Janssen R&D Ireland has signed a license agreement with PATH for the early development of the human immunodeficiency virus type 1 (HIV-1) medicine rilpivirine in a long-acting injection (depot formulation) as potential pre-exposure prophylaxis (PrEP) against HIV infection.
A drug development program of PATH, an international nonprofit organization, has the right to develop rilpivirine long-acting formulation as a possible new way to prevent HIV infection. PATH intends to conduct prophylaxis clinical trials in collaboration with partners including the HIV Prevention Trials Network. Following the completion of phase II, PATH and Janssen will evaluate entering into a late stage development agreement covering the use of rilpivirine as PrEP for uninfected individuals at high risk of acquiring HIV.
Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It currently is commercialized by Janssen for the oral, once-daily treatment of HIV-1, in combination with other antiretroviral agents (ARVs), in ARV treatment-naïve adults, and in most countries, in patients with a viral load less than or equal to 100,000 HIV-1RNA copies/mL.
This license agreement with PATH does not affect commercialization of rilpivirine by Janssenor the use of rilpivirine in combination treatments.