Novartis announces positive phase III results showing efficacy of BAF312 in patients with secondary progressive MS
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Novartis International AG /
Novartis announces positive phase III results showing efficacy of BAF312 in
patients with secondary progressive MS
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The issuer is solely responsible for the content of this announcement.
* The Phase III EXPAND study of BAF312 (siponimod) in secondary progressive
multiple sclerosis (SPMS) met its primary endpoint of reducing the risk of
three-month confirmed disability progression versus placebo
* There are currently very limited treatment options for SPMS, a form of MS
associated with gradual worsening of symptoms and accumulation of
disability, independent of relapses
* EXPAND is the largest study ever conducted in SPMS, and is part of Novartis'
ongoing leadership and commitment to people with MS
Basel, August 25, 2016 - Novartis today announced the Phase III EXPAND study,
evaluating the efficacy and safety of oral, once-daily, BAF312 (siponimod) in
secondary progressive multiple sclerosis (SPMS), met its primary endpoint of a
reduction in the risk of disability progression, compared with placebo. The
EXPAND study represents the largest randomized, controlled study in SPMS to
date.[1]
"SPMS is a particularly disabling form of MS, and there is a need for effective
treatment options to help delay disability progression in those living with the
condition," said Vasant Narasimhan, Global Head of Drug Development and Chief
Medical Officer for Novartis. "The positive EXPAND data are encouraging for a
disease with such a high unmet need. We look forward to sharing the results at
the upcoming ECTRIMS congress, and thank all of the study participants and
investigators."
Topline results of the EXPAND study, including primary and key secondary
endpoints, will be presented as a late breaking oral abstract at the 32(nd)
Congress of the European Committee for Treatment and Research in Multiple
Sclerosis (ECTRIMS), September 17(th), in London, UK. Novartis will complete
full analyses of the data and evaluate next steps in consultation with health
authorities.
About the EXPAND study
The EXPAND study is a randomized, double-blinded, placebo-controlled Phase III
study, comparing the efficacy and safety of BAF312 versus placebo in people with
secondary progressive multiple sclerosis (SPMS).[2] The EXPAND study is the
largest randomized, controlled study in SPMS to date.[1] The study included
1,651 people with SPMS from 31 countries. Patients were randomized to receive
either 2mg BAF312 or placebo in a 2:1 ratio respectively.[2]
The primary endpoint of the study was an improvement in the time to three-month
confirmed disability progression, as measured by the expanded disability status
scale (EDSS), versus placebo.[2] Secondary endpoints included delay in the time
to six-month confirmed disability progression versus placebo, the time to
confirmed worsening of at least 20% from baseline in the timed 25-foot walk test
(T25FW), T2 lesion volume, annualized relapse rate (ARR), and the safety and
tolerability of BAF312 in people with SPMS.[2]
About BAF312 (siponimod)
BAF312 (siponimod) is a selective modulator of specific types of the
sphingosine-1-phosphate (S1P) receptor.[3] The S1P receptor is commonly found on
the surface of specific cells residing in the central nervous system (CNS), that
are responsible for causing CNS damage that drives loss of function in secondary
progressive MS (SPMS).[3] BAF312 enters the brain and by binding to these
specific receptors, may prevent the activation of these harmful cells, helping
to reduce loss of physical and cognitive function associated with SPMS.[3]-[6]
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.[7] There are three types of MS:
relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) and primary
progressive MS (PPMS). The evolution of MS results in an increasing loss of both
physical and cognitive (e.g. memory) function.[8] This has a substantial
negative impact on the approximately 2.3 million people worldwide affected by
MS.[9]
About Novartis in Multiple Sclerosis
The Novartis multiple sclerosis (MS) portfolio includes Gilenya(®) (fingolimod,
an S1P modulator), which is indicated for relapsing forms of MS and is also in
development for pediatric MS. Extavia(®) (interferon beta-1b for subcutaneous
injection) is approved in the US for the treatment of relapsing forms of MS. In
Europe, Extavia is approved to treat people with relapsing remitting MS,
secondary progressive MS (SPMS) with active disease and people who have had a
single clinical event suggestive of MS.
