Bli medlem
Bli medlem

Du är här


Novartis International AG: Gilenya® data at AAN to highlight Novartis leadership in innovation with new MS assessment methods to benefit patients and physicia

Novartis International AG / Gilenya® data at AAN to highlight Novartis
leadership in innovation with new MSassessment methods to benefit patients
and physicians . Processed and transmitted by NASDAQ OMX Corporate
Solutions.The issuer is solely responsible for the content of this
* New analysis will confirm high efficacy of Gilenya® in achieving 'no
evidence of disease activity' (NEDA4) in previously-treated highly-active
RMS patients
* Separate analyses will show adding brain shrinkage to an existing
assessment tool enhances ability to predict disability progression in
relapsing MS (RMS)
* Early data on a novel method to assess motor function in patients with MS
and its potential clinical application will also be presented at AAN

Basel, 13 April 2015
Novartis announced today new Gilenya® analyses to be presented at the 67th
American Academy of Neurology (AAN) Annual Meeting in Washington, DC, USA
from April 18-25, 2015, showing how Novartis is advancing methods assessing
the impact of relapsing multiple sclerosis (RMS) for patients and physicians.
Data will show how adding brain shrinkage (brain volume loss) to an existing
tool to assess MS disease activity (m-Rio) will give a more precise
prediction of the likelihood of future disability progression. Accurate
assessment of disease activity is key to guide treatment decisions in RMS.

A pooled analysis from the two-year phase III FREEDOMS and FREEDOMS II trials
will further confirm Gilenya's high efficacy in previously-treated patients
with highly-active RMS in achieving 'no evidence of disease activity' (NEDA4)
across four key measures: relapses, MRI lesions, brain shrinkage and
disability progression[1],[2]. Achieving NEDA4 is especially critical for
highly-active RMS patients, who are likely to lose more physical and
cognitive functions over time despite being treated.

"Novartis is committed to innovation beyond the research and development of
new treatments, to help physicians and patients improve how multiple
sclerosis is managed," said Vasant Narasimhan, Global Head of Development at
Novartis Pharmaceuticals. "These Gilenya data and new methods of assessing
the impact of MS have the potential to give physicians a more comprehensive
picture of an individual's disease and allow patients to better understand
their MS."

Additional data will also be presented on ASSESS-MS, a project in early
development which uses an innovative movement recording system and aims to
quantify an individual's level of disability in a non-invasive,
patient-friendly manner. It measures a patient's movements using the
Microsoft Kinect®*sensor with machine learning algorithms. Developed in
collaboration with leading MS experts and Microsoft Research, ASSESS-MS may
have the potential to change how neurological dysfunction and disability
progression are assessed in MS patients[3],[4],[5].

Novartis MS portfolio highlights at AAN will include three poster
presentations on ASSESS-MS; 16 presentations on Gilenya trial analyses; and
one poster presentation on BAF312, an S1P-modulator that is being
investigated for secondary progressive MS (SPMS).

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 nerves and
spinal cord through inflammation and tissue loss[6] The evolution of MS
results in an increasing loss of both physical and cognitive (e.g. memory)
function[7]. This has a substantial negative impact on the approximately 2.3
million people worldwide affected by MS[8], a disease that most often begins
in early adulthood[9].

People with MS can be diagnosed with relapsing forms of MS (RMS), which
include relapsing remitting MS (RRMS) and secondary progressive MS
(SPMS)[10], or with primary progressive MS (PPMS).

The loss of physical and cognitive function in RMS is driven by two types of
damage that result in the loss of neurons and brain tissue - distinct
inflammatory lesions (referred to as focal damage), and more widespread
inflammatory neurodegenerative processes (referred to as diffuse damage).
Focal damage results in the loss of brain tissue and can clinically present
as relapses. Diffuse damage starts early in the disease, often goes unnoticed
and is also associated with loss of brain tissue and accumulated loss of

About Gilenya

Gilenya is the only oral disease-modifying therapy (DMT) to impact the course
of relapsing MS (RMS) with high efficacy across four key measures of disease
activity: relapses, MRI lesions, brain shrinkage (brain volume loss) and
disability progression[14-18]. Gilenya is approved in the US for the
first-line treatment of relapsing forms of MS in adults[19]. In the EU,
Gilenya is indicated for adult patients with highly active
relapsing-remitting MS (RRMS) defined as either high disease activity despite
treatment with at least one DMT, or rapidly evolving severe RRMS[20].

Gilenya targets both focal and diffuse CNS damage. It prevents cells that
cause focal inflammation from reaching the brain (referred to as 'peripheral'
action), but also enters the CNS and reduces the diffuse damage by preventing
the activation of harmful cells residing in the CNS (referred to as 'central
action')[21-23]. It is important to address both focal and diffuse damage in
relapsing MS to effectively impact disease activity and help preserve an
individual's functions[7].

The safety profile of Gilenya in RMS is well understood and based on
substantial evidence from three major clinical trials and extensive
real-world experience in more than 114,000 patients, with the total patient
exposure now at approximately 195,000 patient years[23].

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 pediatric MS and
chronic inflammatory demyelinating polyneuropathy (CIDP), the Novartis MS
portfolio includes Extavia®(interferon beta-1b for subcutaneous injection).
Investigational compounds include BAF312, currently in phase III clinical
development and being investigated as an oral therapy for secondary
progressive MS (SPMS). Novartis is also exploring the IL-17 pathway in MS.


The foregoing release contains forward-looking statements that can be
identified by words such as "to highlight," "will," "to be presented,"
"committed," "potential," "being investigated," "ongoing," "investigational,"
"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
and over-the-counter products. Novartis is the only global company with
leading positions in these areas. In 2014, the Group achieved net sales of
USD 58 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 130,000 full-time-equivalent
associates. Novartis products are available in more than 180 countries around
the world. For more information, please visit

Novartis is on Twitter. Sign up to follow @Novartis

* Kinect®is a registered trademark of Microsoft Corporation.


[1] De Stefano N et al. Impact of fingolimod on achieving no evidence of
disease activity and worsening (NEDA)-4 in previously treated patients with
high disease activity. Poster to be presented at: 67th AAN Annual Meeting;
April 18 - 25, 2015; Washington, DC. Poster Session III, P3.246.
[2] Montalban X et al. Effect of fingolimod versus interferon-beta1a on no
evidence of disease activity or worsening (NEDA-4) in the TRANSFORMS study.
Poster to be presented at: 67th AAN Annual Meeting; April 18 - 25, 2015;
Washington, DC. Poster Session IV, P4.001.
[3] Morrison C et al. Usability and acceptability of the ASSESS MS movement
recording tool in Multiple Sclerosis using depth-sensing computer vision.
Abstract to be presented at: 67th AAN Annual Meeting; April 18 - 25, 2015;
Washington, DC. Poster Session III, P3.2...

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.