KUALA LUMPUR, Oct 4 — Malaysia is not included in a list of 120 countries that have been given access to generic versions of Gilead Sciences’ “gamechanger” HIV prevention drug lenacapavir.
The US-based drugmaker announced Wednesday that it had entered into voluntary licensing agreements with six generic pharmaceutical companies – three in India, one in Egypt, one in Pakistan, and one in the United States – to manufacture and sell generic lenacapavir at a lower price in 120 low- and lower-middle income countries.
Lenacapavir, given as a twice-yearly injection, has been described as a “groundbreaking” drug that provides near-total protection from infection with HIV, based on results from two Phase Three trials of lenacapavir for HIV prevention or pre-exposure prophylaxis (PrEP).
The Guardian reported that lenacapavir fully stopped infection in a trial involving girls and women in South Africa and Uganda, and offered almost complete protection (99.9 per cent) in another trial that mainly involved men across Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States.
Currently, lenacapavir is approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals.
Gilead said it signed the voluntary licensing agreements for lenacapavir for PrEP ahead of any global regulatory submissions, targeted by year end, to enable countries to quickly introduce generic versions for HIV prevention once regulatory approval is obtained. The agreements also cover lenacapavir for HIV treatment.
Oral PrEP medication is nearly 100 per cent effective in preventing HIV, but compliance may be difficult with the daily pill, compared to a shot that only needs to be taken twice a year.
Gilead reportedly charges US$42,250 (RM178,918) per patient per year for lenacapavir in the US, where the drug sold under the name Sunleca has been approved as an HIV treatment. Researchers say it can be produced profitably for just US$40 (RM169) per patient per year, if it is purchased in large volumes.
The 120 countries covered by Gilead’s voluntary licensing agreements for lenacapavir include countries with the highest HIV rates, which are in sub-Saharan Africa. Listed Asean countries include Cambodia, Indonesia, Laos, Myanmar, the Philippines, Thailand, and Vietnam. Asean countries excluded are Malaysia, Singapore, and Brunei.
The Philippines, Thailand, and Vietnam are also among 18 target countries that will be prioritised by Gilead for registration of lenacapavir, supplied by Gilead, until generic versions are available, as Gilead noted that it would take time for licencees to build manufacturing capacity for lenacapavir.
“Gilead will support low-cost access to the drug in high-incidence, resource-limited countries through a two-part strategy: establishing a robust voluntary licensing programme, and planning to provide Gilead-supplied product at no profit to Gilead until generic manufacturers are able to fully support demand,” Gilead said in a statement.
Then-Health Minister Dr Zaliha Mustafa told Parliament last November that the rate of decline of new HIV infections in Malaysia slowed to 24 per cent between 2010 and 2022, from 50 per cent in the previous decade, threatening Malaysia’s aim to end AIDS by 2030. An average of 3,000 new HIV cases are reported annually in the country.
The International AIDS Society said in a statement yesterday that Gilead’s current agreements to make generic injectable lenacapavir widely available still leave out millions around the world.
“The licensing agreements enabling generic versions of the HIV prevention drug, lenacapavir, in certain countries is an important step forward, but large parts of the world remain excluded, including countries where trials were conducted,” said IAS President Beatriz Grinsztejn.
“We are hopeful that the speed with which these agreements were reached will be maintained, and that the rest of the world will soon benefit from similar agreements to make lenacapavir more affordable and offer a further potent option in the HIV prevention toolbox.”
Malaysia’s exclusion from Gilead’s voluntary licensing agreements for lenacapavir occurred seven years after the Malaysian government rejected the American pharmaceutical company’s voluntary licence offer for its Hepatitis C drug sofosbuvir and approved compulsory licensing in 2017 instead.
A compulsory licence for pharmaceuticals is a process where a government allows someone else to produce generics of a drug without the original drug maker’s consent.
The Pharmaceutical Research and Manufacturers of America, which represents the US’ pharmaceutical research companies, said in its Special 301 submission in 2019 to the United States Trade Representative (USTR) that Malaysia should be designated a “priority foreign country” over its “unjustified” compulsory licence for sofosbuvir.
