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* Multiple sclerosis (MS) causes progressive disability and affects
2.5 million people worldwide including many young adults[1]
* Extavia offers patients and physicians a new branded version of
standard-of-care interferon beta-1b
* Approved to treat MS patients from first signs of active disease to
more advanced, relapsing forms
* Launch marks start of planned long-term partnership between
Novartis and MS community
Basel, January 22, 2009 - Novartis has today announced the launch of
Extavia®, a new version of the standard-of-care for relapsing forms
of multiple sclerosis (MS), providing patients and physicians with an
alternative option to help manage this devastating disease.
Extavia, a new branded version of interferon beta-1b, is available
initially in Germany and Denmark with other European launches to
follow during 2009. It is approved to treat a broad range of
patients, from those with early signs of MS to those with more
advanced relapsing forms of the disease.
"Extavia will provide patients and physicians with an additional
option for receiving a mainstay of care in MS," said Trevor Mundel,
MD, Global Head of Development at Novartis Pharma AG. "This important
first step also opens the way for Novartis to build supportive
partnerships with the MS community and lays the foundations for
providing innovative approaches to MS care."
Extavia is the same medicinal product as Betaferon®*, an interferon
beta-1b. This has a well characterised efficacy and safety profile
with more than 700,000 patient-years' experience[2] and a 17-year
track record of clinical use - the longest for any interferon beta in
the treatment of MS[3].
MS is estimated to affect up to 2.5 million patients worldwide and is
one of the leading causes of neurological disability in young
adults1. The disease typically presents in relapsing forms involving
acute self-limiting attacks of neurological dysfunction (or
"relapses"), followed by complete or partial restoration of function.
Data have shown that interferon beta-1b produces a 34% reduction in
annualized relapse rates (p<0.001), and patients are almost twice as
likely to remain relapse-free for over two years compared to those on
placebo (31% vs. 16%, p=0.007)[4]. Treatment with interferon beta-1b
can also slow disease progression. After two years, nearly
three-quarters of patients who had experienced a single episode of
neurological disease lasting at least 24 hours did not progress to
clinically definite MS[5].
The launch of Extavia in Europe by the Pharmaceuticals Division of
Novartis marks the beginning of a long-term commitment to meet the
therapeutic needs of the MS community. This will include the
establishment of a support program for Extavia users that will foster
cross-communication between patients and their physicians and nurses.
In turn, this will lay the foundations for future potential
innovations in MS therapy. The rollout of Extavia in key EU countries
is expected during the coming months.
Novartis acquired the rights to its own branded version of interferon
beta-1b in an agreement with Bayer Schering, the company that markets
Betaferon. In backing Extavia, Novartis brings over 50 years of
neuroscience expertise and resources to the MS community. This
expertise has helped to pioneer early breakthrough treatments for a
number of neurological and pathological conditions, some of which
remain important therapies to this day.
MS is a chronic autoimmune disease of the central nervous system that
causes inflammation and neurodegeneration. Pathology is characterised
by the destruction of myelin, which helps neurons carry electrical
signals in the brain[6]. The disease causes problems with muscle
control and strength, vision, balance, sensation and mental
function[6].
The beneficial effects of interferon beta are believed to be due to
its modulation of the immune system to reduce inflammatory damage.
Specifically, interferon beta limits the activation of immune cells
that attack myelin, suppresses the production of inflammatory
cytokines - a type of protein that amplifies the inflammatory
response causing damage to myelin - and stimulates the production of
anti-inflammatory cytokines.
Extavia has been filed with the US Food and Drug Administration for
the treatment of relapsing forms of MS to reduce the frequency of
clinical exacerbations (or relapses). Patients with MS in whom
efficacy has been demonstrated include those who have experienced a
first clinical episode and have features consistent with MS as shown
by magnetic resonance imaging (MRI)[7].
Extavia is administered by subcutaneous (or under the skin)
injection. Patients will have the choice of using either a fine (30
gauge) needle for manual injection or a convenient autoinjector.
* Betaferon® is a registered trademark of Bayer Schering Pharma AG.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "launches," "planned," "long-term,"
"can," "will," "likely," "commitment," "future," "potential,"
"expected," "estimated," "believed," or similar expressions, or by
express or implied discussions regarding potential additional
marketing approvals for Extavia, the roll-out of Extavia in potential
additional markets, the potential development of additional MS
therapies, or regarding potential future revenues from Extavia or
additional MS therapies. Such forward-looking statements reflect the
current views of the Company 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 will be approved for sale
in any additional markets. Nor can there be any guarantee that
Extavia will be launched in any additional markets. Neither can
there be any guarantees that Novartis will successfully develop and
bring to market any additional MS therapies. Nor can there be any
guarantee that Extavia or such additional therapies will achieve any
particular levels of revenue in the future. In particular,
management's expectations regarding Extavia and any such additional
MS therapies 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, 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 AG 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 2007, the
Group's continuing operations (excluding divestments in 2007)
achieved net sales of USD 38.1 billion and net income of USD 6.5
billion. Approximately USD 6.4 billion was invested in R&D activities
throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 97,000 full-time associates and
operate in over 140 countries around the world. For more information,
please visit http://www.novartis.com.
References
[1] World Health Organization. Neurology atlas, 2004. Accessed 16 Jan
2009.
http://www.who.int/mental_health/neurology/neurogy_atlas_review_references.pdf
[2] FDA approves Betaseron® for use after the first event suggestive
of multiple sclerosis [press release]. Wayne, NJ: Berlex: 23 October
2006.
[3] Ebers G, Traboulsee A, Langdon D, Goodin D, Konieczny A. The
interferon beta-1b 16-year long-term follow-up study: the results.
Presented at the 16th meeting of the European Neurological Society;
27-31 May, 2006.
[4] The IFNB Multiple Sclerosis Study Group. Interferon beta-1b is
effective in relapsing-remitting multiple sclerosis. Neurology.
1993;43:655-661.
[5] Kappos L, Freedman MS, Polman CH, et al. Effect of early versus
delayed interferon beta-1b treatment on disability after a first
clinical event suggestive of multiple sclerosis: a 3-year follow-up
analysis of the BENEFIT study. Lancet. 2007;370:389-97.
[6] National Multiple Sclerosis Society website.
http://www.nationalmssociety.org/about-multiple-sclerosis/symptoms/index.aspx.
Accessed January 12, 2009.
[7] Extavia proposed US Prescribing Information.
# # #
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