Indian pharma firms sign deal to produce, sell generic HIV drug lenacapavir

Indian pharmaceutical companies are set to produce generic versions of lenacapavir, an HIV prevention drug, under agreements with US-based Gilead Sciences to distribute it in 120 resource-limited countries.

In Short

• Indian pharmaceutical firms sign a deal to produce and sell generic versions of US-made HIV drug
• The approval of the HIV drug lenacapavir for prevention is pending
• The drug is also being explored for treatment in individuals with multi-drug-resistant HIV

Indian pharmaceutical giants, including Dr. Reddy’s Laboratories and Emcure Pharmaceuticals, are going to produce generic versions of lenacapavir, an HIV prevention drug, following non-exclusive licensing agreements signed with Gilead Sciences, Inc.

These agreements will allow the companies to manufacture and distribute lenacapavir to 120 resource-limited countries, pending regulatory approvals, according to Gilead's official statement.

The agreements aim to expedite access to the drug in countries with high HIV incidence, particularly in low and lower-middle-income nations.

Lenacapavir, currently being investigated for pre-exposure prophylaxis (PrEP), is expected to transform HIV prevention if approved. It has been approved by the US Food and Drug Administration (FDA) and is used for the treatment for HIV in adults. Its investigation in the prevention of HIV is underway.

Gilead's collaboration with pharmaceutical firms across the globe, also including Eva Pharma, Ferozsons Laboratories Limited, Hetero and Mylan, a subsidiary of Viatris, ensures that, once approved, generic versions of the drug will be made available quickly and at low cost in high-need regions in 120 countries, including India.

“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.

Earlier this year, two important Phase 3 trials for lenacapavir as a preventive HIV treatment, named PURPOSE 1 and PURPOSE 2, were concluded ahead of schedule due to achieving their primary effectiveness goals.

These trials demonstrated that twice-yearly lenacapavir outperformed the daily oral Truvada in reducing HIV incidence.

PURPOSE 1 involved cisgender women in South Africa and Uganda, while PURPOSE 2 focused on cisgender men, transgender individuals, and non-binary people across several countries including Argentina, Brazil, and the United States.

Participants in these studies can continue accessing lenacapavir after the trials.

In addition to HIV prevention, the drug is being explored for treatment in individuals with multi-drug-resistant HIV, adding to its potential impact.

There is currently no cure for HIV or Aids.