Document 56
Ref. Ares(2020)2879172 - 04/06/2020
From:
(SANTE)
Sent:
mercredi 3 juin 2020 18:50
To:
BUCHER Anne (SANTE); ROSSIDES Giorgos (CAB-KYRIAKIDES); OJALA
Annukka (CAB-KYRIAKIDES);
(CAB-KYRIAKIDES); SEYCHELL Martin
(SANTE); RYS Andrzej Jan (SANTE);
SANTE)
Cc:
(CAB-KYRIAKIDES);
(SANTE);
(SANTE);
(SANTE)
Subject:
Gilead Sciences - meeting report 2 June 2020
BTO – 2 June 2020 Video-call – Commissioner Kyriakides and Gilead Sciences Europe Ltd
Present: Commissioner Stella Kyriakides; Cabinet Members: Giorgos Rossides (Head of CAB),
Annukka Ojala (Dep Head of CAB),
,
,
DG SANTE: Martin Seychell (DDGI), Andrzej Rys (Dir B)
C3),
(B5)
Gilead Sciences:
(
Regulatory Affairs),
Regulatory Affairs),
Medical
)
European Medicines Agency: Noel Wathion (Deputy Executive Director),
(
Clinical Studies and Manufacturing Task Force),
This was a follow-up to the meetings on 7 May & 7 April 2020.
Summary - Gilead gave an update on recently available data on the investigational medicine
remdesivir. They intend to submit an application for a conditional marketing authorisation for
assessment by the European Medicines Agency at the end of the week (5 June). For supply
there are still only 1.5 million vials for donation worldwide, there needs to be agreement of US
government for export of US production. Supply will increase in the autumn and will include
production outside the United States. Gilead is interested in exploring the possibility of using
the Joint Procurement mechanism as a means to distribute the potential supply for the EU
according to the medical needs of the Member States. The Commissioner stressed the
importance of distribution on a needs basis first.
Details of the discussion
Gilead representatives explained the
emerging evidence, noting that more details of the US
National Institute of Allergy and Infectious Diseases (NIAID) study had been published. The
median recovery time with 10 day treatment was 11 days compared to of 15 days in the
placebo group. In Gilead’s trial comparing 5 day and 10 day treatment, in severe COVID-19
patients the clinical improvement was similar. Gilead had issued a press release[1] on 1 June
with the results of the SIMPLE trial with evidence of improvement in time to recovery in COVID-
19 patient with moderate pneumonia, this was significant compared to the standard of care in
the 5 day remdesivir treatment group although significance was not reached in the 10 day
treatment group. Gilead will submit this data to the European Medicines Agency (EMA) to
support the treatment indication they will be seeking. Gilead intend to submit to EMA on 5 June
an application for a conditional marketing authorisation supported by a dossier with all the
currently available evidence.
The
Commissioner asked for clarification on the expected
supply in the EU.
Gilead explained
that the supply would continue to be limited until the end of the year by when additional
manufacturing capacity would be on stream. At the moment, they are supplying through clinical
trials, named patient or compassionate use programmes, or emergency/temporary
authorisations. The limited supply means that Gilead has to have permission from the US
government to ship the product to other countries. The 6 month lead-time to produce the
active ingredient means that the additional manufacturing capacity will not be on stream until
around October (expect additional 4 million vials) and by the end of the year another 4 million
vials. Some of this additional manufacturing is outside the USA.
Gilead explained they are interested in the possibility of the supply of remdesivir to be initially
through a
joint procurement process as they believe it would allow faster access on the basis of
need and would like to have all Member States supplied through this mechanism with the
Commission determining the allocation. They wish to seek a mechanism for distribution on the
basis of medical need and to avoid stockpiling during the period while stocks are limited. They
wish to avoid having parallel discussion with Member States for the supply during the initial
period, but the supply after the first 6 months would be through the usual process of pricing
and reimbursement procedures with individual Member States.
Martin Seychell noted that the
Joint Procurement is a voluntary process and asked how limited the supply would be to the EU.
Gilead was unable to say what the supply to the EU would be.
The
Commissioner stressed the importance of having distribution on a needs basis first.
END
Author:
[1]
https://www.gilead.com/news-and-press/press-room/press-releases/2020/6/gilead-announces-results-from-
phase-3-trial-of-remdesivir-in-patients-with-moderate-covid-19