Pivotal study published in JAMA confirms potential of Novartis candidate vaccine Bexsero® to help protect infants against devastating meningococcal serogroup B disease
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Pivotal study published in JAMA confirms potential of Novartis candidate vaccine
Bexsero® to help protect infants against devastating meningococcal serogroup B
disease
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The issuer is solely responsible for the content of this announcement.
* Data previously presented at ESPID annual meeting add to the body of
evidence showing that Bexsero can help protect all vulnerable age groups
* Study including more than 1,800 infants showed Bexsero induces robust immune
response when given alone or with other routine vaccines in different
vaccination schedules[1]
* Current vaccines do not broadly protect against MenB which is easily
misdiagnosed and can kill within 24 hours; infants are at highest risk[2]
Basel, February 7, 2012 - The Journal of the American Medical Association (JAMA)
published a study today that shows Bexsero induced a robust immune response
against meningococcal B disease in the vast majority of infants vaccinated.
These results also show that Bexsero can fit into various vaccination schedules
in the first year of life when the likelihood of contracting this often-deadly
disease is greatest. The study also demonstrated that Bexsero has an acceptable
tolerability profile.
These data were first presented in 2011 at the 29(th) Annual Meeting of the
European Society of Paediatric Infectious Diseases (ESPID)[3].
"The publication of these results in JAMA add to the growing body of evidence
supporting Bexsero's potential to help protect all age groups, from infants to
adults, against this devastating disease." said Andrin Oswald, Head of Novartis
Vaccines and Diagnostics Division. "Bexsero holds great promise in providing a
solution to a major public health concern - the lack of a routine vaccine
providing broad protection against MenB,"
Meningococcal disease is feared and often deadly[3]; it is easily misdiagnosed,
can kill within 24 hours of onset and may cause serious, life-long
disabilities[2],[6] ,[4]. The majority of cases in some of the developed world
are due to serogroup B (MenB)[5], with a disproportionate disease burden in
infants[5]. In general, approximately one in ten of people who contract
meningococcal disease will die despite appropriate treatment[2],[6] ,[7] of the
survivors, around one in five suffers permanent disabilities such as brain
damage, hearing loss, or learning difficulties[6],[7]. Meningococcal disease
most commonly affects otherwise healthy persons, and in many cases physicians
cannot diagnose and treat an infected child soon enough to avoid serious
outcomes, therefore prevention through vaccination is the best means to counter
meningococcal disease.
"The development of a broadly protective vaccine against MenB disease has been a
formidable challenge and, if successful, would represent an enormous step
forward in the prevention of childhood meningitis," said Dr Matthew Snape,
Consultant in Vaccinology and General Paediatrics, University of Oxford, UK.
"This study provides important data on how well infants' immune systems respond
to this new MenB vaccine when given in a variety of schedules. This information
is vital when considering how the vaccine could be incorporated into different
immunization regimens around the world."
Study Design and Results
This pivotal Phase IIb open-label immunogenicity study[1] randomized 1,885
infants to receive Bexsero at 2, 4, 6 months together with routine infant
vaccines; at 2, 4, 6 months with routine vaccines given separately at 3, 5, 7
months; or at 2, 3, 4 months together with routine infant vaccines. A control
group received the routine vaccines only at 2, 3, 4 months. The routine vaccines
used were 7-valent pneumococcal glycoconjugate vaccine and a combined
diphtheria, tetanus, acellular pertussis, inactivated polio, hepatitis B and
Haemophilus influenzae type b vaccine.
Immune response was measured using the human serum bactericidal antibody (hSBA)
assay with a titer >= 1:5, which is the accepted level that correlates with
protection. The study met all of its primary endpoints, and showed that the
majority of infants vaccinated with Bexsero, at either dosing schedule with or
without routine vaccines, achieved hSBA >= 1:5 against all vaccine antigens in
tested MenB strains (H44/76, 5/99, NZ98/254). More than 99% of participants
receiving Bexsero at 2, 4, 6 months (with or without routine vaccines) or at
2, 3 and 4 months (with routine vaccines) developed hSBA titers >= 1:5 against
the reference strains 44/76 and 5/99. For NZ98/254 the >= 1:5 result was reached
or exceeded in 79% (2, 4, 6 months with routine vaccines), 87% (2, 4, 6 months
without routine vaccines) and 81% (2, 3, 4 months with routine vaccines) of
patients on the corresponding schedules.
