New data show potential for Novartis Meningitis B vaccine (4CMenB) candidate to cover majority of diverse meningococcal serogroup B strains
(Thomson Reuters ONE) -
Novartis International AG /
New data show potential for Novartis Meningitis B vaccine (4CMenB) candidate to
cover majority of diverse meningococcal serogroup B strains
Processed and transmitted by Thomson Reuters.
The issuer is solely responsible for the content of this announcement.
* Data show that antibodies induced by Novartis 4CMenB candidate killed 85
percent of a large collection of MenB strains in adults and 74 percent in
infants[1], who are at highest risk for meningococcal disease[2]
* Findings highlight the benefit of a multi-component MenB vaccine to provide
broad coverage against diverse strains[1]
* Innovative Meningococcal Antigen Typing System (MATS) has been developed to
predict strain coverage and evolution across the globe
Basel, November 4, 2010 - New data demonstrated that antibodies induced by
Novartis Vaccines investigational, four component, Meningococcal Serogroup B
Vaccine (4CMenB) killed the majority of a collection of geographically and
genetically diverse meningococcal serogroup B (MenB) strains. The strain
coverage research findings were recently published in the Proceedings of the
National Academy of Sciences.
To define the potential coverage of 4CMenB against circulating MenB strains, the
research investigators examined the characteristics of a collection of 124 MenB
strains using pooled sera from immunized adults, and 57 strains using pooled
sera from immunized infants[1] The strains were selected to represent a wide
range of variability of antigens but were not intended to represent any specific
regional epidemiologic sample of MenB strains. The data demonstrated that 85
percent of the tested strains were killed by pooled sera of adults vaccinated
with 4CMenB, as measured by serum bactericidal assay (SBA)[1].( )SBA is an
established and validated correlate of protection. Additionally, the vaccine
performed well in infants; even though infant immune systems are still
maturing[3], 74 percent of strains were killed using pooled sera from infants
vaccinated with 4CMenB[1].( )Infants are most at risk of MenB disease and their
protection presents the greatest unmet need[2].( )
In addition to the vaccine coverage results, a subsequent analysis of a new
predictive model, "Meningococcal Antigen Typing System" (MATS), against the
tested MenB strains, supported the potential benefits of a multi-component
vaccine. When MATS detected that three vaccine antigens were sufficiently
present on any MenB strain, 100 percent of the time these strains were killed by
pooled sera from immunized adults[1]. In addition, when one or two antigens were
detected to be sufficiently present on any MenB strain, 85 and 94 percent of the
time, respectively, they were killed[1].
"These important findings support our innovative approach using multiple novel
components in a single vaccine to provide broad coverage against the deadly and
unpredictable MenB disease," said Andrin Oswald, Head of Novartis Vaccines and
Diagnostics Division. "Novartis is committed to developing a MenB vaccine that
protects all age groups who are at highest risk of contracting often deadly MenB
disease, especially infants and young children[2]".
MATS is a new, simple and reproducible assay that correlates with SBA to
overcome the challenge of traditional SBA testing on large collections of
strains. The immense diversity and number of circulating MenB strains around the
world[2] and the limited infant serum volume derived from clinical trials makes
traditional testing difficult and cannot be made a routine procedure[1].
Novartis Vaccines, in collaboration with Novartis Diagnostics, developed MATS as
a scientific model to predict whether MenB strains are potentially covered by
the vaccine.
The MATS method allows simple and rapid prediction of potential vaccine coverage
in different geographic regions and monitoring of strain evolution. Its results
alone are not intended to demonstrate, and do not imply, clinical effectiveness.
"The MATS model is a milestone in meningococcal serogroup B vaccine
development," said Joel Ward MD, Professor of Pediatrics at the Center for
Vaccine Research, School of Medicine, University of California Los Angeles.
"Given the geographic diversity of MenB and the potential for mutation, it was
previously considered impossible to evaluate immune responses to the many
circulating strains that can cause deadly disease[2]. MATS has the potential to
be used for vaccines against meningococcal diseases and for vaccines against
other bacteria as well."
Novartis is providing the MATS assay platform to national and regional reference
laboratories around the world. These institutions are analyzing their local or
regional circulating strains to predict the potential coverage of 4CMenB in
their territories. National coverage data on more than 1,500 MenB strains are
expected to be available by the middle of 2011.
