New data for Menveo(TM) vaccine show excellent immune response and
broad protection for infants against meningococcal meningitis
* Menveo(TM) (MenACWY-CRM) the first quadrivalent conjugated
meningitis vaccine to demonstrate an excellent immune response in
infants[1]
* Infants considered the highest at-risk group in need of
protection against four common meningococcal meningitis
serogroups - A, C, W-135 and Y
* Menveo currently on track for regulatory submissions in 2008;
conjugated technology offers improved immune response over older
bacterial polysaccharide vaccines
Basel, November 15, 2007 - New clinical data for the Novartis
development vaccine Menveo(TM) [2] (MenACWY-CRM) show an excellent
and broad immune response in infants as young as six months of age
against four common serogroups (or types) of meningococcal
meningitis, a potentially fatal bacterial disease involving
inflammation of membranes around the brain and spinal cord.
Menveo is currently the only vaccine to generate protective immune
responses in infants, expanding beyond the coverage of currently
available vaccines for teenagers and adults. This response was seen
in all four of the common serogroups - A, C, W-135 and Y -
associated with meningococcal meningitis, which is caused by the
bacteria Neisseria meningitidis.
The infant clinical trial data for this conjugated meningococcal
vaccine, which utilizes technology that offers improved immunization
responses compared to older bacterial polysaccharide vaccines, were
presented for the first time today at the 5th World Congress of The
World Society for Pediatric Infectious Diseases (WSPID) in Bangkok.
Using a flexible administration schedule, results from the Phase II
study of 175 infants who received either two doses of Menveo at ages
six and 12 months or one dose of Menveo at age 12 months showed a
robust immune response against serogroups A, C, W-135, and Y after
one month[1].
The data reinforce earlier findings showing that Menveo - which is
currently on track for regulatory submissions in 2008 - was
well-tolerated and immunogenic in the first year of life and has the
potential to protect against the A, C, W-135 and Y serogroups from
early infancy[3].
"These data are encouraging given the unmet need for an effective
meningococcal meningitis vaccine with broad serogroup coverage that
can be given to infants," said Scott Halperin, MD, the lead study
investigator and Director of the Canadian Center for Vaccinology as
well as Professor of Pediatrics and Microbiology and Immunology at
Dalhousie University in Halifax, Canada.
Meningococcal meningitis primarily affects young children, with the
highest attack rate seen in infants during the first 3 to 12 months
of life[4].
However, currently available polysaccharide vaccines covering these
serogroups (called "quadrivalent vaccines") are only approved in
certain countries for use in children age two and older due mainly to
poor efficacy, while a conjugated vaccine approved for use in infants
is only available against the C serogroup.
Approximately 500,000 cases of meningococcal meningitis are estimated
to occur each year around the world, with 50,000 deaths blamed on the
disease annually[4]. Up to 20% of those who survive are left with
permanent disability such as deafness, neurological damage or limb
loss[5].
"Menveo has shown in clinical trials that it is well-tolerated and
generates high immune responses across all age groups, including
infants," said Joerg Reinhardt, CEO of Novartis Vaccines and
Diagnostics. "Novartis is rapidly developing this vaccine in a broad
range of ages as an effective new option against meningitis and
expects to make regulatory submissions in 2008."
Menveo is currently in multiple Phase III clinical trials involving
infants, young children, adolescents and adults. It is based on the
same technical expertise used to produce Menjugate®, a meningococcal
serogroup C conjugate vaccine of Novartis approved outside the US
since 2000 for use in individuals from two months old through
adulthood. More than 25 million doses of Menjugate have been
distributed around the world.
In addition to Menveo, Novartis is developing a recombinant vaccine
aiming to provide coverage against the B serogroup, for which no
vaccine has been achieved.
Menveo has high protective antibody levels with two different dosing
schedules[1]
The Phase II multi-center trial randomized 175 infants to receive
either two doses of Menveo at both six and 12 months of age, one dose
of Menveo at age 12 months or a currently approved meningococcal
meningitis serogroup C vaccine also at age 12 months and then
followed by Menveo at age 18 months.
