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09.01.2016

Janssen to Progress Collaboration with ViiV Healthcare to Develop the First Long Acting Two Drug Injectable Regimen for Treatment of HIV Infection

Janssen Sciences Ireland UC (Janssen) formalized its collaboration with ViiV Healthcare on phase III development and commercialization of a two drug regimen of two long acting, all-injectable formulations of rilpivirine (a non-nucleoside reverse transcriptase inhibitor by Janssen) and cabotegravir (ViiV Healthcare).

Janssen and ViiV Healthcare have been working together on this regimen, through a number of clinical trial agreements, for several years. Under this new agreement, the phase III development, to evaluate the efficacy, safety and tolerability of the regimen, will be led by ViiV Healthcare with support from Janssen. Each company will manufacture and supply their individual drug formulations following successful phase III completion and regulatory outcomes.

"Despite great progress in developing HIV treatments, the day-to-day burden of managing HIV remains high and poses challenges to ensure people living with HIV maintain an undetectable viral load," says Paul Stoffels, Chief Scientific Officer, Johnson & Johnson and Worldwide Chairman, Janssen Pharmaceutical Companies. "We are committed to making a real difference for those affected by HIV. The prospect of developing new therapies, such as long acting formulations which are broadly accessible, may offer hope to the many millions affected by HIV around the world."

At week 32, in an ongoing phase IIb study (LATTE 2, NCT02120352), the investigational long acting, all-injectable combination regimen, given every 4 or 8 weeks, showed comparable efficacy to a daily oral regimen of three HIV medicines (investigational cabotegravir and two nucleoside reverse transcriptase inhibitors (NRTIs)). If successfully developed and approved by regulatory authorities, people living with HIV who are virologically suppressed could be offered an alternative option to the standard oral daily regimen* of three drug therapy.

Original news piece available at Prnewswire.com


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