Dr Reddy's, Hetero sign voluntary licenses with Gilead for HIV drug

Hyderabad-based Hetero and Dr Reddy’s Laboratories have signed a non-exclusive, royalty-free voluntary licensing agreement with Gilead Sciences Ireland UC to manufacture and distribute lenacapavir, a breakthrough HIV treatment drug, in 120 primarily low- and lower-middle-income countries (LMICs), including India.

Lenacapavir is a United States Food and Drug Administration (USFDA)-approved drug indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection, failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations. Additionally, lenacapavir is currently under investigation for the prevention of HIV (PrEP), which is yet to be approved globally.

Gilead Sciences first launched lenacapavir under the brand name Sunlenca in the United States and European markets in 2022. It is a first-in-class HIV-1 capsid inhibitor.

Deepak Sapra, chief executive officer of API and services, Dr Reddy’s Laboratories, said: “Lenacapavir marks an important milestone for Dr Reddy’s in patient access and affordability for pre- and post-exposure treatment of HIV. The collaboration with Gilead will help us make this latest treatment option available to patients in 120 primarily low- and lower-middle-income countries, including India. Many of these countries have a very high disease burden of HIV. This is an important endeavour in our journey to create impact on 1.5 billion patients by 2030.”

These agreements broaden access to lenacapavir. Gilead's price for lenacapavir in high-income countries is $42,250 annually, but researchers estimate that Indian generic manufacturers could produce the drug for as little as $100 per person per year, with further reductions possible as demand increases.

Vamsi Krishna Bandi, managing director of Hetero Group of Companies, emphasized: “For over three decades, Hetero has been at the forefront of the global fight against HIV/AIDS, pioneering affordable, life-saving treatments where the need is greatest. With over 30 combinations addressing nearly 40 per cent of the global HIV/AIDS population, we take immense pride in the positive impact our efforts have made so far. We will further bring quick access to lenacapavir in Africa, India, and other LMICs, where we’ve been a cornerstone of HIV/AIDS care.”

Earlier this month, Gilead announced promising results from a pivotal Phase 3 clinical trial. The interim analysis demonstrated that lenacapavir reduced HIV infections by 96 per cent compared to the background HIV incidence. This highlights the transformative potential of lenacapavir as a long-acting treatment and prevention option.

Further, lenacapavir is also being studied as a long-acting HIV prevention drug in ongoing clinical trials. This drug’s long-acting version can be administered every six months via a subcutaneous injection, following an initial oral loading dose.

Recently, patient groups, including Sankalp Rehabilitation Trust, a civil society organisation, had argued that patent applications for this drug could impact access to affordable treatment in India and hinder access to affordable generic versions of the drug. Sankalp had alleged that Gilead is trying to ‘evergreen’ the patent over this drug, extending monopolies on drugs through minor, unoriginal modifications.

If patents were to be approved in India, patient groups had claimed that this would extend Gilead’s monopoly over the drug in India until 2038.

However, the signing of these voluntary licences now ensures access to this drug in LMICs at affordable costs.

The opposition to Gilead’s patent applications in India is part of a larger global movement. Public health groups in countries including Argentina, Thailand, and Vietnam have filed a total of nine patent challenges against lenacapavir as part of the Make Medicines Affordable campaign.

In 2012, India’s Supreme Court upheld the rejection of a Novartis patent for a modified cancer drug, blocking the company from extending its monopoly and opening the door to generics.

Earlier in 2020, Gilead had signed voluntary licensing agreements with Indian firms like Cipla, Jubilant Life Sciences, Hetero, and Mylan for the manufacturing and distribution of Remdesivir, a therapy for COVID-19. The medicine had been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA) to treat COVID-19 patients.