Geneva, 4 March 2022 — Pharmaceutical corporation ViiV has just announced they will not pursue a voluntary licensing deal for long-acting injectable cabotegravir (CAB-LA) to allow generic production and affordable prices for low- and middle-income countries (LMICs). The drug is patented in many countries including India, Brazil and South Africa, and these patent barriers have a chilling effect on the development of low-cost generic formulations.
CAB-LA was approved for the prevention of HIV infection by the USFDA in December 2021, and ViiV currently charges $3,700 per vial in the US ($22,200 per person per year). Research from the Clinton Health Access Initiative (CHAI) has shown that generic manufacturers could produce this drug for around $2.60 per vial (less than $20 per person per year). Although ViiV has publicly said they would provide CAB-LA for their at-cost price in many LMICs, they have yet to announce what that price is.
Experience has shown that generic manufacturer prices are frequently drastically lower than the patented drug – and that generic manufacturers have the capacity for developing even complicated formulations like CAB-LA. Even in the case of ViiV’s pediatric formulation of the HIV drug dolutegravir, also sold at their at-cost price in LMICs, the generic equivalent costs 22 times less than ViiV’s.
Amanda Banda, Infectious Diseases Policy and Advocacy Advisor, MSF Access Campaign:
“What good is HIV prevention if the people who need it can’t afford it? This is the most effective form of HIV prevention for vulnerable and marginalised communities and yet ViiV is delaying the ability of generic manufacturers to supply the drug, meaning that many people across low- and middle-income countries who would benefit from the medicine to prevent HIV infection won’t be able to access it. CAB-LA will need to be available at a price that is comparable to currently available oral PrEP if country treatment programs and donors are expected to scale up its use to the levels needed – and it’s hard to imagine that ViiV will make CAB-LA available at less than $40 USD per year. ViiV needs to immediately sign a licensing deal with the Medicines Patent Pool so that more affordable generics can be produced, and more lives can be saved.”
Dr. Tom Ellman, Head of MSF’s South African Medical Unit:
“We want to urgently make this drug available for people at high risk of HIV infection in our programs in sub-Saharan Africa – we don’t want a donation with many strings attached from the corporation; it is not the role of ViiV to control the use of a drug that is approved by the USFDA. We want ViiV to sell us this drug at an affordable price.”
UPDATE: Shortly after release of MSF's communication, Viiv updated its statement with a mention that they are "open to voluntary licensing"