Subject: RE: Update on Clinical Trials for Remdesivir
From: Tamar Gabunia </O=EXCHORGANIZATION/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=E6CA04F38EC94D0CADAB9CBDF90FCDDE-TAMAR G>
To: "Aparicio, Juan J (Tbilisi)" <[email-masked]>
Cc: Maia Nikoleishvili </o=ExchOrganization/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=2d9c4ecc95234453ad52ccfeaee8a8ee-Maia Ni>; Hedges, Sarah <[email-masked]>; Rowe, Mackenzie L (Tbilisi) <[email-masked]>
Date: Wed, 15 Apr 2020 16:30:48 +0000

Dear Juan

Many thanks for your e-mail and follow up on Remdesivir access for Georgian patients. We’ve approached Gilead Pharmaceuticals few week ago with this request and received negative reading. We fully understand the circumstances and appreciate all efforts made Gilead colleagues for reviewing our application. We are now working with the WHO for joining the Solidarity Trial. Dr, Tsertsvadze’s team is closely coordinating with Dr. Masoud Dara to meet all needed formalities. Hopefully this will work and clinical sites in Georgia will get access to novel drugs for COVID19 treatment.

I will keep you updated on this.

With kind regards

პატივისცემით,

თამარ გაბუნია

მინისტრის პირველი მოადგილე

Sincerely,

Tamar Gabunia, MD, MPH

First Deputy Minister

From: Aparicio, Juan J (Tbilisi) [mailto:[email-masked]]
Sent: 15 April, 2020 20:06
To: Tamar Gabunia <[email-masked]>
Cc: Maia Nikoleishvili <[email-masked]>; Hedges, Sarah <[email-masked]>; Rowe, Mackenzie L (Tbilisi) <[email-masked]>
Subject: Update on Clinical Trials for Remdesivir

Dr. Gabunia,

As I'm sure you know, Ambassador Degnan spoke to the Minister of Environmental Protection and Agriculture earlier today and he mentioned Georgia's desire to take part in the clinical trials for Gilead's Remdesivir.

I was in touch with a representative from Gilead Pharmaceuticals today to discuss Georgia's request to participate.  They informed me that, unfortunately, the participants for the multi-site study - which I understand the WHO is implementing - have already been selected and enrollment has completed for almost all of them.  Please see below for the additional information they provided us, though you may already have it yourself.

Please let me know if you have any further questions.

Information on Remdesivir

Gilead is working closely with global health authorities to respond to the novel coronavirus (COVID-19) outbreak through the appropriate experimental use of the investigational compound remdesivir. Our first priority is to determine the safety and efficacy of remdesivir through the six ongoing trials. We believe we can best address the need in all countries by focusing our efforts on generating data that can support regulatory approvals as quickly as possible. Given the global health impact of COVID-19, we anticipate that the data from these studies could support regulatory filings around the world, including countries that are not participating in these trials.

Gilead is working to establish emergency access programs in many countries, it is unfortunately not feasible to do so in every country around the world. For countries without expanded access programs and also not participating in the six ongoing studies, we suggest adopting the master protocol developed by WHO as opportunity to access investigational treatments. We are in active discussions with WHO regarding support of this study to continue to enable access to remdesivir, in a streamlined way around the world, through critically important clinical trials that will hopefully clarify whether remdesivir is safe and effective for the treatment of COVID-19.

Please visit https://clinicaltrials.gov/ for the latest update on Gilead clinical trials and https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments for WHO Solidarity Trial

To get more information you can always check https://www.gilead.com/purpose/advancing-global-health/covid-19  and can connect Gilead through [email-masked] for any questions, requests etc.

Best,

Juan José Aparicio | Political Officer

United States Embassy Tbilisi, Georgia

(O): +995 32 227 76 29 | (M) +995 598 080 254

Email: [email-masked]