ViiV Healthcare, Janssen Partner for an HIV Combination TherapyBy
ViiV Healthcare has formed an agreement with Janssen R&D Ireland Ltd for developing and commercializing a single-tablet combining dolutegravir, the active ingredient in ViiV’s Tivicay, a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor, and Janssen's non-nucleoside reverse transcriptase inhibitor rilpivirine, the active ingredient in Edurant. ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline and Pfizer; Shionogi joined as a 10% shareholder in October 2012.
This represents ViiV Healthcare's first external collaboration to develop a single-tablet regimen with another company's branded product and builds on ViiV Healthcare's strategy to expand its portfolio of dolutegravir-based regimens. Tivicay received FDA approval in 2013 for use in combination with other anti-retroviral medicinal products for treating HIV-1 infection in adults and children aged 12 years and older weighing at least 40 kg. EMA approved the drug in 2014 for use in combination with other anti-retroviral medicinal products for the treatment of HIV-infected adults and adolescents above 12 years of age.
Under the agreement, the two companies will investigate the potential of combining dolutegravir and rilpivirine into a single-tablet to expand the treatment options available to people living with HIV. Studies included in the new development program are expected to begin by the first quarter of 2015 and will investigate the two-drug combination regimen as an HIV maintenance therapy for patients already virally suppressed on a three-drug regimen. The companies will further investigate the development of pediatric fixed-dose formulations that combine dolutegravir and rilpivirine.