Aspen urges ViiV to licence injectable HIV drug to African generic manufacturers

SA’s biggest pharmaceutical manufacturer Aspen Pharmacare has urged ViiV Healthcare to licence African generic drug makers to produce cheap copies of its long-acting cabotegravir injection, which offers protection against HIV.

The debate about access to cabotegravir has taken on new impetus after the SA Health Products Regulatory Authority (Sahpra) announced it had registered the drug, administered every two months, for preventing HIV infection. Research has shown it is more effective than taking daily pills to prevent HIV, known as pre-exposure prophylaxis (PrEP), but whether it will be affordable and readily available to SA and other countries hard hit by the disease remains an open question.

The risks associated with Africa’s limited pharmaceutical manufacturing capacity were sharply exposed during the coronavirus pandemic, as countries with domestic vaccine manufacturing capacity prioritised their own citizens when Covid-19 shots were in short supply.

“Africa sits with 68% of the world’s HIV prevalence,” said Aspen’s head of strategic trade, Stavros Nicolaou. “It is really important in light of the AU push to develop local manufacturing capacity to consider African producers for licences.” Failure to include African manufacturers could compromise Africa’s supply security, he added. 

Aspen has the sterile manufacturing capacity needed to produce cabotegravir, Nicolaou said.

ViiV Healthcare announced in August it had reached an agreement with the Medicines Patent Pool to licence three generic manufacturers for the production and distribution of cabotegravir to 90 low- and middle-income countries, including SA. It has yet to indicate which firms have been licensed or announce the price of its original version for low- and middle-income countries.

“Cabotegravir is potentially a game changer. But [researchers] have modelled that for low- and middle-income countries it should cost just a bit more than generic PreP, which is about R60 per month,” said Yogan Pillay, professor extraordinaire at Stellenbosch University’s department of global health.

“I have met ViiV and their view is this is a difficult injection to make and that is why it is as expensive as it is,” he said. Cabotregravir costs $2,200 per patient per year in the US and $9,275 per patient per year in the UK, he said.

Ezintsha director Francois Venter, who has been involved in HIV/Aids research for the past two decades, said ViiV’s pricing strategy is “bizarre”.

“We have ViiV, the originator, who are not experts in making cheap drugs, telling the world that the drug is very hard to make and that is why they are restricting the numbers of generic companies getting access to the patents. It is uncomfortably similar to what I heard about triple therapy in 2000, and around new drugs in 2001 and 2002. Why not grant licences and let the generics fight it out? I have heard from one major company that they can get the price close to oral PrEP, and from multiple companies that they can easily get it way below ViiV’s price,” he said.

A ViiV spokesperson declined to disclose pricing details, saying only that the company has committed to offering a not-for-profit price to public programmes in SA, and in all low-income, least developed and sub-Saharan African countries, until a generic is available.

“We know that in low- and middle-income countries affordability is a real challenge when it comes to health care and we’re committed to engaging, collaborating positively and working openly with global health partners and the HIV community to reduce the cost of (cabotegravir) to help enable broad access for people who could benefit from it,” said the company.

kahnt@businesslive.co.za