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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."

In the analysis of the per protocol population of the 52-week SUSTAIN study,
which compared the P-selectin inhibitor crizanlizumab with placebo in patients
with sickle cell disease, crizanlizumab (5.0 mg/kg) significantly:
* Increased the percentage of patients who did not experience any VOCs vs
placebo (37.5% vs. 12.2%, p=0.008) during treatment
* More than doubled the median time to first on-treatment VOC (6.55 vs 1.58
months, p < 0.001) and
* Decreased the annual rate of VOCs (1.04 vs 2.18, p=0.02).

SUSTAIN is part of the SENTRY clinical trial program including seven active or
planned clinical studies designed to generate an array of additional data on the
role crizanlizumab plays in the management of sickle cell disease. More studies
may be added as plans are finalized.

Major active trials in the SENTRY program include:
* SOLACE-adults (A2202) Phase II study investigating the pharmacological
properties and safety of crizanlizumab in patients with sickle cell disease
aged 16 and above
* SOLACE-kids (B2201) Phase II study investigating the safety and efficacy of
crizanlizumab in pediatric patients with sickle cell disease
* STAND (A2301) Phase III study investigating the efficacy and safety of
crizanlizumab in sickle cell disease patients aged 12 and above
* SUCCESSOR retrospective cohort study among adult sickle cell disease
patients in the US

"The SENTRY program emphasizes our long-term commitment to reimagining sickle
cell disease treatment for as many people as possible," said Samit Hirawat, MD,
Head, Novartis Oncology Global Drug Development. "The outcomes of these trials,
alongside our analyses of SUSTAIN, will increase our understanding of the
disease and, we hope, take us a step forward in our aspiration to reduce the
burden of sickle cell pain crises."

About the SUSTAIN trial
The Phase II SUSTAIN trial was a multicenter, multinational, randomized,
placebo-controlled, double-blind,12-month study to assess safety and efficacy of
the anti-P-selectin antibody crizanlizumab with or without concomitant use of
hydroxyurea therapy in sickle cell disease patients with sickle cell-related
pain crises. Primary results were published in The New England Journal of
Medicine and showed that crizanlizumab reduced the median annual rate of sickle
cell pain crises (SCPCs) by 45.3% compared to placebo (1.63 vs 2.98, p=0.010) in
patients with or without hydroxyurea therapy[6].

Adverse events that occurred in 10% or more of the patients in either active-
treatment group (2.5 mg/kg; 5 mg/kg) and at a frequency that was at least twice
as high as that in the placebo group were arthralgia, diarrhea, pruritus,
vomiting, and chest pain. There were no apparent increases in infections with
crizanlizumab treatment[6].

About crizanlizumab (SEG101)
Crizanlizumab (SEG101) is a humanized anti-P-selectin monoclonal antibody being
investigated for the prevention of vaso-occlusive crises (VOCs) in patients with
sickle cell disease (SCD)[6]. Crizanlizumab binds a molecule called P-selectin
on the surface of endothelial cells and platelets in the blood vessels, causing
a blockade of P-selectin[6]. P-selectin is one of the major drivers of the vaso-
occlusive process[6]. Results from the Phase II SUSTAIN study demonstrated
that crizanlizumab reduced the median annual rate of VOCs that lead to a
healthcare visit compared to placebo in patients with SCD regardless of whether
or not they were taking hydroxyurea[6].

Disclaimer
This press release contains forward-looking statements within the meaning of the
United States Private Securities Litigation Reform Act of 1995. Forward-looking
statements can generally be identified by words such as "potential," "can,"
"will," "plan," "expect," "anticipate," "look forward," "believe," "committed,"
"investigational," "pipeline," "launch," or similar terms, or by express or
implied discussions regarding potential marketing approvals, new indications or
labeling for the investigational or approved products described in this press
release, or regarding potential future revenues from such products. You should
not place undue reliance on these statements. Such forward-looking statements
are based on our current beliefs and expectations 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 the
investigational or approved products described in this press release will be
submitted or approved for sale or for any additional indications or labeling in
any market, or at any particular time. Nor can there be any guarantee that such
products will be commercially successful in the future. In particular, our
expectations regarding such products could be affected by, among other things,
the uncertainties inherent in research and development, including clinical trial
results and additional analysis of existing clinical data; regulatory actions or
delays or government regulation generally; global trends toward health care cost
containment, including government, payor and general public pricing and
reimbursement pressures; our ability to obtain or maintain proprietary
intellectual property protection; the particular prescribing preferences of
physicians and patients; general political and economic conditions; safety,
quality or manufacturing issues; potential or actual data security and data
privacy breaches, or disruptions of our information technology systems, 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 is reimagining medicine to improve and extend people's lives. As a
leading global medicines company, we use innovative science and digital
technologies to create transformative treatments in areas of great medical need.
In our quest to find new medicines, we consistently rank among the world's top
companies investing in research and development. Novartis products reach nearly
1 billion people globally and we are finding innovative ways to expand access to
our latest treatments. About 125 000 people of more than 140 nationalities work
at Novartis around the world. Find out more at www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at
http://twitter.com/novartis
For Novartis multimedia content, please visit www.novartis.com/news/media-
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For questions about the site or required registration, please contact
media.relations@novartis.com

References
    [1]    Puri L, Nottage KA, Hankins JS, et al. State of the art management of
acute vaso-occlusive pain in sickle cell disease. Paediatr Drugs.
2018;(1)20:29-42.
    [2]    Gutsaeva D, Parkerson J, Yerigenahally S, et al. Inhibition of cell
adhesion by anti-P-selectin aptamer: a new potential therapeutic agent for
sickle cell disease. Blood. 2011;117(2):727-735.
    [3]    Ballas SK, Gupta K, Adams-Graves P. Sickle cell pain: a critical
reappraisal. Blood. 2012:120(18):3647-3656
    [4]    Piel F, Steinberg M, Rees D. Sickle cell disease. N Engl J Med.
2017;376(16):1561-1573.
    [5]    Ballas SK, Lusardi M. Hospital readmission for acute adult sickle
cell painful episodes: frequency, etiology, and prognostic significance. Am J
Hematol. 2005;79(1):17-25.
    [6]    Ataga KI, Kutlar A, Kanter J et al. Crizanlizumab for the Prevention
of Pain Crises in Sickle Cell Disease. N Engl J Med. 2017 Feb 2;376(5):429-439.

# # #

Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations@novartis.com

Eric Althoff Michael Billings
Novartis Global Media Relations Benign Hematology Communications
+41 61 324 7999 (direct) +1 862 778 8656 (direct)
+41 79 593 4202 (mobile) +1 201 400 1854 (mobile)
eric.althoff@novartis.com michael.billings@novartis.com


Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com

Central   North America

Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448

Pierre-Michel Bringer +41 61 324 1065 Cory Twining +1 212 830 2417

Thomas Hungerbuehler +41 61 324 8425

Isabella Zinck +41 61 324 7188



Media release (PDF):
http://hugin.info/134323/R/2227491/874513.pdf



This announcement is distributed by West Corporation on behalf of West Corporation clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Novartis International AG via GlobeNewswire



 
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