Novartis announces new crizanlizumab (SEG101) data analysis in sickle cell disease, and investment in SENTRY clinical program

Novartis International AG / Novartis announces new crizanlizumab (SEG101) data analysis in sickle cell disease, and investment in SENTRY clinical program . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• New post-hoc analysis of SUSTAIN study, presented at ASH 2018, highlights results among patients who were treated per protocol compared with all randomized patients

Crizanlizumab, a monthly infusion being investigated for the treatment of sickle cell disease, approximately halved the annual rate of sickle cell disease-related pain crises (also called vaso-occlusive crises, or VOCs) vs placebo

SENTRY is an umbrella clinical trial program comprising initially seven active or planned trials of crizanlizumab in sickle cell disease; more trials may be added

Basel, December 1, 2018 - New data from a post hoc analysis of the Phase II SUSTAIN study of crizanlizumab -- a once-a-month, humanized anti-P-selectin monoclonal antibody infusion being investigated for the treatment of sickle cell disease (SCD) -- shows greater reductions of vaso-occlusive crises (VOCs) in patients who were adherent to the treatment protocol. The data were presented during the 60^th Annual Meeting of the American Society of Hematology (ASH) in San Diego.

Sickle cell VOCs are painful complications of the disease and the main reason why patients seek medical care in hospitals[1],[2]. These crises are triggered by multi-cell adhesion, or clusters of cells that block blood flow, and are associated with increased morbidity and mortality[3],[4]. Currently, treatment options to prevent VOCs are limited. By targeting P-selectin, crizanlizumab reduces multicellular adhesion[2],[5].

"Patients with sickle cell disease experience recurrent and severe episodes of debilitating pain that often require medical attention and emergency medical care," said Kenneth Ataga, MD, Director of the Center for Sickle Cell Disease at the University of Tennessee Health Science Center at Memphis, and Principal Investigator of the SUSTAIN analysis. "It is encouraging that these data show treatment per protocol not only reduced the frequency of painful crises, but also increased the number patients with no crises at all. These findings underscore the potential of crizanlizumab and the importance of proactive management of sickle cell disease."