Novartis Menveo Vaccine Shows Superior Immune Response Against Four Types of Meningitis Disease in Pivotal Phase III Trial
* First Phase III, head-to-head data show Menveo may offer greater protection for adolescents compared to Menactra* * Novartis expects Menveo to be first quadrivalent meningococcal vaccine to protect from early infancy through adulthood * More than 8 million infants and adolescents in the US and a significant number of children and travellers globally could benefit from Menveo[1]
* First Phase III, head-to-head data show Menveo may offer greater protection for adolescents compared to Menactra*
* Novartis expects Menveo to be first quadrivalent meningococcal vaccine to protect from early infancy through adulthood
* More than 8 million infants and adolescents in the US and a significant number of children and travellers globally could benefit from Menveo[1]
BASEL, Switzerland, May 6, 2008 - New Phase III data for
Menveo® (MenACWY-CRM) show that the vaccine produced a greater
immune response against meningococcal serogroups A, C, W-135 and Y
in adolescents 11-18 years of age compared to Menactra®.
Infection with any of these four vaccine-preventable serogroups can
lead to bacterial meningitis, an infection of the membrane around
the brain and spinal cord, or sepsis, a serious infection of the
blood stream.
Results of this first head-to-head trial of Menveo compared to
Menactra, show that
adolescents who were immunized with Menveo generated higher levels
of antibodies
against all four serogroups2.
Notably for serogroup Y, among adolescents with low levels of
immunity at the time of
vaccination, 81% of subjects receiving Menveo generated a
protective immune response vs.
54% with Menactra2, as measured by the hSBA assay. Serogroup Y
causes approximately
39% of meningococcal disease cases in the US3.
“To protect children against all major serogroups of
meningococcal disease, we need
vaccines that provide broad coverage and that can be used in all
at-risk age groups,” said
Keith S. Reisinger, MD, MPH, Medical Director, Primary Physicians
Research, Inc.
Pittsburgh, PA. ”These data are encouraging because they show
that Menveo may provide
greater protection for the more than 8 million infants and
adolescents in the US against
these four vaccine-preventable serogroups than the currently
available vaccine.”
Menveo is an investigational quadrivalent meningococcal conjugate
vaccine in Phase III
clinical development by Novartis Vaccines. The data were presented
at a late-breaker
platform session on May 5 during the 2008 Pediatric Academic
Societies (PAS) Annual
Meeting in Honolulu, Hawaii.
Meningococcal disease, a leading cause of bacterial meningitis, is
a rare but contagious and
potentially life-threatening infection. Infants and adolescents
have the highest rates of
disease4a, which can be fatal. Each year approximately 1,400 to
2,800 cases of disease
occur in the US4b, and about 10-14 percent of patients die4c. The
currently available
vaccines are not licensed for use in infants, in whom the highest
rates of meningococcal
disease are observed. Phase II data published in the January 9,
2008, issue of the Journal of
2/4
the American Medical Association demonstrated Menveo to be the
first meningococcal
vaccine to produce a strong immune response in infants5.
The US Centers for Disease Control and Prevention (CDC) recommends
routine
immunization with a quadrivalent meningococcal conjugate vaccine
for all adolescents 11-
18 years of age, college freshmen living in dormitories and people
in other high risk groups
who are two to ten or 19 to 55 years of age6,7.
“The patient need for vaccines for meningococcal disease
remains substantial. We appear
to be quickly realizing our goal of providing broad coverage
against all serogroups of
meningococcal disease across all age groups,” said Joerg
Reinhardt, CEO of Novartis
Vaccines and Diagnostics. “Given the broad range of age
groups this vaccine is expected to
protect, Menveo could truly fulfill an unmet need in the meningitis
vaccine market.”
Study details2
This Phase III trial involved more than 2,100 11-18 year olds who
received a single
vaccination with either Menveo or Menactra. One month after
vaccination, geometric
mean titers (a measure of immune response) for Menveo vs. Menactra
were: serogroup A,
29 vs. 18; serogroup C, 59 vs. 47; serogroup W-135, 87 vs. 44; and
serogroup Y, 51 vs.
18. Additionally, the percentage of participants who achieved a
protective immune
response, determined by a human serum bactericidal antibody titer
(hSBA) > 1:8, with
Menveo vs. Menactra was: serogroup A, 75% vs. 67%; serogroup C, 84%
vs. 84%;
serogroup W-135, 96% vs 88%; and serogroup Y, 88% vs. 69%. Similar
results were
seen in the large subset of sero-negative participants, who are the
participants without any
natural immunity to the bacteria before vaccination. The hSBA assay
measures the body’s
protective immune response to the meningococcus based on the
ability of antibodies to kill
the bacteria.
About Menveo
These data build on previous studies that demonstrated Menveo
generates a strong
protective immune response against these four vaccine-preventable
serogroups in people
across age groups from infancy to adulthood. Novartis expects to
submit a Biologics
License Application (BLA) to the US Food and Drug Administration
later this year.
