Gilead Sciences, Inc. has expanded its agreement with Janssen R&D Ireland for the development and commercialization of a new once-daily single tablet regimen containing Gilead's tenofovir alafenamide (TAF) and emtricitabine, and Janssen's rilpivirine. The original agreement was established in 2009 for the development and commercialization of Complera, marketed as Eviplera in the European Union, which combines tenofovir disoproxil fumarate, emtricitabine, and rilpivirine in a once-daily tablet. Gilead will initiate Phase III studies of emtricitabine/rilpivirine/TAF in the coming months. Pending the product's approval, Gilead will be responsible for the manufacturing, registration, distribution, and commercialization of the regimen in most countries while Janssen will distribute in approximately 17 markets.

TAF is a novel nucleotide reverse transcriptase inhibitor that has demonstrated high antiviral efficacy at a dose 10 times lower than Gilead's Viread (tenofovir disoproxil fumarate), as well as an improved renal and bone safety profile.

Gilead and Janssen also have amended a licensing agreement for the development and commercialization of a once-daily single tablet regimen for HIV containing Gilead's TAF, emtricitabine, and cobicistat, and Janssen's darunavir. Under the amended agreement, Janssen will be responsible for further development of the regimen and, subject to regulatory approval, the manufacturing, registration, distribution and commercialization of the product worldwide. Separate to the Janssen agreements, Gilead is advancing its own TAF-based single tablet regimen containing elvitegravir, cobicistat, emtricitabine, and TAF, and in November 2014, Gilead filed for regulatory approval in the United States for this  

Source: Gilead Sciences