Gilead Sciences and Tibotec Pharmaceuticals, a unit of Johnson & Johnson, have entered an agreement to develop and commercialize a new fixed-dose combination of Truvada and TMC278 (rilpivirine).

Gilead will assume the lead role in the manufacturing, registration, distribution and commercialization of the fixed-dose combination drug worldwide, excluding the developing world and Japan. Tibotec will be responsible for the commercialization of rilpivirine as a stand-alone product and will hold rights to co-promote the fixed-dose combination in these territories. The companies will also work to make the combination drug available in the developing world.

“Gilead and Tibotec share a strong focus on bringing safe and effective treatment options to people living with HIV/AIDS,” said John C. Martin, Ph.D., chairman and chief executive officer, Gilead Sciences. “Fixed-dose regimens have become the standard of care as HIV treatment has evolved toward more simplified regimens for patients. We are very pleased to collaborate with Tibotec and look forward to advancing this new fixed-dose product.”

Tibotec is currently studying the combination of Truvada and rilpivirine in Phase III trials. If approved, it will be second complete antiretroviral treatment regimen for HIV available in a single tablet taken once daily.

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