Press Release: Third Novartis Phase III trial -2-

were blood and lymphatic system disorders (including abnormally low

neutrophil and white blood cell count), headache, back pain, nausea,

fatigue, diarrhea, vomiting, constipation, hair loss and rash and

abnormally low levels of neutrophils or white blood cells, abnormal

liver function tests (increased alanine and aspartate aminotransferase),

abnormally low lymphocyte count, low levels of phosphate, vomiting,

nausea, fatigue and back pain, respectively. Low levels of neutrophils

was the most commonly seen severe adverse event; fever in addition to a

low neutrophil count was reported in 1.5% of patients.

Kisqali can cause serious side effects such as a significant decrease in

neutrophil count, abnormal liver function tests and may have an effect

on the electrical activity of the heart known as QT/QTc interval

prolongation, which could lead to disturbances in heart rhythm. As a

precaution, patients should have complete blood counts, liver function,

and serum electrolyte levels measured prior to starting treatment as

well as during treatment with Kisqali. Patients should also have their

heart activity checked before and monitored during treatment.

The efficacy and safety of ribociclib have not been studied in patients

with critical visceral disease.

The use of Kisqali with medicinal products known to prolong QTc interval

or strong CYP3A4 inhibitors should be avoided as this may lead to

prolongation of the QT/QTc interval. If treatment with a strong CYP3A4

inhibitor cannot be avoided, the Kisqali dose should be reduced.

Concomitant administration with other medicines that could affect

cardiac repolarization or prolong the QT/QTc interval should be taken

into account prior to and during treatment with Kisqali. Patients taking

sensitive CYP3A4 substrates with narrow therapeutic index should use

caution because of the increased risk of adverse events that may occur

if these medications are co-administered with Kisqali.

Kisqali contains soya lecithin and therefore it should not be taken by

patients who are allergic to peanut or soya.

Animal studies suggest that Kisqali may cause fetal harm in pregnant

women. Therefore, as a precaution, women of childbearing potential

should use effective contraception while receiving Kisqali during

treatment and up to 21 days after stopping treatment. Women should not

breast feed for at least 21 days after the last dose of Kisqali. Kisqali

may affect fertility in males.

Please see full Prescribing Information for Kisqali, available at

www.kisqali.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 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 124,000

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

approximately 155 countries around the world. For more information,

please visit http://www.novartis.com.

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For Novartis multimedia content, please visit

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References

[1] Slamon J, et al. Ribociclib (RIB) + fulvestrant (FUL) in

postmenopausal women with hormone receptor-positive (HR+), HER2-negative

(HER2-) advanced breast cancer (ABC): Results from MONALEESA-3. Journal

of Clinical Oncology 2018.

[2] Hurvitz S, et al. Ribociclib (RIB) + tamoxifen (TAM) or a

non-steroidal aromatase inhibitor (NSAI) in premenopausal women with

hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast

cancer (ABC) who received prior chemotherapy (CT): MONALEESA-7 subgroup

analysis. Presented at the 54th Annual Meeting of the American Society

of Clinical Oncology (ASCO), June 2, 2018, Chicago, Illinois (abstract

#1047).

[3] De Laurentiis M, et al. Ribociclib (RIBO) + letrozole (LET) in

patients (pts) with hormone receptor-positive (HR+), human epidermal

growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC)

with no prior endocrine therapy (ET) for ABC: Preliminary results from

the phase 3b CompLEEment-1 trial. Presented at the 54th Annual Meeting

of the American Society of Clinical Oncology (ASCO), June 2, 2018,

Chicago, Illinois (abstract #1056).

[4] Hortobagyi G, et al. First-line ribociclib (RIB) + letrozole (LET)

in hormone receptor-positive (HR+), HER2-negative (HER2-) advanced

breast cancer (ABC): MONALEESA-2 biomarker analysis. Presented at the

54th Annual Meeting of the American Society of Clinical Oncology (ASCO),

June 2, 2018, Chicago, Illinois (abstract #1022).

# # #

Novartis Media Relations

Central media line: +41 61 324 2200

E-mail: media.relations@novartis.com

Eric Althoff Julie Masow

Novartis Global Media Relations Novartis Oncology Media Relations

+41 61 324 7999 (direct) +1 862 778 7220 (direct)

+41 79 593 4202 (mobile) +1 862 579 8456 (mobile)

eric.althoff@novartis.com julie.masow@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/2196845/851437.pdf

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contained therein.

Source: Novartis International AG via Globenewswire

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Novartis International AG

P.O. Box Basel Switzerland

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http://www.novartis.com

(END) Dow Jones Newswires

June 03, 2018 09:00 ET (13:00 GMT)