Press Release : Novartis 177Lu-PSMA-617 -2-

regarding potential marketing approvals, new indications or labeling for 
(177) Lu-PSMA-617, or regarding potential future revenues from (177) 
Lu-PSMA-617. 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 (177) 
Lu-PSMA-617 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 (177) Lu-PSMA-617 will be commercially 
successful in the future. In particular, our expectations regarding 
(177) Lu-PSMA-617 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 media update as of this date and does 
not undertake any obligation to update any forward-looking statements 
contained in this media update as a result of new information, future 
events or otherwise. 
 
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   References 
 
 
   1. Novartis Data on File 
 
   2. SEER. Cancer stat facts: prostate cancer April 2021. 
      [https://seer.cancer.gov/statfacts/html/prost.html] 
 
   3. Hupe MC, Philippi C, Roth D, et al. Expression of prostate-specific 
      membrane antigen (PSMA) on biopsies is an independent risk stratifier of 
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      2018;8:623 
 
   4. Bostwick DG, Pacelli A, Blute M, et al. Prostate specific membrane 
      antigen expression in prostatic intraepithelial neoplasia and 
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   5. Pomykala KL, Czernin J, Grogan TR, et al. Total-body 68Ga-PSMA-11 PET/CT 
      for bone metastasis detection in prostate cancer patients: potential 
      impact on bone scan guidelines. J Nucl Med 2020;61(3):405--11 
 
   6. Sant GR, Knopf KB, Albala DM. Live-single-cell phenotypic cancer 
      biomarkers-future role in precision oncology? NPJ Precision Oncology 
      2017;1(1):21 
 
   7. Kirby M, Hirst C, Crawford ED. Characterising the castration-resistant 
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   8. Minner S, Wittmer C, Graefen M, et al. High level PSMA expression is 
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   9. Hope TA, Aggarwal R, Chee B, et al. Impact of 68Ga-PSMA-11 PET on 
      management in patients with biochemically recurrent prostate cancer. J 
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  10. Hofman MS, Violet J, Hicks RJ et al. [177Lu]-PSMA-617 radionuclide 
      treatment in patients with metastatic castration-resistant prostate 
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  11. Kratochwil C, Giesel FL, Stefanova M, et al. PSMA-targeted radionuclide 
      therapy of metastatic castration-resistant prostate cancer 
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      [https://pubmed.ncbi.nlm.nih.gov/26985056/] 
 
  12. Eder M, Schäfer M, Bauder-Wüst U, et al. 68Ga-complex 
      lipophilicity and the targeting property of a urea-based PSMA inhibitor 
      for PET imaging. Bioconjug Chem 2012;23(4):688--97. 
 
  13. Benešová M, Schäfer M, Bauder-Wüst U, et al. 
      Preclinical evaluation of a tailor-made DOTA-conjugated PSMA inhibitor 
      with optimized linker moiety for imaging and endoradiotherapy of prostate 
      cancer. J Nucl Med 2015;56(6):914--20 
 
  14. Haberkorn U, Eder M, Kopka K, et al. New Strategies in Prostate Cancer: 
      Prostate-Specific Membrane Antigen (PSMA) Ligands for Diagnosis and 
      Therapy. Clin Cancer Res 22(1):9-15.2016 
 
  15. Violet J, Jackson P, Ferdinandus J et al. Dosimetry of (177)Lu-PSMA-617 
      in metastatic castration-resistant prostate cancer: correlations between 
      pretherapeutic imaging and whole-body tumor dosimetry with treatment 
      outcomes. J Nucl Med 2019;60(4):517--23 
 
  16. Current K, Meyer C, Magyar CE et al. Investigating PSMA-targeted 
      radioligand therapy efficacy as a function of cellular PSMA levels and 
      intra-tumoral PSMA heterogeneity. Clin Cancer Res 2020;26(12):2946--55. 
 
  17. Kassis A. Therapeutic Radionuclides: Biophysical and Radiobiologic 
      Principles. Semin Nucl Med. 2008; 38(5): 358--366 
 
  18. Fendler W, Stuparu A, et al. Establishing 177Lu-PSMA-617 Radioligand 
      Therapy in a Syngeneic Model of Murine Prostate Cancer. J Nucl Med 2017; 
      58: 1786--1792 
 
  19. Ruigrok E, van Vliet N, et al. Extensive preclinical evaluation of 
      lutetium-177-labeled PSMA-specific tracers for prostate cancer 
      radionuclide therapy. Eur J Nucl Med Mol Imaging. 2020; 48: 1339-1350 
 
  20. Sartor AO, Morris MJ, Krause BJ. VISION: an international, prospective, 
      open-label, multicenter, randomized phase 3 study of 177Lu-PSMA-617 in 
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      suppl):TPS5099 
 
 
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June 03, 2021 12:04 ET (16:04 GMT)