Novartis International AG : Novartis receives EU approval for Bexsero®, first
vaccine to prevent the leading cause of life-threatening meningitis across
Novartis International AG / Novartis receives EU approval for Bexsero®, first
vaccine to prevent the leading cause of life-threatening meningitis across
Europe . Processed and transmitted by Thomson Reuters ONE. The issuer is
solely responsible for the content of this announcement.
*Bexsero is indicated to help protect all age groups against meningococcal
serogroup B (MenB) disease, including infants who are the most
*MenB disease is associated with a high human toll for families and
communities, as it can be fatal or may cause serious, life-long
disabilities in survivors,
*Novartis is working with health authorities to provide access to Bexsero
as soon as possible
Basel, January 22, 2013- Novartis announced today that the European Commission
has approved Bexsero^® (Meningococcal Group B Vaccine [rDNA, component,
adsorbed]) for use in individuals from 2 months of age and older. Novartis is
committed to making Bexsero available as soon as possible.
"This meningitis B vaccine is the most important medical breakthrough in the
30 years since I lost my son to the disease," said Meningitis UK Founder Steve
Dayman MBE. "It could save thousands of lives and prevent other parents
suffering the same tragedy. The vaccine must be made widely available through
the immunisation schedule as soon as possible - any delay could mean lives
MenB disease is a bacterial infection and is the leading cause of meningitis
across Europe, particularly in infants. Although rare, one reason this
disease is so feared is that it affects healthy people rapidly and without
warning,. Symptoms can often resemble the flu, making this disease
easily misdiagnosed in its early stages. In many cases, doctors simply
cannot treat infected patients soon enough to avoid serious outcomes. About
one in ten 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. Prevention through vaccination is therefore the best defense against
this aggressive disease.
"Each year, thousands of parents see their children die or left with severe
disabilities as a result of this devastating disease. Through the combined
efforts of many people over two decades, we are closer than ever to seeing an
end to this suffering," said Andrin Oswald, Division Head, Novartis Vaccines
and Diagnostics. "Our vision is a world without meningitis, and our priority
is to work with decision makers across Europe to ensure there is broad and
timely access to vaccination."
Following today's approval, EU member states will evaluate Bexsero for
potential inclusion into national immunization programs and, where relevant,
reimbursement schemes. Novartis is already engaging with governments
interested in the early adoption of the vaccine.
Bexsero is the result of more than 20 years of pioneering vaccine research,
and its tolerability profile and immunogenicity have been established through
a comprehensive clinical program involving infants, children, adolescents and
adults,,,,,. Starting at two months of age, Bexsero
offers several immunization schedule options that could fit with routine
The approval of Bexsero underscores the unique leadership position of Novartis
in the global fight against devastating meningococcal disease. Together,
Bexsero and Menveo^® help to protect against all five main serogroups of
meningococcal bacteria (A, C, W-135, Y and now B) that cause the majority of
cases around the world.
The foregoing release contains forward-looking statements that can be
identified by terminology such as "as soon as possible," "committed," "could,"
"vision," "priority," "will," "potential," or similar expressions, or by
express or implied discussions regarding the potential timing of the
availability of Bexsero to the public, 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 available to
the public in any particular country 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, including uncertainties as to whether Bexsero
will be included in particular countries' national immunization programs;
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; 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 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 @Novartis at
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