Novartis Phase III study shows meningococcal B vaccine candidate could be first to provide broad coverage against deadly disease
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Novartis International AG / Novartis Phase III study shows meningococcal B vaccine candidate could be first to provide broad coverage against deadly disease processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
* Pivotal data show that the large majority of infants vaccinated with
Novartis investigational 4CMenB achieved robust immune response against all
vaccine afntigens[1]
* Tolerability profile supports potential use of vaccine to protect infants
against a serious and often deadly disease around the globe[2]
* 4CMenB holds promise as single multi-component vaccine that is broadly
protective against a large variety of MenB strains worldwide
Basel, September 12, 2010 - New Phase III data presented by Novartis Vaccines
indicate that the investigational Multicomponent Meningococcal Serogroup B
Vaccine (4CMenB) has the potential to be the first broad-coverage vaccine
against the dynamic and deadly meningococcal B (MenB) disease. The data were
presented at the International Pathogenic Neisseria Conference (IPNC) in Banff,
Canada.
This trial involving more than 3,600 infants has met its primary end points.
Results show that the large majority of those vaccinated with 4CMenB at the same
time as other routine vaccines achieved a robust immune response against all
vaccine MenB antigens[1]. Additionally, results show that 4CMenB had an
acceptable tolerability profile when co-administered with other routine infant
vaccines[2], which supports potential use of the vaccine in the first year of
life, when the medical need is greatest[3].
These new phase III data are part of a comprehensive clinical program led by
Novartis to show that 4CMenB can be used across all age groups and can be either
co-administered with other routine vaccines or as part of a flexible vaccination
schedule. Additional Phase III trial results from ongoing studies are expected
this autumn. The comprehensive data of more than 7,500 subjects is expected to
be the basis for the planned filing in the EU by year end.
MenB is a sudden, aggressive illness that can lead to death within 24-48 hours
of the first symptoms[4, 5]. The disease poses a significant burden to people
around the world[6], especially infants, who are at highest risk for
infection[3]. MenB causes up to 80 percent of meningococcal disease cases in
Europe[7], up to 55 percent of cases in Canada[8] and 30 percent of cases in the
US[7]. MenB strains circulate worldwide, can mutate and may result in long-term
regional outbreaks[9].
"The challenge with MenB is that there are thousands of circulating strains and
developing a broadly protective vaccine has, until now, been difficult[9]," said
Andrin Oswald, Head of Novartis Vaccines and Diagnostics Division. "These
critical data highlight the promise of our innovative candidate 4CMenB vaccine
in addressing the unmet public health need of MenB, the most common cause of
bacterial meningitis for which there is no readily available global vaccine[6]."
The Novartis 4CMenB vaccine was developed using a pioneering approach known as
"reverse vaccinology." In contrast to conventional methods of producing
vaccines, reverse vaccinology decodes the genetic makeup of MenB and finds the
specific components that most typically cause infection[10]. 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.
"Meningitis B can be devastating for affected families and is a major concern
for pediatricians who care for children with this serious illness. The disease
can strike healthy children without warning and, in some countries, is the
leading infectious cause of death in early life[11, 12]," said Andrew Pollard
FRCPCH PhD, Professor of Paediatric Infection and Immunity at the University of
Oxford. "Many cases of meningitis are prevented today by the vaccines we give to
our children, but the more complex meningitis B remains as a major threat to
public health[6]. The encouraging data presented on 4CMenB indicate the
potential for additional protection to be provided by this new vaccine."