Menveo is currently in multiple Phase III clinical trials involving
infants, young children,
adolescents and adults. The vaccine is based on the same technology
Novartis pioneered to
produce Menjugate®, a meningococcal serogroup C conjugate
vaccine approved outside
the US since 2000 for use in individuals from two months of age
through adulthood.
Novartis is a global leader in providing vaccines to protect
against the deadly
meningococcal disease. In addition to developing Menveo, Novartis
has already distributed
more than 26 million doses of Menjugate around the world and
produced MenZB®, a
vaccine against a strain of meningococcus B specific to a recent
outbreak in New Zealand.
Novartis is also developing a recombinant vaccine to provide broad
coverage against
multiple strains of serogroup B, for which no vaccine is currently
available.
About meningococcal disease, a leading cause of bacterial
meningitis
Meningococcal disease can manifest as bacterial meningitis –
an infection of the
membranes around the brain and spinal cord – or sepsis, a
bloodstream infection. It is
caused by the bacterium Neisseria meningitidis (N. meningitidis).
The symptoms – which
can include sudden onset of fever, rash, headache, and stiff neck
– can progress rapidly.
Even with early and appropriate treatment, some cases are fatal4b,
typically within 24-48
hours8. For those who survive, as many as 19 percent suffer serious
long-term
consequences such as deafness, neurological damage or limb
loss4d.
3/4
Disclaimer
The foregoing release contains forward-looking statements that can
be identified by
terminology such as “may”, “expects”, and
“encouraging”, “potentially”, “can
be”,
“goal”, “expected”, or similar expressions,
or by express or implied discussions regarding
potential future regulatory filings or approvals for, or potential
future sales of, Menveo or
other 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 Menveo
to be materially different from any future results, performance or
achievements expressed
or implied by such statements. There can be no guarantee that
Menveo or any other
vaccine currently in development by Novartis will be submitted or
approved for any
indications in any market. Nor can there be any guarantee that
Menveo or any other
vaccine, if approved, will achieve any particular levels of sales.
In particular, management’s
expectations regarding Menveo could be affected by, among other
things, unexpected
clinical trial results, including unexpected new clinical data and
unexpected additional
analysis of existing 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;
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 include
influenza,
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 provides healthcare solutions that address the evolving
needs of patients and
societies. Focused on growth areas in healthcare, Novartis offers a
diversified portfolio to
best meet these needs: innovative medicines, cost-saving generic
pharmaceuticals,
preventive vaccines and diagnostic tools, and consumer health
products. Novartis is the
only company with leading positions in these areas. In 2007, the
Group’s continuing
operations (excluding divestments in 2007) achieved net sales of
USD 38.1 billion and net
income of USD 6.5 billion. Approximately USD 6.4 billion was
invested in R&D activities
throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies
employ approximately 98,000 full-time associates and operate in
over 140 countries
around the world. For more information, please visit http://www.novartis.com.
References
1. Novartis Vaccines and Diagnostics Earnings Presentations. Growth
Through Innovation. January 17,
2008.
2. Jackson L, et al. A Phase III study comparing the safety and
immunogenicity of a novel qualdrivalent
meningococcal conjugate vaccine, MenACWY-CRM, with the licensed
MCV4, Menactra® in adolescents.
Abstract # 5628.8, 2008 Pediatric Academic Society Annual Meeting,
Honolulu, HI.
3. Centers for Disease Control and Prevention. Active Bacterial
Core Surveillance Report, Emerging
Infections Program Network, Neisseria meningitidis, 2006.
Available at: http://www.cdc.gov/ncidod/dbmd/abcs/survreports/mening06.pdf
4. U.S. Centers for Disease Control. Fact Sheet: Meningococcal
Disease and Meningococcal Vaccines (April
25, 2006). Available at: http://www.cdc.gov/vaccines/vpd-vac/mening/vac-mening-fs.htm
5. Snape, MD et al. Immunogenicity of a Tetravalent Meningococcal
Glycoconjugate Vaccine in Infants: A
Randomized Controlled Trial. Journal of the American Medical
Association. 2008; 299(2):173-184
4/4
6. Centers for Disease Control and Prevention. Revised
recommendations of the Advisory Committee on
Immunization Practices to vaccinate all persons aged 11--18 years
with meningococcal conjugate vaccine.
MMWR 2007;56:794--795.
7. Centers for Disease Control and Prevention. Notice to readers:
Recommendations from the Advisory
committee on Immunization Practices for use of quadrivalent
meningococcal conjugate vaccine (MCV4) in
children aged 2-10 years at increased risk for invasive
meningococcal disease. MMWR. 2007;56(48):1265-
1266.
8. WHO. Meningococcal meningitis Fact sheet #141. May 2003.
http://www.who.int/mediacentre/factsheets/fs141/en/
# # #
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* Menactra is a registered trademark of Sanofi Pasteur.
Posted: May 2008