The immune response to routine vaccine antigens when co-administered with
Bexsero was similar to that in the control group[1], except for slightly lower
immune responses to pneumococcal serotype 6B and pertactin, comparable with
other licensed vaccines.
The data also showed that Bexsero, when administered alone, had a reactogenicity
profile that was comparable to those of the routine vaccines[1]. Fever, which is
a common event following routine childhood immunizations, was observed more
frequently in infants who received Bexsero together with routine infant vaccines
compared to infants receiving routine vaccines alone[1]. Fever was generally
mild-to-moderate and of short duration, with more than 95% of cases resolving
within 24-48 hours[1].
Bexsero is the result of more than 20 years of pioneering research in the fight
to protect infants and other populations at risk of infection from MenB[6],[7].
To address the unpredictable and changing nature of meningococcus bacteria over
time, Bexsero - comprising four key components that independently are highly
immunogenic[8] - was designed to protect against the majority of disease-causing
strains worldwide. The immunogenicity and tolerability of Bexsero has been
demonstrated in large Phase III clinical trials involving more than 8,000
infants, adolescents and adults with post-vaccination reactions comparable to
those of other routine vaccines[4],[9]. In December 2010, a Marketing
Authorization Application (MAA) for Bexsero was submitted in Europe and in other
countries, including a proposed infant vaccination schedule consisting of three
doses for the primary series. Regulatory action is expected later in 2012.
The study was published in the February 8, 2012 issue of JAMA[1] with the title
of "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" by Nicoletta
Gossger MD, Matthew D Snape FRCPCH MD, et al.
About Bexsero
The Novartis Bexsero vaccine (also known as 4CMenB) was developed using a
pioneering approach known as "reverse vaccinology[9]." This was necessary
because the approach used to produce a conjugate meningococcal vaccine against
serogroups A, C, W-135 and Y could not be used for MenB. The capsular
polysaccharide of MenB is identical to a polysaccharide component present in the
human body and is therefore not immunogenic. In contrast to conventional methods
of developing vaccines, reverse vaccinology was used to decode the genetic
makeup (genome sequence) of MenB and select those proteins that were most likely
to be broadly effective vaccine candidates[9]. Bexsero contains multiple
components, which are highly immunogenic independently and, taken together, have
the potential to protect against a broad range of disease-causing MenB
strains[11](). To date, more than 8,000 infants, toddlers, and adults have been
enrolled in studies of Bexsero[1],[10] ,[11] ,[12] ,[13] ,[14].( )Bexsero is not
currently licensed for use in any country.
Licensed vaccines are available to protect against meningococcal disease caused
by serogroups A, C, W-135 and Y[7]; however, MenB remains an important unmet
public health challenge[5].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "would," "could," "will," "promise," "potential,"
"proposal," or similar expressions, or by express or implied discussions
regarding potential future marketing approvals for Bexsero 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, or at any particular time. 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; 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;
competition in general; 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's
continuing operations 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 124,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.
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References
[1] 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.
[2] Thompson MJ, et al. Clinical recognition of meningococcal disease in
children and adolescents. Lancet 2006;367:397-403.
[3] Rosenstein NE, et al. Meningococcal disease. N Engl J Med 2001;344:1378-88.
[4] World Health Organization. Meningococcal meningitis. Fact sheet #141.
December 2010 update. Available at:
http://www.who.int/mediacentre/factsheets/fs141/en/. Last accessed 9 Jan
2012.
[5] Centers for Disease Control and Prevention. Meningitis: Signs and Symptoms.
June 2009. Available at: http://www.cdc.gov/meningitis/about/symptoms.html.
Last accessed on 9 Jan 2012.
[6] Rappuoli R. Reverse vaccinology, a genome-based approach to vaccine
development. Vaccine 2001;19:2688-91.
[7] Giuliani MM, et al. A universal vaccine for serogroup B meningococcus. Proc
Natl Acad Sci USA 2006;103:10834-9.
[8] 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.
[9] 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 IPNC, Sept
11-16, 2010. Banff, Canada. Poster #182.
[10] Santolaya ME, et al. Immunogenicity and tolerability of a multicomponent
meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile.
Lancet 2012 Jan 17. [ePub ahead of print].
[11] 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.
[12] 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.
[13] 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 29(th) ESPID Meeting, June
7-11, 2011; The Hague, The Netherlands. Poster #706.
[14] 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 IPNC, Sept 11-16, 2010; Banff, Canada. Poster #180.
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Datum: 07.02.2012 - 22:00 Uhr
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