4CMenB Clinical Trial Results Presented at IPNC
Results from the clinical Phase III trial show that a majority of infants
vaccinated with 4CMenB concomitantly with other routine vaccines achieved a
robust immune response against the three vaccine MenB antigens. The vaccine was
administered at 2, 4, and 6 months of age[1, 2]. One month after the third
4CMenB dose, the percentage of subjects achieving serum bactericidal antibodies
using human complement (hSBA) ?1:5 against three MenB strains (5/99, NZ98/254
and H44/76) were 100 percent, 84 percent and 100 percent, respectively[1]. All
three lots of investigational 4CMenB showed highly consistent immune
responses[1]. In addition, responses to routine infant vaccine antigens when
co-administered with 4CMenB were similar with the exception of a slightly
diminished polio 2 response when compared to routine vaccine administration
alone[1].
4CMenB also had an acceptable tolerability profile when co-administered with
other routine infant vaccines[2]. Typical vaccine associated events solicited
for 7 days after each vaccination showed a similar incidence (83 percent after
routine vaccine alone compared to 87 percent following routine vaccine
co-administered with 4CMenB)[2]. The events were similar in nature and quality
(mostly injection site reactions and systemic reactions such as sleepiness,
changed eating habits, irritability, unusual crying and rash, or
gastrointestinal events)[2]. Events in both groups were mostly mild or moderate
reactions and transient, following a typical pattern of routine vaccinations[2].
Fever, which is a common event following routine childhood immunizations, was
observed more frequently in infants who received the 4CMenB vaccine together
with routine infant vaccines compared to infants receiving routine vaccines
alone[2]. Fever was generally low-grade, mild and of short duration, with 95
percent of cases resolving within 24-48 hours[2]. These preliminary data
findings will complement additional safety data that Novartis is evaluating as
part of its complete phase III program.
Incidence of serious adverse events in infants who received 4CMenB with routine
vaccines was comparable to those who received routine infant vaccines alone and
those who received meningococcal C conjugate vaccine with routine infant
vaccines[2]. In the study, less than one percent of infants discontinued the
trial due to reactogenicity following vaccination with no difference between
groups[2].
Trial Design
This Phase III, randomized, controlled, multi-center study involved 3,630
healthy infants in trial sites throughout Europe. The primary endpoints of the
study were to determine the consistency of immune response to three lots of
4CMenB, and assess the immunogenicity and tolerability of three doses of 4CMenB
(three lots combined) given concomitantly with routine infant vaccines.
The trial included an open-label immunogenicity and tolerability subset in which
participants were randomized to receive one of three lots of 4CMenB vaccine with
routine infant vaccines, or routine vaccines alone. Also included was an
observer-blind safety subset in which participants were randomized to receive
4CMenB vaccine or meningococcal C conjugate vaccine with routine vaccines, or
routine vaccines alone. Immunizations were administered at 2, 4, and 6 months of
age. Primary immunogenicity was based on a serum bactericidal assay using human
complement (hSBA) against three serogroup B strains (5/99, NZ98/254 and H44/76)
30 days after the final study vaccination. Injection site and systemic reactions
were recorded for seven days post-vaccination, and adverse events were evaluated
throughout the study[1, 2].
About 4CMenB Clinical Program
The entire 4CMenB Clinical program consists of clinical trials studying the
immunogenicity, safety and tolerability of the investigational vaccine in four
major age groups, including infants, toddlers, adolescents and adults worldwide.
Results from a Phase II study in adults showed that 4CMenB generated an immune
response and was generally well tolerated[13].
In addition, studies are under way to confirm the expected coverage of the
broad-based vaccine against MenB strains circulating in several countries. The
first results are expected prior to filing.
About Meningococcal Disease
Meningococcal disease is a leading cause of bacterial meningitis - an infection
of the membrane around the brain and spine - and sepsis - a bloodstream
infection[14, 15, 16]. Survivors may experience side effects, called sequelae,
such as brain damage, learning disabilities, hearing loss and limb loss[16].
Five main groups of meningococcal bacteria (A, B, C, W-135 and Y) cause the
majority of all cases around the world[3].
Meningococcal disease caused by groups A, C, W-135 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 readily available global vaccine[6].
