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The companies will combine combining Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, into a two-drug regimen aimed at treating HIV.
Gilead Sciences and Merck, known as MSD outside of the United States and Canada, announced on March 15, 2021 that they have entered into an agreement to co-develop and co-commercialize long-acting treatments in human immunodeficiency virus (HIV) by combining Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, into a two-drug regimen.
Under the terms of the agreement, the partnership will focus on long-acting oral formulations and long-acting injectable formulations of the combination products, while other formulations may be added to the collaboration later on, Gilead said in a company press release. Gilead will head the commercialization for long-acting oral products in the United States, while Merck leads commercialization in the European Union (EU) and the rest of the world. For long-acting injectable products, Merck will handle commercialization in the US and Gilead will lead commercialization in the EU and rest of the world. Both companies plan to co-promote the products in the US and other major markets.
Clinical studies of the oral combination are set to begin in the second half of 2021, according to the press release. Gilead and Merck will share operational responsibilities including development, commercialization and marketing costs, and any future revenues.
“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 C. Frazier, chairman and CEO, Merck, in the press release. “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,” added Daniel O’Day, chairman and CEO, Gilead Sciences, in the press release. “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.”