Novartis receives approval in the European Union for Menveo®, first quadrivalent conjugate vaccine in the EU to help prevent meningococcal disease
(Thomson Reuters ONE) -
Novartis International AG / Novartis receives approval in the European Union for Menveo®, first quadrivalent conjugate vaccine in the EU to help prevent meningococcal disease processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
* Meningococcal disease is a major cause of bacterial meningitis and sepsis
with high consequent disability and mortality rates worldwide[1]
* Dominant groups of meningococcal disease vary by country and region, and can
change over time, making it an even more unpredictable disease[2]
* Menveo helps protect against four of the five major bacterial groups
responsible for meningococcal disease
* One year after vaccination, more adolescents maintained protective immune
response against three of the four groups when immunized with Menveo than
with polysaccharide vaccine[3]
Basel, March 18, 2010 - Novartis announced today that the European Commission
(EC) granted a Marketing Authorization for Menveo(®) (Meningococcal Group A, C,
W135 and Y conjugate vaccine) in all 27 European member states. Menveo is
indicated for the active immunization of adolescents (from 11 years of age) and
adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to
prevent invasive disease. Menveo is the first conjugate vaccine commercially
available in Europe that helps protect against four major groups of
meningococcal disease. Novartis intends to submit additional data to the
European Medicines Agency to support the use of Menveo in other age groups.
Meningococcal infection is a leading cause of bacterial meningitis - an
infection of the membrane around the brain and spinal cord - and sepsis - a
bloodstream infection[4],[5]. Meningococcal disease progresses rapidly and can
lead to death within 24-48 hours of the first symptoms[6]. Of those who survive,
as many as one in five will suffer life-long complications such as brain damage,
learning disabilities, hearing loss and limb loss[4].
"Marketing approval for Menveo for people ages 11 and older is the culmination
of 10 years of dedicated effort by Novartis Vaccines to provide a vaccine that
can help protect against meningococcal disease," said Andrin Oswald, Division
Head of Novartis Vaccines and Diagnostics. "Our priority is to advance the fight
against meningitis through innovative vaccines that help save lives."
The majority of all meningococcal disease cases around the world can be
attributed to five main groups - called serogroups - of the bacteria that cause
meningococcal disease, Neisseria meningitidis[2]. Importantly, dominant groups
of meningococcal disease can vary by country and region, and change over time,
making it an even more unpredictable disease[2]. The most effective way to
prevent this deadly disease is through the use of a vaccine that offers
protection against as many bacterial groups as possible[1].
Adolescents and young adults are at increased risk of contracting meningococcal
disease, often because they start to encounter new situations and undergo
changes in their lifestyles[5],[7]. Other groups at increased risk of
contracting meningococcal disease include travelers, military personnel and
Muslim pilgrims traveling to the Hajj or Umrah[6].
Menveo was developed using conjugate technology, which was pioneered by Novartis
Vaccines in the development of its meningococcal group C conjugate vaccine,
Menjugate(®). A conjugate vaccine is developed by attaching a polysaccharide
antigen - the key component of a vaccine that prompts the body to respond to
infection - to a carrier protein in order to enhance the body's immune response
to the vaccine[7].
When utilized in a national immunization program, conjugate vaccines (such as
those designed to help protect against Hib, pneumococcal and meningococcal group
C disease) have reduced the number of people (both vaccinated and unvaccinated)
who carry the bacteria that cause the disease[7]. Novartis is currently studying
the long-term safety and immunogenicity of Menveo, and is considering clinical
studies on carriage.
Menveo has been administered to more than 18,500 people and is currently in
multiple Phase III clinical studies in infants and toddlers worldwide[8]. The
U.S. Food and Drug Administration (FDA) recently approved Menveo for use in
11-55 year olds.
