In a Phase II Study, Novartis Meningitis B Vaccine Has Potential to
Produce a Protective Immune Response in Infants, the Age Group Most
- Data show Novartis
Meningitis B (MenB) vaccine has potential to be first vaccine to
provide broad protection to infants against meningococcal B
- The meningococcal B strain
causes 72% of meningococcal disease in Europe and is a major cause
of the disease in other regions of the world
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- Novartis MenB vaccine and
Novartis Menveo® (MenACWY-CRM) vaccine on track to establish
strong portfolio of meningitis vaccines
- Data show
Novartis Meningitis B (MenB) vaccine has potential to be first
vaccine to provide broad protection to infants against
meningococcal B infections
meningococcal B strain causes 72% of meningococcal disease in
Europe and is a major cause of the disease in other regions of the
MenB vaccine and Novartis Menveo® (MenACWY-CRM) vaccine on
track to establish strong portfolio of meningitis
Switzerland, May 14, 2008 - New data for the investigational
recombinant meningococcal group B vaccine developed by Novartis
Vaccines, support its promise as the first potentially broad
coverage vaccine capable of protecting infants against the
meningococcal B strain. Prevention of meningococcal B infections
remains a high medical need to protect infants and children
worldwide from infection of this often deadly disease.
The meningococcal B strain is a
leading cause of bacterial meningitis throughout the world,
particularly among infants, accounting for 72 percent of
meningococcal disease in Europe in 2006. The new Phase II data
for the novel Novartis MenB vaccine were presented at the European
Society for Paediatric Infectious Diseases (ESPID) annual meeting
in Graz, Austria on May 14, 2008.
"The prospect of one vaccine
that protects infants worldwide against meningococcal serogroup B
would be a key achievement in global disease prevention of our
time," said Ray Borrow, PhD, MRCPath, Head, Vaccine Evaluation
Unit, Health Protection Agency, UK. "Of those infected with the
meningococcal B strain, there is a strong likelihood that the
bacterium contains at least one of the antigens included in the
Novartis MenB vaccine. These new findings tell us that the vaccine
is likely to kill strains that contain the vaccine's
According to new Phase II study
results, a series of three immunizations with the Novartis MenB
vaccine starting at two months of age produced a protective immune
response in infants, as evaluated by a biomarker of clinical
protection. One month after the third dose, the percentage of
subjects achieving a protective immune response against strains
representing multiple antigens included in the Novartis MenB
vaccine were 89%, 96% and 85%. A fourth dose given at 12 months of
age also resulted in 100%, 98% and 93% of subjects achieving a
protective immune response and was indicative of an immune memory
response. The vaccine contains multiple bacterial surface
proteins - or antigens - that are believed to be found in most
meningococcal B strains responsible for the disease globally.
Novartis scientists pioneered an
innovative approach called "reverse vaccinology" to develop the
Novartis MenB vaccine. By first decoding the entire genetic makeup
of a pathogenic meningococcal serogroup B strain, Novartis
discovered 600 novel proteins. Reproduced through genetic
engineering for further investigation, the vaccine contains
multiple antigens that showed the greatest ability to stimulate the
immune system to kill bacteria from a panel of 85 strains of
meningitis B representative of global and temporal diversity.
"There is a strong medical need
for an effective vaccine to prevent meningitis B infections, and
our commitment to developing new vaccine technologies may soon
provide a broad spectrum meningitis B vaccine," said Joerg
Reinhardt, CEO of Novartis Vaccines and Diagnostics. "Through our
scientific expertise, Novartis is rapidly advancing toward our goal
of providing immunizations that protect infants, children and
adults around the world from all causes of this deadly
Based on the positive results
from this and similar studies across other age groups, the Novartis
MenB vaccine is potentially the first broad coverage meningitis B
vaccine to advance to the final stage of clinical testing. The
vaccine entered Phase III clinical trials in the first quarter of
2008. Novartis is currently the only company with vaccines against
all five key disease-causing meningococcal serogroups (A, B, C,
W-135, Y) in international Phase III trials.
