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Novartis International AG: Novartis announces presentation of data at AAN showing Gilenya® slowed the rate of brain volume loss in MS patients

Novartis International AG / Novartis announces presentation of data at AAN
showing Gilenya® slowed the rateof brain volume loss in MS patients .
Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is
solely responsible for the content of this announcement.
* MS patients have accelerated brain volume loss (up to 3-5 times faster than
people without MS), which is associated with physical&cognitive loss of

* Data at AAN showed significantly more Gilenya-treated patients (vs.
patients on placebo) had brain volume loss rates comparable to people
without MS

* Brain volume loss, one of the four key measures of MS disease activity,
starts early in the disease and is a predictor of long-term disability

The digital press release with multimedia content can be accessed here:

Basel, April 30, 2014
- Novartis announced today new data presented at the 66thAmerican Academy of
Neurology (AAN) Annual Meeting, which showed more patients with relapsing
multiple sclerosis (MS) treated with Gilenya®(fingolimod) achieved an average
annual rate of brain volume loss within the range of those expected for
healthy adults of a similar age vs. those patients taking placebo[1].
Everybody loses brain volume (also referred to as "shrinkage of the brain")
as they age[1],[2], but people with MS experience shrinkage of the brain up
to three to five times faster[1]-[4]. This acceleration starts early in
people with relapsing MS, even before symptoms are apparent[5]-[8].

"These data are impressive as they show that Gilenya slows brain volume loss
in relapsing MS patients, an important indicator of disease activity," said
David Epstein, Division Head, Novartis Pharmaceuticals. "Brain volume loss is
a topic of growing interest to the MS community as reducing it may benefit
patients by slowing long term physical and cognitive loss of function."

Based on growing evidence, damage from lesions and brain volume loss leads to
worsening of the symptoms for MS (e.g. problems walking or difficulties with
mental tasks)[5],[9]-[11]. Brain volume loss is strongly associated with
long-term disability[4],[5],[11]-[13].

About the data at AAN

The average brain volume loss in people without MS ranges from 0.2% to 0.4%
per year[1],[2], depending on age (as described in the literature). MS
patients typically lose brain volume at an approximate rate of 0.5% to 1.35%
per year[1],[3],[4].

Post hoc analyses presented at AAN showed that significantly more Gilenya
treated patients had annual brain volume loss rates below 0.4% (within the
range of people without MS), compared to placebo (37.2% vs 26.7%
respectively, p=0.0001)[1].This effect was consistent across different age

About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic disorder of the central nervous system
(CNS) that disrupts the normal functioning of the brain, optic nerve and
spinal cord[14]. The evolution of MS results in an increasing loss of both
physical (e.g. difficulty with walking) and cognitive (e.g. problems with
mental tasks or memory) function[15]. This has a substantial negative impact
on the approximately 2.3 million people worldwide affected by MS[16], a
disease that begins in early adulthood, most often between the ages of 20 and

The loss of physical and cognitive function is driven by two main types of
damage that both contribute to widespread loss of neurons (nerve cells in the
brain and spinal cord that transmit impulses): discrete inflammatory lesions,
focal damage, in the brain that can clinically manifest as relapses; and
ongoing, more diffuse damage that starts early in the disease and causes the
progressive loss of brain tissue, including neurons, and over time is
associated with both physical and cognitive problems[18]-[20].

About Gilenya
Gilenya is the only oral disease modifying therapy (DMT) that works on four
key measures of multiple sclerosis (MS) disease activity - relapses, MRI
lesions, brain volume loss and disability progression[21]-[26].

Gilenya reduces both the distinct inflammatory lesions in the brain (focal
damage) that can clinically manifest as relapses, and the ongoing, underlying
damage in the brain (diffuse damage) that starts early in the
disease[18]-[20],[27]-[29]. Diffuse damage often goes unnoticed, causes the
loss of neurons and over time is associated with both physical and cognitive
problems[18]-[20]. Gilenya's reduction of both focal and diffuse damage is
due to its impact on the inflammatory process (peripheral action) and its
ability to enter the CNS and impact from within the CNS (central
action)[17]-[29]. It is by addressing both focal and diffuse damage that the
course of MS can be effectively impacted, helping to preserve a patient's
physical (e.g. difficulty with walking) and cognitive (e.g. problems with
mental tasks or memory) function.

To date, more than 91,500 patients worldwide have been treated with Gilenya in
both clinical trial and post-marketing setting[29].

About Novartis in Multiple Sclerosis
Novartis is committed to the research and development of new treatment options
to offer the right treatment to the right patient at the right time, to meet
patients' needs at every stage of disease with innovative and targeted drugs.

