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2014-04-29

Novartis International AG: CHMP recommends EU label expansion of Novartis' Gilenya and data at AAN confirm efficacy on pre-treated MS patients

Novartis International AG / CHMP recommends EU label expansion of Novartis'
Gilenya and data at AAN confirmefficacy on pre-treated MS patients .
Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is
solely responsible for the content of this announcement.
* CHMP has recognized Gilenya's favorable benefit/risk profile and recommends
EU label expansion to patients not responding to DMTs beyond interferon

* AAN data: Gilenya reduces relapse rates, new MRI lesion counts, brain
volume loss&disability progression in pre-treated MS patients with high
disease activity

* Gilenya is the only oral DMT that is effective across four key measures of
MS (relapse rates, MRI lesions, brain volume loss and disability
progression)

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

Basel, April 29, 2014
-
Novartis announced today that the Committee for Medicinal Products for Human
Use (CHMP) has issued a positive opinion to expand the EU label for
Gilenya®(fingolimod) in relapsing remitting multiple sclerosis (RRMS). The
recommendation is to expand the label to include adult patients who have not
responded to at least one disease-modifying therapy (DMT), including
newly-approved oral DMTs. Gilenya is currently licensed in the EU for adult
patients with RRMS who have not responded to treatment with interferons, or
have rapidly evolving severe MS[1].

Novartis also announced new pooled analyses presented at the 66thAmerican
Academy of Neurology (AAN) Annual Meeting in Philadelphia, Pennsylvania from
the pivotal FREEDOMS and FREEDOMS II trials in multiple sclerosis (MS),
confirming the consistent efficacy of Gilenya across four key measures of MS
(relapse rates, MRI lesions, brain volume loss and disability
progression)[2]. Addressing these four measures through effective treatment
and disease management is important for improving the course of MS for
patients

"We are very pleased that the CHMP has recognized the favorable benefit-risk
profile of Gilenya and made a recommendation to broaden its label to allow
patients who have failed on other disease-modifying therapies to be switched
to Gilenya treatment," said Tim Wright, Global Head of Development, Novartis
Pharmaceuticals. "Additionally, the new analyses at AAN confirm Gilenya's
robust efficacy across four key measures of MS disease activity, which is
important to give patients as much time free of functional impairment."

The pooled analyses from the FREEDOMS and FREEDOMS II trials show that in
patients with high disease activity previously treated in the past year,
Gilenya demonstrated significant efficacy across the following measures:

* Relapses - Gilenya reduced relapses (as measured by the annualized relapse
rate) by almost half (48%) compared to placebo
* MRI lesions - new T2 lesion formation was reduced by 69% compared to
placebo
* Brain volume loss - Gilenya reduced the rate of brain volume loss by 46%
compared to placebo
* Disability progression - using a stringent six-month disability measure,
Gilenya reduced disability progression by 45% compared to placebo[2].

About the FREEDOMS and FREEDOMS II trials
FREEDOMS and FREEDOMS II are pivotal phase 3, 2-year, placebo-controlled
trials that assessed the efficacy and safety of Gilenya[3],[4]. Although the
study designs were similar, patient baseline characteristics were different
between FREEDOMS and FREEDOMS II, including patient age, disease duration and
previous treatment history[2]-[4].

The pooled post-hoc analyses presented at AAN look at clinical and MRI
outcomes in patients previously treated in the past year who had at least one
relapse in the previous year and either at least one gadolinium-enhancing T1
lesion or at least 9 T2 lesions at baseline; or a patient who had equal or
more relapses in the year before baseline than in the previous year[2].

The clinical and MRI outcomes were annualized relapse rate (ARR), time to 3
and 6 month confirmed disability progression, the percentage of change from
baseline in brain volume (brain volume loss), the number of
gadolinium-enhancing T1 lesions and the number of new/newly enlarged T2
lesions (MRI lesions)[2].

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[5]. 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[6]. This has a substantial negative impact
on the approximately 2.3 million people worldwide affected by MS[7], a
disease that begins in early adulthood, most often between the ages of 20 and
40[8].

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[9]-[11].

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[2],[3],[12]-[15].

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[9]-[11],[16]-[18]. Diffuse damage often goes unnoticed, causes the
loss of neurons and over time is associated with both physical and cognitive
problems[9]-[11]. Gilenya's reduction of both focal damage 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)[16]-[18]. 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[18].

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), 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 MS.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by words such as "recommends," "positive opinion," "can,"
"committed," "ongoing," "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
visithttp://www.novartis.com.

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

References
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