Novartis to reveal landmark Phase III data for AIN457 (secukinumab) in psoriatic arthritis and ankylosing spondylitis at ACR 2014
(Thomson Reuters ONE) -
Novartis International AG /
Novartis to reveal landmark Phase III data for AIN457 (secukinumab) in psoriatic
arthritis and ankylosing spondylitis at ACR 2014
. Processed and transmitted by NASDAQ OMX Corporate Solutions.
The issuer is solely responsible for the content of this announcement.
* Detailed results of four pivotal Phase III studies of secukinumab in
psoriatic arthritis (PsA) and ankylosing spondylitis (AS) to be presented
for the first time at ACR 2014
* Secukinumab is the first selective interleukin-17A (IL-17A) inhibitor with
Phase III data to demonstrate efficacy and improve symptoms in patients with
PsA and AS
* Data will include study results from FUTURE 1 and FUTURE 2 in PsA and
MEASURE 1 and MEASURE 2 in AS; data to be presented include joint structural
damage progression in PsA and symptoms, quality of life/physical function in
PsA and AS
* PsA and AS are part of a family of long-term diseases impacting joints,
known as spondyloarthritis (SpA); high unmet treatment need exists for
patients living with SpA[1]
Basel, 10 November 2014 - Novartis announced today that four oral presentations
and four posters for AIN457 (secukinumab) will be presented at the American
College of Rheumatology (ACR) Congress, 14-19 November, in Boston,
Massachusetts, USA. The secukinumab abstracts include data from two pivotal
Phase III studies (FUTURE 1 and FUTURE 2) in psoriatic arthritis (PsA) patients
and two pivotal Phase III studies (MEASURE 1 and MEASURE 2) in patients with
ankylosing spondylitis (AS). All studies met primary endpoints. Global
regulatory applications of secukinumab in PsA and AS will be submitted in 2015.
Secukinumab is the first selective IL-17A inhibitor with positive results in PsA
and AS which are common conditions of spondyloarthritis (SpA). SpA is a family
of long-term debilitating diseases impacting joints (inflammatory diseases)
which can lead to irreversible damage. There is a high unmet need for new
treatment options for both PsA and AS[1],[2]. Specifically, many people with PsA
do not respond to or tolerate anti-TNF (tumor-necrosis-factor) medicines, the
current standard of care, with approximately 45% of people dissatisfied with
current treatments[3]. Additionally, people with AS have very few therapeutic
options available to them. In case of non-response to non-steroidal anti-
inflammatory drugs (NSAIDs), anti-TNF medicines are the only currently available
biologic treatment alternative but are not effective for all patients[1].
"There remains a significant unmet need for new Psoriatic Arthritis and
Ankylosing Spondylitis therapies as many patients have an inadequate or no
response to available treatments," said Vasant Narasimhan, Global Head of
Development, Novartis Pharmaceuticals. "At Novartis, we are committed to
providing new treatment options for patients suffering from these debilitating
joint diseases that can significantly impact a patient's quality of life. We're
excited about the Phase III data we're presenting at ACR 2014 and what these
results could mean for patients."