Research Design
The research included 124 meningococcal serogroup B strains that were obtained
from meningococcal reference laboratories in the UK, France, Germany, Italy,
Norway, New Zealand, Australia and the US[1]. Healthy human adult volunteers
were immunized with 4CMenB and sera were collected[1] and pooled[1]. A
prioritized subset of 57 strains was analyzed with serum from infants immunized
at 2, 4, 6 and 12 months of age[1]. Since less serum was available from infants,
fewer strains were tested in this age group[1].
MATS accurately predicted the percentage of epidemiologically diverse, disease-
causing MenB strains that 4CMenB would cover (or kill in SBA) in adults and
infants by evaluating their antigen detection level and cross-protective immune
response[1]. To establish the MATS method, results were compared with killing of
MenB, determined by SBA in human complement (hSBA), the most direct and
established approach to measure vaccine's protective immune response, using
pooled sera from adults and infants vaccinated with 4CMenB[1].
About 4CMenB
The Novartis 4CMenB 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 protective vaccine
candidates[4]. 4CMenB targets multiple components and is designed to provide an
optimal immune response against the majority of MenB strains, while at the same
time addressing the constantly changing nature of the bacteria.
4CMenB is the only candidate MenB vaccine currently in Phase III testing.
Comprehensive data from more than 7,500 infant and adolescent/adult subjects is
expected to be the basis for the planned filing in the EU by year end.
About Meningococcal Disease
Invasive meningococcal disease is a sudden, aggressive illness that can lead to
death within 24-48 hours of the first symptoms[5],[6]. The disease poses a
significant burden to people around the world, especially infants, who are at
highest risk for infection[2],[7]. MenB causes up to 80 percent of meningococcal
disease cases in Europe[8], up to 55 percent of cases in Canada[9] and 30
percent of cases in the US[8]. MenB strains circulate worldwide, can mutate and
may result in long-term regional outbreaks[2].
Meningococcal disease caused by groups A, C, W135 and Y is vaccine-preventable;
however, MenB remains an unmet public health need as the most common cause of
bacterial meningitis for which there is no licensed broad-spectrum vaccine[7].
Global incidence of MenB infection is estimated to be between 20,000 and 80,000
cases per year, with a 10 percent fatality rate[10].
Meningococcal disease is a leading cause of bacterial meningitis - an infection
of the membrane around the brain and spine - and sepsis - a bloodstream
infection[11],[12],[13]. Survivors may experience side effects, called sequelae,
such as brain damage, learning disabilities, hearing loss and limb loss[13].
About Novartis Vaccines' global meningococcal franchise
Novartis Vaccines is a global leader in providing vaccines to help protect
against potentially deadly meningococcal disease. Through industry-leading
scientific expertise, the Company is focused on extending critical meningococcal
vaccines research. In addition to the Men ACWY conjugate vaccine, Menveo(®),
Novartis Vaccines is developing an investigational, four component,
Meningococcal Serogroup B Vaccine (4CMenB), which has the potential to provide
protection against a range of serogroup B strains. Menveo vaccine is based on
the same proprietary technology Novartis Vaccines pioneered to produce
Menjugate(®), a meningococcal serogroup C conjugate vaccine approved in many
countries outside the US since 2000, and of which more than 45 million doses
have been distributed around the world[14]. Novartis Vaccines also developed and
produced MenZB(®), a vaccine targeting specifically one strain of meningococcus
B causing an outbreak in New Zealand.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "potential," "risk," "predict," "committed,"
"prediction," "expected," "planned," "can," "may," "potentially," "developing,"
or similar expressions, or by express or implied discussions regarding potential
marketing approvals for 4CMenB, or the timing of such approvals, or regarding
potential future revenues from 4CMenB. 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 4CMenB to be
materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that 4CMenB
will be approved for sale in any market, or at any particular time. Nor can
there be any guarantee that 4CMenB will achieve any particular levels of revenue
in the future. In particular, management's expectations regarding 4CMenB 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; government, industry and general public pricing pressures;
competition in general; 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 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 visithttp://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis
athttp://twitter.com/novartis.
References:
[1.] Donnelly, J et al. Qualitative and 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 October 31, 2010.
[2.] Perrett KP, Pollard AJ. Towards an improved serogroup B Neisseria
meningitidis vaccine. Expert Opin Biol Ther. 2005; 5:1611-1625.
