Subject: RE: Georgia HCV Program - Current Stock and Future Supply
From: Sean Barr <[email-masked]>
To: Tamar Gabunia <[email-masked]>, Sopo Belkania <[email-masked]>
Cc: Graeme Robertson <[email-masked]>, "[email-masked]" <[email-masked]>, David Novoa <[email-masked]>, Michael Clancy <[email-masked]>, Alina Visnakova <[email-masked]>, Ben Dunne <[email-masked]>, Ekaterine Adamia <[email-masked]>, "Patrick Murray (Contractor)" <[email-masked]>
Date: Tue, 21 May 2019 16:34:28 +0000

Hello Tamar,

The current pack plan is as follows.  If all goes well product should be in Dublin by end of June, allowing for an early July shipment.

We’ll let you know if anything changes.

Regards,

Sean

AOEM #

Lot

Item Number

Product

Detail

Qty

Mfg. Date

SL Months

Requested

Needed DUB

COA

Pack Date

2019-046

YNHH

61958-2202-3

Epclusa

GAP v3

6834

3-Jul-17

48

30-Apr-19

30-Jun-19

Georgia

31/05/2019

2019-047

YPPG

61958-2202-3

Epclusa

GAP v3

3734

26-Jul-17

48

30-Apr-19

30-Jun-19

Georgia

31/05/2019

2019-048

YPPH

61958-2202-3

Epclusa

GAP v3

205

16-Aug-17

48

30-Apr-19

30-Jun-19

Georgia

31/05/2019

From: Tamar Gabunia [mailto:[email-masked]]

Sent: Thursday, May 09, 2019 9:54 PM

To: Sean Barr; Sopo Belkania

Cc: Graeme Robertson; [email-masked]; David Novoa; Michael Clancy; Alina Visnakova; Ben Dunne; Ekaterine Adamia

Subject: [EXTERNAL] RE: Georgia HCV Program - Current Stock and Future Supply

Dear Sean

This is to follow up on the Epclusa order status. May I kindly if the order has been processed.

Many thanks!

პატივისცემით,

თამარ გაბუნია

მინისტრის მოადგილე

Sincerely,

Tamar Gabunia, MD, MPH

Deputy Minister

From: Tamar Gabunia

Sent: Monday, April 22, 2019 7:00 PM

To: 'Sean Barr' <[email-masked]>; Sopo Belkania <[email-masked]>

Cc: Graeme Robertson <[email-masked]>; [email-masked]; David Novoa <[email-masked]>; Michael Clancy <[email-masked]>; Alina Visnakova <[email-masked]>; Ben Dunne <[email-masked]>; Ekaterine Adamia
<[email-masked]>

Subject: RE: Georgia HCV Program - Current Stock and Future Supply

Dear Sean,

Please find attached the official order for Epclusa. We’ll follow up on next steps as needed.

Sincerely

Tamar Gabunia

From: Sean Barr [mailto:[email-masked]]

Sent: Thursday, April 18, 2019 10:45 PM

To: Tamar Gabunia <[email-masked]>; Sopo Belkania <[email-masked]>

Cc: Graeme Robertson <[email-masked]>; David Sergeenko <[email-masked]>;
[email-masked]; David Novoa <[email-masked]>; Michael Clancy <[email-masked]>; Alina Visnakova <[email-masked]>;
Ben Dunne <[email-masked]>

Subject: RE: Georgia HCV Program - Current Stock and Future Supply

Dear Tamar,

Greetings to you as well and many thanks for this comprehensive update.  I’m glad to see the Epclusa rollout is progressing as planned.  Yes, please go ahead
and place an order for 11,000 Epclusa bottles.

Regarding Harvoni, I suggest we tentatively plan a packaging run of 3,000 to 5,000 bottles for delivery in September, to give you enough time to replace the
expiring product in November.  Let’s try to make sure you have enough to cover Q1 ’20 demand as well.  For all bottles expiring, we’ll need proof of destruction when the time comes.