Study Details
Marketing Authorization was based on data from a pivotal Phase III clinical
trial and a non-inferiority study. In the non-inferiority study, immune response
was assessed among adolescents 11-17 years of age. Menveo was shown to be
non-inferior to a quadrivalent meningococcal polysaccharide vaccine (ACWY-PS)
for all four meningococcal groups contained in the vaccine[3]. At one year after
vaccination, a higher proportion of adolescents who received Menveo had
maintained a protective immune response against three of the four meningococcal
groups (groups C, W135 and Y) than those who received ACWY-PS[3]. Further, when
evaluated in adults 56-65 years of age, Menveo was shown to be non-inferior to
ACWY-PS in all four meningococcal groups contained in the vaccine and
statistically superior for groups A and Y[3]. The clinical significance of these
findings is unknown.
Achieving and maintaining an immune response in adolescents is considered
important because they are particularly susceptible to meningococcal disease and
are more likely to carry the bacteria than other age groups[9]. In addition,
adolescents and young adults have relatively high death rates from meningococcal
infection[10]. A study in the United States found that nearly a quarter of
meningococcal infections in 15- through 24-year-olds were fatal[10].
"Meningitis often develops without warning, and progresses rapidly, making it a
particularly dangerous disease[6],[11]," said Chris Head, Chief Executive of the
Meningitis Research Foundation, UK. "Awareness of symptoms, understanding
treatment and, above all, prevention with a vaccine that helps to protect
against multiple groups of bacteria will help save lives and prevent
devastating, lifelong after-effects."
About meningococcal disease
Most cases of meningococcal disease occur in previously healthy people without
any warning[11]. Even small changes in lifestyle - such as going out to clubs,
travelling, smoking, going to college or military duty - can increase the
likelihood to become a carrier of meningococcal bacteria and the chance of a
person contracting meningococcal disease[7]. The World Health Organization (WHO)
and several national governments recommend the use of meningococcal vaccination
for people considered to be at increased risk for developing meningococcal
disease, such as adolescents, travelers to areas known for outbreaks, military
personnel and Muslim pilgrims travelling to the Hajj or Umrah[6],[7].
Because the initial symptoms of meningococcal disease can be non-specific and
flu-like[12], it can be difficult for health care professionals to diagnose
early. Classic symptoms, such as neck stiffness and petechial rash, do not
appear until relatively late in the illness - 13 to 22 hours after the first
symptoms appear[13].
According to the WHO, approximately 5-10 percent of those who contract
meningococcal disease will die, even if they are diagnosed and receive
treatment[6]. Of those who survive meningococcal disease, as many as one in five
will suffer life-long complications, such as brain damage, learning
disabilities, hearing loss and limb loss[4].
Infants are the most vulnerable population and represent the greatest unmet
need. About 6-10 percent of children under 12 months of age who contract
meningococcal disease will die[14].
About Novartis Vaccines' global meningococcal franchise
Menveo vaccine is based on the same proprietary technology Novartis Vaccines
pioneered to produce Menjugate(®), a meningococcal serogroup C conjugate vaccine
approved outside the U.S. since 2000 for use in individuals from 2 months of age
through adulthood. The company has already distributed more than 41 million
doses of Menjugate around the world. Novartis also produced MenZB(®), a vaccine
against a strain of meningococcus B specific to an outbreak in New Zealand.
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. In
addition to developing Menveo vaccine, Novartis Vaccines is developing a
recombinant protein vaccine for its potential to provide broad coverage against
multiple strains of serogroup B, for which no vaccine is currently available.
Important Safety Information
Menveo is indicated for active immunization of adolescents (from 11 years of
age) and adults at risk of exposure to Neisseria meningitidis groups A, C, W-135
and Y, to prevent invasive disease.
