Press Release: Novartis Pluvicto(TM) shows -2-

At Novartis, we are harnessing the innovation of our world-class scientists, strategic partnerships and one of the industry's most competitive pipelines to explore the potential of new, targeted therapies and precision medicine platforms to address the greatest unmet needs in prostate cancer.

Our goal is to reduce the global disease burden, extend the lives of patients with prostate cancer and elevate current standards of care.

Novartis and Radioligand Therapy (RLT)

Novartis is reimagining cancer care with RLT for patients with advanced cancers. By harnessing the power of radioactive atoms and applying it to advanced cancers, RLT is theoretically able to deliver radiation to target cells anywhere in the body(1) (7,18).

Novartis is investigating a broad portfolio of RLTs, exploring new isotopes, ligands and combination therapies to look beyond gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and prostate cancer and into breast, colon, lung and pancreatic cancer.

Novartis has established global expertise, specialized supply chain and manufacturing capabilities across its network of RLT production sites. In order to support growing demand for our RLT platform, we have expanded our production capabilities in Millburn, New Jersey (U.S.), Zaragoza (Spain) and Ivrea (Italy) and have a new-state-of-the art facility in Indianapolis, Indiana (U.S.), which is expected to open in the coming months, pending approval from the U.S. Food and Drug Administration (FDA) approval. We are continually evaluating additional opportunities to expand capacity around the world.

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," "may," "could," "would," "expect," "anticipate," "seek," "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, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; 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 a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.

Reimagine medicine with us: Visit us at https://www.novartis.com/ https://www.novartis.com and connect with us on https://www.linkedin.com/company/novartis LinkedIn, https://www.facebook.com/novartis/ Facebook, https://twitter.com/Novartis X/Twitter and https://www.instagram.com/novartis/?hl=de Instagram.

References

1. Novartis Data on File.

2. Novartis. Press release. Novartis Pluvicto(TM) shows statistically

significant and clinically meaningful radiographic progression-free

survival benefit in patients with PSMA-positive metastatic

castration-resistant prostate cancer. December 5, 2022.

https://www.novartis.com/news/media-releases/novartis-pluvictotm-shows-statistically-significant-and-clinically-meaningful-radiographic-progression-free-survival-benefit-patients-psma-positive-metastatic-castration-resistant-prostate-cancer

3. American Cancer Society (ACS). Survival Rates for Prostate Cancer.

Accessed October 2022.

https://www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/survival-rates.html.

4. de Bono J, Mateo J, Fizazi K, et al. Olaparib for Metastatic

Castration-Resistant Prostate Cancer. N Engl J Med.

2020;382(22):2091-2102. doi:10.1056/NEJMoa1911440.

5. de Wit R, de Bono J, Sternberg CN, et al. Cabazitaxel versus Abiraterone

or Enzalutamide in Metastatic Prostate Cancer. N Engl J Med.

2019;381(26):2506-2518. doi:10.1056/NEJMoa1911206.

6. Komura K, Fujiwara Y, Uchimoto T, et al. Comparison of Radiographic

Progression-Free Survival and PSA Response on Sequential Treatment Using

Abiraterone and Enzalutamide for Newly Diagnosed Castration-Resistant

Prostate Cancer: A Propensity Score Matched Analysis from Multicenter

Cohort. J Clin Med. 2019;8(8):1251. Published 2019 Aug 19.

doi:10.3390/jcm8081251.

7. Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or

mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med.

2004;351(15):1502-1512. doi:10.1056/NEJMoa040720.

8. Novartis Pharmaceuticals. 177Lu-PSMA-617 vs. Androgen Receptor-directed

Therapy in the Treatment of Progressive Metastatic Castrate Resistant

Prostate Cancer (PSMAfore). U.S. National Library of Medicine: Clinical

Trials. 2020; NCT04689828.

9. Sartor O, de Bono J, Chi KN, et al. Lutetium-177-PSMA-617 for Metastatic

Castration-Resistant Prostate Cancer. N Engl J Med.

2021;385(12):1091-1103. doi:10.1056/NEJMoa2107322.

10. University of Chicago Medicine. Lutetium-177 PSMA Therapy for Prostate

Cancer (Pluvicto). Accessed October 3,

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ancer/treatment/lutetium-177-psma-therapy-for-prostate-cancer

11. Pluvicto [prescribing information]. Millburn, NJ: Advanced Accelerator

Applications USA, Inc.; 2022.

12. Pluvicto [Summary of Product Characteristics]. EMA. 2022

13. Advanced Accelerator Applications USA, Inc. PLUVICTO(TM) Canadian Product

Monograph. August 25, 2022.

14. Pluvicto [Summary of Product Characteristics]. Great Britain. 2022.

15. Swissmedic. Pluvicto(R) und Pluvicto(R) CA

Injektions-/Infusionslösung i.v.

(Lutetium(177Lu)-vipivotid-Tetraxetan). Accessed October 3,

2023. https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/auth

orisations/new-medicines/pluvicto-pluvicto-ca-inj-inf-lsg-iv.html

16. Sung H, Ferlay J, Siegel RL, Sung H, et al. Global cancer statistics

2020: GLOBOCAN estimates of incidence and mortality worldwide for 36

cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209-249.

doi:10.3322/caac.21660.

17. Jadvar H. Targeted Radionuclide Therapy: An Evolution Toward Precision

Cancer Treatment [published correction appears in AJR Am J Roentgenol.

2017 Oct;209(4):949]. AJR Am J Roentgenol. 2017;209(2):277-288.

doi:10.2214/AJR.17.18264.

18. Jurcic JG, Wong JYC, Knoc SJ, et al. Targeted radionuclide therapy. In:

Tepper JE, Foote RE, Michalski JM, eds. Gunderson & Tepper's Clinical

Radiation Oncology. 5th ed. Elsevier, Inc. 2021;71(3):209-249.

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October 23, 2023 10:30 ET (14:30 GMT)