Regards,

Sean

From: Tamar Gabunia [mailto:[email-masked]]

Sent: Wednesday, April 17, 2019 8:53 AM

To: Sean Barr; Sopo Belkania

Cc: Graeme Robertson; David Sergeenko;
[email-masked]; David Novoa; Michael Clancy; Alina Visnakova; Ben Dunne

Subject: [EXTERNAL] Georgia HCV Program - Current Stock and Future Supply

Dear Sean

Greetings! With this I would like to provide you with updated information on HCV Program and adjusted plan on treatment.

From the beginning of the HCV program implementation more then
55 000 HCV patients were registered, more then
54
000 out of registered patients
have already started treatment and more
than
50
000 completed treatment.

As you have already been informed,
at this moment, we have patients on both treatment regimens, with Epclusa and with Harvoni;

·
From December 2018, we included Epclusa in treatment regimens for all untreated (treatment naïve) or already treated (treatment experienced) patients with genotype 2 and 3, also, for already treated (treatment experienced) patients with genotype 1 and
4. For all other patients we used Harvoni regimens.

·
Currently, the number of patients receiving Epclusa treatment regimens is about 550 per month and with Harvoni treatment regimens - about 500 per month.

·
With this picture of inflow, from now, until the end of the year, about 4950 new patients will be enrolled in HCV program on Epclusa containing regimens, out of them about 88% will be on 12-week regimens and 12% on 24-week treatment regimens. To provide
medicines for this group of patients, we will need about 17 400-bottles of Epclusa, by the end of the year. It should be noted that at the moment the number of Epclusa bottles remaining in central warehouse is about 6400, so the total number of required bottles
is 11 000 bottles (=17400-6400).

If our request is acceptable, we will provide an official order for 11000 Epclusa bottles in the next few days.

As for Harvoni, at the moment number of bottles, remaining at the warehouse is enough for about 6 months (the estimated number of patients 500
per month on average). We estimate that 14000 bottles of Harvoni will be needed in April-December. Currently the available stock includes 10550 bottles with the expiry date on
December 31, 2019. We would appreciate your guidance on managing the available stock  given the anticipated expiry by the end of 2019.

Many thanks and look forward to hearing from you.

With Kind Regards,

Tamar Gabunia

Deputy Minister

From: Sean Barr [mailto:[email-masked]]

Sent: 24 March, 2019 19:10

To: Tamar Gabunia <[email-masked]>; Sopo Belkania <[email-masked]>

Cc: Graeme Robertson <[email-masked]>; David Sergeenko <[email-masked]>;
[email-masked]; David Novoa <[email-masked]>; Michael Clancy <[email-masked]>; Alina Visnakova <[email-masked]>;
Ben Dunne <[email-masked]>

Subject: RE: Georgia HCV Program - Current Stock and Future Supply

Dear Tamar,

Thank you and nice to meet you.  I look forward to the update.

Regards,

Sean

From: Tamar Gabunia [mailto:[email-masked]]

Sent: Friday, March 22, 2019 11:33 PM

To: Sopo Belkania; Sean Barr

Cc: Graeme Robertson; David Sergeenko;
[email-masked]; David Novoa; Michael Clancy; Alina Visnakova; Ben Dunne

Subject: Re: Georgia HCV Program - Current Stock and Future Supply

Dear Sopo

Thanks for this introduction.

Dear Sean,

Thanks for your e-mail and follow up. I'll provide an updated information on the HCV drug stock status early next week. I'll follow up on all other issues as needed.

I look forward to working with you to ensure smooth and effective implementation of the HCV elimination program.

With kind regards

Tamar Gabunia, MD, MPH

Deputy Minister

Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia

144 A.Tsereteli Avenue, 0159, Tbilisi, Georgia

Mobile number: +995 599 22 32 32

From: Sopo Belkania

Sent: Thursday, March 21, 2019 8:51 PM

To: Sean Barr

Cc: Graeme Robertson; David Sergeenko;
[email-masked]; David Novoa; Michael Clancy; Alina Visnakova; Ben Dunne; Tamar Gabunia

Subject: RE: Georgia HCV Program - Current Stock and Future Supply

Dear Sean,

Hope you are doing well.

Please be informed that Mrs. Maia Lagvilava has resigned from the position of a Deputy Minister (DM).

