GSK Extends License for HIV Medicine to Developing Countries

ViiV Healthcare, a global specialist HIV company majority owned by GlaxoSmithKline (GSK), with Pfizer Inc. and Shionogi Limited as shareholders, has extended overall country coverage of its existing license agreement for adults formulation of dolutegravir to the Medicines Patent Pool (MPP) to cover all lower middle-income countries (LMICs). Dolutegravir is an integrase strand transfer inhibitor for use in combination with other antiretroviral agents for the treatment of HIV.

The existing licenze agreement already covers all low income, least developed and all sub-Saharan African countries. This extension to include all remaining LMICs means that more than 94% of adults living with HIV in the developing world are now covered by the license agreement.

This is of particular importance in four countries, Armenia, Moldova, Morocco and Ukraine, where ViiV Healthcare has a registered patent for dolutegravir. The revised agreement means that dolutegravir and dolutegravir-based fixed-dose combinations could now be made available through generic manufacturers subject to the necessary regulatory approval.

The extension is aligned to GSK's recent commitment to seek to offer and agree to licenses that allow supplies of generic versions of its current and future portfolio of patented medicines in most LMICs for 10 years.

ViiV Healthcare entered in a license agreement with the Medicines Patent Pool in 2014 to increase access to dolutegravir for children and adults in countries where the need is the greatest. The collaboration with the MPP in adults includes two distinct approaches: a royalty-free voluntary licence in all least-developed, all low-income and all sub-Saharan African countries and a tiered royalty license for some middle-income countries, where a small percentage of the net sales value is paid according to the gross national income per capita.

Source: GlaxoSmithKline

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