Novartis data at AAN reinforces commitment to address high unmet medical need and to provide a treatment at every stage of multiple sclerosis
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Novartis International AG /
Novartis data at AAN reinforces commitment to address high unmet medical need
and to provide a treatment at every stage of multiple sclerosis
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* New data from three Phase III studies underlines efficacy and adds to
growing global experience with Gilenya in more than 50,000 patients
worldwide
* Data from over 500 patients treated for up to four years reinforces the
known, manageable safety profile of once-daily oral Gilenya
* Progress reported with Novartis portfolio in studies of patients with
primary-progressive MS and secondary-progressive MS, forms of the condition
where treatment options are limited
Basel, March 13, 2013 - New data will be presented at the 65th annual meeting of
the American Academy of Neurology (AAN) that show continued innovation within
the Novartis Multiple Sclerosis (MS) portfolio[1]. Growing clinical trial and
real-world experience with Gilenya(®) (fingolimod), the first once-daily oral
therapy approved to treat people with relapsing MS (RMS),will be highlighted[2-
7]. Updates on studies of Gilenya in people with primary-progressive MS
(PPMS)[8] and the investigational agent BAF312 (siponimod) in people with
secondary-progressive MS (SPMS) will also be communicated[9].
"Novartis is pleased to present new data that underscore Gilenya's pioneering
role in the treatment of MS," said Dr. Timothy Wright, Global Head Development,
Novartis Pharmaceuticals AG. "These results, as well as updates on our
investigational MS compound BAF312 (siponimod) show that we are making real
progress in our commitment to address unmet medical need in MS and to provide a
treatment at every stage of the disease."
Data from three large Phase III studies will highlight the efficacy of Gilenya
in reducing the rate of brain volume loss[2], the best characterized magnetic
resonance imaging (MRI) predictor of long-term disability. There will also be a
presentation on the INFORMS study, which is evaluating Gilenya in patients with
PPMS[8]. This form of MS affects about 10% of people with MS and follows a
steady course of worsening neurologic function for which there are no approved
disease modifying treatments[12].
Additional data will showcase Gilenya's high efficacy and well characterized and
manageable safety profile[4,10,11].Latest information shows that the growing
real-world and clinical trial experience base for Gilenya now encompasses more
than 50,000 patients and 60,000 patient years of exposure worldwide[13].
New details will be provided on the design of a Phase III study evaluating the
efficacy, safety and tolerability of BAF312 (siponimod) in patients with SPMS,
which is a sub-type of MS where there are limited treatment options[9]. The vast
majority (85%) of people with relapsing-remitting MS will transition to SPMS;
50% within 10 years of disease onset and 90% within 25 years[14].
During the AAN congress, Novartis will present a Corporate Therapeutic Update,
"The Gilenya Experience: A Focus on the Patient in Clinical Practice," on
Tuesday 19 March at 19:00 - 22:00 PDT at the San Diego Marriott Marquis.
Novartis will also host a Patient Advocacy Forum.
Additionally, to support the exchange of educational information within the MS
community, the Novartis exhibit at the congress will showcase an expanded
Gilenya online and social media platform including the new Gilenya Facebook and
GilenyaGo Twitter accounts, YouTube channel, and Gilenya.com mobile site.
Novartis MS portfolio highlights at AAN include:
Gilenya (fingolimod) in relapsing-remitting MS
* Fingolimod - effect on brain atrophy and clinical/MRI correlations in three
Phase III studies - TRANSFORMS, FREEDOMS and FREEDOMS II. Platform
presentation, S51.006 Cohen: 21 March, 15:15 hrs. PDT.
* Fingolimod reduces annualized relapse rate in patients with relapsing-
remitting multiple sclerosis: FREEDOMS II study subgroup analysis. Poster
P07.102, Goodin: 21 March, 14:00 hrs. PDT.
* Long-term safety of fingolimod in patients with relapsing-remitting multiple
sclerosis. Results from Phase III FREEDOMS extension study. Poster P01.165,
Vollmer: 18 March, 14:00 hrs. PDT.
* Effect of switching from intramuscular interferon b-1a to fingolimod on time
to relapse in patients with relapsing-remitting multiple sclerosis enrolled
in a 1-year extension of TRANSFORMS. Poster P07.107, Meng: 21 March, 14:00
hrs. PDT.
* Effects of fingolimod on disability progression in patients with disability
as measured by EDSS at baseline: post-hoc analyses of FREEDOMS I and II.
Poster P04.128, Bergvall: 20 March, 07:30 hrs. PDT.
* Fingolimod observational studies program in patients with relapsing-
remitting multiple sclerosis: Study designs. Poster P07.100, Butzkueven: 21
March, 14:00 hrs. PDT.
Gilenya (fingolimod) in primary progressive MS
* Study design and baseline characteristics of the INFORMS study: Fingolimod
in patients with primary progressive multiple sclerosis. Poster P07.116,
Miller: 21 March, 14:00 hrs. PDT.
