Dr. Reddy’s Laboratories has entered into a significant collaboration with Gilead Sciences to manufacture and commercialize the HIV drug Lenacapavir in India and 120 other countries. Under a royalty-free, non-exclusive voluntary licensing agreement, Dr. Reddy’s will focus on expanding the availability of this vital medication to regions with high HIV burdens. Lenacapavir, approved by the U.S. FDA for treating multi-drug resistant HIV-1, represents a crucial advancement in HIV care. The agreement also opens the door for Dr. Reddy’s to potentially commercialize Lenacapavir as a preventive treatment (PrEP) pending global approval.

Key Partnership to Address Global HIV Crisis

Dr. Reddy’s Laboratories has formalized a partnership with Gilead Sciences Ireland UC, one of the world’s leading pharmaceutical firms, to ensure wider access to Lenacapavir. This partnership, governed by a royalty-free, non-exclusive voluntary licensing agreement, aims to bring this advanced HIV drug to countries that bear a high disease burden, including India and 120 other low- and lower-middle-income nations. The move is seen as a major step in addressing the ongoing global HIV crisis.

Lenacapavir: A Breakthrough in HIV Treatment

Lenacapavir is a novel HIV-1 drug approved by the U.S. Food and Drug Administration (FDA) for adults with multi-drug-resistant HIV-1 who are no longer responding to their current antiretroviral regimen. The drug targets treatment-experienced patients, providing a new line of defense where other treatments have failed due to resistance, intolerance, or safety issues. This breakthrough medication, first launched by Gilead in 2022 under the brand name *Sunlenca*, is now set to reach wider global markets through Dr. Reddy’s.

Potential for Preventive Use Under Investigation

In addition to its current approval for treating HIV-1, Lenacapavir is also being studied for its potential use as a preventive treatment (PrEP). This would mark a significant expansion in the drug’s application, offering protection against HIV transmission. While PrEP approval for Lenacapavir is still pending, the agreement with Gilead grants Dr. Reddy’s the right to manufacture and distribute the drug for preventive use in the event of global regulatory approval, particularly in the 120 countries included in this deal.

Technology Transfer and Local Manufacturing

Under the terms of the agreement, Dr. Reddy’s will assume responsibility for the complete technology transfer of Lenacapavir’s manufacturing process to its production facilities. This includes conducting bioequivalence and clinical studies, as well as ensuring the drug meets regulatory requirements for its eventual launch in these markets. The initiative underscores Dr. Reddy’s commitment to making cutting-edge treatments locally available at scale, furthering its reputation as a key player in global health.

Expanding Access in Low- and Middle-Income Countries

This collaboration with Gilead is poised to make a substantial impact on HIV treatment across low- and lower-middle-income countries, where the burden of HIV remains severe. Dr. Reddy’s CEO of API and Services, Deepak Sapra, emphasized the importance of expanding access to these regions, highlighting the high disease burden faced by many of these nations. The partnership not only strengthens Dr. Reddy’s global presence but also aligns with broader global health goals of reducing disparities in access to essential medications.

Future Implications for HIV Care

As Lenacapavir moves closer to being available in more countries, the agreement between Dr. Reddy’s and Gilead reflects a broader trend toward innovative global health partnerships. The eventual availability of Lenacapavir as a treatment and potentially as a preventive measure could reshape HIV care in underserved regions. This collaboration serves as a model for future partnerships aimed at overcoming geographical and economic barriers to advanced healthcare solutions.