Biotech Values

[DewDiligence]

GILD/JNJ revise collaborations re Prezista- and Edurant-based FDCs for HIV:

http://finance.yahoo.com/news/janssen-announces-collaboration-gilead-develop-133000484.html

Janssen R&D Ireland announced today an amendment to its existing agreement with Gilead Sciences, Inc., initially established in 2011 [#msg-64697419], 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).

…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.

…Janssen and Gilead have also expanded a separate agreement initiated in 2009 regarding the approved single-tablet regimen, COMPLERA [#msg-39660789], 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 [Viread] within COMPLERA/ EVIPLERA… Gilead will be responsible for the development and commercialization in most countries, while Janssen will lead the commercialization in select markets.