Novartis receives positive CHMP opinion for Bexsero®, a groundbreaking vaccine to help prevent devastating MenB infections, the leading cause of meningitis in Europe
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Novartis International AG /
Novartis receives positive CHMP opinion for Bexsero®, a groundbreaking vaccine
to help prevent devastating MenB infections, the leading cause of meningitis in
Europe
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The issuer is solely responsible for the content of this announcement.
* Meningococcal serogroup B (MenB) disease is easily misdiagnosed, can kill
within 24 hours and may cause serious, life-long disabilities[1],[2]
* Upon approval, Bexsero will be the first and only broad coverage MenB
vaccine to help protect all age groups, including infants
* Anticipated approval of Bexsero highlights Novartis leadership position in
global fight against meningococcal disease
Basel, November 16, 2012 - Novartis announced today that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)
has adopted a positive opinion for Bexsero (Meningococcal Group B Vaccine [rDNA,
component, adsorbed]) for use in individuals from 2 months of age and older.
Upon regulatory approval, Bexsero will be the first licensed broad coverage
vaccine that can help protect all age groups against MenB disease,[3] including
infants, the age group at the greatest risk of infection.[4]
"We are proud of the major advance that Bexsero represents within the field of
vaccine development against what up until now has been a very challenging
disease target," said Andrin Oswald, Division Head, Novartis Vaccines and
Diagnostics. "For over two decades, our researchers and clinicians have been
dedicated to finding a solution to prevent MenB disease. Our steadfast
determination has been inspired by the testimonies from survivors and families
who have lost loved ones to this disease."
Currently available vaccines do not offer broad protection against MenB, which
accounts for up to 90% of all meningococcal disease cases in some European
countries.[5] MenB disease is easily misdiagnosed, can kill within 24 hours and
may cause serious, life-long disabilities.[1],[2] About 1 in 10 of those who
contract the disease dies despite appropriate treatment.[2] Up to one in five
survivors suffers from devastating, life-long disabilities such as brain damage,
hearing impairment or limb loss.[5] The highest rates of MenB disease occur in
the first year of life, peaking by 7 months of age.[6]
"MenB disease is a major cause of meningitis and septicemia in children, and its
ability to cause a rapidly progressive, devastating illness makes it one of the
infections most feared by both parents and pediatricians," said Dr Matthew
Snape, Consultant in Pediatrics and Vaccinology at the Oxford Vaccine Group,
University of Oxford. "A vaccine that is able to reduce the incidence of this
disease would be a major advance towards the prevention of childhood
meningitis."
The European Commission generally follows the recommendations of the CHMP and
delivers its final decision within three months, which will be applicable to all
European Union (EU) and European Economic Area (EEA) countries. Upon approval,
each member state will evaluate Bexsero reimbursement schemes and determine the
potential inclusion of the vaccine into National Immunization Programs. Novartis
is committed to making Bexsero available as soon as possible and is already
engaging with governments interested in the early adoption of the vaccine.
The tolerability profile and immunogenicity of Bexsero has been established
through a comprehensive clinical program including data from large Phase II/III
clinical trials involving almost 8,000 infants, children, adolescents and
adults.[7],[8],[9],[10],[11],[12] Starting from two months of age, Bexsero
offers several immunization schedule options that can fit with routine
vaccination visits.
"We welcome this news, which is immensely significant for parents and doctors.
For the first time in the fight against meningococcal disease, we have in sight
a potential solution in protecting against MenB disease," said Bruce Langoulant,
President and Member, Governing Council of Confederation of Meningitis
Organisations (CoMO), and father of a meningitis survivor. "Many of our members
and supporters have been personally impacted by meningitis and have watched as
loved ones suffered the devastating effects of this disease."
Bexsero is the result of more than 20 years of pioneering vaccine research.[13]
MenB has been a particularly challenging target because the outer coating of the
bacteria is not well recognized as an antigen by the immune system, making it
especially difficult to develop a broadly effective vaccine until recent
scientific developments.[14] Bexsero was developed using an award-winning
scientific approach that involved decoding the genetic makeup (genome sequence)
of MenB.[14],[15] This innovative approach provides the foundation for a new
generation of vaccines that can help prevent other diseases with a significant
diversity of disease-causing strains.
Following the approval of Menveo(®) in 2010, the anticipated approval of the
groundbreaking vaccine Bexserounderscores the unique leadership position of
Novartis in the global fight against devastating meningococcal disease.
Together, the two vaccines help to protect against all five main serogroups of
meningococcal bacteria (A, B, C, W-135 and Y) that cause the majority of cases
around the world.[15]
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "anticipated," "positive opinion," "can," "may," "will,"
"generally follows," "recommendations," "prospect," or similar expressions, or
by express or implied discussions regarding potential marketing approvals for
Bexsero, or the timing of any such approvals, 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 127,000 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] Thompson MJ, et al. Clinical recognition of meningococcal disease in
children and adolescents. Lancet 2006;367:397-403.
[2] World Health Organization. Meningococcal meningitis. Fact sheet #141.
December 2011 update. Available at:
http://www.who.int/mediacentre/factsheets/fs141/en/. Last accessed 26
Sep 2012.
[3] 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.
[4] Rosenstein NE, et al. Meningococcal disease. N Engl J Med
2001;344:1378-88.
[5] Health Protection Agency. Meningococcal Reference Unit isolates of
Neisseria meningitidis: England and Wales, by serogroup &
epidemiological year, 1998/99-2008/09. August 17, 2010. Available at
http://www.hpa.org.uk/web/HPAweb&HPAwebStandard/HPAweb_C/1234859711901.
Last accessed 26 Sep 2012.
[6] Cohn, A. et al. Changes in Neisseria meningitidis disease epidemiology
in the United States, 1998-2007: Implications for prevention of
meningococcal disease. Clin Infect Dis 2010;50:184-91.
[7] Santolaya ME, et al. Immunogenicity and tolerability of a multicomponent
meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in
Chile. Lancet 2012;379:617-24.
[8] 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.
[9] 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.
[10] 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.
[11] 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.
[12] 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 29th ESPID
Meeting, 7-11 June 2011; The Hague, The Netherlands.
[13] Rappuoli R. Reverse vaccinology, a genome-based approach to vaccine
development. Vaccine 2001;19:2688-91.
[14] Giuliani MM, et al. A universal vaccine for serogroup B meningococcus.
Proc Natl Acad Sci USA 2006;103:10834-9.
[15] World Health Organization. Meningococcal position paper. Weekly
epidemiological record No. 44, 2002, 77, 329-40. Available at:
http://www.who.int/immunization/wer7740meningococcal_Oct02_position_pape
r.pdf. Last accessed 26 Sep 2012.
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Datum: 16.11.2012 - 13:42 Uhr
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News-ID 204613
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