By Sharon Atieno
To increase access to injectable lenacapavir pre-exposure prophylaxis (PrEP), Gilead Sciences, an American biopharmaceutical company, has signed licensing agreements with six generic medicine manufacturers to manufacture and supply high-quality, low-cost versions of the drug to 120 resource-limited and high HIV incidence countries.
The manufacturers include Dr. Reddy’s Laboratories Limited (India), Emcure (India), Eva Pharma (Egypt), Ferozsons Laboratories Limited (Pakistan), Hetero (India) and Mylan, a subsidiary of Viatris (US).
The agreements also cover lenacapavir for HIV treatment in heavily treatment-experienced (HTE) adults with multi-drug resistant HIV.
“Given the transformative potential of lenacapavir for prevention, our focus is on making it available as quickly and broadly as possible where the need is greatest,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead.
“Gilead teams have been working with urgency to bring on high-volume generic manufacturers now, so that we can ensure a rapid transition to these voluntary license partners after lenacapavir for PrEP is approved.”
Clinical trials
The twice-yearly injectable drug, lenacapavir, showed 100% protection against HIV acquisition among more than 5,000 cisgender women (women born and identify as women) in South Africa and Uganda in the Phase 3 PURPOSE 1 trial.
The results of the PURPOSE 2 trial released in September 2024, showed that 99.9% of the 2,180 cisgender men and gender-diverse participants in the United States, South Africa, Peru, Brazil, Argentina, Mexico and Thailand who received the injection did not acquire HIV.
New data will be released at the 5th HIV Research for Prevention Conference, taking place on 6-10 October 2024.
Responses
Different stakeholders have welcomed the move amid concerns of limited access.
“We applaud Gilead for licensing the medicine without waiting for registration, which should be the norm. We are battling a pandemic and the speed at which generic versions come to market will dictate whether this medicine can really be transformative,” said Winnie Byanyima, Executive Director, UNAIDS.
“Including an African producer in Egypt is also very welcome. Much more work is still urgently needed to ensure that no one who needs lenacapavir is left behind and that Gilead’s commitment to rapid, affordable access is fulfilled.”
The International AIDS Society (IAS) has called for global access to the drug noting that millions of people have been left out.
“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,” IAS President Beatriz Grinsztejn said.
“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.”
The AIDS Vaccine Advocacy Coalition (AVAC) noted that the process of granting licensing agreements with generic manufacturers before regulatory submissions could reduce the time to market for generic products by up to three years.
“This is notable improvement both in timelines for licensing and in geographic coverage, with LEN licenses being granted before regulatory approval, compared to the two-year gap after approval for injectable cabotegravir. Additionally, the six generics for LEN come from three different countries, whereas the three cabotegravir licenses were concentrated in one country. Expanding manufacturing across multiple regions can hopefully further enhance efforts to accelerate global access,” Mitchel Warren, AVAC’s Executive Director said.
However, AVAC has raised two major concerns. One, countries with significant HIV incidence, including several of those hosting the PURPOSE 2 trials of lenacapavir, have been left out of the license geographies. This will slow down efforts to reduce the rate of HIV infection as quickly as possible to meet global targets.
Additionally, the price of lenacapavir for prevention – for both the originator product and the future generics – is still unknown, making it difficult to build a sustainable impactful market.
Modeling studies suggest that with bulk production of the drug, the generic price of LEN for PrEP could be as low as $100 per person-year of protection. This represents a significant increase in the current PrEP market and would require scaling up additional investment in product procurement and programming by donors and governments, the AVAC statement reads.
Before the generic versions are available, Gilead is prioritizing registration in 18 countries, representing 70% of the HIV burden in the countries named in the license. These include Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia and Zimbabwe.