BAF312 (siponimod) in secondary-progressive MS
* Siponimod (BAF312) for the treatment of secondary-progressive multiple
sclerosis: design of the Phase III EXPAND trial. Poster P07.126, Kappos: 21
March, 14:00 hrs. PDT.
In addition to marketed products Gilenya and Extavia(®) (interferon beta-1b for
subcutaneous injection) the Novartis MS portfolio includes investigational
compounds BAF312 (siponimod), and AIN457 (secukinumab), a fully human monoclonal
antibody inhibiting interleukin-17A (IL-17A), a key pro-inflammatory cytokine.
About Gilenya
Gilenya is the first oral therapy approved to treat relapsing forms of MS and
the first in a new class of compounds called sphingosine 1-phosphate receptor
modulators[15,16]. Gilenya is thought to act on inflammatory processes
implicated in the MS disease process[15,16].
Data has shown significant efficacy with Gilenya in reducing relapses and
significant slowing of six-month disability progression sustained at four
years[17]. Nearly half of Gilenya patients were disease-free after one year of
treatment[18] and in the pivotal FREEDOMS study eight out of ten patients
remained on treatment at two years[10]. Gilenya is the only oral treatment shown
to consistently decrease brain volume loss, the best characterized magnetic
resonance imaging (MRI) predictor of long-term disability.
Gilenya has demonstrated superior efficacy compared to Avonex(®) (interferon
beta-1a IM), a commonly prescribed treatment, showing a 52% relative reduction
in annualized relapse rate (primary endpoint) at one year in a pivotal head-to-
head trial in patients with relapsing-remitting multiple sclerosis[11]. In a
post hoc sub-group analysis, Gilenya showed a 61% relative reduction in
annualized relapse rate compared to interferon-beta-1a (IM) at one year in
subgroups of patients with highly active relapsing-remitting MS not responding
to interferon treatment[19].
In clinical trials, Gilenya was generally well-tolerated with a manageable
safety profile. The most common side effects were headache, liver enzyme
elevations, influenza, diarrhea, back pain, and cough. Other Gilenya-related
side effects included transient, generally asymptomatic, heart rate reduction
and atrioventricular block upon treatment initiation, mild blood pressure
increase, macular edema and mild bronchoconstriction[10,11]. The rates of
infections overall, including serious infections, were comparable among
treatment groups, although a slight increase in lower respiratory tract
infections (primarily bronchitis) was seen in patients treated with Gilenya. The
number of malignancies reported across the clinical trial program was small,
with comparable rates between the Gilenya and control groups[10,11].
Gilenya is licensed from Mitsubishi Tanabe Pharma Corporation.
About BAF312 (siponimod)
BAF312 (siponimod) is an investigational compound in the Novartis Multiple
Sclerosis (MS) portfolio. BAF312 is an oral, selective modulator of the
sphingosine 1-phosphate (S1P) receptor subtypes 1 and 5 (S1P1, 5R modulator)
with a short half-life leading to relatively rapid washout (6 days)[20]. The
short half-life allows for a rapid recovery of blood lymphocyte counts following
treatment discontinuation[21]. In the Phase II BOLD study, BAF312 demonstrated a
favorable safety and tolerability profile when an initial dose titration regimen
was used at the start of treatment. The most common adverse events were
headache, bradycardia, dizziness and nasopharyngitis[21].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "commitment," "will," or similar expressions, or by
express or implied discussions regarding potential new indications or labeling
for Gilenya, potential future marketing submissions or approvals for other MS
products, or regarding potential future revenues from Gilenya or such other
products. You should not place undue reliance on these statements. Such forward-
looking statements reflect the current views of management regarding future
events, and involve known and unknown risks, uncertainties and other factors
that may cause actual results to be materially different from any future
results, performance or achievements expressed or implied by such 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 other MS products will be submitted or
approved for sale in any market, or at any particular time. Neither can there
be any guarantee that Gilenya or any other such products will achieve any
particular levels of revenue in the future. In particular, management's
expectations regarding Gilenya could be affected by, among other things,
unexpected clinical trial results, including unexpected new clinical data and
unexpected additional analysis of existing clinical data; competition in
general, including potential competition from additional newly-approved oral
multiple sclerosis treatments; unexpected regulatory actions or delays or
government regulation generally; government, industry and general public pricing
pressures; unexpected manufacturing issues; the company's ability to obtain or
maintain patent or other proprietary intellectual property protection; the
impact that the foregoing factors could have on the values attributed to the
Novartis Group's assets and liabilities as recorded in the Group's consolidated
balance sheet, and other risks and factors referred to in Novartis AG's current
Form 20-F on file with the US Securities and Exchange Commission. Should one or
more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those
anticipated, believed, estimated or expected. 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
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2012, the Group
achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted
to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 128,000
full-time-equivalent associates and operate in more than 140 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.
