Dr. Reddy's and Hetero sign voluntary licenses with Gilead for HIV drug | Company news

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

Deepak Sapra, Chief Executive Officer of API and Services at Dr. Reddy's Laboratories, said: “Lenacapavir marked for Dr. “Reddy's marks an important milestone in patient access and affordability of pre- and post-exposure treatment for HIV.” Collaboration with Gilead will help us bring this newest treatment option to patients in 120 primarily low- and lower-middle-income countries, including India , to make accessible. In many of these countries, the burden of HIV disease is very high. This is an important undertaking on our journey to impact 1.5 billion patients by 2030.”

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

Vamsi Krishna Bandi, Managing Director of Hetero Group of Companies, said: “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 targeting nearly 40 percent of the global HIV/AIDS population, we are very proud of the positive impact our efforts have had to date. We will also enable rapid access to lenacapavir in Africa, India and other LMICs, where we are a cornerstone of HIV/AIDS treatment.”

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

In addition, lenacapavir is also being investigated as a long-acting HIV prevention drug in ongoing clinical trials. The long-acting version of this drug can be administered via subcutaneous injection every six months after an initial oral loading dose.

Recently, patient groups including the Sankalp Rehabilitation Trust, a civil society organization, 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 keep the drug's patent “evergreen” and expand drug monopolies through minor, unoriginal modifications.

If patents are approved in India, patient groups had claimed it would extend Gilead's monopoly over the drug in India until 2038.

However, the signing of these voluntary licenses now ensures access to this drug in LMICs at an affordable cost.

The opposition to Gilead's patent applications in India is part of a larger global movement. Health groups in countries including Argentina, Thailand and Vietnam have filed a total of nine patent lawsuits 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, preventing the company from expanding its monopoly and opening access to generic drugs.

In early 2020, Gilead had signed voluntary licensing agreements with Indian companies such as Cipla, Jubilant Life Sciences, Hetero and Mylan for the manufacture and distribution of remdesivir, a drug against COVID-19. The drug has been granted an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the treatment of COVID-19 patients.

First published: Oct 02, 2024 | 9:33 p.m IS