The meningococcal B strain
causes the majority of meningococcal infections in developed
nations including Europe, Canada, Australia and the US. In these
countries, serogroup B is responsible for 42 to 80 percent of
meningococcal cases. Worldwide incidence of serogroup B disease
is estimated to be 20,000 to 80,000 cases per year.
vaccine study details
The Novartis MenB vaccine was
administered to 150 healthy UK infants concomitantly with routine
immunizations at 2, 4 and 6 months of age, along with a booster
dose at 12 months of age. The vaccine's protective immune response
was assessed by the percentage of subjects achieving hSBA titers
>1:4 using strains representing three major
vaccine antigens. One month after the third dose, the percentages
of subjects achieving a protective immune response were 89%, 96%
and 85%. After the booster dose given at 12 months of age the
percentages of subjects with a protective immune response were
100%, 98% and 93% and was indicative of an immune memory response.
The hSBA titers were measured one month following the third and
fourth doses. The hSBA assay measures the body's protective immune
response based on the ability of antibodies to kill the bacteria.
The vaccine was well tolerated.
broad portfolio of meningitis vaccines
Two other presentations at ESPID
detail other positive clinical trial results for vaccines for
prevention of meningococcal disease from Novartis. Pooled data from
Phase II studies involving 2,190 participants showed that
Menveo® (MenACWY-CRM), the investigational vaccine for the four
other common meningococcal serogroups, A, C, W-135 and Y, produced
a strong protective immune response in individuals from two months
to 17 years of age. Results from another phase III study showed
that Menveo can be safely given to adolescents at the same time as
the commonly used diphtheria, tetanus and pertussis (whooping
cough) (Tdap) vaccine.
Menveo has the potential to
become the first meningococcal vaccine to protect people in age
groups from infancy to adulthood against these four
vaccine-preventable meningococcal serogroups. Regulatory marketing
applications are anticipated in the EU and US later this
Novartis is a global leader in
providing vaccines to protect against deadly meningococcal disease.
In addition to developing Novartis MenB vaccine and Menveo,
Novartis pioneered the development of meningococcal conjugate
vaccines with Menjugate®, a meningococcal serogroup C conjugate
vaccine approved outside the US since 2000 for use in individuals
from two months of age through adulthood. More than 26 million
doses of Menjugate have been distributed. Three million doses of
MeNZB, a vaccine against a strain of meningococcus B specific to
New Zealand, have been administered to help in successfully curbing
a recent outbreak there.
disease, a leading cause of bacterial meningitis
Meningococcal disease, a
contagious and potentially deadly infection caused by the bacterium
Neisseria meningitidis (N. meningitidis), may
occur suddenly in previously healthy individuals. It can manifest
as bacterial meningitis - an infection of the membranes around the
brain and spinal cord - or sepsis, a bloodstream infection. Each
year, approximately 500,000 cases of meningococcal disease occur
around the world, causing about 50,000 deaths.
The symptoms - which can include
sudden onset of fever, rash, headache, and stiff neck - can
progress rapidly. There are effective treatments; however, the
disease can be difficult to diagnose, can progress very quickly and
is associated with high fatality even with appropriate treatment.
Deaths can occur within 24 hours[9, 10] of the onset of symptoms.
Up to 10 percent of cases are fatal and up to 20 percent of
survivors are left with permanent disability such as deafness,
neurological damage or limb loss.
The foregoing release contains forward-looking
statements that can be identified by terminology such as
"potential," "on track," "promise," "potentially," "would,"
"likelihood," "likely," "believed," "commitment," "goal,"
"estimated," "may," "can," or similar expressions, or by express or
implied discussions regarding potential future regulatory filings
or approvals for, or potential future sales of, Novartis MenB
vaccine, Menveo 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 Novartis MenB
vaccine or Menveo to be materially different from any future
results, performance or achievements expressed or implied by such
statements. There can be no guarantee that Novartis MenB vaccine or
Menveo 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 Novartis MenB vaccine,
Menveo 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 Novartis MenB
vaccine or 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.
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 provides healthcare
solutions that address the evolving needs of patients and
societies. Focused solely 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
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Posted: May 2008