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Real-world data show Novartis drug Revolade® improves outcomes for ITP patients compared to other second-line therapies

Novartis International AG /
Real-world data show Novartis drug Revolade® improves outcomes for ITP patients
compared to other second-line therapies
. Processed and transmitted by West Corporation.
The issuer is solely responsible for the content of this announcement.

* Revolade (eltrombopag) showed lower rate of bleeding-related episodes and
similar rate of thrombotic events vs. romiplostim, rituximab and
splenectomy, in a retrospective analysis of US electronic health records

* Patients who received splenectomy, as second-line regimen, showed highest
platelet counts and most frequent thrombotic event rates among groups
receiving other therapies

* Immune thrombocytopenia (ITP) is a rare blood disorder where there is an
increased risk of bleeding due to a low number of platelets

Basel, December 2, 2018 - Novartis announced results of a retrospective, real-
world evidence study in patients with immune thrombocytopenia (ITP) treated with
Revolade(® )(eltrombopag), compared to other second-line therapies. The data
demonstrated that patients experienced better clinical outcomes with Revolade,
in terms of fewer bleeding episodes. The data were presented during the 60(th)
Annual Meeting of the American Society of Hematology (ASH) in San Diego.

"Despite advances in treating immune thrombocytopenia, many patients remain at
risk for bleeding episodes," said Samit Hirawat, MD, Head, Novartis Oncology
Global Drug Development. "With these kind of real-world data, we can reimagine
care by more clearly understanding the outcomes of a range of treatments and, in
turn, helping healthcare providers better navigate available options with their
patients."

Electronic health records (EHR) data from January 1, 2009 to September 30, 2016
from the Optum(®) EHR database were used to evaluate the effect of second-line
agents for ITP. Identified patients had the following characteristics: 18 years
or older, evidence of previous treatment with steroids or immune globulin
products, and activity in the database for at least 6 months prior to and 12
months post initiation of a second-line agent. Treatment outcomes evaluated
included platelet counts, bleeding related episodes (BREs), and thrombotic
events (TEs) over the 12-month period following starting a second-line therapy.

Of the 2,526 adults that met the inclusion criteria, 110 (4.4%) received
eltrombopag, 189 (7.5%) romiplostim, 1,488 (58.9%) rituximab, and 260 (10.3%)
splenectomy, with the remaining 479 (18.9%) receiving a mix of other second-line
agents. Compared to baseline, platelet counts increased in all treatment
cohorts. The proportion of patients who experienced BREs ranged from 25.5%
(eltrombopag) to 36.5% (romiplostim), while TEs were observed in all treatment
cohorts ranging from 11.6% (eltrombopag) to 15.7% (splenectomy). An additional
analysis demonstrated that patients with ITP who had a splenectomy as second-
line treatment had the highest mean platelet counts during the first 12 months
post treatment initiation, but were at greatest risk for TEs (15.7%) (e.g.,
stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis,
and pulmonary embolism) compared to 11.6% (eltrombopag), 12.7% (romiplostim),
and 13.9% (rituximab).

"These real-world data can help doctors as they weigh options for second-line
therapy with their patients." Adam Cuker, MD, Assistant Professor of Medicine at
the University of Pennsylvania. "They may also help explain the long-term trend
toward deferring splenectomies until after other lines of treatment have been
tried."

Immune thrombocytopenia is a rare and potentially serious blood disorder where
there is an increased risk of bleeding due to a low number of platelets. As a
result, patients with ITP experience bruising, bleeding and, in rare cases,
serious hemorrhage that can be fatal.[1] The goal of treatment in
chronic/persistent ITP is to maintain a safe platelet count that reduces the
risk of bleeding.[1]

Promacta(®)/Revolade(®) (eltrombopag)
Eltrombopag, marketed as Promacta(®) in the US and Revolade(®) in countries
outside the US, is approved in more than 90 countries worldwide for the
treatment of thrombocytopenia in adult patients with chronic immune
thrombocytopenic purpura (ITP) who have had an inadequate response or are
intolerant to other treatments. It is also approved for the treatment of
patients with severe aplastic anemia (SAA) as first-line therapy in the US
(patients 2 years and older) and Japan, and in many other countries for patients
who are refractory to other treatments. In more than 40 countries,
Promacta/Revolade is indicate for the treatment of thrombocytopenia in patients
with chronic hepatitis C to allow them to initiate and maintain interferon-based
therapy. Promacta/Revolade is approved in the US and in the European Union for
the treatment of thrombocytopenia in pediatric patients 1 year and older with
chronic immune thrombocytopenia (ITP) who have had an insufficient response to
corticosteroids, immunoglobulins, or splenectomy. Promacta should only be used
in patients with ITP whose degree of thrombocytopenia and clinical condition
increase the risk for bleeding.

Important Safety Information
Promacta can cause serious side effects, including liver problems, abnormal
liver function tests, high platelet counts and higher risk for blood clots, and
new or worsened cataracts (a clouding of the lens in the eye).

