Date: 2014-06-12
Type of information: Development agreement
Compound: single tablet regimen containing Janssen\'s rilpivirine (Edurant®) and ViiV\'s dolutegravir (Tivicay®)
Company: Janssen R&D Ireland, a J&J company (Ireland - USA) - ViiV Healthcare (USA - UK)
Therapeutic area: Infectious diseases
Type agreement: development commercialisation
Action mechanism: integrase inhibitor/non-nucleoside reverse transcriptase inhibitor. Dolutegravir is an investigational integrase inhibitor (INI). Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Given the stage of development of this investigational HIV therapy, the full picture of the efficacy and safety of dolutegravir has not been conclusively determined. Rilpivirine (Edurant®) is a non-nucleoside reverse transcriptase inhibitor.
Disease: maintenance treatment of people living with Human Immunodeficiency Virus (HIV)
Details: * On June 12, 2014, Janssen R&D Ireland announced that they have entered into a collaboration with ViiV Healthcare to develop and commercialize a new single tablet regimen containing Janssen\'s non-nucleoside reverse transcriptase inhibitor rilpivirine (marketed as Edurant®) and ViiV\'s Integrase Inhibitor dolutegravir (marketed as Tivicay®) as the sole active ingredients for the maintenance treatment of people living with Human Immunodeficiency Virus (HIV). The companies will further investigate development of this drug combination for pediatric use. If successfully developed and approved by regulatory authorities, this treatment could offer people living with HIV who are virologically suppressed an option to switch from a standard three-drug therapy to a two-drug, Nucleoside Reverse Transcriptase Inhibitor (NRTI)-sparing antiviral regimen. Formulation and clinical development for the single tablet regimen will begin in the coming months.
Financial terms:
Latest news: * On May 6, 2015, ViiV Healthcare announced the start of a phase III clinical trial programme to evaluate the safety and efficacy of dolutegravir (Tivicay®) and rilpivirine (Edurant®) as maintenance therapy for adult patients with HIV.