Let me introduce you to a new Deputy Minister Ms. Tamar Gabunia (copied to this email), who is responsible for Health Care issues, including HCV program. Please
contact her for any related issues to Hepatitis C elimination program.

Best regards,

Sopo Belkania

Head of Analytics, HR Management and International Relations Department

Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia

144 A.Tsereteli Avenue, 0159, Tbilisi, Georgia

Mobile number: +995 599 22 32 32

From: Sean Barr [mailto:[email-masked]]

Sent: Wednesday, March 20, 2019 9:49 AM

To: Maia Lagvilava <[email-masked]>; Sopo Belkania <[email-masked]>

Cc: Graeme Robertson <[email-masked]>; David Sergeenko <[email-masked]>;
[email-masked]; David Novoa <[email-masked]>; Michael Clancy <[email-masked]>; Alina Visnakova <[email-masked]>;
Ben Dunne <[email-masked]>

Subject: RE: Georgia HCV Program - Current Stock and Future Supply

Dear Maia,

Hope all is well with you.  It’s been a while since we last supplied product so wanted to follow-up to see how your inventory is doing?  Are you still expecting
~18k of Epclusa this year?

Agreed path forward for supply through Q1 ’19:  ship
9k of Eplcusa this year and plan for 18k of Epclusa next year unless the patient flow dramatically increases, in which case we may need to keep a Harvoni/Epclusa mix throughout ’19.

Regards,

Sean

From: Maia Lagvilava [mailto:[email-masked]]

Sent: Wednesday, November 07, 2018 4:04 AM

To: Sean Barr; Sopo Belkania

Cc: Graeme Robertson; David Sergeenko;
[email-masked]; David Novoa; Michael Clancy; Alina Visnakova; Ben Dunne

Subject: RE: Georgia HCV Program - Current Stock and Future Supply

Dear Sean,

Thank you for your feedback, we will greatly appreciate if you could progress the original plan, shipping 2-3k now and the remaining balance at the end of November.

Kind regards,

Maia Lagvilava, MD, MHA

Deputy Minister

144 A. Tsereteli ave.

0119 Tbilisi, Georgia

Tel: (+995 32) 251 00 27 (0503)

E-mail:
[email-masked]

From: Sean Barr [mailto:[email-masked]]

Sent: Tuesday, November 6, 2018 10:22 PM

To: Maia Lagvilava <[email-masked]>; Sopo Belkania <[email-masked]>

Cc: Graeme Robertson <[email-masked]>; David Sergeenko <[email-masked]>;
[email-masked]; David Novoa <[email-masked]>; Michael Clancy <[email-masked]>; Alina Visnakova <[email-masked]>;
Ben Dunne <[email-masked]>

Subject: RE: Georgia HCV Program - Current Stock and Future Supply

Dear Maia,

Apologies, I’ve been out of the office for a few weeks and have not had the chance to follow-up on the partial shipment request until now.

The balance of the 9,000 bottle order is packing next week and is expected to transfer to the Dublin warehouse by Friday the 23rd, meaning we could
likely ship the fully quantity of 9k during the last week of November if that’s acceptable?  If not, we can ask Dublin Customer Service to progress the original plan, shipping 2-3k now with the remaining balance of 6-7k shipping at the end of November.  Let
us know how you would like to proceed.

Regards,

Sean

From: Maia Lagvilava [mailto:[email-masked]]

Sent: Tuesday, November 06, 2018 5:49 AM

To: Sopo Belkania; Sean Barr

Cc: Graeme Robertson; David Sergeenko; [email-masked];
David Novoa; Michael Clancy; Alina Visnakova; Ben Dunne

Subject: RE: Georgia HCV Program - Current Stock and Future Supply

Dear Sean,

As per your latest communication we were expecting 2500-3000 bottles of  Epculsa by the end of October. Could you please advice as per progress.

Your kind reply will be greatly appreciated.

