risks and factors referred
to in Novartis AG's
current Form 20-F on file with the U.S.
Securities and Exchange
Commission. Should one or more of these risks or
uncertainties
materialize, or should underlying assumptions
prove incorrect, actual
results may vary materially from those
anticipated, believed,
estimated or expected. Novartis is providing the
information in this
press release as of this date and does not
undertake any obligation
to update any forward-looking statements
contained in this press
release as a result of new information, future
events or otherwise.
About Novartis
Novartis Vaccines & Diagnostics is a new
division of Novartis focused
on the development of preventive treatments and
tools, formed through
the acquisition of Chiron Corporation. The
division has two
businesses: Novartis Vaccines and Chiron, the
blood testing and
molecular diagnostics unit. Novartis Vaccines is
the world's
fifth-largest vaccines manufacturer and
second-largest supplier of
flu vaccines in the US. Key products also
include meningococcal,
pediatric and travel vaccines. The Chiron
business is dedicated to
preventing the spread of infectious diseases
through novel
blood-screening tools that protect the world's
blood supply.
Novartis AG (NYSE: NVS) is a world leader in
offering medicines to
protect health, treat disease and improve
well-being. Our goal is to
discover, develop and successfully market
innovative products to
treat patients, ease suffering and enhance the
quality of life.
Novartis is the only company with leadership
positions in both
patented and generic pharmaceuticals. We are
strengthening our
medicine-based portfolio, which is focused on
strategic growth
platforms in innovation-driven pharmaceuticals,
high-quality and
low-cost generics, human vaccines and leading
self-medication OTC
brands. In 2005, the Group's businesses achieved
net sales of USD
32.2 billion and net income of USD 6.1 billion.
Approximately USD 4.8
billion was invested in R&D. Headquartered in
Basel, Switzerland,
Novartis Group companies employ approximately
97,000 people and
operate in over 140 countries around the world.
For more information,
please visit http://www.novartis.com .
Media contacts
Alison Marquiss John Gilardi
Novartis Vaccines & Diagnostics Novartis Global
Media Relations
Global Communications +41 61 324 3018 (direct)
+1-510-923-6500 +41 79 596 1408 (mobile)
alison_marquiss@chiron.com
john.gilardi@novartis.com
SOURCE Novartis
08/09/2006
CONTACT: Alison Marquiss, Novartis Vaccines &
Diagnostics, Global
Communications, +1-510-923-6500, or
alison_marquiss@chiron.com; or
John Gilardi, Novartis Global Media Relations,
+41-61-324-3018, or
mobile, +41-79-596-1408, or
john.gilardi@novartis.com
Web site: http://www.novartis.com
(NVS)
BNED: NG
FONTE: PR NEWSWIRE LATIN AMERICA
CORAL GABLES - MIAMI-US
CONTATOS: USA-MARY D'LEON
BRASIL-NÉLIA GARCIA
TELS: USA:1-305-507-2550/BRASIL:55-21-2132-8461
FAXES: USA:1-305-461-8670/BRASIL:55-21-2132-8469
E-MAILS: nelia_garcia@prnewswire.com.br
mary_dleon@prnewswire.com
PALAVRA-CHAVE: RJ
PALAVRA-CHAVE/RAMO DE ATIVIDADE: INDÚSTRIA
FARMACÊUTICA
PALAVRA-CHAVE/EMPRESA: NOVARTIS
O texto acima, distribuído pela PR Newswire
Brasil, é de inteira responsabilidade de seu
cliente. A utilização deste material não implica
em custo. |
|
|
|
