Gilead Sciences is wasting no time in promoting worldwide access to its twice-yearly pre-exposure prophylaxis (PrEP) HIV candidate lenacapavir.
Before filing for global regulatory approvals, the company has lined up six generics manufacturers to make and sell the drug in 120 high-incidence, resource-limited countries through voluntary license agreements.
Through the nonexclusive, royalty-free license agreements (PDF), the generics companies can make and sell lenacapavir under its current indication—to treat heavily treatment-experienced adults with multidrug-resistant HIV—and as a PrEP medicine after appropriate regulatory approvals.
The six drugmakers that were selected based on “rigorous criteria” are Dr. Reddy’s Laboratories, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero and Viatris subsidiary Mylan, Gilead said in a release. The six companies are scattered across countries and continents and have all worked with Gilead on similar collaborations.
To take the arrangement a step further, Gilead will supply the manufacturers with the product at “no profit to Gilead” until the generics makers can make enough on their own to fully support demand.
Since building out required capacity “will take time” for the licensees, Gilead said it will prioritize registration in 18 countries that make up around 70% of the HIV burden across the 120 countries covered in the licensing agreements.
“Given the transformative potential of lenacapavir for prevention, our focus is on making it available as quickly and broadly as possible where the need is greatest,” CEO Daniel O’Day explained in a statement. “Gilead teams have been working with urgency to bring on high-volume generic manufacturers now, so that we can ensure a rapid transition to these voluntary license partners after lenacapavir for PrEP is approved.”
With data from two phase 3 studies proving the med's stellar efficiency, Gilead plans to pursue global bids for lenacapavir's PrEP indication by the end of this year. The company is exploring regulatory frameworks such as the European Medicines Agency’s EU Medicines for All, a review process that could enable the drug’s use in low- and middle-income countries outside of the EU.
Lenacapavir first hit the market in 2022 under the brand name Sunlenca for use alongside other agents in patients with multidrug-resistant HIV, a classification that makes up 2% of adults living with HIV.
But with the twice-yearly drug showing strong potential as a long-acting PrEP option, Gilead is looking to “redefine the PrEP market as a whole,” Chief Commercial Officer Johanna Mercier said on a second-quarter earnings call.
Gilead has been supporting global access to its medicines through voluntary licensing deals since 2006, when it offered Indian generics makers the rights to make and export HIV med Viread to 97 countries.
These days, HIV sales continue to make up the majority of the company's revenue. In the second quarter, leading HIV treatment Biktarvy pulled down $3.2 billion of the company's global $4.7 billion haul.
Mizuho analysts have put lenacapavir's peak sales at around $4 billion, according to a note to clients last month.