[3.] 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_Meningococca
l_Disease.pdf. Accessed on October 31, 2010.
[4.] Rappuoli, R. Reverse vaccinology, a genome-based approach to vaccine
development. Vaccine. 2001; 19: 2688-2691.
[5.] Centers for Disease Control and Prevention. Meningitis: Diagnosis. June
2009 update. Available at:http://www.cdc.gov/meningitis/about/diagnosis.html.
Accessed on October 31, 2010.
[6.] World Health Organization. Meningococcal meningitis fact sheet. Available
at:http://www.who.int/mediacentre/factsheets/fs141/en. Accessed on October
31, 2010.
[7.] 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.pdf. Accessed on October 31, 2010.
[8.] 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.
[9.] National Advisory Committee on Immunization (NACI). Update on the Invasive
Meningococcal Disease and Meningococcal Vaccine Conjugate Recommendations.
Volume 35. ACS-3 April 2009. Available at:http://www.phac-
aspc.gc.ca/publicat/ccdr-rmtc/09vol35/acs-dcc-3. Accessed on October 31, 2010.
[Referenced in Menveo Canada Approval Release, June 8, 2010]
[10.] World Health Organization. Initiative for Vaccine Research, Bacterial
Infections. Neisseria meningitidis. Introduction, second sentence. Available
at:http://www.who.int/vaccine_research/diseases/soa_bacterial/en/index1.html.
Accessed on October 31, 2010.
[11.] Centers for Disease Control and Prevention. Prevention and Control of
Meningococcal Disease - Recommendations of the Advisory Committee on
Immunization Practices. MMWR 2005; 54 (RR07): 1-21. Available
at:http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5407a1.htm. Accessed on October
31, 2010.
[12.] Centers for Disease Control and Prevention. Meningitis Questions &
Answers. Available at:http://www.cdc.gov/meningitis/about/faq.html. Accessed on
October 31, 2010.
[13.] Centers for Disease Control and Prevention. Epidemiology and Prevention of
Vaccine-Preventable Diseases (The Pink Book: Course Textbook). 10th Edition,
2nd printing. February 2008 update. Available
at:http://www.cdc.gov/vaccines/pubs/pinkbook/default.htm. Accessed on October
31, 2010.
[14.] Novartis data on file.
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff Natacha Gassenbach
Novartis Global Media Relations Novartis Division Communications
+41 61 324 7999 (direct) +1 617 871 8341 (direct)
+41 79 593 4202 (mobile) +1 617 852 8609 (mobile)
eric.althoff(at)novartis.com natacha.gassenbach(at)novartis.com
e-mail: media.relations(at)novartis.com
For Novartis multimedia content, please visit www.thenewsmarket.com/Novartis
For questions about the site or required registration, please
contact:journalisthelp(at)thenewsmarket.com.
Novartis Investor Relations
Central phone: |+41 61 324 7944 | |
----------------------+-----------------+---------------+---------------------
Susanne Schaffert |+41 61 324 3769 |North America: |
----------------------+-----------------+---------------+---------------------
Pierre-Michel Bringer|+41 61 324 1065 |Richard Jarvis |+1 212 830 2433
----------------------+-----------------+---------------+---------------------
Thomas Hungerbuehler |+41 61 324 8425 |Jill Pozarek |+1 212 830 2445
----------------------+-----------------+---------------+---------------------
Isabella Zinck |+41 61 324 7188 |Edwin Valeriano|+1 212 830 2456
----------------------+-----------------+---------------+---------------------
| | |
----------------------+-----------------+---------------+---------------------
e-mail: investor.relations(at)novartis.com|e-mail:
|investor.relations(at)novartis.com
[HUG#1458801]
--- End of Message ---
Novartis International AG
Postfach Basel null
WKN: 904278;ISIN: CH0012005267;
Media release (PDF):
http://hugin.info/134323/R/1458801/398313.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Novartis International AG via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 04.11.2010 - 07:16 Uhr
Sprache: Deutsch
News-ID 48396
Anzahl Zeichen: 20193
contact information:
Town:
Basel
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 215 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"New data show potential for Novartis Meningitis B vaccine (4CMenB) candidate to cover majority of diverse meningococcal serogroup B strains"
steht unter der journalistisch-redaktionellen Verantwortung von
Novartis International AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
