Pivotal study in The Lancet shows potential of Novartis vaccine Bexsero® to help provide broad protection to infants against MenB
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Pivotal study in The Lancet shows potential of Novartis vaccine Bexsero® to help
provide broad protection to infants against MenB
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The issuer is solely responsible for the content of this announcement.
* Phase III results show that Bexsero induced a robust immune response when
administered concomitantly with routine vaccines, and also as a booster
dose[1]
* Data confirm Bexsero's acceptable safety and tolerability profile in
infants, who are among the most vulnerable to MenB, a leading cause of
meningitis
* Bexsero was recommended for European licensure in November 2012; upon
approval, Bexsero will be the first and only broad coverage vaccine against
MenB
Basel, January 14, 2013 - The Lancet published findings online today from a
pivotal Phase III clinical trial of Bexsero(®) (Meningococcal Group B Vaccine
[rDNA, component, adsorbed]) involving 3,630 infants from two months of age. The
study showed that Bexsero demonstrated a protective immune response and has an
acceptable safety profile when administered as a three-dose primary series
concomitantly with routine vaccines. The investigators also observed a robust
booster response in toddlers to a fourth dose administered at 12 months, which
may contribute to an extended duration of protection. These data were first
presented in 2010 at the 17(th) International Pathogenic Neisseria Conference
(IPNC)[2].
"As a practicing pediatrician, I see how devastating MenB is for infants and
toddlers, as well as the agony for their families. It is a disease that can
strike with little warning and progress very rapidly, even when parents are
quick to respond," said Prof. Susanna Esposito, Pediatric Clinic 1, Fondazione
IRCCS Ca' Granda Ospedale Maggiore Policlinico, Department of Pathophysiology
and Transplantation, Università degli Studi di Milano, Italy, and Committee
Member of the European Society for Pediatric Infectious Disease. "The prospect
of a new vaccine that helps to prevent MenB is the advance that we have been
awaiting for decades."
In November 2012, Bexsero was recommended for European licensure by the
Committee for Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA). The European Commission generally follows the recommendations of
the CHMP and delivers its final decision within three months, which will be
applicable to all European Union (EU) and European Economic Area (EEA)
countries. Novartis is committed to making Bexsero available as soon as possible
and is already engaging with governments interested in the early adoption of the
vaccine.
"Our company has made a strong commitment to addressing the public health need
for a vaccine that can provide broad protection against MenB. The findings from
this and other studies have built a substantial body of evidence showing that
Bexsero can be an effective vaccine against this deadly disease," said Andrin
Oswald, Division Head, Novartis Vaccines and Diagnostics. "Upon the licensure of
Bexsero, Novartis will be able to offer vaccines to help prevent all five of the
most common and most virulent meningococcal serogroups."
Meningococcal disease is easily misdiagnosed and kills approximately one in ten
people within 24 hours of onset despite appropriate treatment[3],[4]. Of the
survivors, around one in five suffers permanent disabilities such as brain
damage, hearing impairment or limb loss[5]. Therefore prevention through
vaccination is the best means to reduce the burden of meningococcal disease. The
majority of cases in the developed world are due to MenB[6], with a
disproportionate disease burden in infants[7].
Study Design and Results
This pivotal (Phase III) immunogenicity study randomized 3,630 infants to
receive routine vaccines at 2, 4 and 6 months, either alone or concomitantly
with either Bexsero or a serogroup C conjugate vaccine. The routine vaccines
administered were 7-valent pneumococcal glycoconjugate vaccine and a combined
diphtheria, tetanus, acellular pertussis, inactivated polio, hepatitis B and
Haemophilus influenzae type b vaccine[1].
Immune response against each of the four vaccine components (fHbp, NadA, OMV,
and NHBA) was measured using the human serum bactericidal antibody (hSBA) assay
with a pre-defined threshold titer of >=1:5, the accepted correlate for
protection[1].
A total of 1,555 toddlers were enrolled in the booster phase of the study and
randomized to receive either a Bexsero booster dose at the same time as measles-
mumps-rubella-varicella (MMRV) vaccine, or given the Bexsero booster alone at
12 months and MMRV given one month later.
Following the booster dose of Bexsero at 12 months, more than 95% of recipients
showed a protective response to all four vaccine components. Furthermore, one
month after the third dose, all infants in the study showed a 100% protective
antibody response against two vaccine components (fHbp, NadA) and 84% against
the other two components (NHBA, OMV). These findings are important given that
the burden of disease is highest in infants and toddlers[1].
In this study, Bexsero was shown not to interfere with the immunogenicity of any
other vaccine it was administered with, except for a slightly lower immune
response to polio vaccine that the investigators concluded was not to be
clinically meaningful[1].
Bexsero had an acceptable tolerability profile when co-administered with other
routine infant vaccinations. During the primary series, local injection site
reactions (e.g., tenderness) and fever occurred more frequently when Bexsero was
co-administered with routine vaccines than when the routine vaccines were given
alone. When fever occurred, it was generally mild-to-moderate in severity and of
short duration, with the majority of cases resolving within 24 hours. During the
booster phase, the frequency of fever was similar when Bexsero was administered
alone to when it was co-administered with MMRV[1].