References:
[1] American Academy of Neurology. 2013 AAN annual meeting.
http://www.aan.com/go/am13. Last accessed 30 January 2013.
[2] Cohen J, et al. Fingolimod-effect on brain atrophy and clinical/MRI
correlations in Three Phase 3 studies - TRANSFORMS, FREEDOMS and FREEDOMS II.
Abstract presented at AAN, San Diego, March 2013.
[3] Goodin D, et al. Fingolimod reduces annualized relapse rates in patients
with relapsing-remitting multiple sclerosis: FREEDOMS II study subgroup
analysis. Abstract presented at AAN, San Diego, March 2013.
[4] Vollmer T, et al. Long-term safety of fingolimod in patients with relapsing-
remitting multiple sclerosis: Results from phase 3 FREEDOMS extension study.
Abstract presented at AAN, San Diego, March 2013.
[5] Meng X, et al. Effect of switching from intramuscular interferon b-1a to
fingolimod on time to relapse in patients with relapsing-remitting multiple
sclerosis enrolled in a 1-year extension of TRANSFORMS. Abstract presented at
AAN, San Diego, March 2013.
[6] Bergvall N, et al. Effects of fingolimod on disability progression in
patients with disability as measured by EDSS at baseline: Post-hoc analyses of
FREEDOMS I and II. Abstract presented at AAN, San Diego, March 2013.
[7] Butzkueven H, et al. Fingolimod observational studies program in patients
with relapsing-remitting multiple sclerosis: Study designs. Abstract presented
at AAN, San Diego, March 2013.
[8] Miller D, et al. Study design and baseline characteristics of the INFORMS
study: Fingolimod in patients with primary progressive multiple sclerosis.
Abstract presented at AAN, San Diego, March 2013.
[9] Kappos L, et al. Siponimod (BAF312) for the treatment of secondary-
progressive multiple sclerosis: design of the Phase III EXPAND trial. Abstract
presented at AAN, San Diego, March 2013.
[10] Kappos L. et al; for FREEDOMS Study Group. A placebo-controlled trial of
oral fingolimod in relapsing multiple sclerosis. N Engl J Med.
2010;362(5):387-401.
[11] Cohen JA, Barkhof F, Comi G, et al; for TRANSFORMS Study Group. Oral
fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl
J Med. 2010;362(5):402-415.
[12] National Multiple Sclerosis Society.
http://www.nationalmssociety.org/about-multiple-sclerosis/progressive-
ms/primary-progressive-ms/index.aspx. Last accessed 30 January 2013.
[13] Data on file. Novartis Pharma AG.
[14] National Multiple Sclerosis Society.
http://www.nationalmssociety.org/about-multiple-sclerosis/relapsing-
ms/secondary-progressive-ms-spms/index.aspx. Last accessed 25 February 2013.
[15] Brinkmann V. FTY720 (fingolimod) in multiple sclerosis: therapeutic effects
in the immune and the central nervous system. Br J Pharmacol
2009;158(5):1173-1182.
[16] Chun J, Hartung HP. Mechanism of Action of Oral Fingolimod (FTY720) in
Multiple Sclerosis. Clin Neuropharmacol. 2010 March-April;33(2):91-101.
[17] Kappos L. et al. Phase 3 FREEDOMS study extension: fingolimod (FTY720)
efficacy in patients with relapsing-remitting multiple sclerosis receiving
continuous or placebo-fingolimod switched therapy for up to 4 years. Poster
presented at: 28th Congress of the European Committee for Treatment and Research
in Multiple Sclerosis; October 10-13, 2012: Lyon, France. Poster P979.
[18] Khatri B. et al. Fingolimod treatment increases the proportion of patients
who are free from disease activity in multiple sclerosis compared to interferon
beta-1a: results from a phase 3 active controlled study (TRANSFORMS). Abstract
presented at: 64th AAN Annual Meeting; April 21-28, 2012; New Orleans, LA.
Abstract PD5:006.
[19] Havrdová E, et al. Clinical outcomes in subgroups of patients with highly
active relapsing-remitting multiple sclerosis treated with Fingolimod (FTY720):
Results from the FREEDOMS and TRANSFORMS phase III studies. Poster presented at
ECTRIMS, Amsterdam, October 2011.
[20] Gergely P, et al. The selective S1P receptor modulator BAF312 redirects
lymphocyte distribution and has species-specific effects on heart rate:
translation from preclinical to clinical studies. BJ Pharmacol, May 30 2012.
[21] Selmaj K, et al. BAF312, a selective sphingosine 1-phosphate receptor
modulator, effectively suppresses MRI lesion activity in relapsing-remitting
multiple sclerosis: Findings of an adaptive dose-ranging Phase 2 study. Poster
presented at the 5th Joint Triennial Congress of the European and Americas
Committees for Treatment and Research in Multiple Sclerosis, Amsterdam, The
Netherlands, 19-22 October 2011.
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Datum: 13.03.2013 - 07:15 Uhr
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