ViiV Healthcare has formalised its collaboration with Janssen Sciences Ireland UC for the Phase III investigation and commercialisation of the long-acting, injectable formulations of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen) for the treatment of HIV-1 infection.
Cabotegravir is an investigational integrase strand transfer inhibitor (INSTI) and analogue of dolutegravir while rilpivirine is a once daily non-nucleoside reverse transcriptase inhibitor (NNRTI).
The long-acting formulations of cabotegravir (CAB LA) and rilpivirine (RPV LA) are being investigated as an injectable maintenance treatment for patients who have achieved viral suppression.
“As a company committed to innovation in the field of HIV, this agreement with Janssen will enable us to progress the development of the first long-acting, injectable two drug regimen,” said Dominique Limet, CEO, ViiV Healthcare. “If successful, this regimen would offer people living with HIV who have achieved viral suppression an alternative option to the standard oral daily, three drug therapy.”
While HIV is now considered a chronic manageable condition for most individuals, there are remaining treatment challenges that continue to impact the lives of people living with HIV; which may include tolerability, safety, dosing schedules, drug interactions and adherence.
Phase III programme to start in mid-2016
As part of this agreement, the two companies expect to start a Phase III programme to evaluate the efficacy, safety and tolerability of the long-acting, two drug injectable regimen in mid-2016.
This is the second development agreement with Janssen. In June 2014 both companies entered into an agreement to develop and commercialise a single-tablet combining ViiV Healthcare’s dolutegravir (Tivicay) and Janssen’s rilpivirine. A phase III clinical trial programme to evaluate the safety and efficacy of both medicines as maintenance treatment of HIV-1 infection began in May 2015. These agreements build on ViiV Healthcare’s strategy to collaborate with other companies, institutions and not-for-profit organisations to contribute to the understanding and management of HIV.
