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Novartis Menveo® vaccine shows superior immune response against four
types of meningitis disease in pivotal phase III trial |
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Corporate news announcement processed and transmitted by Hugin ASA.
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announcement.
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* 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, 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 serogroups[2].
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 Menactra[2], as
measured by the hSBA assay. Serogroup Y causes approximately 39% of
meningococcal disease cases in the US[3].
"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 disease[4a], which
can be fatal. Each year approximately 1,400 to 2,800 cases of disease
occur in the US[4b], and about 10-14 percent of patients die[4c]. 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 the
American Medical Association demonstrated Menveo to be the first
meningococcal vaccine to produce a strong immune response in
infants[5].
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 age[6,7].
"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 details[2]
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 fatal[4b], typically within 24-48 hours[8]. For those who
survive, as many as 19 percent suffer serious long-term consequences
such as deafness, neurological damage or limb loss[4d].
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
[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/
* Menactra is a registered trademark of Sanofi Pasteur.
# # #
Novartis Media Relations
Beatrix Benz Beth Birke
Novartis Global Media Novartis Vaccines and Diagnostics
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