Promacta is not for treatment of people with a precancerous condition called
myelodysplastic syndromes (MDS). If you have MDS and receive Promacta, your MDS
condition may worsen and become AML. If MDS worsens to become AML, you may die
sooner from AML.

For patients who have chronic hepatitis C virus and take Promacta with
interferon and ribavirin treatment, Promacta may increase the risk of liver
problems. Patients should tell a healthcare provider right away if they have any
of these signs and symptoms of liver problems including yellowing of the skin or
the whites of the eyes (jaundice), unusual darkening of the urine, unusual
tiredness, right upper stomach area pain, confusion, swelling of the stomach
area (abdomen).

A healthcare provider will order blood tests to check the liver before starting
Promacta and during Promacta treatment. In some cases, treatment with Promacta
may need to be stopped due to changes in liver function tests.

The risk of getting a blood clot is increased if the platelet count is too high
during treatment with Promacta. The risk of getting a blood clot may also be
increased during treatment with Promacta if platelet counts are normal or low.
Some forms of blood clots, such as clots that travel to the lungs or that cause
heart attacks or strokes can cause severe problems or death. A healthcare
provider will check blood platelet counts, and change the dose of Promacta or
stop Promacta, if platelet counts get too high. Patients should tell a
healthcare provider right away if they have signs and symptoms of a blood clot
in the leg, such as swelling, pain, or tenderness in the leg.

People with chronic liver disease may be at risk for a type of blood clot in the
stomach area. Patients should tell a healthcare provider right away if they have
stomach area pain that may be a symptom of this type of blood clot.

New or worsened cataracts have happened in people taking Promacta. A healthcare
provider will check the patient's eyes before and during treatment with
Promacta. Patients should tell a healthcare provider about any changes in
eyesight while taking Promacta.

Patients should tell a healthcare provider about all the medicines they take,
including prescription and over-the-counter medicines, vitamins, and herbal
supplements. Promacta may affect the way certain medicines work. Certain
medicines may keep Promacta from working correctly. Patients should take
Promacta at least 4 hours before or 4 hours after taking products such as
antacids used to treat stomach ulcers or heartburn and multivitamins or products
that contain iron, calcium, aluminum, magnesium, selenium, and zinc, which may
be found in mineral supplements. Patients should ask a healthcare provider if
they are not sure if the medicine is one that is listed above.

Patients should avoid situations and medications that may increase the risk of
bleeding while taking Promacta.

The most common side effects of Promacta when used to treat chronic ITP in
adults are: nausea; diarrhea; upper respiratory tract infection (symptoms may
include runny nose, stuffy nose, and sneezing); vomiting; muscle aches; urinary
tract infection (symptoms may include frequent or urgent need to urinate, low
fever in some people, pain or burning with urination); pain or swelling
(inflammation) in the throat or mouth (oropharyngeal pain and pharyngitis);
abnormal liver function tests; back pain; flu-like symptoms (influenza),
including fever, headache, tiredness, cough, sore throat, and body aches; skin
tingling, itching, or burning; and rash.

The most common side effects of Promacta in children 1 year and older when used
to treat chronic ITP are: upper respiratory tract infections (symptoms may
include runny nose, stuffy nose, and sneezing); pain or swelling (inflammation)
in the nose and throat (nasopharyngitis); cough; diarrhea; pyrexia; runny,
stuffy nose (rhinitis); stomach (abdominal) pain; pain or swelling
(inflammation) in the throat or mouth; toothache; abnormal liver function tests;
rash; runny nose (rhinorrhea).

The most common side effects when Promacta is used in combination with other
medicines to treat chronic HCV are: low red blood cell count (anemia); fever;
tiredness; headache; nausea; diarrhea; decreased appetite; flu-like symptoms
(influenza), including fever, headache, tiredness, cough, sore throat, and body
aches; feeling weak; trouble sleeping; cough; itching; chills; muscle aches;
hair loss; and swelling in the ankles, feet, and legs.

The most common side effects of Promacta when used to treat severe aplastic
anemia (SAA) are: nausea, feeling tired, cough, diarrhea, headache, pain in
arms, legs, hands or feet, shortness of breath, fever, dizziness, pain in nose
or throat, abdominal pain, bruising, muscle spasms, abnormal liver function
tests, joint pain, and runny nose. Laboratory tests may show abnormal changes to
the cells in bone marrow.

The most common side effects of Promacta when used to treat adults and pediatric
patients 2 years and older with SAA in combination with standard
immunosuppressive therapy are: abnormal liver function tests, rash and skin
discoloration including darkening of skin patches
(hyperpigmentation).

Please see full Prescribing Information, including Boxed WARNING and Medication
Guide, for Promacta(®).

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.

Optum(®) is a registered trademark of UnitedHealth Group.

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]    National Heart, Lung and Blood Institute. Immune Thrombocytopenia.
https://www.nhlbi.nih.gov/health-topics/immune-thrombocytopenia. Accessed
October 2, 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 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/2227503/874517.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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