In a significant step towards improving HIV treatment access, Hyderabad-based pharmaceutical companies Hetero and Dr. Reddy’s Laboratories have signed a non-exclusive, royalty-free voluntary licensing agreement with Gilead Sciences Ireland UC. This collaboration allows them to manufacture and distribute lenacapavir, a groundbreaking HIV treatment drug, in 120 primarily low- and lower-middle-income countries (LMICs), including India.
What is Lenacapavir?
Lenacapavir, marketed as Sunlenca in the United States and Europe, is a first-in-class HIV-1 capsid inhibitor that was approved by the United States Food and Drug Administration (USFDA) for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant strains. The drug is particularly beneficial for patients who are failing their current antiretroviral regimens due to resistance, intolerance, or safety concerns. Additionally, lenacapavir is under investigation for its potential use in HIV prevention (PrEP), although it has yet to receive global approval for this indication.
A Milestone for Patient Access
Deepak Sapra, CEO of API and Services at Dr. Reddy’s Laboratories, emphasized the significance of lenacapavir for improving patient access and affordability in HIV treatment. He stated, “This 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.”
Currently, Gilead’s pricing for lenacapavir in high-income countries stands at an eye-watering $42,250 annually. In contrast, researchers estimate that Indian generic manufacturers could produce the drug for as little as $100 per person per year, with the potential for further cost reductions as demand rises.
Hetero’s Commitment to Affordable Treatments
Vamsi Krishna Bandi, Managing Director of Hetero Group of Companies, highlighted the company’s long-standing commitment to affordable HIV/AIDS treatments. “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. We will further bring quick access to lenacapavir in Africa, India, and other LMICs, where we’ve been a cornerstone of HIV/AIDS care.”
The agreement not only expands access to lenacapavir but also represents a crucial victory for public health advocates. Earlier this month, Gilead announced promising results from a pivotal Phase 3 clinical trial, revealing that lenacapavir reduced HIV infections by 96% compared to the background incidence. This establishes lenacapavir as a transformative long-acting treatment and prevention option for HIV.
Addressing Patent Concerns
While this licensing agreement brings hope, concerns about patent applications for lenacapavir persist. Patient advocacy groups, including Sankalp Rehabilitation Trust, have voiced fears that patent approvals could limit access to affordable generic versions of the drug in India, potentially extending Gilead’s monopoly until 2038. These concerns echo a global movement against such monopolies, with public health groups in countries like Argentina, Thailand, and Vietnam filing patent challenges as part of the Make Medicines Affordable campaign.
The signing of these voluntary licenses ensures that lenacapavir will be available at affordable costs in LMICs, marking a critical shift in how essential medications can be accessed by those who need them the most. This initiative is reminiscent of previous efforts, such as Gilead’s voluntary licensing agreements with Indian firms like Cipla and Mylan for Remdesivir during the COVID-19 pandemic.
Conclusion
The partnership between Hetero, Dr. Reddy’s Laboratories, and Gilead Sciences marks a pivotal moment in the battle against HIV. By making lenacapavir accessible to millions in low- and lower-middle-income countries, this collaboration not only addresses a pressing healthcare need but also sets a precedent for future partnerships aimed at improving global health outcomes. As lenacapavir progresses in its dual role as a treatment and potential prevention option, the healthcare landscape for HIV is poised for transformative change.