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  De: PR Newswire Brasil
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

- 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

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.

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 .

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)

SOURCE Novartis
CONTACT: Alison Marquiss, Novartis Vaccines & Diagnostics, Global
Communications, +1-510-923-6500, or; or
John Gilardi, Novartis Global Media Relations, +41-61-324-3018, or
mobile, +41-79-596-1408, or
Web site:


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