Novartis rheumatology highlights at ACR 2014 include:
Oral presentations:
* FUTURE 1: Secukinumab, a Human Anti-Interleukin-17A Monoclonal Antibody,
Improves Active Psoriatic Arthritis and Inhibits Radiographic Progression:
Efficacy and Safety Data from a Phase 3 Randomized, Multicenter, Double-
Blind, Placebo-Controlled Study (abstract 953; 16 November, 4:45 PM - 5:00
PM EST)
* FUTURE 1: Secukinumab, A Monoclonal Antibody to Interleukin-17A, Provides
Significant and Sustained Inhibition of Joint Structural Damage in Active
Psoriatic Arthritis Regardless of Prior TNF Inhibitors or Concomitant
Methotrexate: a Phase 3 Randomized, Double-Blind, Placebo-Controlled Study
(abstract 954; 16 November, 5:00 PM - 5:15 PM EST)
* MEASURE 1: Secukinumab, a Monoclonal Antibody to Interleukin-17A,
Significantly Improves Signs and Symptoms of Active Ankylosing Spondylitis:
Results of a 52-Week Phase 3 Randomized Placebo-Controlled Trial with
Intravenous Loading and Subcutaneous Maintenance Dosing (abstract 819; 16
November 12:15 PM - 12:30 PM EST)
* FUTURE 2: Secukinumab, a Human Anti-Interleukin-17A Monoclonal Antibody,
Improves Active Psoriatic Arthritis: 24-Week Efficacy and Safety Data from a
Phase 3 Randomized, Multicenter, Double-Blind, Placebo-Controlled Study
Using Subcutaneous Dosing (Late-breaking abstracts session; 18 November
2:30 PM - 2:45 PM EST)
Posters available throughout the congress:
* FUTURE 1: Secukinumab, An Anti-Interleukin-17A Monoclonal Antibody, Improves
Physical Function, Quality of Life and Work Productivity in Patients with
Active Psoriatic Arthritis: Results from a Phase 3, Randomized, Controlled
Trial (abstract 550, 16 November 8:30 AM - 4:00 PM EST)
* FUTURE 1: Secukinumab, a Human Anti-Interleukin-17A Monoclonal Antibody,
Significantly Reduces Psoriasis Burden in Patients with Psoriatic Arthritis:
Results from a Phase 3 Randomized Controlled Trial (abstract 537, 16
November 8:30 AM - 4:00 PM EST)
* MEASURE 1: Secukinumab, a Monoclonal Antibody to Interleukin-17A,
Significantly Improves Physical Function and Quality of Life in Subjects
with Active Ankylosing Spondylitis: Results of a Phase 3 Randomized,
Placebo-Controlled Trial with Intravenous Loading and Subcutaneous
Maintenance Dosing (abstract 538, 16 November 8:30 AM - 4:00 PM EST)
* MEASURE 2: Secukinumab, a Monoclonal Antibody to Interleukin-17A,
Significantly Improves Signs and Symptoms of Active Ankylosing Spondylitis:
Results of a Phase 3, Randomized, Placebo-Controlled Trial with Subcutaneous
Loading and Maintenance Dosing (abstract 536, 16 November 8:30 AM - 4:00 PM
EST)
About secukinumab (AIN457)
Secukinumab (AIN457) is a human monoclonal antibody (mAb) that selectively binds
to and neutralizes IL-17A[4]. Secukinumab is the first IL-17A inhibitor with
positive Phase III results for the treatment of PsA and AS. Research shows that
IL-17A plays an important role in driving the body's immune response in
psoriasis and certain inflammatory arthritic diseases, such as PsA and AS[5].
In addition to PsA and AS, secukinumab is also in clinical trials for the
treatment of rheumatoid arthritis (RA). Global regulatory applications for
secukinumab in AS and PsA are planned for 2015. This follows the secukinumab
global regulatory applications for moderate-to-severe plaque psoriasis which
were filed in October 2013 with approvals anticipated in late 2014 or early
2015.
About psoriatic arthritis (PsA)
Psoriatic arthritis (PsA) is a debilitating, long-lasting inflammatory disease
linked with significant disability, poor quality of life and reduced life
expectancy[6]. PsA is associated with joint pain and stiffness, skin and nail
psoriasis, swollen toes and fingers, persistent painful tendonitis, and
irreversible joint damage[6]. Between 0.3% and 1% of the general population may
be affected by PsA and as many as one in four people with psoriasis may have
undiagnosed PsA[5],[7].
About ankylosing spondylitis (AS)
Ankylosing spondylitis (AS) is a common type of spondyloarthritis (SpA), a
family of long-term diseases of joints (inflammatory disease)[1],[2]. Up to 70%
of patients with severe AS can develop spinal fusion (bones grow together),
significantly reducing mobility and quality of life[8]-[10]. AS occurs in up to
1% of the general population and typically affects young men and women aged 25
or older[11],[12]. Certain genetic factors may increase a person's risk of
developing AS by more than 50%[13].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "to reveal," "to be presented," "will," "committed," "could,"
"planned," "anticipated," or similar terms, or by express or implied discussions
regarding potential marketing authorizations for AIN457, or regarding potential
future revenues from AIN457. 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 AIN457 will be
submitted in AS or PsA in any market, or approved for any indication, or at any
particular time. Nor can there be any guarantee that AIN457 will be commercially
successful in the future. In particular, management's expectations regarding
AIN457 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 133,000 full-time-equivalent
associates and sell products in more than 150 countries around the world. For
more information, please visit http://www.novartis.com.
