Janssen R&D Ireland (Janssen), part of the Janssen Pharmaceutical Companies of Johnson & Johnson, 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 programme 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 programme, 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.
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"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.
About Janssen R&D Ireland
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases, and cardiovascular and metabolic diseases.
We are further committed to making a meaningful difference in global public health. Inspired by the legacy of Dr. Paul Janssen and our commitment to patients, we work passionately to discover and responsibly deliver innovative medicines and vaccines that address serious unmet health needs, including HIV, tuberculosis, intestinal worms and neglected tropical diseases.
We collaborate with members of the global healthcare community, including the Bill and Melinda Gates Foundation, the Global TB Alliance, the Drugs for Neglected Diseases Initiative, the International Partnership for Microbicides, and many others, to bring new solutions that deliver years of life and quality of life for people around the world.