Best regards,

Maia Lagvilava, MD, MHA

Deputy Minister

144 A. Tsereteli ave.

0119 Tbilisi, Georgia

Tel: (+995 32) 251 00 27 (0503)

E-mail:
[email-masked]

From: Sopo Belkania

Sent: Saturday, September 29, 2018 5:30 AM

To: Sean Barr <[email-masked]>

Cc: Graeme Robertson <[email-masked]>;
David Sergeenko <[email-masked]>;
Maia Lagvilava <[email-masked]>;
[email-masked];
David Novoa <[email-masked]>;
Michael Clancy <[email-masked]>;
Alina Visnakova <[email-masked]>;
Ben Dunne <[email-masked]>

Subject: RE: Georgia HCV Program - Current Stock and Future Supply

Dear Sean,

I discussed the issue with the Minister, so please ship the PO in two parts.

Best regards,

Sopo

From: Sean Barr [mailto:[email-masked]]

Sent: Saturday, September 29, 2018 3:27 AM

To: Sopo Belkania <[email-masked]>

Cc: Graeme Robertson <[email-masked]>;
David Sergeenko <[email-masked]>;
Maia Lagvilava <[email-masked]>;
[email-masked];
David Novoa <[email-masked]>;
Michael Clancy <[email-masked]>;
Alina Visnakova <[email-masked]>;
Ben Dunne <[email-masked]>

Subject: RE: Georgia HCV Program - Current Stock and Future Supply

Hello Sopo,

As an update the site is currently ordering more labeling components for the 9k order.  Given this, we will only have 2500 to 3000 bottles available towards
the end of October.  Should we ship the PO in two parts or wait until November and ship the full 9k?

Regards,

Sean

From: Sopo Belkania [mailto:[email-masked]]

Sent: Saturday, September 08, 2018 1:04 AM

To: Sean Barr

Cc: Graeme Robertson; David Sergeenko; Maia Lagvilava; [email-masked]

Subject: RE: Georgia HCV Program - Current Stock and Future Supply

Dear Sean,

Please find attached PO for 9,000 Epclusa.

In case of questions do not hesitate to contact me.

Best regards,

Sopo Belkania

Head of HR Management and International Relations Department

Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia

144 A.Tsereteli Avenue, 0159, Tbilisi, Georgia

Mobile number: +995 599 22 32 32

From: Sean Barr [mailto:[email-masked]]

Sent: Saturday, September 8, 2018 3:49 AM

To: David Sergeenko; Maia Lagvilava; [email-masked]

Cc: Graeme Robertson; Sopo Belkania

Subject: RE: Georgia HCV Program - Current Stock and Future Supply

Hello all,

Thanks again for your time yesterday.  Please do issue the PO for 9,000 Epclusa by next week.  As discussed, I’ve asked the packaging site to schedule some
line time for the run.

Regards,

Sean

-----Original Appointment-----

From: Sean Barr

Sent: Wednesday, September 05, 2018 11:39 AM

To: Sean Barr; David Sergeenko ([email-masked]);
[email-masked];
[email-masked]

Cc: Graeme Robertson; Sopo Belkania

Subject: Georgia HCV Program - Current Stock and Future Supply

When: Thursday, September 06, 2018 8:00 AM-9:00 AM (UTC-08:00) Pacific Time (US & Canada).

Where: TC

Current Country Stock

Remaining Harvoni in central stock = 28,168 bottles?

Remaining Harvoni stock in clinics?

All remaining Harvoni in central stock and in all clinics carries the same expiration date, December 31st,
2019.

Future Supply (Q4)

Option 1 - Epclusa will be used only for retreatment of already treated and unresponsive patients with Harvoni

75 new patients

1,911 bottles of Epclusa would be ordered

19,800 bottles of Harvoni needed (remaining in central stock:  28,168)

Option 2 - Both medications Epclusa and Harvoni will be used for treatment

3490 new patients

14,880 bottles of Epclusa would be ordered

16,500 bottles of Harvoni needed (remaining in central stock:  28,168)

Option 3 - Epclusa will be used for treatment of all patients

26,000 bottles of Epclusa

Future Supply (Q1 & Q2 ’19)

TBD – How long will existing Harvoni stock last?

SEAN BARR invites you to an online meeting using WebEx.

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