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31.01.2018 22:59:59

Press Release: Novartis announces NEJM -2-

loss of balance. Patients should be advised to call their health care

provider or get emergency help right away if they experience any of

these signs and symptoms of CRS or neurological toxicities.

Because of the risk of CRS and neurological toxicities, Kymriah is only

available through a restricted program under a Risk Evaluation and

Mitigation Strategy (REMS) in the US called Kymriah REMS.

Serious allergic reactions, including anaphylaxis, may occur after

Kymriah infusion.

Kymriah can increase the risk of life-threatening infections that may

lead to death. Patients should be advised to tell their health care

provider right away if they develop fever, chills, or any signs or

symptoms of an infection.

Patients may experience prolonged low blood cell counts (cytopenia),

where one or more types of blood cells (red blood cells, white blood

cells, or platelets) are decreased. The patient's health care provider

will do blood tests to check all of their blood cell counts after

treatment with Kymriah. Patients should be advised to tell their health

care provider right away if they get a fever, are feeling tired, or have

bruising or bleeding.

Patients may experience hypogammaglobulinemia, a condition in which the

level of immunoglobulins (antibodies) in the blood is low and the risk

of infection is increased. It is expected that patients may develop

hypogammaglobulinemia with Kymriah, and may need to receive

immunoglobulin replacement for an indefinite amount of time following

treatment with Kymriah. Patients should tell their health care provider

about their treatment with Kymriah before receiving a live virus

vaccine.

After treatment with Kymriah, patients will be monitored life-long by

their health care provider, as they may develop secondary cancers or

recurrence of their leukemia.

Patients should not drive, operate heavy machinery, or do other

dangerous activities for 8 weeks after receiving Kymriah because the

treatment can cause temporary memory and coordination problems,

including sleepiness, confusion, weakness, dizziness, and seizures.

Some of the most common side effects of Kymriah are difficulty breathing,

fever (100.4degF/38degC or higher), chills/shaking chills, confusion,

severe nausea, vomiting and diarrhea, severe muscle or joint pain, very

low blood pressure, and dizziness/lightheadedness. However, these are

not all of the possible side effects of Kymriah. Patients should talk to

their health care provider for medical advice about side effects.

Prior to a female patient starting treatment with Kymriah, their health

care provider may do a pregnancy test. There is no information available

for Kymriah use in pregnant or breast-feeding women. Therefore, Kymriah

is not recommended for women who are pregnant or breast feeding. If

either sex partner has received Kymriah, patients should talk to their

health care provider about birth control and pregnancy.

Patients should tell their health care provider about all the medicines

they take, including prescription and over-the-counter medicines,

vitamins, and herbal supplements.

After receiving Kymriah, patients should be advised that some commercial

HIV tests may cause a false positive test result. Patients should also

be advised not to donate blood, organs, or tissues and cells for

transplantation after receiving Kymriah.

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

Kymriah, regarding our ability to scale and sustain commercial

manufacturing for Kymriah, or regarding potential future revenues from

Kymriah. 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

Kymriah will be submitted or approved for sale or for any additional

indications or labeling in any market, or at any particular time.

Neither can there be any guarantee that Novartis will successfully scale

and sustain commercial manufacturing for Kymriah, or successfully

sustain a network of treatment centers to offer Kymriah. Nor can there

be any guarantee that Kymriah will be commercially successful in the

future. In particular, our expectations regarding Kymriah could be

affected by, among other things, our ability to successfully scale and

sustain commercial manufacturing and sustain a network of treatment

centers; 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; our ability to obtain or maintain proprietary intellectual

property protection; the particular prescribing preferences of

physicians and patients; global trends toward health care cost

containment, including government, payor and general public pricing and

reimbursement pressures; general economic and industry conditions,

including the effects of the persistently weak economic and financial

environment in many countries; safety, quality or manufacturing issues,

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 provides innovative healthcare solutions that address the

evolving needs of patients and societies. Headquartered in Basel,

Switzerland, Novartis offers a diversified portfolio to best meet these

needs: innovative medicines, cost-saving generic and biosimilar

pharmaceuticals and eye care. Novartis has leading positions globally in

each of these areas. In 2017, the Group achieved net sales of USD 49.1

billion, while R&D throughout the Group amounted to approximately USD

9.0 billion. Novartis Group companies employ approximately 122,000

full-time-equivalent associates. Novartis products are sold in

approximately 155 countries around the world. For more information,

please visit http://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

# # #

Novartis Media Relations

Central media line: +41 61 324 2200

E-mail: media.relations@novartis.com

Eric Althoff Fiona Phillips

Novartis Global Media Relations Novartis Oncology Communications

+41 61 324 7999 (direct) +1 862-778-7705 (direct)

+41 79 593 4202 (mobile) +1 862-217-9396 (mobile)

eric.althoff@novartis.com fiona.phillips@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/2165241/833083.pdf

This announcement is distributed by Nasdaq Corporate Solutions on behalf

of Nasdaq Corporate Solutions 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

--- End of Message ---

Novartis International AG

P.O. Box Basel Switzerland

WKN: 904278;ISIN: CH0012005267;

http://www.novartis.com

(END) Dow Jones Newswires

January 31, 2018 17:00 ET (22:00 GMT)

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Aktien in diesem Artikel

Novartis AG 80,10 -0,27% Novartis AG
Novartis AG (Spons. ADRS) 99,60 2,05% Novartis AG (Spons. ADRS)

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NASDAQ Comp. 19 003,65 0,16%