J&J Expands Pediatric Access to HIV MedicineBy
Johnson & Johnson reports that Janssen Pharmaceutical Companies have furthered their commitment to improve the health of children living with HIV through an expanded policy aimed at enhancing access to its HIV medicine darunavir. This policy enables the development of and access to new pediatric products of darunavir in 128 low- and middle-income countries, home to 99.8% of children and adolescents living with HIV worldwide.
Janssen is expanding the geographic scope of its 2012 policy not to enforce the patents it owns and controls on the antiretroviral (ARV) drug darunavir, for pediatric products used in low- and middle-income countries. This doubles the original territory of sub-Saharan Africa and Least Developed Countries announced in 2012. The 2012 policy outlines that Janssen will not enforce its darunavir patent rights, provided the generic versions of darunavir are quality, medically acceptable, and only used in the indicated countries. The expanded policy is applicable only for pediatric darunavir products used in the defined territory. Manufacturers are still responsible for obtaining permissions from other darunavir patent holders and health authorities where appropriate.
These renewed efforts are an outcome of engagement between Janssen and the Medicines Patent Pool (MPP), directly supporting the recently launched Pediatric HIV Treatment Initiative (PHTI). PHTI is a partnership between the MPP, UNITAID, the Drugs for Neglected Diseases initiative (DNDi), and the Clinton Health Access Initiative (CHAI) dedicated to speeding the development of high-priority pediatric co-formulations of HIV medicines and addressing other potential barriers to treatment access for children living with HIV.
Janssen will collaborate with PHTI partners to develop critical new formulations of pediatric HIV medicines for children and adolescents living with HIV. Janssen and PHTI organizations will explore the possible development of a fixed-dose combination (FDC) of darunavir with the boosting agent ritonavir for children living with HIV. Darunavir administered with ritonavir and in combination with other antiretroviral medicines is currently indicated for highly treatment-experienced adult and pediatric HIV patients (third-line) in resource-limited settings and has been recommended by the World Health Organization. A novel FDC that is safe, effective and child-friendly would be an important step in realizing the global health imperative to close the pediatric HIV treatment gap, said the company.
Johnson & Johnson has supported efforts to reduce the number of new HIV infections among children for more than a decade, and in 2011, the company pledged an additional $15 million to support the Global Plan to eliminate pediatric HIV. In December 2013, Janssen launched the New Horizons Advancing HIV Care initiative, a collaborative effort to strengthen country-level capacity, knowledge, and action around the needs of HIV treatment-experienced children. A key feature of this initiative is a treatment donation program for Prezista (darunavir) and Intelence (etravirine) for HIV treatment-experienced children and adolescents.
Source: Johnson & Johnson