New extension study data with Novartis drug Gilenya® shows patients successfully treated for up to 7 years in relapsing MS
(Thomson Reuters ONE) -
Novartis International AG /
New extension study data with Novartis drug Gilenya® shows patients successfully
treated for up to 7 years in relapsing MS
. Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement.
* Results from open label phase III extension and 7-year phase II extension
studies show sustained low disease activity on clinical and MRI measures in
patients continuing on Gilenya (fingolimod) treatment
* Extension study results demonstrate a safety profile for Gilenya consistent
with pivotal trials
* Data from FIRST study in more than 2,400 patients show overall low incidence
of first dose bradycardia and conduction abnormalities at treatment
initiation with Gilenya
* New findings from phase IIb trial for investigational compound BAF312
(siponimod) show positive outcomes for MS patients
Basel, April 19, 2012 - New data will be presented at the 64(th) annual meeting
of the American Academy of Neurology (AAN) that support the efficacy and safety
profile of Gilenya(®) (fingolimod), the only oral therapy approved to treat
relapsing forms of multiple sclerosis (MS)[1],[2]. Novartis will also showcase
new data on its investigational compound BAF312 (siponimod), a selective
modulator of the S1P receptor subtypes 1 and 5 (S1P1, -5R modulator) in its
multiple sclerosis portfolio[3].
"The data being presented reinforce our confidence in the sustained efficacy and
safety profile of Gilenya," said David Epstein, Head of the Pharmaceuticals
Division of Novartis Pharma AG. "We also are pleased to present encouraging data
for our investigational compound BAF312 (siponimod). The clinical development of
BAF312 demonstrates our commitment to developing new therapeutic options for the
MS community."
New data presented on long-term efficacy and safety profile of Gilenya
New results from the phase III FREEDOMS extension study showed significant
improvements in clinical and MRI measures in patients who switched from placebo
(administered during the 24-month core study) to Gilenya (administered during
the extension). 1033 patients completed the two-year, double-blind FREEDOMS 24
month core study. Of these, 90% of patients completed 3 years observation and
45% were followed for 4 years in this study before being transferred to the
umbrella follow-up study (LONGTERMS). Patients who switched from placebo to
Gilenya saw a 55% decrease in their annualized relapse rate (ARR) during the
extension phase compared to the core phase (ARR [core] = 0. 29 vs. ARR
[extension] 0.13; p<0.001). Significantly more patients on continuous fingolimod
treatment compared to those first randomized to placebo remained relapse-free
(59% vs. 37%) and free from three-month confirmed disability progression (74 %
vs. 66 %). MRI measures continued to show significant effects in favor of
fingolimod treatment, including a significantly reduced rate of brain atrophy in
the patients treated continuously as compared to switch patients (mean (%)
change in brain volume -1.67% vs. -2.24%; p = 0.001)[1] at the end of the
observation. In the core FREEDOMS study, Gilenya reduced the rate of brain
atrophy by 38% versus placebo at two years (0-24 months)[4].
The phase III FREEDOMS extension showed a safety profile consistent with that of
the pivotal phase III trials[1]. The most common adverse events were
nasopharyngitis, low lymphocyte counts (to be expected from the mode of action),
upper respiratory tract infections and influenza[4]-[5].
"This extension study confirms the efficacy shown in the published phase III
studies and supports the positive long term impact of continuous treatment. The
favorable longer term safety profile is consistent with results from the phase
III studies," said Ludwig Kappos, Department of Neurology, University of Basel,
Switzerland. "These observations in a large group of patients, now for four and
more years, confirm that fingolimod is a valuable treatment option for patients
with relapsing remitting MS."
Additionally, new data for up to 7 years of treatment from the phase II
extension study demonstrated patients treated with Gilenya (n=122) had sustained
low MRI and clinical disease activity[2]. The overall ARR for the continuous
Gilenya treatment group was 0.16, which can be expressed as one relapse every 6
years. Of patients on continuous Gilenya treatment since study start and who
completed the long-term extension, over half had remained free of relapses
throughout the study[2].