Menveo should not be administered to individuals with known hypersensitivity to
any component of Menveo or other meningococcal vaccines, or other vaccines
containing derivatives of Corynebacterium diphtheriae. Because of the risk of
hematoma, Menveo should not be administered to individuals with any bleeding
disorder, such as hemophilia or thrombocytopenia, nor to persons receiving
anticoagulant therapy, unless the potential benefit outweighs the risk of
administration. Menveo should not be administered to people who have an acute
severe febrile illness, although a mild fever of short duration is not a
contraindication. Due to the absence of supporting data, the decision to
administer Menveo to pregnant women should be evaluated according to the risk of
meningococcal infection.
The most common local adverse reactions to Menveo include injection site pain,
erythema, and induration. The most common systemic adverse reactions include
headache, myalgia, malaise, nausea, arthralgia, chills, rash and fever. Some
reactions may be severe.
Vaccination with Menveo may not protect all individuals. Patients who are
immunocompromised or receiving immunosuppressive therapy may have an inadequate
response to vaccination.
Before administering Menveo, please see full Prescribing Information.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "risk," "intends," "will," "can," priority," "potential,"
or similar expressions, or by express or implied discussions regarding potential
new indications or labeling for Menveo, potential future approvals of additional
Novartis vaccines or regarding potential future revenues from 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 to be materially different from any future results, performance
or achievements expressed or implied by such statements. There can be no
guarantee that Menveo will be approved for any additional indications or
labeling in any market. Nor can there be any guarantee that any additional
vaccines will be approved for sale in any markets. Neither can there be any
guarantee that Menveo or any additional vaccines will achieve any particular
levels of revenue in the future. In particular, management's expectations
regarding Menveo or any additional vaccines 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; competition in
general; government, industry and general public pricing pressures; 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 and molecular
diagnostics 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
# # #
References
1. 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 January 19, 2010.
2. 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_Meningococcal_Disease.pdf. Accessed on January 19, 2010.
3. Jackson, L. et al. (2009). A randomized trial to determine the tolerability
and immunogenicity of a quadrivalent meningococcal glycoconjugate vaccine
in healthy adolescents. The Pediatric Infectious Disease Journal
2009: 28(2), 86-91.
4. 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 January
19, 2010.
5. Centers for Disease Control and Prevention. Meningitis: Questions &
Answers. June 2009 update. Available at:
http://www.cdc.gov/meningitis/about/faq.html. Accessed on January 19, 2010.
6. World Health Organization. Meningococcal Meningitis Fact Sheet. May 2003.
http://www.who.int/mediacentre/factsheets/fs141/en/print.html. Accessed on
January 19, 2010.
7. 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 January
19, 2010.
8. Novartis Data on File.
9. National Advisory Committee on Immunization. (2009). Update on the invasive
meningococcal disease and meningococcal vaccine conjugate recommendations.
Canada Communicable Disease Report, April 2009, Vol. 36. Available at:
http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/09pdf/acs-dcc-3.pdf. Accessed
on January 19, 2010.
10. Harrison, L. et al. (2001). Invasive meningococcal disease in adolescents
and young adults. Journal of the American Medical Association
2001: 286(6), 694-699. Available at:
http://jama.ama-assn.org/cgi/reprint/286/6/694. Accessed on January
19, 2010.
11. Pollard, A. J. and Maiden, C.J. (Eds.) (2001). Meningococcal Disease:
Methods and Protocols. Totowa, NJ: Humana Press, Inc.
12. Mayo Foundation for Medical Education and Research. Meningitis. August
2008. Available at: http://www.mayoclinic.com/health/meningitis/DS00118.
Accessed on January 19, 2010.
13. Thompson, M.J. et al. (2006). Clinical recognition of meningococcal disease
in children and adolescents. Lancet, 367(9508), 397-403. Available at:
http://www.ncbi.nlm.nih.gov/pubmed/16458763. Accessed on January 19, 2010.
14. Cohn, A. et al. (2010). Changes in Neisseria meningitidis disease
epidemiology in the United States, 1998-2007: Implications for prevention
of meningococcal disease. Clinical Infectious Diseases
2010, 50(2): 184-191.
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