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    NOVN   CH0012005267

NOVARTIS AG

(NOVN)
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Novartis : prostate cancer drug receives U.S. FDA breakthrough designation

06/16/2021 | 12:08pm EDT

ZURICH, June 16 (Reuters) - Swiss drugmaker Novartis AG has received breakthrough therapy designation from the U.S. Food and Drug Administration for an experimental treatment for advanced castration-resistant prostate cancer, the company said on Wednesday.

Men with a deadly form of prostate cancer that has spread and who were not helped by other treatments on average survived four months longer after getting Novartis' Lu-PSMA-617 - a tumour-targeting radiation therapy - than those who received standard care, data from a clinical trial released earlier in June showed.

The therapy attaches a radioactive isotope, lutetium-177, with a half-life of less than seven days, to a small molecule drug, PSMA-617, that binds to an antigen expressed in large amounts by prostate cancer cells. It aims to kill cancer cells in a targeted way while limiting damage to surrounding, healthy cells.

The FDA breakthrough designation is used to help expedite development and review of therapies that demonstrate the potential to be a substantial improvement over available treatments.

Novartis, which acquired the therapy with its $2.1 billion purchase of Endocyte three years ago, has a growing portfolio of radioligand medicines that includes already approved cancer therapy Lutathera.

Prostate cancer can often be treated via surgery, radiation therapy or through hormone therapy that stops production of tumour-driving testosterone.

Metastatic castration-resistant prostate cancer, however, has failed to respond to such hormone treatment, making it difficult to treat - and a potentially lucrative market. Novartis has forecast eventual Lu-PSMA-617 annual sales topping $1 billion.

(Reporting by Brenna Hughes Neghaiwi Editing by Mark Heinrich and Bill Berkrot)


ę Reuters 2021
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Financials (USD)
Sales 2021 51 962 M - -
Net income 2021 9 849 M - -
Net Debt 2021 22 988 M - -
P/E ratio 2021 20,1x
Yield 2021 3,59%
Capitalization 222 B 222 B -
EV / Sales 2021 4,71x
EV / Sales 2022 4,40x
Nbr of Employees 109 000
Free-Float 87,4%
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Mean consensus OUTPERFORM
Number of Analysts 26
Last Close Price 91,05 $
Average target price 105,42 $
Spread / Average Target 15,8%
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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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