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American biopharmaceutical company Gilead has signed licensing agreements with six pharmaceutical companies to manufacture and distribute generic versions of its innovative long-acting injectable HIV drug, lenacapavir.

Once the necessary regulatory approvals are secured, the drug will become available in over 100 low- and middle-income countries facing a significant HIV burden.

The burden of HIV

Despite breakthrough advancements in science, HIV still remains a source of suffering for many.

In 2022, for example, 380,000 people died from AIDS-related illness in Africa, with another 760,000 new infections recorded in the same year.

The need to explore and quickly avail new innovative therapies can’t be understated.

About lenacapavir

Lenacapavir is a long-acting injectable anti-retroviral drug that acts as a capsid inhibitor, preventing viral replication.

It has been licensed by the U.S. Food and Drug Administration (FDA) for the treatment of HIV and is currently under studies exploring its efficacy as a medicine for HIV prevention.

In the trials coded PURPOSE 1 and PURPOSE 2, data showed that lenacapavir has superior efficacy when administered once every six months compared to a once-daily oral emtricitabine and tenofovir disoproxil fumarate dose in HIV infection prevention.

Based on these results, Gilead has stated its intention to initiate global regulatory filings to register the drug as a PrEP option by the end of 2024.

More details on the deal

Gilead has engaged Mylan, Eva Pharma, Dr. Reddy’s Laboratories Limited, Emcure, Hetero, and Ferozsons Laboratories Limited in a royalty-free, non-exclusive deal to supply the generic products.

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The companies will supply lenacapavir for both HIV treatment in heavily-treated, experienced adults with multi-drug-resistant HIV and for pre-exposure prophylaxis (upon approval).

The firms were selected based on their unique capabilities to manufacture sterile injectable medicines, proven ability to produce Gilead-standard generic HIV medicines, and spread across countries and continents.

As Gilead waits for these firms to enhance specific capacity for lenacapavir production, it doesn’t envision leaving any gaps.

So, the company has committed to register and supply the medicine “at no profit” to 18 nations including Kenya, Tanzania, Botswana, Eswatini, Ethiopia, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Uganda, Zambia, Zimbabwe and more.

“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.”

 

Daniel O’Day, CEO, Gilead.

Bigger picture

Currently, Gilead’s lenacapavir costs more than $40,000 for the first year, and with these new licenses, it is expected that these figures could go as low as $40, making the drug available to millions of vulnerable high-risk groups who struggle with adherence to standard therapy.

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