Novartis AIN457 (secukinumab) meets primary endpoint in two Phase III studies in ankylosing spondylitis, a debilitating joint condition of the spine

Novartis International AG / Novartis AIN457 (secukinumab) meets primary endpoint in two Phase III studies in ankylosing spondylitis, a debilitating joint condition of the spine . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Secukinumab is the first selective IL-17A inhibitor to meet primary endpoint in two pivotal Phase III studies showing improvement in active ankylosing spondylitis (AS) patients' symptoms versus placebo
   
• AS is a painful, progressively debilitating condition associated with inflammation of the spine, causing irreversible consequences that significantly reduce patients' mobility and quality of life[1],[2]
   
• Up to 40% of patients have an inadequate or no response to standard of care anti-TNF (tumor-necrosis-factor)  medicines, currently the only biologic therapies available for patients with AS[1]
   
• The secukinumab results in AS follow positive topline data in psoriatic arthritis (PsA) announced in September; joint regulatory filing of secukinumab in AS and PsA planned for 2015

Basel, October 23, 2014 - Novartis today announced that AIN457 (secukinumab) met primary and key secondary endpoints in two pivotal Phase III studies (MEASURE 1 and MEASURE 2) in patients with ankylosing spondylitis (AS). Key endpoints included improvements in signs and symptoms of the disease versus placebo and associated improvements in physical function and quality of life. Secukinumab is an investigational medicine that works by stopping the action of interleukin-17A (IL-17A)[3], a protein that is central to the development of inflammatory diseases[4], including AS. MEASURE 1 and MEASURE 2 enrolled a combined total of approximately 600 patients. Detailed results of the studies will be presented at an upcoming medical congress.

"We are thrilled to see positive results with secukinumab in AS, a gravely debilitating condition with a significant remaining unmet need as up to 40% of patients do not respond to anti-TNF therapies," said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. "With these results in AS and the recently announced positive results in psoriatic arthritis, we now have data from four Phase III trials of secukinumab in spondyloarthropathies which we look forward to presenting at a congress later this year."