– Expanded Policy will Increase Access for Darunavir Pediatric Formulations in 128 Resource-Limited Countries
RARITAN, New Jersey, May 11, 2015 / PRNewswire – Johnson & Johnson today announced that its 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  today.
As part of 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. To that end, Janssen 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 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. Today’s 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 to help safeguard the lives of 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.
“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, M.D., Chief Scientific Officer, Johnson & Johnson and Worldwide Chairman, Janssen. “We are committed to ensuring that no child is without access to appropriate, child-friendly HIV treatment options and, most importantly, the hope of a healthy future.”
Janssen and Johnson & Johnson have a longstanding commitment to helping children living with HIV and enhancing access to its medicines for those in need. For more than a decade, Johnson & Johnson has supported efforts to reduce the number of new HIV infections among children, 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.
Johnson & Johnson and Janssen are committed to advancing global health. Its family of companies has launched and continues to support a variety of comprehensive efforts toward strengthening the health of communities, improving maternal and child health, and preventing the spread of infectious and preventable diseases worldwide. For more information on Johnson & Johnson global health programs, visit www.jnj.com.
About Janssen, the Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are dedicated to addressing and solving the most important unmet medical needs of our time, including in oncology (e.g., multiple myeloma and prostate cancer), immunology (e.g., rheumatoid arthritis, IBD and psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, Hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g., diabetes).
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 In addition to all Least Developed Countries (LDCs) as defined by the United Nations and the countries of sub-Saharan Africa (SSA), countries included in this policy expansion are Algeria, American Samoa, Anguilla, Antigua and Barbuda, Aruba, Bahamas, Barbados, Belize, Bolivia, British Virgin Islands, Colombia, Costa Rica, Cuba, Democratic People’s Republic of Korea, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Fiji, Grenada, Guatemala, Guyana, Honduras, India, Indonesia, Iran, Iraq, Jamaica, Jordan, Lebanon, Libya, Malaysia, Marshall Islands, Micronesia, Moldova, Mongolia, Montserrat, Morocco, Nauru, Nicaragua, Pakistan, Palau, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Sri Lanka, Suriname, Syrian Arab Republic, Thailand, Tonga, Trinidad and Tobago, Tunisia, Turks and Caicos, Ukraine, Uruguay, Venezuela, Vietnam, and West Bank and Gaza.
 Calculated using data from: UNICEF. Children, Adolescents and AIDS (2014 Statistical Update). http://www.childrenandaids.org/
 Resource-limited settings under this policy include all Least Developed Countries (“LDCs”) as defined by the United Nations (http://www.unohrlls.org/en/ldc/25/) and the countries of sub-Saharan Africa (SSA) which are not classified as LDCs.
 World Health Organization. Antiretroviral Therapy for HIV Infection in Adults and Adolescents: Recommendations for a Public Health Approach, 2010 Revision. http://whqlibdoc.who.int/publications/2010/9789241599764_eng.pdf