2013-08-15 07:19:01 -
Novartis International AG /
Novartis vaccine Bexsero® approved in Australia to help protect against MenB
disease, a deadly form of bacterial meningitis
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* Australia approval marks a key step in expanding access to the first and
only broad coverage vaccine against MenB disease,;Bexsero was granted
European licensure this past January
* MenB disease is a leading cause of meningitis and sepsis globally, and
causes approximately 85 percent of all meningococcal disease cases in
* Bexsero safety and efficacy have been shown through clinical trials
involving more than 8,000 people including infants, children, adolescents
Basel, August 15, 2013 - Novartis announced today that the Australian
Therapeutic Goods Administration (TGA) has added Bexsero(®), a multi-component
Meningococcal B (MenB) vaccine (recombinant, adsorbed) suspension for injection
0.5 ml pre-filled syringe, to the Australian Register of Therapeutic Goods
(ARTG) for use in individuals from two months of age and older. Bexsero is
the first and only broad coverage vaccine to help protect all age groups against
MenB disease, including infants who are at the greatest risk of
Across Australia, approximately 85 percent of all meningococcal disease and
sepsis cases have been caused by MenB, a percentage that has risen in recent
years as the number of cases in other serogroups has fallen,. The
introduction of vaccines for other strains of bacterial meningitis has been
successful in reducing the disease burden in Australia; specifically, following
the rollout of a national meningococcal serogroup C vaccination program in
Australia, cases decreased from 162 in 2002 to nine by 2011,.
"Novartis welcomes the Australian health authorities' decision to license
Bexsero, which is further testament to the vaccine's demonstrated robust
efficacy and safety profiles and an important step in preventing further
suffering caused by MenB disease," said Andrin Oswald, Division Head, Novartis
Vaccines and Diagnostics. "We are committed to bringing Bexsero to parents
around the globe that want to protect their children against this devastating
MenB is a potentially deadly disease which is easily misdiagnosed and can kill
within 24 hours of onset. About one in 10 of those who contract the disease will
die despite appropriate treatment. Up to one in five survivors may suffer from
devastating, life-long disabilities such as brain damage, hearing impairment or
limb loss. The consequences for those affected and the healthcare system are
"Today marks another victory, particularly for Australian children, parents and
pediatricians, in the fight against meningococcal disease," said Bruce
Langoulant, President and Asia Pacific Regional Leader, Confederation of
Meningitis Organisations. "We are now entering a critical period for public
health authorities to provide funding to include the new MenB vaccine in the
routine immunization schedules to ensure community-wide protection against the
tragic deaths and lasting disabilities MenB can cause."
As a next step, Novartis will work with Australian regulatory authorities to
make doses of Bexsero available in the private market in the coming months. In
parallel, the Pharmaceutical Benefits Advisory Committee (PBAC), taking into
account advice from the Australian Technical Advisory Group on Immunisation
(ATAGI), is expected to make recommendations regarding reimbursement and
potential inclusion of Bexsero in the National Immunisation Program
In January 2013, Bexsero received marketing authorization from the European
Commission which applies to all 28 European Union (EU) member states, Iceland,
Liechtenstein and Norway,. With this TGA decision, Bexsero is now licensed
in more than 30 countries and further regulatory filings are underway.
Meningococcal disease is a leading cause of bacterial meningitis. Five main
groups of meningococcal bacteria (A, B, C, W-135 and Y) cause the majority of
all cases around the world. Prior to Bexsero, vaccines were available to
help protect only against A, C, W-135 and Y.
Bexsero Important Safety Information
Hypersensitivity to the active substances or to any excipients of Bexsero is a
contraindication to administration. Administration of Bexsero should be
postponed in subjects suffering from an acute severe febrile illness. Minor
infection, such as cold, should not result in the deferral of vaccination.
There are no data on the use of Bexsero in individuals above 50 years of age, in
patients with chronic medical conditions or in individuals with impaired immune
responsiveness. In immunocompromised individuals, vaccination may not result in
a protective antibody response. Insufficient clinical data on exposed
pregnancies are available and there are no data on fertility in humans.
Bexsero is not expected to provide protection against all circulating
meningococcal group B strains.
The most common adverse reactions observed in clinical trials of infants were
tenderness and erythema at the injection site, fever, and irritability. Fever
occurred more frequently when Bexsero was co-administered with other routine
infant vaccines than when it was given alone.
When Bexsero was given alone, the frequency of fever was similar to that
associated with routine infant vaccines administered during clinical trials.
When fever occurred, it generally followed a predictable pattern, with the
majority resolving by the day after vaccination.
The safety profiles of the co-administered vaccines were unaffected by
concomitant administration of Bexsero with the exception of more frequent
occurrence of fever, tenderness at the injection site, change in eating habits
and irritability. Prophylactic use of paracetamol reduces the incidence and
severity of fever without affecting the immunogenicity of either Bexsero or
In adolescents and adults the most common local and systemic adverse reactions
observed were pain at the injection site, malaise and headache.
The foregoing release contains forward-looking statements that can be identified
by terminology such as "committed," "potentially," "now
"expected," "potential," "underway," or similar expressions,
or by express or
implied discussions regarding the potential outcome of the PBAC's evaluation of
Bexsero regarding reimbursement and potential inclusion in the NIP, the
potential outcome of similar evaluations in other countries, potential marketing
approvals for Bexsero in additional countries, 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
ultimately be approved for reimbursement or routine vaccination schedules in
Australia or in any other country. Nor can there be any guarantee that Bexsero
will be approved for sale in any additional market, or at any particular time.
Neither 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; the company's ability to obtain
or maintain patent or other proprietary intellectual property protection;
competition in general; government, industry and general public pricing
pressures; unexpected manufacturing issues; 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.
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 2012, the Group
achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted
to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 131,000
full-time-equivalent associates and operate in more than 140 countries around
the world. For more information, please visit www.novartis.com
Novartis is on Twitter. Sign up to follow @Novartis at
 EMA. Authorization Details for Bexsero. Available at:
33/human_med_001614.jsp&mid=WC0b01ac058001d124. Accessed August 7, 2013.
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 Wright, Claire et al. Counting the Cost of Meningitis: A severe case of
bacterial meningitis. Meningitis Research Foundation. 2011. Available at:
. Accessed August 7, 2013.
 Pharmaceutical Benefits Advisory Committee. Available at:
1/section-1. Accessed August 7, 2013.
 Australian Government Department of Health. Immunisation Advisory Bodies.
bodies. Accessed August 7, 2013.
 Centers for Disease Control and Prevention. Epidemiology and Prevention of
Vaccine-Preventable Diseases (The Pink Book: Course Textbook). 12th Edition,
2nd printing. May 2012 update. Available at:
. Accessed August 7, 2013.
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