Health Minister: Negotiations concluded for second DMD drug, procurement contract to be signed shortly
“Negotiations on all key commercial terms for a second drug to treat Duchenne muscular dystrophy (DMD) have concluded, with all regulatory and legal acts finalised in preparation for contract signing in the coming days,” Minister of Health Mikheil Sarjveladze has stated.
According to the Minister, Georgia will mark World Duchenne Awareness Day on 7 September with major progress on expanding treatment access.
“I wish to share positive news with the public regarding a second medication for Duchenne muscular dystrophy. Negotiations on all essential commercial terms have concluded. All required legal acts have been prepared and issued from our side, confirming our complete readiness to execute the contract. We are now awaiting the manufacturer, and we are confident that the procurement contract will be signed in the coming days.
You may have noted that the negotiation process was drawn out. This was primarily due to our principled stance that the duties and legal liabilities of the relevant parties regarding product quality guarantees be unequivocally defined and secured. Parents have followed this entire process closely, and I wish to thank them for their involvement, which played a vital and highly constructive role in bringing these talks to a successful conclusion.
Thus, on 7 September, World Duchenne Awareness Day, Georgia will mark the occasion with this significant achievement and welcome news.
One parent recalled a meeting with a manufacturer in which a representative expressed scepticism about whether Georgia could successfully procure such a drug. I am delighted that Georgia has proven it possible. Georgia stands as one of the pioneering nations globally to achieve such progress in the fight against Duchenne muscular dystrophy,” Sarjveladze stated.
The Minister did not specify the name of the second drug during his statement.
On 31 July, Georgia signed a procurement agreement with the Italian pharmaceutical company Italfarmaco for Givinostat, making Georgia one of the first countries worldwide to purchase the drug and incorporate it into its state healthcare management program for Duchenne muscular dystrophy.