Press Release: FDA approves Novartis Piqray(R) - -2-

Hyperglycemia is common with PIQRAY and can be severe. Health care

providers will monitor patients' blood sugar levels before they start

and during treatment with PIQRAY. Health care providers may monitor

patients' blood sugar levels more often if they have a history of Type 2

diabetes. Patients should tell their health care provider right away if

they develop symptoms of hyperglycemia, including excessive thirst, dry

mouth, urinate more often than usual or have a higher amount of urine

than normal, or increased appetite with weight loss. PIQRAY can cause

lung problems (pneumonitis). Patients should tell their health care

provider right away if they develop new or worsening symptoms of lung

problems, including shortness of breath or trouble breathing, cough, or

chest pain. Diarrhea is common with PIQRAY and can be severe. Severe

diarrhea can lead to the loss of too much body water (dehydration) and

kidney problems. Patients who develop diarrhea during treatment with

PIQRAY should tell their health care provider right away.

Before taking PIQRAY, patients should tell their health care provider if

they have a history of diabetes, skin rash, redness of skin, blistering

of the lips, eyes or mouth, or skin peeling, are pregnant, or plan to

become pregnant as PIQRAY can harm their unborn baby. Females who are

able to become pregnant should use effective birth control during

treatment with PIQRAY and for 1 week after the last dose. Do not

breastfeed during treatment with PIQRAY and for 1 week after the last

dose. Males with female partners who are able to become pregnant should

use condoms and effective birth control during treatment with PIQRAY and

for 1 week after the last dose. Patients should also read the Full

Prescribing Information of fulvestrant for important pregnancy,

contraception, infertility, and lactation information.

Patients should tell their health care provider all of the medicines

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

vitamins, and herbal supplements. PIQRAY and other medicines may affect

each other causing side effects. Know the medicines you take. Keep a

list of them to show your health care provider or pharmacist when you

get a new medicine.

The most common side effects of PIQRAY when used with fulvestrant are

rash, nausea, tiredness and weakness, decreased appetite, mouth sores,

vomiting, weight loss, hair loss, and changes in certain blood tests.

Please see full Prescribing Information for Piqray, available at

https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/piqray.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; global trends toward health care cost containment,

including government, payor and general public pricing and reimbursement

pressures and requirements for increased pricing transparency; 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 more than 750 million people

globally and we are finding innovative ways to expand access to our

latest treatments. About 105 000 people of more than 140 nationalities

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References

[1] Piqray (alpelisib) Prescribing Information. East Hanover., New

Jersey, USA: Novartis Pharmaceuticals Corporation; May 2019.

[2] André F, Ciruelos E, Rubovszky G. Alpelisib for

PIK3CA-Mutated, Hormone-Receptor-Positive Advanced Breast Cancer. N Eng

J Med 2019.

[3] André F, Ciruelos EM, Rubovszky G et al. Alpelisib (ALP) +

fulvestrant (FUL) for advanced breast cancer (ABC): Results of the phase

III SOLAR-1 trial. Annals of Oncology, Vol 29, Suppl 8, October 2018,

Abstract LBA3_PR.

[4] Juric D, Ciruelos EM, Rubovszky G et al. Alpelisib (ALP) +

fulvestrant (FUL) for advanced breast cancer (ABC): Phase 3 SOLAR-1

trial results. Presented at the San Antonio Breast Cancer Symposium

(SABCS) (Abstract #GS3-08) on December 6, 2018.

[5] Tolaney S, Toi M, Neven P, et al. Presented at: 2019 American

Association for Cancer Research (AACR) Annual Meeting; March 29-April 3,

2019; Atlanta, GA.

[6] Di Leo A, Johnston S, Seok Lee K, et al. Lancet Oncol.

2018;19(1):87-100.

[7] Moynahan ME, Chen D, He W, et al. Br J Cancer.

2017;116(6):726-730002E

[8] The Cancer Genome Atlas Network. Comprehensive molecular

portraits of human breast tumours. Nature. 2012;490(7418):61-70.

[9] Sobhani N, Roviello G, Corona SP et al. The prognostic value of

PI3K mutational status in breast cancer: a meta-analysis. J Cell

Biochem. 2018;119(6):4287-4292.

[10] Sabine V, Crozier C, Brookes C, et al. Mutational analysis of

PI3K/AKT signaling pathway in tamoxifen exemestane adjuvant

multinational pathology study. Journal of Clinical Oncology.

2014;32:2951-2958.

[11] Miller TW, Rexer BN, Garrett JT, et al. Mutations in the

Phosphatidylinositol 3-Kinase Pathway: Role in Tumor Progression and

Therapeutic Implications in Breast Cancer. Breast Cancer Res. 2011.

[12] Saal LH, Johansson P, Holm K. Poor prognosis in carcinoma is

associated with a gene expression signature of aberrant PTEN tumor

suppressor pathway activity. PNAS. 2007;104(18):7564-7569.

*therascreen is a registered trademark of QIAGEN N.V.

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Novartis Media Relations

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Media release (PDF): http://hugin.info/134323/R/2242179/886823.pdf

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Source: Novartis International AG via Globenewswire

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(END) Dow Jones Newswires

May 24, 2019 16:12 ET (20:12 GMT)