Gilead and MSD partner to develop and commercialise two-drug HIV regimen

pharmafile | March 16, 2021 | News story | Manufacturing and Production Gilead, HIV, MSD 

Gilead and MSD, known as Merck in the US and Canada, have entered into an agreement to co-develop and co-commercialise long-acting HIV treatments.

The treatments will combine Gilead’s investigational capsid inhibitor, lenacapavir, and MSD’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, into a two-drug regimen for people living with HIV.

Islatravir and lenacapavir are both potentially first-in-class medicines in late-stage clinical trials, with significant clinical data generated to date. Both medicines have long half-lives and have demonstrated activity at low dosages in clinical studies, which support development as an investigational combination regimen with long-acting formulations, both oral and injectable.

The first clinical studies of the oral combination are expected to begin in the second half of this year.

Under the terms of the agreement, Gilead and MSD will work as partners, sharing operational responsibilities, as well as development, commercialisation and marketing costs, and any future revenues.

Kenneth C Frazier, Chairman and Chief Executive Officer of MSD, 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.”

Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences, also commented: “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.”

Lenacapavir and islatravir, alone and in combination, are investigational and not approved anywhere globally. Their safety and efficacy have not yet been established.

Darcy Jimenez

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