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    NOVN   CH0012005267

NOVARTIS AG

(NOVN)
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Press Release: Novartis 177Lu-PSMA-617 -2-

06/03/2021 | 12:05pm EDT
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. 
 
   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 
treatments. About 110,000 people of more than 140 nationalities work at 
Novartis around the world. Find out more at https://www.novartis.com. 
 
   Novartis is on Twitter. Sign up to follow @Novartis at 
https://twitter.com/novartisnews https://twitter.com/novartisnews 
 
   For Novartis multimedia content, please visit 
https://www.novartis.com/news/media-library 
 
   For questions about the site or required registration, please contact 
media.relations@novartis.com 
 
   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 
      prostate cancer patients at time of initial diagnosis. Front Oncol 
      2018;8:623 
 
   4. Bostwick DG, Pacelli A, Blute M, et al. Prostate specific membrane 
      antigen expression in prostatic intraepithelial neoplasia and 
      adenocarcinoma: a study of 184 cases. Cancer 1998;82(11):2256--61 
 
   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 
      prostate cancer population: a systematic review. Int J Clin Pract 
      2011;65(11):1180--92 
 
   8. Minner S, Wittmer C, Graefen M, et al. High level PSMA expression is 
      associated with early PSA recurrence in surgically treated prostate 
      cancer. Prostate 2011;71(3):281--8 
 
   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 
      Nucl Med 2017;58(12):1956--61 
 
  10. Hofman MS, Violet J, Hicks RJ et al. [177Lu]-PSMA-617 radionuclide 
      treatment in patients with metastatic castration-resistant prostate 
      cancer (LuPSMA trial): a single-centre, single-arm, phase 2 study. Lancet 
      Oncol 2018;19(6):825--33 
 
  11. Kratochwil C, Giesel FL, Stefanova M, et al. PSMA-targeted radionuclide 
      therapy of metastatic castration-resistant prostate cancer 
      with 177Lu-labeled PSMA-617. J Nucl Med 2016;57(8):1170--6 
      [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 
      the treatment of patients with progressive PSMA-positive metastatic 
      castration-resistant prostate cancer (mCRPC). J Clin Oncol 2019;37(15 
      suppl):TPS5099 
 
 
   # # # 
 
   Novartis Media Relations 
 
   E-mail: media.relations@novartis.com 
 
 
 
 
Anja von Treskow                   Rachel Levine 
 Novartis External Communications   Advanced Accelerator Applications, 
 +41 79 392 8697                    a Novartis Company 
 anja.von_treskow@novartis.com      +1 917 375 2935 
 Julie Masow                        rachel.levine@novartis.com 
 Novartis US External Engagement 
 +1 862 579 8456 
 julie.masow@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  Sloan Simpson  +1 862 778 5052 
Thomas Hungerbuehler   +41 61 324 8425 
Isabella Zinck         +41 61 324 7188 
 
 
   Attachment 
 
 
   -- Media release (PDF).pdf 
      https://ml-eu.globenewswire.com/Resource/Download/6c247985-794b-481a-b729-5e952559f774 
 
 
 
 
 
 
 

(END) Dow Jones Newswires

June 03, 2021 12:04 ET (16:04 GMT)

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CRAWFORD & COMPANY -0.97% 10.25 Delayed Quote.42.36%
DJ INDUSTRIAL -0.28% 34838.16 Delayed Quote.14.14%
NOVARTIS AG 0.61% 84.28 Delayed Quote.0.14%
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Financials (USD)
Sales 2021 51 982 M - -
Net income 2021 9 881 M - -
Net Debt 2021 22 970 M - -
P/E ratio 2021 20,3x
Yield 2021 3,56%
Capitalization 225 B 226 B -
EV / Sales 2021 4,77x
EV / Sales 2022 4,46x
Nbr of Employees 109 000
Free-Float 87,4%
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Number of Analysts 26
Last Close Price 92,51 $
Average target price 105,60 $
Spread / Average Target 14,2%
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Managers and Directors
Vasant Narasimhan Chief Executive Officer
Harry Werner Kirsch Chief Financial Officer
Hans J÷rg Reinhardt Independent Non-Executive Chairman
John Tsai Chief Medical Officer
Klaus Moosmayer Chief Ethics Risk & Compliance Officer
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