Janssen and Gilead Sciences have extended an existing agreement to develop a single-tablet treatment for HIV.
The two companies – both of which have made major developments in infectious diseases in the past year – have completed several phase I and phase II trials involving a single, once-daily drug for HIV having originally agreed to work together in 2011.
The treatment in development combines Janssen’s Prezista (darunavir) with Gilead’s Tybost (cobicistat), generic emtricitabine and tenofovir alafenamide, an investigational prodrug in development by Gilead.
Now the two companies have agreed to take the partnership further with the amended deal seeing Janssen responsible all further clinical development and all manufacturing, registration, distribution and commercialisation of the combination drug.
Paul Stoffels, chief scientific officer and chairman of pharmaceuticals at Johnson & Johnson, said: “We are proud to be extending our collaboration and leading the development of this darunavir-based single tablet regimen. Our ultimate goal is to offer new treatment options for people living with HIV.”
If successfully developed and approved, the treatment would be the first protease inhibitor-based STR available for people with HIV.
Janssen and Gilead have also expanded another agreement concerning Complera, a combination of rilpivirine, tenofovir disoproxil fumarate and emtricitabine that is marketed as Eviplera in the EU. The alterations to the agreement will mean Gilead’s tenofovir alafenamide will replace tenofovir disoproxil fumarate within Eviplera.
In clinical trials, tenofovir alafenamide has proved to have a better renal and bone safety profile than TDF.