Janssen R&D Ireland (Janssen) announced today it 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.
Under the terms of the agreement, a Drug Development program of PATH, an international nonprofit organization that transforms global health through innovation, has the right to develop rilpivirine long-acting formulation as a possible new way to prevent HIV infection. PATH has the intent to conduct prophylaxis clinical trials in collaboration with partners including the HIV Prevention Trials Network. Following the completion of the clinical Phase 2 program, 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 an important treatment option for patients today and we are pleased to work with PATH to evaluate it as an injectable depot formulation that may help to reduce the spread of infection," said Wim Parys, Global Head of Research & Development, Janssen Global Health. "We believe that evaluating a long-acting formulation, which could help improve adherence in a PrEP regimen, is an important part of the Janssen commitment to the global fight against HIV and AIDS."
Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It is currently 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 impact the commercialization of rilpivirine by Janssen, and does not impact the use of rilpivirine in combination treatments.
SOURCE Janssen R&D Ireland