Janssen amends agreement with Gilead

The companies amends agreement to develop and commercialise Tenofovir Alafenamide-based single tablet regimens for HIV treatment

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The original agreement was established in 2009

Gilead Sciences has announced an expansion to its agreement with Janssen R&D Ireland for the development and commercialisation 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 three 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.

"We believe that TAF's efficacy and safety advantages may make it a strong backbone of new fixed-dose combinations and single tablet regimens. Gilead is pleased to continue its collaboration with Janssen to bring improved treatment options to patients living with HIV," said Dr Norbert Bischofberger, executive vice president, R&D and chief scientific officer, Gilead Sciences.

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.

 

 

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