The phase III registration program for Gilenya included the two-year FREEDOMS
study and a head-to-head study in which Gilenya showed a 52% relative reduction
in annualized relapse rate (primary endpoint) compared to Avonex(®) (interferon-
beta-1a IM), a commonly prescribed treatment, at one year[5].
Low incidence of ECG abnormalities and symptomatic heart rate reduction at
treatment initiation in 2,400 patient FIRST Study
New data from the large, 4-month, open-label, single-arm multi-center FIRST
study demonstrate an overall low incidence of significant first dose bradycardia
[i.e. 1.3% of patients experienced bradycardia < 45 bmp and no patient
experienced a heart rate <30 bpm] and conduction abnormalities at treatment
initiation with Gilenya[6]. Importantly, this study provides data on continuous
ECG monitoring by ambulatory Holter Electrocardiogram (ECG) for six hours
following the administration of the first dose to identify any heart rate or ECG
abnormalities. Results from more than 2,400 patients showed the incidence of
Mobitz I second degree atrioventricular blocks (AVBs) was 1.4% at the post-dose
Holter ECG for 6 hours after administration, and the incidence of Mobitz II
second degree, or 2:1 AVBs was 0.5%. The short-term safety profile of Gilenya in
the FIRST study was generally consistent with that observed in the phase III
studies. This included the low incidence of the known cardiac effects of
fingolimod at treatment initiation (typically transient decreases in heart rate
and generally asymptomatic atrioventricular blocks).
Positive phase IIb data for BAF312 (siponimod)
Novartis will also present the key results from a phase II dose finding study of
its investigational compound BAF312 (siponimod), a selective modulator of the
S1P receptor subtypes 1 and 5 (S1P1, 5-R modulator), in MS. This double-blind
placebo-controlled study applied an innovative adaptive trial design to
optimally describe the dose response relationship. A statistically significant
dose response relationship could be established. Further, the study showed that
treatment with BAF312, when compared to placebo, reduced brain MRI lesions up to
80%[3]. Relapses were infrequent and appeared reduced with treatment (ARR for 2
mg 0.20 vs. placebo 0.58; p=0.044). Data also showed that BAF312 was generally
well-tolerated with an initial dose titration. The most frequent adverse events
were headache, bradycardia, dizziness and nasopharyngitis[3]. A phase III MS
program is planned to start later this year.
About Gilenya
Gilenya, licensed from Mitsubishi Tanabe Pharma Corporation, is the first in a
new class of compounds called sphingosine 1-phosphate receptor (S1PR)
modulators. It has demonstrated superior efficacy compared to Avonex, a commonly
prescribed treatment, showing a 52% relative reduction in annualized relapse
rate (primary endpoint) and a 40% relative reduction in the rate of brain
atrophy (secondary endpoint) at one year in a pivotal head-to-head trial in
patients with relapsing-remitting multiple sclerosis[4]. In a recent sub-
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[7].
Gilenya is generally a highly effective once-daily oral MS treatment. In
clinical trials it was generally well tolerated with a manageable safety
profile, and there is increasing experience of Gilenya's long-term effectiveness
and safety profile, with approximately 36,000 patients having been treated in
clinical trials and in a post-marketing setting[8]. Currently, there is
approximately 34,000 patient years of exposure. In clinical trials, 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[4],[5].
