Novartis International AG / New Novartis data shows Cosentyx(TM) is
significantly superior to Stelara® and clears skin (PASI 90) in nearly 80% of
psoriasis patients . Processed and transmitted by NASDAQ OMX Corporate
Solutions. The issuer is solely responsible for the content of this
announcement.
o CLEAR study at AAD showed over 21% more psoriasis patients achieved clear
to almost clear skin (PASI 90) with Cosentyx^(TM) compared to Stelara^® at
Week 16[1]
o Cosentyx showed greater improvements to Stelara across all study endpoints
up t
Week 16, including PASI 100 and onset of action[1]
* PASI 90 and PASI 100 are both considered important measures of treatment
success for psoriasis patients, demonstrating clear to almost clear
skin[2],[3]
* Cosentyx, the first and only IL-17A inhibitor approved for psoriasis, has
now shown superiority to both Stelara and Enbrel^®, widely used biologic
treatments[1],[4]
The digital press release with multimedia content can be accessed here:
[IMG]
Basel, March 20, 2015 - Novartis announced today results from the CLEAR
study demonstrating that Cosentyx(TM) (secukinumab) is significantly
superior to Stelara^®* (ustekinumab), a widely used biologic, in achieving
clear or almost clear skin for psoriasis patients[1]. The detailed findings
were presented in a late-breaking research session at the 73rd Annual
Meeting of the American Academy of Dermatology (AAD) in San Francisco, USA.
Cosentyx (at a dose of 300 mg) is the first and only interleukin-17A
(IL-17A) inhibitor approved to treat adult patients with moderate-to-severe
plaque psoriasis.
In this Phase IIIb study, Cosentyx met the primary endpoint of showing
superiority to Stelara as assessed by the Psoriasis Area Severity Index
(PASI) 90 response, known as clear to almost clear skin[2], at Week 16
(79.0% vs. 57.6%, P<0.0001)[1]. PASI 90 is considered an important measure
of treatment success by the European Medicines Agency[2] and an optimal
treatment goal for patients[3]. In addition, completely clear skin (PASI
100) at Week 16 was achieved by significantly more patients treated with
Cosentyx than those receiving Stelara (44.3% vs. 28.4%, P<0.0001)[1].
"The robust results from the CLEAR study further demonstrate how Cosentyx is
changing the way psoriasis is treated and helping patients achieve clear
skin," said Vasant Narasimhan, Global Head of Development, Novartis
Pharmaceuticals. "With Cosentyx now approved in many countries around the
world, we are committed to helping psoriasis patients significantly improve
their overall quality of life."
In addition, Cosentyx demonstrated rapid onset of action and greater
efficacy at all time points in the study up to Week 16, with 50% of Cosentyx
patients achieving PASI 75 as early as Week 4 compared to Stelara (50.0% vs.
20.6%, P<0.0001)[1]. The safety profile of Cosentyx was comparable to
Stelara and consistent with previously reported Phase III clinical trials
for Cosentyx[1],[4]-[6].
About the CLEAR study
CLEAR (Comparison to assess Long-term Efficacy, sAfety and toleRability of
secukinumab vs. ustekinumab), a 52-week, multicenter, randomized,
double-blind study, is a head-to-head Phase IIIb study initiated with
Cosentyx, and compares the efficacy, long-term safety and tolerability of
Cosentyx (secukinumab) versus Stelara (ustekinumab), in patients with
moderate-to-severe plaque psoriasis[1]. Twenty-four countries across North
America, Europe, Asia and Australia participated in the study, with
enrollment reaching 679 patients in record time[1].
The primary endpoint measured at Week 16 is PASI 90[1]. PASI 90 is
considered a more robust measure of the extent of skin clearance compared to
the standard efficacy measures used in most psoriasis clinical studies, such
as PASI 75. Additionally the secondary endpoint measured at Week 4 is PASI
75[1]. PASI 100 at Week 16 was one of the exploratory endpoints[1]. Week 52
data will follow in due course.
The CLEAR study follows the pivotal Phase III FIXTURE study, which showed
Cosentyx was superior to Enbrel^®** (etanercept) in clearing skin[4].
Results from the FIXTURE study were first announced in October 2013.
About Cosentyx (secukinumab) and interleukin-17A (IL-17A)
Cosentyx is a human monoclonal antibody that selectively neutralizes
interleukin-17A (IL-17A)[7],[8]. IL-17A is found in high concentrations in
skin affected by psoriasis and is a preferred target for investigational
therapies[7]-[12]. Cosentyx works by inhibiting the action of IL-17A, a
protein found in high concentrations in skin affected by the
disease[7]-[12]. In the Phase III program, Cosentyx demonstrated a favorable
safety profile, with similar incidence and severity of adverse events
between Cosentyx treatment arms (300 mg and 150 mg)[1],[4]-[6].
In January 2015, Cosentyx (at a dose of 300 mg) became the first and only
interleukin-17A (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, 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).
Cosentyx is also in Phase III development for PsA and ankylosing spondylitis
(AS); global regulatory applications are planned for 2015.
About Psoriasis
Psoriasis is a chronic immune-mediated disease characterized by thick and
extensive skin lesions, called plaques, known to cause itching, scaling and
pain; it is associated with significant impairment of physical and
psychological quality of life[13]-[15]. Psoriasis affects up to 3% of the
world's population, or more than 125 million people[16].
This common and distressing condition is not simply a cosmetic problem -
even people with very mild symptoms are affected everyday[13]. According to
an analysis of surveys conducted of 5,600 patients by the National Psoriasis
Foundation (NPF) between 2003 and 2011, 52% of patients with mild, moderate
and severe psoriasis were dissatisfied with their disease management[17]. Of
the patients surveyed, some were receiving no treatment (9.4-49.2%) or were
undertreated (10.2-55.5%)[17].
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by words such as "committed," "will," "investigational,"
"planned," or similar terms, or by express or implied discussions regarding
potential additional marketing authorizations for Cosentyx, 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 for sale in any additional
markets, or approved for any additional indications, or at any particular
time. Nor can there be any guarantee that Cosentyx will 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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