MenB also has been known to cause outbreaks of meningitis around the world,
including New Zealand, the United Kingdom and Normandy, France[9, 17]. Global
incidence of MenB infection is estimated to be between 20,000 and 80,000 cases
per year, with a 10 percent fatality rate[18].
About Novartis Vaccines' global meningococcal franchise
Using a pioneering approach called "reverse vaccinology" Novartis has developed
the investigational Multicomponent Meningococcal Serogroup B Vaccine (4CMenB).
Novartis Vaccines also used innovative technology to produce Menjugate®, a
meningococcal C conjugate vaccine approved outside the U.S. since 2000 for use
in individuals from 2 months of age through adulthood, and Menveo®, a
quadrivalent conjugate vaccine to help protect against four of the five major
groups of meningococcal bacteria. In addition, Novartis also produced MeNZB®, a
vaccine against a strain of meningococcus B specific to an outbreak in New
Zealand. The company has already distributed more than 45 million doses of
Menjugate around the world[19].
Novartis Vaccines is a global leader in providing vaccines to protect against
deadly meningococcal disease. Through industry-leading scientific expertise, the
company is focused on extending critical meningococcal vaccines research.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "could," "potential," "promise," "can," "expected,"
"planned," "promising," "will" or similar expressions, or by express or implied
discussions regarding potential marketing approvals for 4CMenB, or the potential
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; the company's ability to
obtain or maintain patent or other proprietary intellectual property protection;
government, industry and general public pricing pressures; 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 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 102,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visit http://www.novartis.comf.
References
1. 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.
2. 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.
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_Meningococc
al_Disease.pdf. Accessed on September 8, 2010.
4. Centers for Disease Control and Prevention. Meningitis: Diagnosis. June
2009 update. Available at:
http://www.cdc.gov/meningitis/about/diagnosis.html. Accessed on September
8, 2010.
5. World Health Organization. Meningococcal meningitis fact sheet. Available
at: http://www.who.int/mediacentre/factsheets/fs141/en. Accessed on
September 8, 2010.
6. 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.pd
f. Accessed on September 8, 2010.
7. 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.
8. 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
September 8, 2010. [Referenced in Menveo Canada Approval Release, June
8, 2010]
9. Perrett KP, Pollard AJ. Towards an improved serogroup B Neisseria
meningitidis vaccine. Expert Opin Biol Ther. 2005; 5:1611-1625.
10. Rappuoli, R. Reverse vaccinology, a genome-based approach to vaccine
development. Vaccine. 2001; 19: 2688-2691.
11. Pollard, A. J. and Maiden, C.J. (Eds.) (2001). Meningococcal Disease:
Methods and Protocols. Totowa, NJ: Humana Press, Inc.
12. National Health Service. National Institute for Health and Clinical
Excellence. Bacterial meningitis and meningococcal septicaemia. September
2010 update. Available at:
http://www.nice.org.uk/nicemedia/live/13027/49339/49339.pdf. Accessed on
September 8, 2010.
13. Dull, P et al. Immunogenicity and Safety of a Recombinant Meningococcal
Serogroup B Vaccine and a Quadrivalent Conjugate Vaccine in Laboratory
Workers, presented at the 17th International Pathogenic Neisseria
Conference, September 11-16, 2010, Banff, Canada.
14. 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 September
8, 2010.
15. Centers for Disease Control and Prevention. Meningitis Questions & Answers.
Available at: http://www.cdc.gov/meningitis/about/faq.html. Accessed on
September 8, 2010.
16. 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 September
8, 2010.
17. Rouaud P, Perrocheau A, Taha MK, Sesboué C, Forgues AM, Parent du Châtelet
I, Lévy-Bruhl D. Prolonged outbreak of B meningococcal disease in the
Seine-Maritime department, France, January 2003 to June 2005. Euro Surveill.
2006; 11(7): pii=635.
18. 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/index2.html.
Accessed on September 8, 2010.
19. Novartis data on file.
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