In a huge step forward for Aids prevention in Africa, a licensing agreement was recently inked between Aspen Pharmacare and Merck subsidiary MSD, granting Aspen rights to develop, manufacture and commercialise new anti-HIV drug MK-8527, or alimatravir, reports TimesLIVE.
Also last week, the government announced a shortlist of three firms had been selected to make Gilead’s six-monthly HIV prevention shot lenacapavir (LEN).
Alimatravir is a late-stage investigational, once-monthly, long-acting oral medicine from Merck, which has been at the forefront of research into the prevention of diseases including HIV, cancer and Ebola.
Stavros Nicolaou, Aspen Pharmacare group’s senior executive responsible for strategic trade development, said the introduction of long-acting, preventative HIV medicines, both in injectable and in oral forms, “presents a real opportunity to potentially eliminate the disease in South Africa in the next decade”.
“However, although significant strides have been made in turning the tide against HIV in Africa, some complacency and donor aid cutbacks are unfortunately starting to disrupt programmes, with a risk of some backslide to the gloomy early days,” he warned.
For South Africa to achieve its 95-95-95 target would also require the effective roll-out of the long-acting preventative HIV medicines at scale, added Nicolaou.
“Aspen pioneered the first generic ARVs on the continent, which have gone on to play a significant role in reversing both HIV mortality and morbidity, and its agreement with Merck MSD for the investigational ARV preventative medicine alimatravir is potentially game-changing,” he said.
Although still in clinical trials, once registered and approved, Alimatravir will present an easy-to-use, simple preventative option, meaning one tablet monthly, one hour to work, and a one-week forgiveness on missed doses.
“Merck MSD needs to be applauded for concluding these licences at an investigational drug stage, as this means that the product can be registered and produced earlier in Africa, thereby accelerating access to patients and healthcare systems,” Nicolaou added.
Health Minister Aaron Motsoaledi welcomed the announcement, describing it as “a significant milestone in our collective efforts to end the HIV epidemic in South Africa and globally”.
“A once-a-month oral option, if brought to market through local manufacturing partnerships such as this one between MSD and Aspen, has the potential to improve adherence compared with daily dosing, particularly among young women and adolescent girls, who remain disproportionately affected by new infections.”
Shortlist for SA firm to make LEN
Meanwhile, Deputy Health Minister Joe Phaahla has announced that three local pharmaceutical manufacturers have been shortlisted to make Gilead’s six-monthly HIV prevention shot lenacapavir (LEN) – although he has not yet named the companies.
The news comes as pressure mounts on Gilead Sciences to expand access to LEN. At the 26th International Aids Conference in Brazil last week, Gilead took flak for making only 3m doses of LEN available over three years, with Aids Vaccine Advocacy Coalition (AVAC) estimating that 5m doses a year are needed to make a significant impact on the epidemic.
The company has also been criticised for excluding sub-Saharan pharmaceutical firms from the voluntary licences awarded to generic manufacturers to make cheaper copies of its patent-protected shot, despite the region homing two-thirds of the world’s people with HIV.
Phaahla said the South African National Aids Council had evaluated all bids for local production of lenacapavir and whittled the list down to three candidates.
One company would be selected in consultation with Gilead, and would be expected to manufacture the shot for the SADC region, he said. He would not be drawn on whether the Health department would be prepared to pay a premium for locally manufactured LEN.
Gilead senior vice-president for clinical development Jared Baeten referred Business Day’s request for an update on the process for identifying the licensee to the health ministry.
“We are completely behind the idea of having a South African licensee for any or all components of the lenacapavir manufacturing process, and are working with the government of South Africa so that they determine who would be best,” he said.
The six firms in Egypt, India and Pakistan that were initially awarded voluntary licences will all be making the active pharmaceutical ingredient in LEN, a capability few South African drugmakers possess.
South Africa has set aside $29.2m from a grant from the Global Fund to Fight Aids, TB and Malaria to buy more than 450 000 doses of lenacapavir at $40 per person a year. It has received only 37 920 doses so far, which activists estimate is enough to reach less than 1% of the people in need. The rollout began at public clinics in six provinces in June.
Business Day article – Three South African firms vie to make HIV prevention shot (Restricted access)
TimesLIVE article – Aspen secures game-changing HIV medicine (Restricted access)
See more from MedicalBrief archives:
Optimism as phase 3 trials launch for new monthly anti-HIV pill
HIV 2030 target unlikely, as funding crisis pummels global Aids response
Lessons learnt in the anti-HIV drug race as CAB-LA falls behind LEN
SA firms lose out on lenacapavir production