Press Release: Novartis drug Tasigna(R) is -2-

potential need to re-initiate treatment with Tasigna during pregnancy.

Women taking Tasigna should not breastfeed.

Cases of cardiovascular events included ischemic heart disease-related

events, peripheral arterial occlusive disease, and ischemic

cerebrovascular events have been reported. Serious cases of hemorrhage

from various sites including gastrointestinal were reported in patients

receiving Tasigna. Grade 3 or 4 fluid retention including pleural

effusion, pericardial effusion, ascites and pulmonary edema have been

reported. Cases of tumor lysis syndrome have been reported in

Tasigna-treated patients who were resistant or intolerant to prior CML

therapy.

In pediatric patients the long-term effects of prolonged treatment with

Tasigna is unknown.

Eligible patients who are confirmed to express the typical BCR-ABL

transcripts, e13a2/b2a2 or e14a2/b3a2, can be considered for treatment

discontinuation. Frequent monitoring of BCR-ABL transcript levels in

patients eligible for treatment discontinuation must be performed with a

quantitative diagnostic test validated to measure molecular response

levels with a sensitivity of at least MR4.5 (BCR-ABL/ABL <=0.0032% IS).

BCR-ABL transcript levels must be assessed prior to and during treatment

discontinuation. Loss of major molecular response (MMR=BCR-ABL/ABL

<=0.1% IS) or confirmed loss of MR4 (two consecutive measures separated

by at least 4 weeks showing loss of MR4 (MR4=BCR-ABL/ABL <=0.01% IS)

will trigger treatment re-initiation within 4 weeks of when loss of

remission is known to have occurred. It is crucial to perform frequent

monitoring of BCR-ABL transcript levels and complete blood count with

differential in order to detect possible loss of remission. For patients

who fail to achieve MMR after three months of treatment re-initiation,

BCR-ABL kinase domain mutation testing should be performed.

The most frequent Grade 3 or 4 adverse events are hematological

(neutropenia, thrombocytopenia, anemia) which are generally reversible

and usually managed by withholding Tasigna temporarily or dose

reduction. Chemistry panels, including electrolytes, lipid profile,

liver enzymes, and glucose should be checked prior to therapy and

periodically. Tasigna can cause increases in serum lipase. The most

frequent non-hematologic adverse events were rash, pruritus, nausea,

fatigue, headache, alopecia, myalgia, constipation and diarrhea.

Musculoskeletal pain, myalgia, pain in extremity, arthralgia, bone pain

and spinal pain may occur upon discontinuing treatment with Tasigna

within the framework of attempting treatment-free remission.

Please see full Prescribing Information including Boxed WARNING at

https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/tasigna.pdf.

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; 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 2016, the Group achieved net sales of USD 48.5

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

9.0 billion. Novartis Group companies employ approximately 121,000

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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*No loss of MMR (BCR-ABL1 <= 0.1%) in newly diagnosed patients, and no

loss of MMR or no confirmed loss of MR4.0 (BCR-ABL1 <= 0.01%) in

patients resistant or intolerant to prior treatment including imatinib.

**Known as Gleevec(R) (imatinib mesylate) tablets in the US and Canada.

References

[1] Tasigna (nilotinib) Prescribing Information. East Hanover, New

Jersey, USA: Novartis Pharmaceuticals Corporation; December 2017.

# # #

Novartis Media Relations

Central media line: +41 61 324 2200

E-mail: media.relations@novartis.com

Eric Althoff Mary Curtin Creaser

Novartis Global Media Relations Novartis Oncology Communications

+41 61 324 7999 (direct) + 1 862 778-2550 (direct)

+41 79 593 4202 (mobile) + 1 862 345-4102 (mobile)

eric.althoff@novartis.com mary.curtin_creaser@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

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Media release (PDF): http://hugin.info/134323/R/2158338/829672.pdf

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Source: Novartis International AG via Globenewswire

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Novartis International AG

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(END) Dow Jones Newswires

December 22, 2017 16:42 ET (21:42 GMT)