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Dear Ron Somers

Many thanks for your e-mail and follow up on our correspondence regarding the next shipment with the Hep C Program. Attached you can find the official order from the ministry. Given the expiry date of drugs we are quite confident in adequate consumption of current and anticipated amount. As of the regulatory requirements. Ministry will apply the registration waver mechanism as we did for the previous order. In order to process the waiver we will need the following:

1.       Invoice

2.       The certificate of pharmaceutical product (Quality Certificate)

3.       Airway bill

4.       Packing list

Last time we worked with Ben Kamarck Ben.Kamarck@gilead.com to have the shipment organized. Our staff member will work with your designee to have all details sorted out as needed.

Should you have additional questions or require clarification please kindly let me know.

პატივისცემით,

თამარ გაბუნია

მინისტრის პირველი მოადგილე

Sincerely,

Tamar Gabunia, MD, MPH

First Deputy Minister

Dear Minister Gabunia:

I am interfacing on behalf of Gilead Sciences with Mylan in India to ensure patient access to these viral hepatitis medicines in Georgia. Thank you for your candid appraisal of how Covid-19 has reduced patient numbers. 

I spoke with Mylan today regarding MyHepAll shelf life as well as the regulatory issues you have raised.  Dhruv Goel of Mylan has addressed these questions to our satisfaction in the following email.   

However, if you are not comfortable accepting this delivery, please let us know.  This is an expensive shipment, and it would be a pity for these medicines to go to waste.

I am relying on your previous mail to Graeme Robertson of Gilead Sciences, wherein during the April time-frame you indicated you had stock of MyHepAll of approx. 9500 bottles. This would provide enough bottles to treat roughly 3000 patients.  You were experiencing at that during the Covid-19 crisis approximately 800 patients per month availing of treatment. Based on your estimates in April, this leaves you with stock on hand.

This next shipment of 10,000 bottles will treat approx. 3500 additional patients – from now and through the end of this year, and into the Spring of 2021.  Please let me know if my estimates are accurate or incorrect.

The bottom line, this shipment being organized is meant to suit your needs and requirements. Accordingly, please do let us know if you are comfortable receiving this shipment of 10,000 bottles.  If so, Mylan’s Dhruv Goel will sort these other details you have raised and ensure this shipment is timely delivered.

Thank you for your diligence in treating viral hepatitis in Georgia – a goal shared by Gilead Sciences and its Licensee, Mylan Labs. 

Sincerely,

Ron Somers for Gilead’s Global Patient Solutions     

Hi Minister Gabunia,

Greetings and Thanks for your kind reply. Please note that the quantity of this shipment is 10,000 bottles of SOF/VELPA with a shelf life of 93% hence it should not be a problem. Given below are the manufacturing and expiry dates of the stock:

Also, as far as registration is concerned, kindly note that it is the same product delivered in the last shipment to you. Can you please let us know who provided you with the below application documents (from Gilead) last time as what I can understand is that you should already have the import permit. I can recall only providing you the invoice, COAs and flight details.

Please let me know your comfortable date of shipment.

Thanks

Dhruv