Gilead Sciences and Merck have entered into an agreement to co-develop and co-commercialize long-acting treatments in HIV. The intended solutions will combine Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, into a two-drug regimen with the potential to provide new, meaningful treatment options for people with HIV.
Islatravir and lenacapavir are potentially first-in-class medicines in late-stage clinical trials, with significant clinical data generated for both to date. Each of the medicines reportedly has a long half-life and has demonstrated activity at low dosages in clinical studies, which support development as an investigational combination regimen with long-acting formulations, both oral and injectable.
“At Merck, we are resolute in our commitment to advancing the care of people living with HIV as part of our mission to save and improve lives,” said Kenneth Frazier, chairman and chief executive officer at Merck. “This collaboration with Gilead brings together two companies dedicated to the fight against HIV to develop potential new long-acting treatment options, and is an important step forward in our strategy to harness the full potential of islatravir for the treatment of HIV.”
“Through this agreement with Merck, Gilead is reinforcing its long-term role in transforming HIV care,” said Daniel O’Day, chairman and chief executive officer of Gilead Sciences. “Our work in HIV over the past decades has been shaped by listening to people living with HIV and the physicians who treat them. Now we are taking the same approach with long-acting therapies, combining the most advanced science from both companies to accelerate progress.”
According to the companies, the first clinical trials of the oral combination are expected to begin in the second half of this year. Under the terms of the agreement, Gilead and Merck will work as partners, sharing operational responsibilities, as well as development, commercialization and marketing costs, and any future revenues.
Merck and Gilead are seeking to build on their records of transforming HIV care by focusing on long-acting therapies, which may represent a meaningful innovation in HIV drug development. While daily, single-tablet regimens are available for people living with HIV, options that would allow for less frequent, oral dosing or infrequent injections rather than daily dosing have the potential to address preference considerations, as well as issues associated with adherence and privacy.
Lenacapavir and islatravir, alone and in combination, are investigational and not approved anywhere globally. Their safety and efficacy have not yet been established.
The collaboration between the two firms initially will focus on long-acting oral formulations and long-acting injectable formulations of these combination products, with other formulations potentially added to the collaboration as mutually agreed.
Across the oral and injectable formulation programs, Gilead and Merck will share global development and commercialization costs 60%/40%, respectively. For long-acting oral products, Gilead will lead commercialization in the US, and Merck will lead commercialization in the EU and the rest of the world. For long-acting injectable products, Merck will lead commercialization in the US and Gilead will lead commercialization in the EU and the rest of the world.
Gilead and Merck will co-promote in the US and other certain major markets. Merck and Gilead will share global product revenues equally until product revenues surpass certain pre-agreed per formulation revenue tiers. Upon passing $2b annually in net product sales for the oral combination, the revenue split will adjust to 65% Gilead and 35% Merck for any revenues above the threshold.
Upon passing $3.5b a year in net product sales for the injectable combination, the revenue split will adjust to 65% Gilead and 35% Merck for any revenues above the threshold.