In addition to its ongoing development program for Gilenya in primary
progressive MS (PPMS), pediatric MS and chronic inflammatory demyelinating
polyneuropathy (CIPD), the Novartis MS portfolio includes Extavia®(interferon
beta-1b for subcutaneous injection). Investigational compounds include BAF312
(siponimod), which is currently in Phase III clinical development and being
developed as the first oral therapy for secondary progressive MS (SPMS), and
VAY736, an anti-B-cell compound for MS that is currently being investigated
in proof of concept studies. Novartis is also exploring the IL-17 pathway in

The foregoing release contains forward-looking statements that can be
identified by words such as "to be," "growing," "may," "can," "committed,"
"onging," "investigational," "being developed," "being investigated,"
"exploring," or similar terms, or by express or implied discussions regarding
potential future indications or labeling for Gilenya, potential future
marketing submissions or approvals for the other investigational compounds in
the Novartis MS portfolio, or regarding potential future revenues from any or
all of the products and investigational compounds in the Novartis MS
portfolio, including Gilenya. You should not place undue reliance on these
statements. Such forward-looking statements are based on the current beliefs
and expectations of management regarding future events, and are subject to
significant known and unknown risks and uncertainties. Should one or more of
these risks or uncertainties materialize, or should underlying assumptions
prove incorrect, actual results may vary materially from those set forth in
the forward-looking statements. There can be no guarantee that Gilenya will
be submitted or approved for any additional indications or labeling in any
market, or at any particular time. Nor can there be any guarantee that any of
the investigational compounds in the Novartis MS portfolio will be submitted
or approved for sale in any market, or at any particular time. Neither can
there be any guarantee that any of the products and investigational compounds
in the Novartis MS portfolio will be commercially successful in the future.
In particular, management's expectations regarding these products could be
affected by, among other things, the uncertainties inherent in research and
development, including unexpected clinical trial results and additional
analysis of existing clinical data; unexpected regulatory actions or delays
or government regulation generally; the company's ability to obtain or
maintain proprietary intellectual property protection; general economic and
industry conditions; global trends toward health care cost containment,
including ongoing pricing pressures; unexpected manufacturing issues, and
other risks and factors referred to in Novartis AG's current Form 20-F on
file with the US Securities and Exchange Commission. 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, over-the-counter and animal health products. Novartis is the only
global company with leading positions in these areas. In 2013, the Group
achieved net sales of USD 57.9 billion, while R&D throughout the Group
amounted to approximately USD 9.9 billion (USD 9.6 billion excluding
impairment and amortization charges). Novartis Group companies employ
approximately 135,000 full-time-equivalent associates and sell products in
more than 150 countries around the world. For more information, please

[1] De Stefano N et al. Proportion of patients with BVL comparable to healthy
adults in fingolimod phase 3 MS studies. Abstract presented at: 66th AAN
Annual Meeting; April 26 - May 3, 2014; Philadelphia, Pennsylvania. Oral
session S13:006.
[2] Hedman AM et al. Human Brain Changes Across the Life Span: a review of 56
longitudinal magnetic resonance imaging studies. Human Brain Mapping 2012;
33: 1987-220
[3] Barkhof F et al. Imaging outcomes for neuroprotection and repair in
multiple sclerosis trials. Nat Rev Neurol. 2009;5(5):256-266.
[4] Bermel RA&Bakshi R. The measurement and clinical relevance of brain
atrophy in multiple sclerosis. Lancet Neurol. 2006;5(2):158-170.
[5] Di Stefano N et al. Clinical Relevance of Brain Volume Measures in
Multiple Sclerosis. CNS Drugs 2014; published online January 22nd
[6] Pérez-Miralles F et al. Clinical impact of early brain atrophy in
clinically isolated syndromes. Mult Scler. Published online: 7 May, 2013.
[7] Filippi M et al. Evidence for widespread axonal damage at the earliest
clinical stage of multiple sclerosis. Brain. 2003;126(Pt 2):433-437.
[8] Filippi M et al. The contribution of MRI in assessing cognitive impairment
in multiple sclerosis. Neurology 2010; 75: 2121-28
[9] Calabrese M et al. Cortical lesions and atrophy associated with cognitive
impairment in relapsing-remitting multiple sclerosis. Arch Neurol. 2009
[10] Bakshi R et al. Regional brain atrophy is associated with physical
disability in multiple sclerosis: semiquantitative magnetic resonance imaging
and relationship to clinical findings. J Neuroi...

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