Novartis announces NEJM publication of secukinumab Phase III data confirming significant efficacy in patients with psoriatic arthritis

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:

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.

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 2014, the Group achieved net sales of USD 58.0 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 120,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.

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References
[1] Mease, PJ, McInnes, IB, Kirkham, B, et. Al. Secukinumab Inhibition of Interleukin-17A in Patients With Psoriatic Arthritis. N Engl J Med. 2015; 373(14):1329-39
[2] Gossec L, Smolen JS, Gaujoux-Viala C, et al. European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies. Ann Rheum Dis. 2012;71:4-12.
[3] Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 6: guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011;65:137-74.
[4] Boehncke WH, Menter A. Burden of disease: psoriasis and psoriatic arthritis. Am J Clin Dermatol. 2013;14:377-88.
[5] Gladman DD, Antoni C, Mease P, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005; 64:ii14-ii17.
[6] Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014;74:423-41.
[7] McInnes IB. 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. Oral presentation at: ACR/ARHP Annual Meeting, Boston, MA, USA, 2014.
[8] American College of Rheumatology (ACR) website. "Spondylarthritis (Spondylarthropathy)." http://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Spondyloarthritis. Accessed August 2015.
[9] Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727-35.
[10] Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in Plaque Psoriasis - Results of Two Phase Three Trials. N Engl J Med. 2014; 371(4):326-338.
[11] 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.
[12] 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.

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