References
[1] Dougados M, Baeten D. Spondyloarthritis. Lancet. 2011; 377:2127-37.
[2] American College of Rheumatology (ACR) website. "Spondylarthritis
(Spondylarthropathy)."
http://www.rheumatology.org/Practice/Clinical/Patients/Diseases_And_Conditions/S
pondylarthritis_(Spondylarthropathy)/. Accessed December 2013.
[3] Armstrong A, Robertson A, Wu J, et al. Undertreatment, Treatment Trends, and
Treatment Dissatisfaction Among Patients With Psoriasis and Psoriatic Arthritis
in the United States: Findings From the National Psoriasis Foundation Surveys,
2003-2011. JAMA Dermatol. 2013; 149(10):1180-1185.
[4] Kirkham BW, Kavanaugh A, Reich K. Interleukin-17A: a unique pathway in
immune-mediated diseases: psoriasis, psoriatic arthritis and rheumatoid
arthritis. Immunology. 2014; 141:133-42.
[5]Van Baarsen LGM, Lebre MC, van der Coelen D, et al. IL-17 levels in synovium
of patients with rheumatoid arthritis, psoriatic arthritis and osteoarthritis:
Target validation in various forms of arthritis. Ann Rheum Dis. 2011;70:A79.
[6] Gladman DD, Antoni C, Mease P, et al. Psoriatic arthritis: epidemiology,
clinical features, course, and outcome. Ann Rheum Dis. 2005; 64:ii14-ii17.
[7] Mease PJ, Armstrong AW. Managing Patients with Psoriatic Disease: The
Diagnosis and Pharmacologic Treatment of Psoriatic Arthritis in Patients with
Psoriasis. Drugs. 2014; 74:423-441.
[8] Sieper J, Braun J, Rudwaleit M, et al. Ankylosing spondylitis: an overview.
Ann Rheum Dis. 2002;61(Suppl III):iii8-iii18.
[9] Lories R. The balance of tissue repair and remodeling in chronic arthritis.
Nat Rev Rheumatol. 2011;7:700-07.
[10] Barkham N, Kong KO, & Tennant A. The unmet need for anti-tumour necrosis
factor (anti-TNF) therapy in ankylosing spondylitis. Rheumatology.
2005;44:1277-81.
[11] Braun J, Bollow M, Remlinger G, et al. Prevalence of spondylarthropathies
in HLA-B27 positive and negative blood donors. Arthritis Rheum.
1998;41(1):58-67.
[12] Feldtkeller E, Khan M, Van Der Heijde D, et al. Age at disease onset and
diagnosis delay in HLA-B27 negative vs. Positive patients with ankylosing
spondylitis. Rheumatology International. 2003;23(2):61-66.
[13] Brown MA. Progress in studies of the genetics of ankylosing spondylitis.
Arthritis Res Ther. 2009;11:254.
# # #
Novartis Media Relations
Central media line: +41 61 324 2200
Eric Althoff Katrina Lucking
Novartis Global Media Relations Novartis Global Pharma Communications
+41 61 324 7999 (direct) +41 61 324 1218 (direct)
+41 79 593 4202 (mobile) +41 79 171 8267 (mobile)
eric.althoff(at)novartis.com katrina.lucking(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
Samir Shah +41 61 324 7944 North America:
Pierre-Michel Bringer +41 61 324 1065 Stephen Rubino +1 862 778 8301
Thomas Hungerbuehler +41 61 324 8425 Susan Donofrio +1 862 778 9257
Isabella Zinck +41 61 324 7188
e-mail: investor.relations(at)novartis.com e-mail:
investor.relations(at)novartis.com
Media release (PDF):
http://hugin.info/134323/R/1869976/657592.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire 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 GlobeNewswire
[HUG#1869976]
Unternehmensinformation / Kurzprofil:
Datum: 10.11.2014 - 07:15 Uhr
Sprache: Deutsch
News-ID 350950
Anzahl Zeichen: 16341
contact information:
Town:
Basel
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 197 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Novartis to reveal landmark Phase III data for AIN457 (secukinumab) in psoriatic arthritis and ankylosing spondylitis at ACR 2014"
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).