About Bexsero
Bexsero, an investigational multicomponent meningococcal group B (MenB) vaccine,
is the result of more than 20 years of pioneering research in vaccine
development[8]. MenB has been a particularly elusive target because the outer
coating of the bacteria is not well recognized by the immune system, making
it especially challenging to develop a broadly effective vaccine until recent
advances in scientific knowledge[9]. Bexsero was developed using an award-
winning scientific approach that involved decoding the genetic makeup (genome
sequence) of MenB[8],[9].This innovative approach provides the foundation for
the potential development of a new generation of vaccines that may help prevent
other diseases with a significant diversity of disease-causing strains.
Upon regulatory approval, Bexsero will be the first and only licensed vaccine
with the potential to protect against a broad range of strains that
cause MenB disease worldwide[10]. The tolerability profile and immunogenicity of
Bexsero have been established through a comprehensive clinical program including
data from large Phase II/III clinical trials involving almost 8,000
patients[1],[11],[12],[13],[14],[15], including infants, the age group at the
greatest risk of infection. Starting from two months of age, Bexsero offers
several immunization schedule options that can fit with routine vaccination
visits.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "potential," "recommended," "will," "prospect,"
"generally follows . and delivers," "committed," "commitment," "can," "may," or
similar expressions, or by express or implied discussions regarding potential
marketing approvals for Bexsero or any other vaccines, or the timing of any such
approvals, or regarding potential future revenues from any such vaccines. You
should not place undue reliance on these statements. Such forward-looking
statements reflect the current views of management regarding future events, and
involve known and unknown risks, uncertainties and other factors that may cause
actual results with Bexsero to be materially different from any future results,
performance or achievements expressed or implied by such statements. There can
be no guarantee that Bexsero or any other vaccines will be approved for sale in
any market, or at any particular time. Nor can there be any guarantee that
Bexsero or any other vaccines will achieve any particular levels of revenue in
the future. In particular, management's expectations 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; competition
in general; government, industry and general public pricing pressures;
unexpected manufacturing issues; the company's ability to obtain or maintain
patent or other proprietary intellectual property protection; the impact that
the foregoing factors could have on the values attributed to the Novartis
Group's assets and liabilities as recorded in the Group's consolidated balance
sheet, and other risks and factors referred to in Novartis AG's current Form 20-
F on file with the US 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 provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2011, the Group
achieved net sales of USD 58.6 billion, while approximately USD 9.6 billion (USD
9.2 billion excluding impairment and amortization charges) was invested in R&D
throughout the Group. Novartis Group companies employ approximately 127,000
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the world. For more information, please visit http://www.novartis.com.
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References
1. Vesikari T, et al. Immunogenicity and safety of an investigational
multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB)
administered concomitantly with routine infant and child vaccinations:
results of two randomised trials. Lancet 2013 Jan 14. [Epub ahead of
print].
2. Vesikari T, et al. Immunogenicity of an investigational multicomponent
meningococcal serogroup B vaccine in healthy infants at 2, 4 and 6 months
of age. Presented at the 17th International Pathogenic Neisseria
Conference, 11-16 September 2010; Banff, Canada.
3. Thompson MJ, et al. Clinical recognition of meningococcal disease in
children and adolescents. Lancet 2006;367:397-403.
4. World Health Organization. Meningococcal meningitis. Fact sheet #141.
November 2012 update. Available at:
http://www.who.int/mediacentre/factsheets/fs141/en/. Last accessed 10 Dec
2012.
5. Rosenstein NE, et al. Meningococcal disease. N Engl J Med 2001;344:1378-88.
6. Perrett KP, Pollard AJ. Towards an improved serogroup B Neisseria
meningitidis vaccine. Expert Opin Biol Ther 2005;5:1611-25.
7. Centers for Disease Control and Prevention. Meningococcal Disease - Age as
a risk factor. Available at: http://www.cdc.gov/meningococcal/about/risk-
age.html. Last accessed 10 Dec 2012.
8. Rappuoli R. Reverse vaccinology, a genome-based approach to vaccine
development. Vaccine 2001;19:2688-91.
9. Giuliani MM, et al. A universal vaccine for serogroup B meningococcus. Proc
Natl Acad Sci USA 2006;103:10834-9.
10. Donnelly J, et al. Qualitative and quantitative assessment of meningococcal
antigens to evaluate the potential strain coverage of protein-based
vaccines. Proc Natl Acad Sci USA 2010;107:19490-5.
11. Santolaya ME, et al. Immunogenicity and tolerability of a multicomponent
meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile.
Lancet 2012;379:617-24.
12. Gossger N, et al. Immunogenicity and tolerability of recombinant
meningococcal serogroup B vaccine administered with or without routine
infant vaccinations according to different immunization schedules: A
randomized controlled trial. JAMA 2012;307:573-82.
13. Findlow J, et al. Multicenter, open-label, randomized phase II controlled
trial of an investigational recombinant meningococcal serogroup B vaccine
with and without outer membrane vesicles, administered in infancy. Clin
Infect Dis 2010;51:1127-37.
14. Snape MD, et al. Immunogenicity of two investigational serogroup B
meningococcal vaccines in the first year of life: a randomized comparative
trial. Pediatr Infect Dis J 2010;29:e71-9.
15. Prymula R, et al. Catch-up vaccination of healthy toddlers with an
investigational multicomponent meningococcal serogroup B vaccine (4CMenB) -
exploration of a two-dose schedule. Presented at 29th ESPID Meeting, 7-11
June 2011; The Hague, The Netherlands.
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Datum: 14.01.2013 - 07:17 Uhr
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