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Novartis International AG: Novartis presents new scientific evidence for Cosentyx in ankylosing spondylitis and psoriatic arthritis patients at EULAR 2016

Novartis International AG / Novartis presents new scientific evidence for
Cosentyx in ankylosing spondylitisand psoriatic arthritis patients at EULAR
2016 . Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer
is solely responsible for the content of this announcement.
* Up to 80% of ankylosing spondylitis and 84% of psoriatic arthritis patients
treated with Cosentyx ® at two years had no radiographic progression in the
spine or joints , respectively[1],[2]
* Cosentyx may improve the signs and symptoms of ankylosing spondylitis and
psoriatic arthritis more than Humira ® [3],[4] - based on new indirect
comparative analyses
* New head-to-head clinical trials planned to compare Cosentyx versus

The digital press release with multimedia content can be accessed here:

Basel, June 8 2016


Novartis announced today that it will present 33 scientific abstracts at the
Annual European Congress of Rheumatology (EULAR 2016) in London, UK. This
includes new long-term analyses suggesting Cosentyx®(secukinumab) may lead to
higher responses than Humira®* (adalimumab) in improving the signs and
symptoms of people living with ankylosing spondylitis (AS) and psoriatic
arthritis (PsA) at 52 weeks[3],[4]. These analyses are from two studies using
the Matching-Adjusted Indirect Comparisons (MAIC) method. MAIC is a valid and
accepted method for comparative effectiveness research[6],[7].

To directly compare Cosentyx versus Humira, Novartis plans to initiate new
head-to-head studies in patients with AS and PsA[5]. These will be the first
ever adequately powered long-term head-to-head studies with biologic
medicines to differentiate the effectiveness of treatment in these

"There is an urgent need for new ankylosing spondylitis and psoriatic
arthritis treatments because a significant number of patients do not respond
well to anti-TNF therapy, the current standard of care," said Vasant
Narasimhan, Global Head, Drug Development and Chief Medical Officer,
Novartis. "There is a growing body of evidence that supports the potential of
Cosentyx to become a gold standard of care for patients living with these
debilitating conditions."

Also presented at the Annual European Congress of Rheumatology (EULAR 2016)
were two-year data showing that up to 80% of AS patients on Cosentyx had no
radiographic progression in the spine on x-ray assessment[1]. A similar
proportion of patients with PsA (84%), who were on Cosentyx for two years,
also had no evidence of progression[2].

More than 9,600 patients have been treated with Cosentyx in clinical trials
across multiple indications, and over 20,000 patients with psoriasis have
already been treated in the post-marketing setting[5]. The safety profile of
Cosentyx was shown to be consistent with that seen in clinical trials across
multiple indications[8]-[10].

About MAIC and limitations of these studies
While these MAIC analyses have been performed using data from randomized
controlled trials, there are limitations to these analyses due to differences
in study designs and lower effective sample size for Cosentyx. In addition,
only publicly available data has been used for Humira. This impacts
availability of comparative data and matching of patient populations in these
studies. Further technical details on the MAIC analyses are available in the
presented scientific abstracts[6],[7].

About Cosentyx and interleukin-17A (IL-17A)
Cosentyx is a fully human monoclonal antibody that selectively neutralizes
circulating IL-17A. Research suggests that IL-17A may play an important role
in driving the body's immune response in psoriasis, AS and PsA[11],[12].

Cosentyx is approved in more than 50 countries for the treatment of
moderate-to-severe plaque psoriasis which includes the European Union
countries, Japan, Switzerland, Australia, the US and Canada. In Europe,
Cosentyx is approved for the first-line systemic treatment of
moderate-to-severe plaque psoriasis in adult patients[13]. In the US,
Cosentyx is approved as a treatment for moderate-to-severe plaque psoriasis
in adult patients who are candidates for systemic therapy or phototherapy
(light therapy)[14].

