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Novartis investigational therapy crizanlizumab (SEG101) receives FDA Breakthrough Therapy designation for the prevention of vaso-occlusive crises in sickle cell disease

Novartis International AG /
Novartis investigational therapy crizanlizumab (SEG101) receives FDA
Breakthrough Therapy designation for the prevention of vaso-occlusive crises in
sickle cell disease
. Processed and transmitted by West Corporation.
The issuer is solely responsible for the content of this announcement.

* Crizanlizumab is a monthly infusion under development to prevent pain crises
(also called vaso-occlusive crises, or VOCs) in patients with sickle cell
disease

* Sickle cell VOCs, which are triggered by multi-cell adhesion or clusters of
cells that block or reduce blood flow, are associated with increased
morbidity and mortality(1)

* FDA filing of crizanlizumab anticipated in first half of 2019

Basel, January 8, 2019 - Novartis announced today that the US Food and Drug
Administration (FDA) has granted crizanlizumab (SEG101) Breakthrough Therapy
designation for the prevention of vaso-occlusive crises (VOCs) in patients of
all genotypes with sickle cell disease (SCD). Also known as sickle cell pain
crises, VOCs are unpredictable and extremely painful events that can lead to
serious acute and chronic complications(2). VOCs happen when multiple blood
cells stick to each other and to blood vessels, causing blockages(1,3).
Treatments that make blood cells and blood vessels less sticky may help reduce
the number of days patients experience VOCs.

"Painful sickle cell crises matter because they can disrupt patients' lives, and
often require hospital visits and medical attention," said Samit Hirawat, MD,
Head, Novartis Oncology Global Drug Development. "We look forward to working
closely with the FDA over the coming months toward making crizanlizumab, a
therapy that has the potential to prevent sickle cell pain crises, available in
the US as soon as possible."

According to FDA guidelines, treatments that receive Breakthrough Therapy
designation are those that treat a serious or life-threatening disease or
condition and demonstrate a substantial improvement over existing therapies on
one or more significant end points based on preliminary clinical evidence.

The FDA granted Breakthrough Therapy designation for crizanlizumab based on
positive results of the Phase II SUSTAIN trial, which compared the P-selectin
inhibitor crizanlizumab with placebo in patients with sickle cell disease.
SUSTAIN showed that crizanlizumab reduced the median annual rate of VOCs leading
to health care visits by 45.3% compared to placebo (1.63 vs 2.98, P=0.010) in
patients with or without hydroxyurea therapy. The study also demonstrated that
crizanlizumab significantly increased the percentage of patients who did not
experience any VOCs vs placebo (35.8% vs 16.9%, P=0.010) during treatment(4).

Patients taking crizanlizumab (5 mg/kg) experienced a similar incidence of
treatment-emergent adverse events (AEs) (86.4% vs 88.7%) and serious AEs (25.8%
vs 27.4%) compared to placebo, and a low incidence of discontinuations (3%) due
to adverse events. 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 included arthralgia,
diarrhea, pruritus, vomiting, and chest pain. There were no apparent increases
in infections with crizanlizumab treatment(4).

About Sickle Cell Disease (SCD)
Sickle cell disease is a debilitating genetic blood disorder that affects the
shape of your red blood cells and can make blood cells and blood vessels
stickier than usual(1,5). When blood cells stick to one another they can form
clusters in the bloodstream. These clusters can block the flow of blood and
oxygen, which can cause damage to the blood vessels and organs(1,3). These
blockages also can lead to painful crises called vaso-occlusive crises, or VOCs.
VOCs are painful complications of the disease and the main reason why patients
seek medical care in hospitals(1). Treatment of sickle cell disease is also
associated with a high economic burden. The average sickle cell disease patient
is estimated to face nearly $1 million in total lifetime health care costs with
annual costs of more than $30,000 for adults(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). Crizanlizumab binds to a molecule called P-selectin
on the surface of platelets and endothelium in the blood vessels and has been
shown to inhibit interactions between endothelial cells, platelets, red blood
cells, sickled red blood cells, and leukocytes, causing a blockade and thereby
preventing these cells from being able to bind to P-selectin. P-selectin is one
of the major drivers of the vaso-occlusive process. Our goal is to deepen
understanding of the true impact of VOCs on patients' bodies and lives and to
explore how crizanlizumab can help to achieve more pain-crisis-free days for
patients with SCD(4).

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-
library
For questions about the site or required registration, please contact
media.relations@novartis.com

References
[1]   Gutsaeva D, Parkerson J, Yerigenahally S, et. Inhibition of cell adhesion
by anti-P-selectin aptamer: a new potential therapeutic agent for sickle cell
disease. Blood. 2011;117(2):727-735.
[2]   Yale SH. Approach to the vaso-occlusive crisis in adults with sickle
cell. Am Fam Physician. 2000 Mar 1;61(5):1349-1356.
[3]   Steinberg M. Management of sickle cell disease. N Engl J Med.
1999;340(13):1021-1030.
[4]   Ataga KI, Kutlar A, Kanter J et al. Crizanlizumab for the prevention of
pain crises in sickle cell disease. N Engl J Med. 2017. 376(5):429-439.
[5]   Sparkenbaugh E, Pawlinski R. Interplay between coagulation and vascular
inflammation in sickle cell disease. J Haematol. 2013;162(1):1-22.
[6]   American Society of Hematology. State of sickle cell disease 2016 report.
Available from:
http://www.scdcoalition.org/pdfs/ASH%20State%20of%20Sickle%20Cell%20Disease%
202016%20Report.pdf. Accessed on July 17, 2018.

# # #

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

Eric Althoff Michael Billings
Novartis Global Media Relations 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/2230725/876675.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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