Subject: RE: [EXT] Information on SOLIDARITY trial medications
From: "LYDON, Patrick" <[email-masked]>
To: Alisa Tsuladze <[email-masked]>
Cc: "SATHIYAMOORTHY, Vaseeharan" <[email-masked]>, M Georgia <[email-masked]>, Ekaterine Adamia <[email-masked]>, Alisa Tsuladze <[email-masked]>, "[email-masked]" <[email-masked]>
Date: Thu, 08 Oct 2020 13:12:29 +0000

Dear Alisa. Thank you for sharing this back with me. I will send
the confidential documents directly with Ekaterine. She can share onwards under the terms of the CDA.

And good news about being able to purchase your own Remdesivir.

All the best

Patrick

From:
Alisa Tsuladze

Sent: 08 October 2020 13:04

To: LYDON, Patrick

Cc: SATHIYAMOORTHY, Vaseeharan ; solidaritytrials ; M Georgia ; Ekaterine Adamia ; Alisa Tsuladze ; [email-masked]

Subject: Re: [EXT] Information on SOLIDARITY trial medications

Dear Patrick,

Please find attached duly signed confidential disclosure agreement form by Ekaterine Adamia, the national coordinator of the trial and the head of healthcare division at the MoH;
Looking forward to receiving the requested information on Acalabrutinib manufacturer;

We have initiated the process of purchasing Remdesivir from one of the above listed manufacturers (Hetero Labs ltd) and will keep you posted on the progress;

thanks a lot for your kind support!

Respectfully,

Alisa

On Mon, Oct 5, 2020 at 10:22 AM LYDON, Patrick <[email-masked]> wrote:

Dear Alisa,

Thank you for your message. If the Investigational Brochure and/or IMPD documents for
Acalabrutinib are needed, we will need the national PI / national coordinator of Solidarity Trial to return to us a signed copy of the CDA document attached as a word document. Once we get a signed copy of the attached, we can share these confidential documents
under the terms of the CDA.

For Remdesivir, we do not have any to ship to you at the moment, but there is a final
allocation pending from Gilead. We are sorry we cannot give you a firm date on when additional supplies might be available for the trial. The best I can do is be transparent with you that this is unknown at the moment while we continue to work on arranging
for supply.

If you have access to Remdesivir from any of the manufacturers listed here

https://www.gilead.com/purpose/advancing-global-health/covid-19/voluntary-licensing-agreements-for-remdesivir Georgia could use that remdesivir for the trial while documenting it appropriately in a note for the record, and as long as of course your relevant
in-country authorities authorize it.

All the best,

Patrick

From: Alisa Tsuladze <[email-masked]>

Sent: 02 October 2020 14:45

To: LYDON, Patrick <[email-masked]>; SATHIYAMOORTHY, Vaseeharan <[email-masked]>

Cc: solidaritytrials <[email-masked]>; M Georgia <[email-masked]>; Ekaterine Adamia
<[email-masked]>; Alisa Tsuladze <[email-masked]>

Subject: [EXT] Information on SOLIDARITY trial medications

Dear Patrick, dear Dr. Vasee,  hope this email finds you well!

I wanted to double check if you have any updates on Remdesivir
shipment and also kindly ask to provide the information on the manufacturer of Acalabrutinib as our NRA needs this to add this medication to the list of registered drugs.

We will hopefully have the requested documents by the end of
next week.

I apologize for using my non-work email for technical reasons
and I'm copying the previous correspondence in the email.

Thank you for your kind support!

Respectfully,

Alisa Tsuladze, MPH

Health Policy Division

Policy Department

Ministry of Internally Displaced persons from

Occupied Territories, Labor, Health and Social Affairs of Georgia

_______________________________________________________

From: LYDON, Patrick [mailto:[email-masked]]

Sent: Tuesday, September 15, 2020 1:10 PM

To: DARA, Masoud; Tengiz Tsertsvadze; SATHIYAMOORTHY, Vaseeharan

Cc: solidaritytrials; Tamar Gabunia; Ekaterine Adamia; Alisa Tsuladze

Subject: RE: [EXT] Solidarity trial

Dear Prof Tsertsvadze,

Thank you for your message. I’m including Dr Vasee on this exchange in order to clarify the situation on Remdesivir
for Georgia.

For Acalabrutinib, we need to have the assurance that you have gotten both ethics and regulatory approvals of the revised
protocol (V.15). Can you share these documents with us?

All the very best

Patrick

From: DARA, Masoud <[email-masked]>

Sent: 14 September 2020 20:00

To: Tengiz Tsertsvadze <[email-masked]>

Cc: LYDON, Patrick <[email-masked]>; solidaritytrials <[email-masked]>; M Georgia <[email-masked]>;
Ekaterine Adamia <[email-masked]>; Alisa Tsuladze <[email-masked]>

Subject: RE: [EXT] Solidarity trial

Dear professor Tsertsvadze,

Thank you for you message. I am doing fine. I hope you and colleagues in Georgia are also doing fine in these trying
times. Supply of medicines under Solidarity trial is led by our headquarters colleagues. Mr Lydon copied here can kindly add.

Thanks and regards,

Masoud

Dr Masoud Dara

Coordinator, Communicable Diseases

Division of Country Health Programmes

World Health Organization Regional Office for Europe

UN City, Marmorvej 51, 2100 Copenhagen, Denmark

Email:
[email-masked]
| Website: www.euro.who.int

From: Tengiz Tsertsvadze <[email-masked]>

Sent: Monday, September 14, 2020 7:04 PM

To: DARA, Masoud <[email-masked]>

Cc: LYDON, Patrick <[email-masked]>; solidaritytrials <[email-masked]>;
M Georgia <[email-masked]>; Ekaterine Adamia <[email-masked]>;
Alisa Tsuladze <[email-masked]>

Subject: [EXT] Solidarity trial

Dear Dr. Dara,

I hope this email finds you well. Once again we would like to express our sincere gratitude for selecting Georgia to participate in WHO sponsored “Solidarity”
trial.

As you are well aware the
initial protocol of the “Solidarity” trial envisioned to study
efficacy of Remdesivir, hydroxychloroquine
and Lopinavir/Ritonavir ± Interferon β1a in hospitalized patients with moderate or severe COVID-19.

On June 17, 2020, WHO
removed hydroxychloroquine from the above-mentioned trial, and on July 4, 2020,
Lopinavir/Ritonavir was also removed. On August 6, 2020, the “Solidarity” research executive broad issued
a recommendation to evaluate the
clinical efficacy of the additional drug
Acalabrutinib as part of this study. Currently, “Solidarity” trial includes following medications:
Remdisivir, Acalabrutinib and β interferon.

In line with WHO recommendation we removed the use of
hydroxychloroquine and Lopinavir/Ritonavir outside of clinical trials in our national COVID-19 treatment protocol. As a result
Interferon β1a is the only medication in the country which we can use for COVID-19 patients
at present. Therefore provision of
Remdesivir and Acalabrutinib within the “Solidarity” trial is a
matter of urgency for us.

We would highly appreciate it if you could consider the above mentioned serious circumstance and facilitate a
timely provision of Remdesivir and
Acalabrutinib to Georgia as soon as possible.

Thank you in advance for your kind consideration and we look forward to your response.

Best regards,

Tengiz Tsertsvadze