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Novartis International AG / Novartis announces NEJM publication of
secukinumab Phase III data confirming significant efficacy in patients
with psoriatic arthritis . Processed and transmitted by NASDAQ OMX
Corporate Solutions. The issuer is solely responsible for the content of
this announcement.
-- In the FUTURE 1 study, secukinumab showed rapid and significant efficacy
in active psoriatic arthritis (PsA) patients, including improvement of
skin and joint disease and reduction in progression of joint structural
damage[1]
-- Clinical benefits with secukinumab observed in patients with previous
treatment with standard of care anti-TNF therapy and those without prior
treatment[1]
-- Secukinumab is the first IL-17A inhibitor to report positive Phase III
results in PsA; new options needed as 45% of patients are dissatisfied
with current therapies[1]-[5]
The digital press release with multimedia content can be accessed here:
http://multimediacapsule.thomsonone.com/novartis/novartis-announces-nejm-publication-of-secukinumab-phase-iii-data-in-psa
Basel, September 30, 2015 - Novartis announced today that results from
the pivotal Phase III FUTURE 1 study for secukinumab in psoriatic
arthritis (PsA) were published online in the New England Journal of
Medicine (NEJM). Secukinumab is the first interleukin-17A (IL-17A)
inhibitor to demonstrate efficacy in a Phase III study in patients with
active PsA, a painful, debilitating condition causing inflammation of
joints and skin[1],[7]. PsA is part of a family of long-term diseases
impacting joints, known as spondylorarthritis[8].
In this study, secukinumab met the primary endpoint with a 20% reduction
in the American College of Rheumatology response criteria (ACR 20) at
Week 24 showing rapid and significant clinical improvements versus
placebo[1]. ACR is a standard tool used to assess improvement of PsA
signs and symptoms[9]. In addition, secukinumab met all secondary
endpoints, including improvements in skin and joint diseases and joint
structural damage progression[1].
Results showed that half of patients (50.0% and 50.5%) in both
secukinumab-treated dose groups (150 mg and 75 mg; p<0.001) achieved ACR
20 response compared with only 17.3% of placebo patients[1]. Clinically
significant improvements with secukinumab were observed as early as Week
1 and sustained throughout 52 weeks of treatment[1].
"Secukinumab is the first IL-17A inhibitor with detailed positive
results for the treatment of PsA, further validating the importance of
the role IL-17A plays in spondyloarthritis," said Vasant Narasimhan,
Global Head of Development, Novartis Pharmaceuticals. "Novartis looks
forward to advancing this important therapy to address the unmet need
for patients living with PsA."
PsA is a debilitating, long-lasting inflammatory disease associated with
joint pain and stiffness, skin and nail psoriasis, swollen toes and
fingers, persistent painful tendonitis and irreversible joint damage[6].
These all lead to significant disability, poor quality of life and
reduced life expectancy[5],[6]. Importantly, in FUTURE 1, clinical
benefits with secukinumab were observed regardless of prior exposure to
anti-tumor-necrosis-factor (anti-TNF) medicines, the current standard of
care[1]. Many patients do not respond to, or tolerate these therapies
and approximately 45% of people are dissatisfied with current
treatments[2]-[5]. There is therefore, a high unmet need for patients
with PsA.
Secukinumab was well tolerated in the study, with a safety profile that
was consistent with that observed in the large psoriasis clinical trial
program involving nearly 4,000 patients[1],[10]. The most common adverse
events (AEs) were the common cold, headache and upper respiratory tract
infections[1].
About the FUTURE 1 study
FUTURE 1 is the first multi-center, randomized, placebo-controlled Phase
III study to evaluate the efficacy of secukinumab in IL-17A inhibition
in PsA[1]. The study enrolled 606 patients with active PsA, including
patients who had been previously treated with DMARDs (disease-modifying
anti-rheumatic drugs) and patients who had an inadequate response or did
not tolerate anti-TNFs, and assessed secukinumab with intravenous
loading (10 mg/kg) and subcutaneous (75 mg and 150 mg) maintenance
dosing[1]. In the study, patients received an intravenous loading dose
every two weeks for the first four weeks of treatment followed by
monthly subcutaneous doses of 75 mg or 150 mg compared to placebo[1].
The intravenous loading period was designed to provide high systemic
exposure for induction of response, in keeping with the initial proof of
concept study in PsA with secukinumab[1].
The study met its primary endpoint, the American College of Rheumatology
response criteria (ACR 20), at Week 24 and all secondary endpoints[1]:
-- FUTURE 1, 50.5% and 50.0% for secukinumab 75 mg and 150 mg treatment
arms,
versus 17.3% for placebo; p<0.001
About psoriatic arthritis (PsA)
Closely associated with psoriasis, psoriatic arthritis (PsA) is part of
a family of long-term diseases impacting joints, known as
spondyloarthritis (SpA). Approximately 30% of patients with psoriasis
have psoriatic arthritis[6],[8]. 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[6],[11].
About Cosentyx (secukinumab) and interleukin-17A (IL-17A)
Secukinumab is a human monoclonal antibody that selectively neutralizes
IL-17A[11]. Secukinumab is the first IL-17A inhibitor with positive
Phase III results for the treatment of PsA and ankylosing spondylitis
(AS). Research shows that IL-17A plays an important role in driving the
body's immune response in psoriasis and spondyloarthritis conditions,
including PsA and AS[12].
In January 2015, Cosentyx (secukinumab) (at a dose of 300 mg) became the
first and only IL-17A inhibitor approved in Europe as a first-line
systemic treatment of moderate-to-severe plaque psoriasis in adult
patients, and in the US as a treatment for moderate-to-severe plaque
psoriasis in adult patients who are candidates for systemic therapy or
phototherapy (light therapy). In addition to the EU and the US, Cosentyx
has been approved in Switzerland, Chile, Australia, Argentina, Canada
and Singapore for the treatment of moderate-to-severe plaque psoriasis
and in Japan for the treatment of moderate-to-severe plaque psoriasis
and active psoriatic arthritis (PsA).
Global regulatory submissions have been filed for secukinumab in PsA and
AS.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by words such as "dedicated," "may," "planned," or similar
terms, or by express or implied discussions regarding potential new
indications or labeling for Cosentyx (secukinumab), or regarding
potential future revenues from Cosentyx. 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 Cosentyx 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 Cosentyx will
receive regulatory approval or be commercially successful in the future.
In particular, management's expectations regarding Cosentyx 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.
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