23.03.2022 21:19:15
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Press Release: Novartis PluvictoTM approved by -2-
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," "may," "expected," "believe," "committed," "investigational," "pipeline," "goal," "expected," "evolution," "to evolve," "continues," "hope," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for Pluvicto or Locametz, 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 Pluvicto or Locametz 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 Pluvicto or Locametz will be successfully launched in the markets where it is approved, or at any particular time. Neither can there be any guarantee that Pluvicto or Locametz will be commercially successful in the future. In particular, our expectations regarding Pluvicto or Locametz 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 Advanced Accelerator Applications
Advanced Accelerator Applications (AAA), a Novartis company, specializes in targeted radioligand therapies and precision imaging radioligands for oncology indications. We are committed to transforming patients' lives by leading innovation in nuclear medicine. AAA has a legacy as a leader in radiopharmaceutical drugs for Positron Emission tomography (PET) and Single-Photon Emission Computed Tomography (SPECT) diagnostic imaging. For more information, please visit: https://www.adacap.com.
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 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.
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References
1. Pluvicto [prescribing information]. Millburn, NJ: Advanced Accelerator
Applications USA, Inc.; 2022.
2. Locametz [prescribing information]. Millburn, NJ: Advanced Accelerator
Applications USA, Inc.; 2022.
3. SEER. Cancer stat facts: prostate cancer April 2021.
[https://seer.cancer.gov/statfacts/html/prost.html]
4. 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.
5. 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
6. 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
7. Sant GR, Knopf KB, Albala DM. Live-single-cell phenotypic cancer
biomarkers-future role in precision oncology? NPJ Precision Oncology
2017;1(1):21
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.
11. American Cancer Society. Deaths from prostate cancer. ACS website.
Available online:
https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html.
Last accessed November 2021.
12. 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.
# # #
Novartis Media Relations
E-mail: media.relations@novartis.com
Anja von Treskow Rachel Levine
Novartis External Communications AAA Global Communications
+41 79 392 8697 (mobile) + 1 917 375 2935 (mobile)
anja.von_treskow@novartis.com rachel.levine@novartis.com
Julie Masow
Novartis US External Communications
+1 862 579 8456 (mobile)
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 +1 862 345 4440
Nicole Zinsli-Somm +41 79 325 2084 Alina Levchuk +1 862 778 3372
Isabella Zinck +41 61 324 7188 Parag Mahanti +1 973 876 4912
(END) Dow Jones Newswires
March 23, 2022 16:18 ET (20:18 GMT)

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