Gilead Widens Royalty-Free Lenacapavir Licensing to 120 Countries

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Gilead Sciences has expanded its royalty-free voluntary licensing of once-yearly lenacapavir for HIV prevention to 120 high-incidence countries. The biopharma group also signed a regional agreement with the Pan American Health Organization to widen access to twice-yearly lenacapavir across Latin America and the Caribbean, creating a direct pathway for 14 additional countries in the region to obtain the drug for HIV prevention programs. The expanded royalty-free licenses and the PAHO agreement tilt Gilead further toward a volume-based access model in HIV prevention, particularly in low and lower middle income markets, with partners such as Dr. Reddy's and Hetero expected to handle much of the production and local distribution. The company said the clearest test over the next couple of years will be whether countries move from agreements to funded rollouts, especially as Phase 3 PURPOSE 365 data matures and PAHO's revolving funds translate into concrete procurement. Uptake in the 14 additional Latin American and Caribbean markets outside the core licensing pool will be a particularly useful early signal.

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