Document 34
Ref. Ares(2020)1991159 - 08/04/2020
From:
(SANTE)
Sent:
mercredi 8 avril 2020 13:10
To:
(SANTE);
(SANTE);
(SANTE);
(SANTE)
Cc:
(SANTE);
(SANTE);
(SANTE); SANTE CONSULT-B5
Subject:
BTO report - video call with Gilead Sciences - 7/4/2020
Dear all,
With thanks to
please find below a summary from the video-call with Gilead Sciences.
Kind regards
Tuesday 7 April 2020
Video-call- Gilead development efforts on the potential treatment for COVID-19
Gilead:
, Gilead Sciences
Gilead Sciences
EC: The Commissioner Stella Kyriakides and the Cabinet Members: Olympia Neocleous,
Giorgos Rossides, Anne Mueller, Ines Prainsack, Annukka Ojala
(DG SANTE/B5)
EMA : Guido Rasi,
,
Gilead firstly presented the Company’s efforts to address COVID-19 crisis. Gilead highlighted its
policy of humanitary efforts in current times. Remdesivir, it’s pipeline product, lacks the
marketing authorisation, and its efficacy and safety profile have not been demonstrated. It is,
however, their intention to apply for full marketing authorisation.
COVID-19 experience comes mainly from the compassionate used schemes, so far, but the
feedback from the field is difficult to interpreted. Company also indicated the aims to increase
production capacity in order to fulfil the demand.
The Commissioner asked about clinical trials and company’s priorities with deliveries and
highlighted actions taken in the EU to address the increased demand on the medicines and
medical devises during crisis.
Gilead explained that the clinical trials (CT) scheme is on going. They highlighted that the
importance to supply clinical trials is recognised, in compassionate use schemes they try to fulfil
MS needs.
Gilead is involved in the solidarity and discovery CT networks.
EMA explained that there are tools for accelerated assessment and authorisation pathways.
CTs are priority, with the controlled setting, and supplies for CT should be guaranteed.
In the end the
Commissioner thanked the company for the information and indicated COM
willingness to follow the evolution of the field, and suggested the next TC for the last week of
April 2020.
From:
(SANTE)
@ec.europa.eu>
Sent: Monday, April 6, 2020 2:05 PM
To:
(SANTE) <
@ec.europa.eu>;
(SANTE)
@ec.europa.eu>
Cc: SANTE CONSULT-B <xxxxxxxxxxxxxxx@xx.xxxxxx.xx>;
@ec.europa.eu>
Subject:
Out of scope
c.europa.eu>
Cc: SANTE CONSULT-B <xxxxxxxxxxxxxxx@xx.xxxxxx.xx>;
(SANTE)
@ec.europa.eu>;
(SANTE)
@ec.europa.eu>
Subject:
Pages 3 and 4 have been removed as they fall outside the scope
of this request