Janssen enhances access to HIV drug.
NEW YORK -- Janssen Pharmaceutical Cos., a unit of Johnson & Johnson, has extended its commitment to improve the health of children living with HIV through an expanded policy aimed at enhancing access to its HIV medicine darunavir. J&J says that this policy enables the development of and access to new pediatric products of darunavir in about 130 low- and middle-income countries that are home to 99.8% of children and adolescents living with HIV worldwide. = As part of the efforts to help meet the needs of children and adolescents living with HIV, Janssen is working to create one of the broadest geographic territories for an access effort for pediatric HIV medicines to date. The company says it will expand 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 those 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 HTV 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).
Janssen will collaborate with PHTI partners to develop critical new formulations of pediatric HIV medicines to help safeguard the lives of children and adolescents living with HIV. The company and PHTI organizations will also 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. "Our vision is that children living with HIV can receive the treatments they need to stay strong and grow to become productive young adults," said Paul Stoffels, chief scientific officer at J&J and worldwide chairman at Janssen.
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|Title Annotation:||RX: RETAIL PHARMACY|
|Publication:||Chain Drug Review|
|Date:||Jun 1, 2015|
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