Dr Reddy’s Laboratories Ltd. has entered into a royalty-free, non-exclusive voluntary licensing agreement with Gilead Sciences for investigational once-yearly lenacapavir for HIV prevention through pre-exposure prophylaxis (PrEP). The agreement builds on the companies’ existing licensing arrangement, signed in October 2024, for twice-yearly lenacapavir for HIV prevention and treatment. The latest collaboration focuses on expanding manufacturing readiness and future access to long-acting HIV prevention options in licensed markets.
Agreement Supports Manufacturing and Supply Planning
Under the new agreement, Dr Reddy’s will work towards manufacturing readiness, technology transfer and future supply planning for investigational once-yearly lenacapavir. Clinical development of the treatment will continue in the licensed territories, primarily in low- and lower-middle-income countries. The collaboration is intended to support future availability if the once-yearly formulation receives the required regulatory approvals.
Focus on Long-Acting HIV Prevention
HIV remains a significant global public health challenge, creating continued demand for effective and convenient prevention options. The collaboration expands Dr Reddy’s Public Health Access portfolio, which focuses on improving access to medicines across communicable diseases, reproductive health, and maternal and child health. Deepak Sapra, Chief Executive Officer, API and Services, Dr Reddy’s Laboratories Ltd., said the agreement builds on the company’s existing collaboration with Gilead and reflects its commitment to supporting global HIV prevention efforts. He added that, if approved, once-yearly lenacapavir could provide an additional long-acting HIV prevention option, particularly for people in regions where access and adherence remain challenges.
Once-Yearly Lenacapavir Under Clinical Evaluation
Investigational once-yearly lenacapavir is currently being evaluated in Gilead’s Phase 3 PURPOSE 365 study. Importantly, once-yearly lenacapavir for HIV prevention remains investigational and has not been approved by any regulatory authority. Its safety and efficacy for this use have not yet been established. Lenacapavir is already approved in multiple countries for treating adults with multidrug-resistant HIV when used in combination with other antiretroviral medicines. Twice-yearly lenacapavir for HIV prevention has also received approval from the US FDA and European Medicines Agency, while the WHO has recommended twice-yearly lenacapavir in its HIV prevention guidelines.
Lenacapavir Targets Multiple Stages of HIV Lifecycle
Lenacapavir has a mechanism of action that differs from currently approved classes of antiviral medicines. While many antivirals target a single stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle. According to the companies, laboratory studies have shown no known cross-resistance between lenacapavir and other existing antiviral drug classes. Gilead is evaluating lenacapavir as a long-acting option across multiple ongoing and planned clinical studies covering HIV prevention and treatment. The company is also exploring different dosing approaches, including long-acting oral and injectable options, to address the needs and preferences of people and communities affected by HIV.
Dr Reddy’s Strengthens Public Health Access Portfolio
The latest agreement further strengthens Dr Reddy’s focus on expanding access to innovative and affordable medicines. Headquartered in Hyderabad, India, Dr Reddy’s Laboratories was established in 1984 and offers a portfolio spanning active pharmaceutical ingredients (APIs), generics, branded generics, biosimilars and over-the-counter products. As reported by pharmabiz.com, through its collaboration with Gilead, the company is preparing for potential future manufacturing and supply of once-yearly lenacapavir in licensed markets, subject to regulatory approvals and successful clinical development.
