Novartis presents results from four pivotal Phase III studies for investigational drug secukinumab (AIN457) in psoriatic arthritis and ankylosing spondylitis at ACR 2014

• Detailed results of four pivotal Phase III studies of investigational secukinumab in psoriatic arthritis (PsA) and in ankylosing spondylitis (AS) presented for the first time at the American College of Rheumatology Annual Meeting (ACR) 2014
• Investigational secukinumab is the first selective interleukin-17A (IL-17A) inhibitor with Phase III data that demonstrated efficacy and improved symptoms in patients with PsA, AS^1-5 and psoriasis (PsO)⁶
• Study results from FUTURE 1 and FUTURE 2 in PsA and MEASURE 1 and MEASURE 2 in AS; included joint structural damage progression in PsA and symptoms, quality of life/physical function in PsA and AS

DORVAL, QC, Nov. 17, 2014 /CNW/ - Novartis presented first-time results of four pivotal phase III studies evaluating the interleukin-17A (IL-17A) inhibitor investigational secukinumab (AIN457) in psoriatic arthritis (PsA) and ankylosing spondylitis (AS) at the American College of Rheumatology (ACR) Annual Meeting, 14-19 November, in Boston, USA.

The abstracts include data from two pivotal Phase III studies, FUTURE 1 and FUTURE 2 in PsA patients and two pivotal Phase III studies, MEASURE 1 and MEASURE 2, in patients with AS. All studies met primary endpoints^1-5. The safety and efficacy of investigational secukinumab are still under investigation and market authorization has not yet been obtained in Canada.

"The Phase III FUTURE 1 and FUTURE 2 studies showed investigational secukinumab demonstrated rapid and significant clinical improvements versus placebo in improving the signs and symptoms of psoriatic arthritis (PsA). PsA is part of a family of chronic inflammatory diseases impacting joints, known as spondyloarthritis (SpA), which also includes ankylosing spondylitis⁸," said Dr. Dafna D Gladman, Rheumatologist, Professor of Medicine at the University of Toronto, Deputy Director, Centre for Prognosis Studies in the Rheumatic Diseases part of the UHN Arthritis and Autoimmunity Research Centre, and Director of Psoriatic Arthritis Program, Toronto Western Hospital in Toronto, Ontario. Dr. Gladman, who was part of the international investigational team for these studies, adds: "There is a high unmet treatment need for patients with PsA. Many patients do not respond to, or tolerate, anti-TNF (tumor-necrosis-factor) medicines, the current standard of care and approximately 45% of people are dissatisfied with current treatments^9,10-12."

"We are thrilled by these Phase III results of investigational secukinumab in PsA and AS, two painful and debilitating conditions with significant impact on people's quality of life," said Tim Maloney, President of Novartis Pharmaceuticals Canada Inc. "These results add to the body of evidence in targeting IL-17A with investigational secukinumab for all three indications: PsO, AS and PsA. We are committed to addressing unmet medical needs in rheumatology and dermatology by pursuing research and development efforts to further improve the health outcomes of people living with these conditions."

About Investigational Secukinumab Psoriatic Arthritis (PsA) Phase III trials
FUTURE 1 and FUTURE 2 are the first multi-center, randomized, placebo-controlled Phase III studies to evaluate the efficacy of investigational secukinumab in IL-17A inhibition in PsA. In the FUTURE 1 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, and FUTURE 2 compared subcutaneous loading dose investigational secukinumab 75 mg, 150 mg and 300 mg to placebo^4,5. The intravenous loading period used in FUTURE 1 was designed to provide high systemic exposure for induction of response, in keeping with the initial proof of concept study in PsA with investigational secukinumab^4,5. FUTURE 2 utilized an administration route (subcutaneous loading dose) and dose range (up to 300 mg) that is more consistent with the psoriasis program⁵. A combined total of more than 1,000 patients were enrolled in the studies^4,5. Both studies met their primary endpoint, the American College of Rheumatology response criteria (ACR 20) at Week 24 – a standard tool used to assess improvement (at least 20% improvement) in PsA signs and symptoms – and findings were consistent across the two studies^4,5,16.

About Investigational Secukinumab Ankylosing Spondylitis (AS) Phase III trials
MEASURE 1 and MEASURE 2 are multi-center, randomized, placebo-controlled Phase III studies to evaluate the efficacy of investigational secukinumab in IL-17A inhibition in AS compared to placebo, and to assess the safety, tolerability and efficacy in patients with AS. Both MEASURE 1 and MEASURE 2 evaluated investigational secukinumab 75 mg and 150 mg versus placebo. Both studies met their primary endpoint of ASAS20 (Assessment of Spondyloarthritis International Society criteria response) and the results of the two studies were consistent for the 150 mg dose.

About Investigational Secukinumab (AIN457) and Interleukin-17A (IL-17A)
Investigational secukinumab (AIN457) is a fully human monoclonal antibody (mAb) that selectively binds to and neutralizes interleukin-17A (IL-17A)¹³. IL-17A is a central cytokine (messenger protein) involved in the development of psoriasis and is found in high concentration in skin affected by the disease^17,18. Research shows that IL-17A plays a key role in driving the body's autoimmune response in disorders such as moderate-to-severe plaque psoriasis (PsO) and certain inflammatory arthritic diseases, such as PsA and AS¹⁹.

Investigational secukinumab is the first IL-17A inhibitor with positive Phase III results for the treatment of PsA and AS^1-5 complementing positive Phase III results for the treatment of moderate-to-severe plaque psoriasis⁶. In addition to PsA and AS, investigational secukinumab is also in clinical trials for the treatment of rheumatoid arthritis (RA).

The safety and efficacy of investigational secukinumab are still under investigation and market authorization has not yet been obtained in Canada.

About Psoriatic Arthritis (PsA)
Psoriatic arthritis (PsA) is part of a family of chronic diseases impacting joints, known as spondyloarthritis (SpA); approximately 30% of patients with psoriasis have psoriatic arthritis^8,10. PsA is a debilitating, chronic inflammatory disease linked with significant disability, poor quality of life and reduced life expectancy¹⁰. PsA is associated with joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis, and irreversible joint damage²¹. 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^10,14.

About Ankylosing Spondylitis (AS)
Ankylosing spondylitis (AS) is a common type of spondyloarthritis (SpA), a family of chronic diseases of joints (inflammatory disease)^7,8. Up to 70% of patients with severe AS can develop spinal fusion (bones grow together), significantly reducing mobility and quality of life^10,15,20. AS occurs in up to 1% of the general population and typically affects young men and women aged 25 or older^21,22. Certain genetic factors may increase a person's risk of developing AS by more than 50%¹⁵.

About Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2013, the company invested close to $100 million in research and development in Canada. Novartis Pharmaceuticals Canada Inc. employs more than 600 people in Canada. For further information, please consult www.novartis.ca.

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 www.novartis.com.

References
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SOURCE: Novartis Pharmaceuticals Canada Inc.

Novartis Media Relations: Elizabeth Tanguay, Novartis Pharmaceuticals Canada Inc. , [phone], [email protected]; Rob McEwan, Argyle Communications, + 1 416 968-7311 ext. 242, [email protected]