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2015-04-21

Novartis International AG: Data at AAN showed Gilenya® high efficacy in achieving 'no evidence of disease activity' in previously-treated highly-active MS pat

Novartis International AG / Data at AAN showed Gilenya® high efficacy in
achieving 'no evidence of diseaseactivity' in previously-treated
highly-active MS patients . Processed and transmitted by NASDAQ OMX Corporate
Solutions.The issuer is solely responsible for the content of this
announcement.
* New FREEDOMS/FREEDOMS II sub-group analysis showed Gilenya-treated patients
were six-times more likely to achieve 'no evidence of disease activity
(NEDA4)' vs placebo

* NEDA4 is based on four key measures of relapsing MS (RMS): relapses, MRI
lesions, MS-related brain shrinkage and disability progression

* Separate analysis from the entire TRANSFORMS study showed that RMS patients
treated with Gilenya were twice as likely to achieve NEDA4 vs Avonex®

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

Basel, 21 April 2015 -
Novartis announced today new analysis from the phase III FREEDOMS and FREEDOMS
II trials presented at the 67thAmerican Academy of Neurology (AAN) Annual
Meeting in Washington, DC, USA. These data showed that previously-treated
patients with highly-active relapsing multiple sclerosis (RMS) who were
treated with Gilenya®(fingolimod) had a six-times greater likelihood of
achieving 'no evidence of disease activity' across four key measures of
disease activity compared to placebo over two years (odds ratio 6.35; 95% CI
3.02-13.35;p
<0.0001). This is referred to as NEDA4 and is achieved when a patient with RMS
has no relapses, no new MRI lesions, no MS-related brain shrinkage and no
disability progression.

This analysis was the first time patients with highly-active RMS who had been
treated in the previous year with an injectable therapy were assessed using
the NEDA4 definition that includes brain shrinkage[1]. Brain shrinkage is a
marker of the widespread inflammatory (diffuse) damage in the central nervous
system and is associated with accumulated loss of function[2]-[9]. By using
this updated NEDA4 definition, physicians are able to get a more complete
picture of a patient's disease and response to treatment, which is crucial to
identify the optimal therapy to slow short- and long-term disease
progression. This is especially important for people with highly-active RMS,
who are at a greater risk of relapses and future loss of function, and may
therefore require a different treatment approach.

"NEDA4 is a major step forward in assessing RMS progression, helping
physicians to develop effective disease management and treatment strategies
for their patients," said Vasant Narasimhan, Global Head of Development at
Novartis Pharmaceuticals. "These data confirm that Gilenya's high efficacy
across the four key measures is maintained in previously-treated
highly-active RMS, and underscores the important role of Gilenya in the
treatment of RMS patients."

Separate analysis from the entire phase III TRANSFORMS study also confirmed
that after one year of treatment, RMS patients on Gilenya were twice as
likely to achieve NEDA4 compared to patients given Avonex®* - interferon
beta-1a i.m. injections (odds ratio 1.93; 95% CI 1.36-2.73;p
=0.0002)[10]. The data provide further evidence of how Gilenya helps RMS
patients achieve NEDA4 across four key measures of disease activity.

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[11]. The evolution of MS
results in an increasing loss of both physical and cognitive (e.g. memory)
function[12]. This has a substantial negative impact on the approximately 2.3
million people worldwide affected by MS[13], a disease that most often begins
in early adulthood[14].

People with MS can be diagnosed with relapsing forms of MS (RMS), which
include relapsing remitting MS (RRMS) and secondary progressive MS
(SPMS)[15], 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
function[16]-[18].

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[19]-[23]. Gilenya is approved in the US for first-line
treatment of relapsing forms of MS in adults[24]. 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[25].

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')[26]-[28]. It is important to address both focal and diffuse damage
in RMS to effectively impact disease activity and help preserve an
individual's functions[12].

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 119,000 patients, with the total patient
exposure now at approximately 218,500 patient years[28].

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 polyradiculoneuropathy (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.

Disclaimer

The foregoing release contains forward-looking statements that can be
identified by words such as "committed," "ongoing," "investigational," "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 and cost-saving generic pharmaceuticals. 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). As of December 31, 2014 Novartis Group companies
employed approximately 133,000 full-time-equivalent associates. Novartis
products are available in more than 180 countries around the world. For more
information, please visithttp://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis
athttp://twitter.com/novartis.

*Avonex®is a registered trademark of Biogen, Inc.

References

[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 presented at: 67th AAN Annual Meeting; April 18
- 25, 2015; Washington, DC. Poster Session III, P3.246.
[2] De Stefano N et al. Clinical Relevance of Brain Volume Measures in
Multiple Sclerosis. CNS Drugs 2014; published online January 22nd.

[3] Pérez-Miralles F et al. Clinical impact of early brain atrophy in
clinically isolated syndromes. Mult Scler. Published online: 7 May, 2013.
[4] Filippi M et al. Evidence for widespread axonal damage at the earliest
clinical stage of multiple sclerosis. Brain. 2003;126(Pt 2):433-437.
[5] Filippi M et al. The contribution of MRI in assessing cognitive impairmen...

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