In addition to BAF312 (siponimod) in development in SPMS, investigational
compounds include ofatumumab (OMB157), a fully human monoclonal antibody in
development for relapsing MS. Ofatumumab targets CD20, and is expected to begin
phase III pivotal studies in the second half of 2016.
In the US, the Sandoz Division of Novartis markets Glatopa(®) (glatiramer
acetate injection) 20mg/mL, the first generic version of Teva's Copaxone(®)*
20mg.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "currently," "ongoing," "commitment," "look forward,"
"upcoming," "will," "in development," "investigational," or similar terms, or by
express or implied discussions regarding potential marketing approvals for
BAF312, potential new indications or labeling for ofatumumab, or regarding
potential future revenues from BAF312, ofatumumab, Gilenya, Extavia, Glatopa
20mg, or any of the other products and investigational compounds in the Novartis
MS portfolio. 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 BAF312 will be submitted or approved
for sale in any market, or at any particular time. Neither can there be any
guarantee that ofatumumab 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 BAF312, ofatumumab, Gilenya, Extavia, Glatopa 20mg, or any
of the other products and investigational compounds in the Novartis MS portfolio
will be commercially successful in the future. In particular, management's
expectations regarding BAF312, ofatumumab, Gilenya, Extavia, Glatopa 20mg, and
the other products and investigational compounds in the Novartis MS portfolio
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 safety, quality or 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 2015, the Group achieved net
sales of USD 49.4 billion, while R&D throughout the Group amounted to
approximately USD 8.9 billion (USD 8.7 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 118,000
full-time-equivalent associates. Novartis products are available in more than
180 countries around the world. For more information, please visit
http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis
For Novartis multimedia content, please visit www.novartis.com/news/media-
library
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media.relations(at)novartis.com
*Copaxone(®) is a registered trademark of Teva Pharmaceutical Industries Ltd.
References
[1] Kappos L et al. Baseline Subgroup Characteristics of EXPAND: A Phase 3 Study
of Siponimod (BAF312) for the Treatment of Secondary Progressive Multiple
Sclerosis (P3.084). Neurology. 2016; 86(16):suppl. P3.084
[2] ClinicalTrials.gov. Exploring the Efficacy and Safety of Siponimod in
Patients With Secondary Progressive Multiple Sclerosis (EXPAND).
https://clinicaltrials.gov/ct2/show/NCT01665144?term=BAF312+expand&rank=1 (link
is external). Last accessed July 2016.
[3] Gergely P et al. The selective sphingosine 1-phosphate receptor modulator
BAF312 redirects lymphocyte distribution and has species-specific effects on
heart rate. Br J Pharmacol 2012; 167(5): 1035-47.
[4] Aslanis V, Faller T, Van de Kerkhof E, Schubart A, Wallström E, Beyerbach A.
Siponimod (BAF312) (and/or its metabolites) penetrates into the CNS and
distributes to white matter areas. Mult Scler J 2012; 18(10(suppl)): P792.
[5] Brana C et al. Immunohistochemical detection of sphingosine-1-phosphate
receptor 1 and 5 in human multiple sclerosis lesions. Neuropathol Appl Neurobiol
2014; 40(5): 564-78.
[6] Tavares A, Barret B, Alagille D, et al. Brain distribution of MS565, an
imaging analogue of siponimod (BAF312), in non-human primates. Neurology
2014; 82(10 (Suppl)): P1.168.
[7] PubMed Health. Multiple Sclerosis.
http://www.ncbi.nlm.nih.gov/pubmedhealth/PMHT0024311/ (link is external). Last
accessed July 2016.
[8] National Multiple Sclerosis Society. Ms Symptoms.
http://www.nationalmssociety.org/Symptoms-Diagnosis/MS-Symptoms (link is
external). Last accessed July 2016.
[9] Multiple Sclerosis International Federation. Atlas of MS 2013.
http://www.msif.org/wp-content/uploads/2014/09/Atlas-of-MS.pdf (link is
external). Last accessed July 2016.
# # #
Novartis Media Relations
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E-mail: media.relations(at)novartis.com
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Novartis Global Media Relations Novartis Global Pharma Communications
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+41 79 593 4202 (mobile) + 41 79 752 6955 (mobile)
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 25.08.2016 - 07:15 Uhr
Sprache: Deutsch
News-ID 491014
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