In addition, Cosentyx is the first IL-17A inhibitor with positive Phase III
results for the treatment of active AS and PsA[8]-[10] and is now approved in
Europe, the US, and other countries for these conditions. Cosentyx is also
approved for the treatment of PsA and pustular psoriasis in Japan.

About ankylosing spondylitis
AS is part of a family of life-long inflammatory diseases that also includes
PsA. It generally results in serious impairment of movement in the spine and
physical function, which has an impact on quality of life. People in their
teens and twenties, particularly males, are affected most often. Family
members of those with AS are at higher risk[15],[16].

Improvements in the symptoms of AS are measured by the ASAS response criteria
(ASAS20), which is defined as an improvement of at least 20% and absolute
improvement of at least 10 units on a 0-100mm scale in at least three of the
following criteria: improvement in flexibility, night time pain, ability to
perform specific tasks, morning stiffness, and no further deterioration in
the condition. The percentage of patients reaching an ASAS20 response is an
accepted way of measuring the efficacy of treatments in AS[17].

About psoriatic arthritis
PsA is part of a family of life-long inflammatory diseases that also includes
AS. It is also closely associated with psoriasis. Approximately 30% of
patients with psoriasis have PsA[18]and as many as one in four people with
psoriasis may have undiagnosed PsA[19]. Symptoms of PsA include joint pain
and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent
painful swelling of the tendons, and irreversible joint damage[20]. Up to 40%
of people can suffer from joint destruction and permanent physical

Improvements in the symptoms of PsA are measured by the ACR response criteria,
which has three levels - ACR20, 50, 70. In ACR20 there is an improvement of
20% or greater of the following criteria: reduction in the number of tender
joints; reduction in the number of swollen joints; and a reduction in three
of five additional criteria, which are the patient's assessment of pain
and/or the patient's assessment of how active his or her PsA is, the
physician's assessment of disease activity, levels of disability measured by
the Stanford Health Assessment Questionnaire, and laboratory tests showing if
inflammation is active. The ACR50 and ACR70 use the same criteria as ACR20,
but are looking for a higher percentage improvement (50% and 70%) instead of

*Humira is a registered trademark of AbbVie Inc.

The foregoing release contains forward-looking statements that can be
identified by words such as "may," "planned," "will," "suggesting," "plans,"
"growing," "potential," "suggests," or similar terms, or by express or
implied discussions regarding potential new indications or labeling 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 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 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 safety, quality or
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 and cost-saving generic pharmaceuticals. Novartis is the
only global company with leading positions in these areas. In 2015, the Group
achieved net sales of USD 49.4 billion, while R&D throughout the Group
amounted to approximately USD 8.9 billion (USD 8.7 billion excluding
impairment and amortization charges). Novartis Group companies employ
approximately 118,000 full-time-equivalent associates. Novartis products are
available in more than 180 countries around the world. For more information,
please visit

Novartis is on Twitter. Sign up to follow @Novartis

For Novartis multimedia content, please For questions about the site or
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[1] Braun J, et al. Effect of secukinumab, an interleukin-17a inhibitor, on
spinal radiographic changes through 2 years in patients with active
ankylosing spondylitis: results of the phase 3 study, MEASURE 1. Abstract
#3177 presented at the 25thEuropean League Against Rheumatism Congress. 2016,
June 8 - 11; London.

[2] Kavanaugh A, et al. Secukinumab provides sustained improvements in the
signs and symptoms of active psoriatic arthritis: 2-year efficacy and safety
results from the Phase 3 randomised, double-blind, placebo-controlled trial,
FUTURE 1. Abstract #3565 presented at the 25thEuropean League Against
Rheumatism Congress. 2016, June 8 - 11; London.

[3] Maksymowych W, et al. Secukinumab for the treatment of ankylosing
spondylitis: comparative effectiveness results versus adalimumab using a
matching-adjusted indirect comparison. Abstract OP114 presented at the
25thEuropean League Against Rheumatism Congress. 2016, June 8 - 11; London.

[4] Na...

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