12.29.14
Janssen R&D Ireland has amended its 2011 agreement with Gilead for the development of a once daily, darunavir-based, single-tablet regimen (STR) for the treatment of HIV. This new STR contains a combination of darunavir (PREZISTA), cobicistat (TYBOST), emtricitabine and tenofovir alafenamide (TAF). Several Phase I and II studies of the new STR have been completed. If approved, this treatment would represent the first protease inhibitor-based STR.
Under this amended agreement, Janssen will conduct all further clinical development of the regimen and, subject to regulatory approval, will be responsible for all manufacturing, registration, distribution and commercialization of the product worldwide.
Additionally, the companies have expanded a separate agreement from 2009 regarding the approved single-tablet regimen, COMPLERA, marketed as EVIPLERA in the EU (rilpivirine, tenofovir disoproxil fumarate (TDF) and emtricitabine). This expanded agreement will allow for Gilead's investigational tenofovir alafenamide (TAF) to replace TDF within COMPLERA/ EVIPLERA. In clinical trials, TAF has been shown to have a better renal and bone safety profile than TDF.
Gilead will be responsible for the development and commercialization in most countries, while Janssen will lead the commercialization in select markets.
Under this amended agreement, Janssen will conduct all further clinical development of the regimen and, subject to regulatory approval, will be responsible for all manufacturing, registration, distribution and commercialization of the product worldwide.
Additionally, the companies have expanded a separate agreement from 2009 regarding the approved single-tablet regimen, COMPLERA, marketed as EVIPLERA in the EU (rilpivirine, tenofovir disoproxil fumarate (TDF) and emtricitabine). This expanded agreement will allow for Gilead's investigational tenofovir alafenamide (TAF) to replace TDF within COMPLERA/ EVIPLERA. In clinical trials, TAF has been shown to have a better renal and bone safety profile than TDF.
Gilead will be responsible for the development and commercialization in most countries, while Janssen will lead the commercialization in select markets.