Date: 2016-01-07
Type of information: Clinical research agreement
Compound: cabotegravir and rilpivirine
Company: Janssen Sciences Ireland, a J&J company (USA - NJ) ViiV Healthcare (USA - UK)
Therapeutic area: Infectious diseases
Type agreement: clinical research commercialisation
Action mechanism: integrase strand transfer inhibitor/non-nucleoside reverse transcriptase inhibitor. Cabotegravir is an investigational integrase strand transfer inhibitor (INSTI) and analogue of dolutegravir (Tivicay®). The drug is being developed by ViiV Healthcare for the treatment and prevention of HIV and is currently being evaluated as a once-daily oral tablet formulation and as a long-acting nanosuspension formulation for intramuscular (IM) injection. Rilpivirine (Edurant®) is a once daily non-nucleoside reverse transcriptase inhibitor (NNRTI) used for the treatment of human immunodeficiency virus (HIV-1) infection in combination with other antiretroviral agents in antiretroviral treatment-naïve adult patients with a viral load ? 100,000 HIV RNA copies/mL. The drug was developed by Janssen.
Disease: maintenance treatment for VIH patients who have achieved viral suppression.
Details: * On January 7, 2016, ViiV Healthcare, a global specialist HIV company with GSK, Pfizer Inc. and Shionogi Limited as shareholders, formalised its collaboration with Janssen Sciences Ireland UC (Janssen) 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. 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 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 integrase strand transfer inhibitor (INSTI), dolutegravir (Tivicay®) and Janssen’s non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (EDURANT®). 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.
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