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29.05.2020 12:44:58

Press Release: Novartis Piqray(R) receives -2-

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

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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, economic and

business conditions, including the effects of and efforts to mitigate

pandemic diseases such as COVID-19; safety, quality, data integrity 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 800 million people globally

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

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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.


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


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.


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.

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(END) Dow Jones Newswires

May 29, 2020 06:45 ET (10:45 GMT)