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Injectable HIV medicines deal to provide access to generic lifesaver in developing nations

A landmark agreement has been reached allowing for the production of low-cost, injectable HIV medicines in some 90 developing countries where more the majority of infections occur, UNITAID said on Friday.

Selected manufacturers will be able to develop, manufacture and supply lower-cost generic versions of long-acting Cabotegravir (CAB-LA), in line with a deal reached with pharmaceutical firm ViiV Healthcare (ViiV).

“The Medicines Patent Pool, a structure created and largely funded by UNITAID, has reached a voluntary licensing agreement for patents relating to Cabotegravir long-acting, an injectable form of HIV prevention, or PrEP, to generic formulations of the product in least-developed, low-income, lower-middle income and sub-Saharan African countries,” said UNITAID spokesperson Hervé Verhoosel.

The deal is significant because Cabotegravir injections are only needed once every few months. Increasing its supply at a cost that is affordable to low-income countries could help to overcome the stigma that’s associated with taking daily HIV pills - and the burden of having to remember to take them.

“In the 90 countries that we are talking about, 80 countries are royalty-free, meaning that ViiV won’t ask for any royalty on the product and for 10 of those countries, ViiV is asking for a smaller-than-usual royalty,” Mr. Verhoosel explained.

The agreement comes after UNITAID-led discussions began in May this year with ViiV, a subsidiary of pharma giant GlaxoSmithkline. It is only seven months since Cabotegravir LA received regulatory approval.

But the process of selecting the companies that will develop, manufacture and supply generic versions of Cabotegravir will take much longer.

“This product will not be there for everybody, that’s first for people who are there the most at risk,” said Mr. Verhoosel, who noted that the cost of the medicine in the US when it comes onstream there “really soon”, was likely to be around $20,000. “That’s a lot of money; that’s why that product cannot be used in low and middle-income countries.”

According to UNITAID, the deal offers the possibility of making the injectable prophylactic medicine available in 90 countries where more than 70 per cent of all new HIV infections occurred in 2020.

Up to three drug manufacturers will be licensed to develop the product on a generic basis to avoid supply and distribution issues. “That’s done in a way that we’re sure (that) one, it’s easy for logistics, two…availability, and three, of course, that it will help to bring the cost of the generic version down”, said Mr. Verhoosel.

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Injectable HIV Prevention Medicines Deal - UNITAID 29 July 2022

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