Novartis submits Bexsero®, a multi-component meningococcal B vaccine, for regulatory review in Europe
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Novartis International AG /
Novartis submits Bexsero®, a multi-component meningococcal B vaccine, for
regulatory review in Europe
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The issuer is solely responsible for the content of this announcement.
* Bexsero is the first vaccine with the potential to offer broad coverage
against a large number of circulating, deadly disease-causing MenB
strains[1], [2]
* Data from more than 7,500 subjects support use of the vaccine in infants
from two months of age and older, adolescents, and adults[3], [4], [5]
Basel, December 23, 2010 - Novartis announced today that it has submitted a
Marketing Authorization Application (MAA) to the European Medicines Agency (EMA)
for Bexsero(®) (Multi-Component Meningococcal B Vaccine; formerly known as
4CMenB). Upon approval, Bexsero will be the first broad-coverage vaccine
licensed for use against disease caused by meningococcal serogroup B bacteria
(MenB) in all European Union (EU) and European Economic Area (EEA)
countries[1],[2]. Submission is supported by comprehensive clinical and
epidemiological data which characterize the safety and immunogenicity profile,
and the predicted coverage of Bexsero[3], [4], [5].
"The Bexsero submission in the EU is an important milestone toward achieving the
world's first broad-coverage MenB vaccine through our unique multi-component
approach[1],[2]," said Andrin Oswald, Head of Novartis Vaccines and Diagnostics
Division. "Meningococcal disease is sudden and aggressive, leaving little time
for treatment[6], [7]. Proactive vaccination of individuals has been shown to
offer the best protection against fatal infectious diseases. Novartis is
committed to providing vaccines to protect people of all ages, including
infants, and against all causes, of meningococcal disease."
The tremendous diversity of MenB strains around the world has been one of the
main challenges to developing an effective broad-coverage MenB vaccine[13]. The
four distinct antigen components of Novartis' Bexsero vaccine were selected
because they are important for the bacteria's survival, function or ability to
cause infection, and can be found in the majority of MenB strains circulating
worldwide[1], [14], [15]. Data predict that the majority of strains would be
covered by more than one of the Bexsero vaccine antigens, preventing disease
caused by current MenB strains and by eventual genetic strain shifts[5].
Coverage data have been generated to predict the ability of the vaccine to
protect infants vaccinated at 2, 4, 6 and 12 months of age against the disease-
causing MenB strains circulating in their local environments[5]. Preliminary
data show that Bexsero covers potentially 77 percent (95% confidence limits from
66-91%) of more than 800 genetically diverse disease-causing MenB strains
isolated in Europe in recent years[5]. The strong coverage estimates of Bexsero
highlight the unique benefits of the multi-component approach. Analysis of
additional strains is currently ongoing and expected to be shared in 2011.
Completed clinical trials involved more than 7,500 infants, adolescents and
adults. In infants, studies show that Bexsero could be either co-administered
with other routine vaccines or as part of a flexible vaccination schedule.
The EU regulatory submission for Bexsero is planned to form the basis for
further submissions. Novartis has prioritized future submissions where the
potential public health impact is greatest, including countries in Asia, Latin
America and North America.
About Bexsero
The Novartis Bexsero vaccine was developed using a pioneering approach known as
"reverse vaccinology." In contrast to conventional methods of developing
vaccines, reverse vaccinology decodes the genetic makeup (genome sequence) of
MenB and selects those proteins that are most likely to be broadly-effective
vaccine candidates[16]. Bexsero contains multiple components, which
independently are highly immunogenic and, taken together, have the potential to
protect against a broad range of disease-causing strains[1], [14], [15].
About Meningococcal Disease
Invasive meningococcal disease is a sudden, aggressive illness that can lead to
death within 24-48 hours of the first symptoms[6], [7]. It is a leading cause of
bacterial meningitis - an infection of the membrane around the brain and
spine[8] - and sepsis - a bloodstream infection[7], [12]. Survivors may
experience side effects, called sequelae, such as brain damage, learning
disabilities, hearing loss, and limb amputations[12].