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[4],[5].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "will," "encouraging," "commitment," "planned," or
similar expressions, or by express or implied discussions regarding potential
new indications or labeling for Gilenya, potential future marketing approvals
for BAF312, or regarding potential future revenues from Gilenya or BAF312. 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 approved for any additional indications or
labeling in any market, or at any particular time. Nor can there be any
guarantee that BAF312 will be submitted for approval, or approved for sale, in
any market or at any particular time. Neither can there be any guarantee that
either Gilenya or BAF312 will achieve any particular levels of revenue in the
future. In particular, management's expectations could be affected by, among
other things, unexpected regulatory actions or delays or government regulation
generally; unexpected clinical trial results, including unexpected new clinical
data and unexpected additional analysis of existing clinical data; competition
in general; 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 2011, the Group's
continuing operations achieved net sales of USD 58.6 billion, while
approximately USD 9.6 billion (USD 9.2 billion excluding impairment and
amortization charges) was invested in R&D throughout the Group. Novartis Group
companies employ approximately 124,000 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] Kappos L. et al. Long-term Efficacy and Safety of Fingolimod (FTY720) in
Relapsing-Remitting Multiple Sclerosis (RRMS): Results from the Extension of the
Phase III FREEDOMS Study. Abstract Presented at AAN, New Orleans, April 2012.
[2] Antel J. et al. Long-term (7-Year) Data from A Phase 2 Extension Study of
Fingolimod in Relapsing Multiple Sclerosis. Poster Presentation at AAN, New
Orleans, April 2012.
[3] Stüve O. et al. BAF312, a Selective Sphingosine-1-Phosphate Receptor
Modulator Improves MRI and Clinical Outcomes in Relapsing-Remitting Multiple
Sclerosis (RRMS). Platform Presentation at AAN, New Orleans, April 2012.
[4] Kappos L, et al. Placebo-Controlled Study of Oral Fingolimod in Relapsing
Multiple Sclerosis. N Eng J Med. Vol.362 No.5, Feb 4, 2010; 362:387-401.
[5] Cohen J. et al. Oral Fingolimod vs. Intramuscular Interferon in Relapsing
Multiple Sclerosis. N Eng J Med. Vol.362 No.5, Feb 4, 2010;362:402-415.
[6] Comi G. et al. Cardiac Safety of Fingolimod 0.5 mg During the First Dose
Observation in 4-month, Open-Label, Multi-Centre FIRST Study in Patients with
Relapsing MS. Platform Presentation at AAN, New Orleans, April 2012.
[7] Havrdová E. et al. Clinical outcomes in subgroups of patients with highly
action relapsing-remitting multiple sclerosis treated with Fingolimod (FTY720):
Results from the FREEDOMS and TRANSFORMS phase III studies. Poster presented at
ECTRIMS, Amsterdam, October 2011.
[8] Data on file.
Avonex(® )is a registered trademark of Biogen Idec.
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff Julie Morrow
Novartis Global Media Relations Novartis Pharma Communications
+41 61 324 7999 (direct) +41 61 696 7581 (direct)
+41 79 593 4202 (mobile) +41 79 357 3259 (mobile)
eric.althoff(at)novartis.com julie.morrow(at)novartis.com
e-mail: media.relations(at)novartis.com
For Novartis multimedia content, please visit www.thenewsmarket.com/Novartis
For questions about the site or required registration, please contact:
journalisthelp(at)thenewsmarket.com.
Novartis Investor Relations
Central phone: +41 61 324 7944
Susanne Schaffert +41 61 324 7944 North America:
Pierre-Michel +41 61 324 1065 Helen Boudreau +1 212 830 2404
Bringer
Thomas +41 61 324 8425 Jill Pozarek +1 212 830 2445
Hungerbuehler
Isabella Zinck +41 61 324 7188 Edwin Valeriano +1 212 830 2456
e-mail: e-mail:
investor.relations(at)novartis.com investor.relations(at)novartis.com
Media release (PDF):
http://hugin.info/134323/R/1604172/507503.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Novartis International AG via Thomson Reuters ONE
[HUG#1604172]
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 19.04.2012 - 11:31 Uhr
Sprache: Deutsch
News-ID 1105191
Anzahl Zeichen: 0
contact information:
Contact person:
Town:
Basel
Phone:
Kategorie:
Business News
Anmerkungen:
Diese Pressemitteilung wurde bisher 150 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"New extension study data with Novartis drug Gilenya® shows patients successfully treated for up to 7 years in relapsing MS
"
steht unter der journalistisch-redaktionellen Verantwortung von
Novartis International AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
