Date: 2014-12-29
Type of information: Licensing agreement
Compound: combination of darunavir (Prezista®), cobicistat (Tybost®), emtricitabine and tenofovir alafenamide (TAF)
Company: Gilead (USA - CA) Janssen R&D, a J&J company (USA - NJ)
Therapeutic area: Infectious diseases
Type agreement: licensing development manufacturing production commercialisation
Action mechanism:
Disease: HIV-1 infection
Details: * On December 29, 2014, Janssen R&D Ireland (Janssen) announced an amendment to its existing agreement with Gilead Sciences, initially established in 2011, for the development of a once daily, darunavir-based, single-tablet regimen (STR) for the treatment of people living with HIV. This new STR contains a combination of darunavir (Prezista®), cobicistat (Tybost®), emtricitabine and tenofovir alafenamide (TAF). A number of Phase 1 and 2 studies of the new STR have been completed. 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. In addition to this collaboration, Janssen and Gilead have also expanded a separate agreement initiated in 2009 regarding the approved single-tablet regimen, Complera®, marketed as Eviplera® in the European Union (EU) (rilpivirine, tenofovir disoproxil fumarate (TDF) and emtricitabine). This expanded agreement will allow for Gilead\'s investigational tenofovir alafenamide (TAF), a novel nucleotide reverse transcriptase inhibitor, to replace TDF within Complera®/ Eviplera®. TAF has been shown in clinical trials to have a better renal and bone safety profile than TDF.1 Gilead will be responsible for the development and commercialization in most countries, while Janssen will lead the commercialization in select markets.
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