Licensed vaccines are available to protect against meningococcal disease caused
by serogroups A, C, W135 and Y[8]; however, meningococcal disease caused by
serogroup B has posed a significant burden to people around the world,
especially infants, who are at highest risk for infection[10], [11]. Global
incidence of MenB infection is estimated to be between 20,000 and 80,000 cases
per year, with a 10 percent fatality rate[17]. In Europe, MenB causes up to 80
percent of meningococcal disease cases[9]. MenB strains circulate worldwide, can
mutate and may also result in long-term regional outbreaks over and above the
ongoing baseline threat. MenB has caused such outbreaks of disease around the
world, including in New Zealand, the United Kingdom, and France[1].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "potential," "would," "predicted," "committed," "will,"
"predict," "potentially," "expected," "planned," "may," "can," or similar
expressions, or by express or implied discussions regarding potential marketing
approvals for Bexsero, potential strain coverage for Bexsero, potential future
regulatory submissions to market Bexsero in additional countries, or regarding
potential future revenues from Bexsero. 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
will be approved for sale in any market. Nor can there be any guarantee that
Bexsero will achieve any particular levels of strain coverage. Neither can
there be any guarantee that Bexsero will be submitted for marketing approval in
any additional countries, including the United States. Nor can there be any
guarantee that Bexsero will achieve any particular levels of revenue in the
future. In particular, management's expectations regarding Bexsero 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; unexpected strain coverage analysis results, or unexpected
efficacy issues; the company's ability to obtain or maintain patent or other
proprietary intellectual property protection; competition in general;
government, industry and general public pricing pressures; 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 Vaccines and Diagnostics is a division of Novartis, focused on the
development of preventive treatments. The division has two businesses: Novartis
Vaccines and Novartis Diagnostics. 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. Novartis Diagnostics, the blood testing 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 provides healthcare solutions that address the evolving needs of
patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines, cost-
saving generic pharmaceuticals, preventive vaccines, diagnostic tools and
consumer health products. Novartis is the only company with leading positions in
these areas. In 2009, the Group's continuing operations achieved net sales of
USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D
activities throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 100, 000 full-time-equivalent associates
and operate in more than 140 countries around the world. For more information,
please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References
[1] Perrett KP, Pollard AJ. Towards an improved serogroup B Neisseria
meningitidis vaccine. Expert Opin Biol Ther. 2005; 5:1611-1625.
[2] Donnelly, J et al. Qualitative and quantitative assessment of meningococcal
antigens to evaluate the potential strain coverage of protein-based
vaccines. Proceedings of the National Academy of Sciences. November 2010.
Available at:
http://www.pnas.org/content/early/2010/10/19/1013758107.full.pdf. Accessed
on December 8, 2010.
[3] Esposito, S et al., Tolerability of a three-dose schedule of an
investigational, multicomponent meningococcal serogroup B vaccine and
routine infant vaccines in a lot consistency trial, presented at the 17th
International Pathogenic Neisseria Conference, September 11-16, 2010,
Banff, Canada.
[4] 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, September 11-16, 2010, Banff, Canada.
[5] Novartis Data on File. (Draft summary of product characteristics for
Bexsero)
[6] Centers for Disease Control and Prevention. Meningitis: Diagnosis. June
2009 update. Available at:
http://www.cdc.gov/meningitis/about/diagnosis.html. Accessed on December
9, 2010.
[7] World Health Organization. Meningococcal meningitis fact sheet. Available
at: http://www.who.int/mediacentre/factsheets/fs141/en. Accessed on
December 9, 2010.
[8] World Health Organization. Meningococcal position paper. Weekly
epidemiological record No. 44, 2002, 77, 329-340. Available at:
http://www.who.int/immunization/wer7740meningococcal_Oct02_position_paper.p
df. Accessed on December 9, 2010.
[9] Pizza M, Scarlato V, Masignani V, et al. Identification of vaccine
candidates against serogroup B meningococcus by whole-genome sequencing.
Science. 2000; 287:1816-1820.
[10] Schaffner, W et al. The changing epidemiology of meningococcal disease
among US children, adolescents, and young adults. National Foundation for
Infectious Diseases. November 2004. Available at:
http://www.nfid.org/pdf/meningitis/FINALChanging_Epidemiology_of_Meningococ
cal_Disease.pdf. Accessed on December 9, 2010.
[11 Pollard, A. J. and Maiden, C.J. (Eds.) (2001). Meningococcal disease:
Methods and protocols. Totowa, NJ: Humana Press, Inc.
[12] Centers for Disease Control and Prevention. Epidemiology and prevention of
vaccine-preventable diseases. Atkinson W, Wolfe S, Hamborsky J, McIntyre L,
eds. 11th ed. Washington DC: Public Health Foundation, 2009.
[13] HarrisonLH. Prospects for vaccine prevention of meningococcal infection.
Clin Microbiol Rev. 2006; 19(1):142-1643. Available at:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1360272/. Accessed on December
9, 2010.
[14] Comanducci M, Bambini S, Brunelli B, et al. NadA, a novel vaccine candidate
of Neisseria meningitidis. J Exp Med. 2002;195(11):1445-1454.
[15] Lucidarme J, Comanducci M, Findlow J, et al. Characterization of fHbp, nhba
(gna2132), nadA, porA, sequence type (ST), and genomic presence of IS1301
in group B meningococcal ST269 clonal complex isolates from England and
Wales. J Clin Microbiol. 2009;47(11):3577-3585.
[16] Rappuoli, R. Reverse vaccinology, a genome-based approach to vaccine
development. Vaccine. 2001; 19: 2688-2691.
[17] World Health Organization. Initiative for vaccine research, bacterial
infections. Neisseria meningitidis. Available at:
http://www.who.int/vaccine_research/diseases/soa_bacterial/en/index2.html.
Accessed on December 9, 2010.
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