ARV Global Access Program

The HIV/AIDS epidemic poses an unparalleled challenge. Recognizing the global need for access to HIV treatment, Tibotec provides access to its medications to people in need in resource-limited settings.



Antiretroviral (ARV) regimens must be taken for life. Currently, in resource-poor settings the top public health priority is access to the first-line of ARV regimens. Yet, many patients who were among the first to start treatment are already in need of new regimens. According to the World Health Organization (WHO), only two percent of patients in the developing world have advanced to a second-line therapy. However, access to ARVs is expanding at a rapid rate, especially in sub-Saharan Africa. As access and need for ARV treatment increases and more patients on ARV treatment need to switch to new regimens, a growing number of patients will be in need of third- and fourth-line therapies.



Tibotec is working today to help fulfill this future need. The Tibotec Global Access Program (GAP) seeks to provide sustainable access to patients in need of darunavir and etravirine in sub-Saharan Africa (SSA) and least developed countries (LDC).



Tibotec believes that strong collaborations can provide the best options for patients by enabling drug access while maintaining the quality of medicines. In 2007, the company signed a royalty-free voluntary licensing agreement with the generic manufacturer Aspen Pharmacare of South Africa to register, package and distribute darunavir at a special access price in sub-Saharan Africa. In August 2009, Tibotec signed another royalty-free, non-exclusive commercialization agreement with Aspen Pharmacare to register and distribute etravirine in SSA.



Twenty-one countries in sub-Saharan Africa with an estimated 80 percent of total patient need for darunavir and etravirine have been targeted for the first wave of regulatory submissions for treatment-experienced patients.









Registration dossiers for darunavir 300mg have been filed in 18 SSA countries. We have received approval for darunavir in Botswana, the Democratic Republic of Congo, Ghana, Namibia, Kenya, Senegal, Tanzania, Uganda and Zambia; the product is also readily accessible in Rwanda and Swaziland.



The first registration dossiers for etravirine have been submitted in Botswana, Burkina Faso, Kenya, Senegal, South Africa, Uganda and Zambia.



Tibotec is currently developing a registration approach for darunavir paediatric formulations (75 mg and 150 mg) for treatment-experienced children.



Tibotec is committed to ensuring access to innovative HIV/AIDS therapies in other resource-limited countries as well. Beyond sub-Saharan Africa, Tibotec, through Janssen-Cilag, works with local health authorities to enable prompt regulatory submission and to ensure that darunavir and etravirine are available to patients in need. Pricing for both ARVs in these countries generally reflects a reduction from those in the U.S. and European Union and health authorities' assessments of patient need.



In 2008, Tibotec signed a royalty-free, non-exclusive license agreement with Emcure Pharmaceuticals Ltd of India to distribute the protease inhibitor darunavir in India under its own trade name.

 

  Global Access Brochure 2010 available

 



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