Gilead Sciences and Merck have signed an agreement to co-develop and co-commercialise long-acting treatments for HIV.
The collaboration will pair Gilead’s lenacapavir and Merck’s islatravir into a two-drug regimen to provide new treatment options for HIV patients.
Both potential medicines are in late-stage clinical trials with significant clinical data generated to date.
Lenacapavir is an investigational capsid inhibitor, while islatravir is an investigational nucleoside reverse transcriptase translocation inhibitor. In clinical studies, both drugs demonstrated activity at low dosages.
However, the safety and efficacy of the two candidates is yet to be established.
Initially, the two companies will focus on the development of long-acting oral and injectable formulations of the drug combination.
As agreed, Gilead and Merck will share global development and commercialisation costs in 3:2 ratio, respectively.
Gilead will lead commercialisation of long-acting oral products in the US and Merck will lead its commercialisation in the EU and the rest of the world. For long-acting injectable products, the responsibilities will get reversed.
The two companies also agreed to share global product revenues equally until product revenues surpass certain pre-agreed per formulation revenue tiers.
Merck chairman and CEO Kenneth C Frazier said: “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.
“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.”
Gilead Sciences chairman and CEO Daniel O’Day said: “Through this agreement with Merck, Gilead is reinforcing its long-term role in transforming HIV care.
“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.”
The two companies plan to initiate clinical studies of the oral combination in the second half of this year.