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GILEAD SCIENCES, INC.

(GILD)
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Amid spike in cases, EU to shortly approve first COVID antibody drugs - sources

11/09/2021 | 08:02am EST

* EMA to approve Regeneron-Roche cocktail of monoclonal antibodies

* EU agency to authorise also Celltrion's antibody therapy

* Full marketing authorisations expected this week - source

BRUSSELS, Nov 9 (Reuters) - The European Union drugs regulator is set to authorise the use of two monoclonal antibodies to treat COVID-19 patients in coming days, two EU sources told Reuters, in its first approvals of such therapies.

The authorisations would come as the bloc faces a new surge in infections and hospitalisations despite high vaccination levels in many countries. The European Medicines Agency (EMA) will this week give the green light to the treatment developed by U.S. biotech firm Regeneron and Swiss giant Roche, one source said. The cocktail of antibodies is known as REGEN-COV in the United States, and is sold elsewhere under the brand name Ronapreve.

The European regulator will also authorise this week the use in the EU of the monoclonal antibody Regkirona, developed by South Korean biotech company Celltrion, the source added, asking not to be named because the information is still confidential.

A second official familiar with the authorisation process said the approvals were "imminent" but the precise dates had not been decided.

Both drugs are currently used to treat COVID-19 patients at risk of developing a severe infection.

The two authorisations would mark an acceleration in the agency's drug approvals.

Applications for both drugs were submitted in early October and EMA said then "it could issue an opinion within two months". Celltrion expects a decision by the end of November, a spokesperson for the company said.

Roche, who applied in Europe for the approval of Ronapreve, did not respond to a request for comment.

EMA declined to comment on the approvals but said the two drugs were being discussed at this week's monthly meetings of the agency's committee that is responsible for authorisations of treatments. The meetings started on Monday and will continue until Thursday.

The review comes after Eli Lilly last week withdrew its application for EU approval of its antibody-based treatment, citing a lack of demand from EU member states as the bloc focuses on other suppliers. (Reporting by Francesco Guarascio @fraguarascio; additional reporting by Cha Sangmi in Seoul; Editing by Nick Macfie)


© Reuters 2021
Stocks mentioned in the article
ChangeLast1st jan.
CELLTRION HEALTHCARE CO., LTD. 3.41% 66800 End-of-day quote.-16.71%
GILEAD SCIENCES, INC. -1.93% 69.07 Delayed Quote.-4.88%
REGENERON PHARMACEUTICALS 1.13% 618.11 Delayed Quote.-2.12%
ROCHE HOLDING AG 0.22% 365.7 Delayed Quote.-3.75%
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Sales 2021 26 576 M - -
Net income 2021 7 176 M - -
Net Debt 2021 22 428 M - -
P/E ratio 2021 12,0x
Yield 2021 4,10%
Capitalization 86 640 M 86 640 M -
EV / Sales 2021 4,10x
EV / Sales 2022 4,26x
Nbr of Employees 13 600
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Andrew D. Dickinson Chief Financial Officer
Merdad V. Parsey Chief Medical Officer
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