01.12.2018 20:29:54

Press Release: Novartis announces longer-term -2-

agitation, anxiety, seizures, difficulty speaking and understanding, or

loss of balance. Patients should be advised to call their healthcare

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) 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 healthcare 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 healthcare provider

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

treatment with Kymriah. Patients should be advised to tell their

healthcare 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 healthcare provider

about their treatment with Kymriah before receiving a live virus

vaccine.

After treatment with Kymriah, patients will be monitored lifelong by

their healthcare provider, as they may develop secondary cancers or

recurrence of their cancer.

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

dangerous activities for eight 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, dizziness/lightheadedness, and headache. However,

these are not all of the possible side effects of Kymriah. Patients

should talk to their healthcare provider for medical advice about side

effects.

Prior to a female patient starting treatment with Kymriah, their

healthcare 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.

Patients should talk to their healthcare provider about birth control

and pregnancy.

Patients should tell their healthcare 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.

Please see the full Prescribing Information for Kymriah, including Boxed

WARNING, and Medication Guide at www.Kymriah.com

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] Grupp S., et al. Updated Analysis of the Efficacy and Safety of

Tisagenlecleucel in Pediatric and Young Adult Patients with

Relapsed/Refractory (r/r) Acute Lymphoblastic Leukemia. 60(th) American

Society of Hematology Annual Meeting and Exposition. Abstract #112599.

[2] Schuster S., et al. Sustained Disease Control for Adult Patients

with Relapsed or Refractory Diffuse Large B-Cell Lymphoma: An Updated

Analysis of Juliet, a Global Pivotal Phase 2 Trial of Tisagenlecleucel,

Acute Lymphoblastic Leukemia. 60(th) American Society of Hematology

Annual Meeting and Exposition. Abstract #11525.

[3] Schuster S., et al. Tisagenlecleucel in Adult Relapsed/Refractory

Diffuse Large B-Cell Lymphoma. N Engl J Med. December 2018.

[4] Van Den Neste E., et al. Outcome of patients with relapsed

diffuse large B-cell lymphoma who fail second-line salvage regimens in

the International CORAL study. Bone Marrow Transplant. January 2016.

# # #

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/2227522/874527.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

--- End of Message ---

Novartis International AG

P.O. Box Basel Switzerland

WKN: 904278;ISIN: CH0012005267;

http://www.novartis.com

(END) Dow Jones Newswires

December 01, 2018 14:30 ET (19:30 GMT)

Analysen zu Novartis AGmehr Analysen

25.11.24 Novartis Hold Joh. Berenberg, Gossler & Co. KG (Berenberg Bank)
22.11.24 Novartis Hold Deutsche Bank AG
22.11.24 Novartis Neutral Goldman Sachs Group Inc.
21.11.24 Novartis Neutral Goldman Sachs Group Inc.
21.11.24 Novartis Underweight Barclays Capital
Eintrag hinzufügen
Hinweis: Sie möchten dieses Wertpapier günstig handeln? Sparen Sie sich unnötige Gebühren! Bei finanzen.net Brokerage handeln Sie Ihre Wertpapiere für nur 5 Euro Orderprovision* pro Trade? Hier informieren!
Es ist ein Fehler aufgetreten!

Aktien in diesem Artikel

Novartis AG 80,10 -0,27% Novartis AG
Novartis AG (Spons. ADRS) 98,60 0,00% Novartis AG (Spons. ADRS)