One month after vaccination, infants receiving Menveo achieved
protective antibody levels as measured by hSBA titer >1:4 for all
four meningococcal serogroups. hSBA is the human serum bactericidal
antibody assay, which measures the body's immune response to
antigens. After two doses of Menveo, the percentage of subjects
achieving hSBA titer >1:4 was 100% for the serogroups C, W-135 and
Y35 and 86% for serogroup A[1]. After a single dose of Menveo at age
12 months, the percentages were > 93% for serogroups C and W-135 as
well as > 75% for serogroups A and Y. Of the subjects who received
the Menveo booster at age 18 months following a single dose at age 12
months, 100% achieved hSBA titers > 1:4 for serogroup C, 62% for A,
84% for W-135 and 81% for Y. Menveo was well-tolerated in this
population[1].
Two doses of Menveo led to markedly greater amounts of antibody
levels, while one dose at age 12 months led to comparable titers for
serogroup C compared to the existing meningitis C vaccine[1].
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "potential", or similar
expressions, or by express or implied discussions regarding potential
future regulatory filings or approvals for, or potential future sales
of, MenACWY-CRM or other related vaccines currently in development by
Novartis. Such forward-looking statements reflect the current views
of Novartis regarding future events, and involve known and unknown
risks, uncertainties and other factors that may cause actual results
with MenACWY-CRM to be materially different from any future results,
performance or achievements expressed or implied by such statements.
There can be no guarantee that MenACWY-CRM or any other related
vaccine currently in development by Novartis will be submitted or
approved for any indications in any market. Nor can there be any
guarantee that MenACWY-CRM or any other related vaccine currently in
development by Novartis, if approved, will achieve any particular
levels of sales. In particular, management's expectations regarding
MenACWY-CRM could be affected by, among other things, unexpected
regulatory actions or delays or government regulation generally;
unexpected clinical trial results, including unexpected new clinical
data and unexpected additional analysis of existing clinical data;
Novartis' ability to obtain or maintain patent or other proprietary
intellectual property protection; competition in general; government,
industry and general public pricing pressures, and other risks and
factors referred to in Novartis AG's 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 and Diagnostics is a division of Novartis focused
on the development of preventive treatments. The division has two
businesses: Novartis Vaccines and Chiron. Novartis Vaccines is the
world's fifth-largest vaccines manufacturer and second-largest
supplier of flu vaccines in the US. The division's products also
include meningococcal, pediatric and travel vaccines. Chiron, the
blood testing and molecular diagnostics business, is dedicated to
preventing the spread of infectious diseases through the development
of 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, cure 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. 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. Novartis is the only company with
leadership positions in these areas. In 2006, the Group's businesses
achieved net sales of USD 37.0 billion and net income of USD 7.2
billion. Approximately USD 5.4 billion was invested in R&D.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 100,000 associates and operate in over 140 countries
around the world. For more information, please visit
http://www.novartis.com.
Reference
[1] Halperin SA et al. Safety and immunogenicity of Novartis
Vaccines MenACWY Conjugate Vaccine After One or Two Doses
Administered to Infants and Young Children. Poster Presentation at
World Society for Pediatric Infectious Diseases Annual Meeting
(WSPID), November 2007.
[2] Brand name awaiting regulatory approval.
[3] Perrett, KP et al. Immunogenicity of a Tetravalent Meningococcal
Glycoconjugate Vaccine in Infants. Presented at Infectious Diseases
Society of America (IDSA) annual meeting, 2006.
[4] WHO Weekly Epidemiological Record. Meningococcal Vaccines:
Polysaccharide and Polysaccharide Conjugate Vaccines. 40(77);
329-340, 2002.
[5] Centers for Disease Control and Prevention. Factsheet:
Meningococcal Diseases and Meningococcal Vaccines. April 25, 2006.
Available at:
http://www.cdc.gov/vaccines/vpd-vac/mening/vac-mening-fs.htm
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