Date: 0000-00-00
Type of information: Collaboration agreement
Compound: Tivicay® (dolutegravir)
Company: ViiV Healthcare (UK - USA) the Medicines Patent Pool
Therapeutic area: Infectious diseases
Type agreement: collaboration
Action mechanism: integrase inhibitor. Dolutegravir is an investigational integrase inhibitor (INI). INI blocks HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.
Disease: HIV1-infection
Details: * On April 1, 2014, ViiV Healthcare has announced an agreement with the Medicines Patent Pool (MPP) with the goal of increasing access to its HIV medicine, dolutegravir (Tivicay®). Through this agreement, ViiV Healthcare will accelerate access to dolutegravir where the need is the greatest, in the countries where 99% of children and 93.4% of adults with HIV in the developing world live. The collaboration with MPP includes two distinct approaches to improve access for adults living with HIV in the developing world: first, a royalty-free voluntary licence in all least-developed, all low-income and all sub-Saharan African countries; second, for specific middle-income countries including India, ViiV Healthcare has established the first-ever MPP licence with a tiered royalty structure, where a small percentage of the sale price is paid based on the gross domestic product (GDP) of the specific country. The licences will also allow for the possible development, manufacture and supply of dolutegravir-based fixed-dose combinations, including those with abacavir, if and when approved by local regulatory agencies.
ViiV Healthcare will grant MPP a voluntary licence for generic manufacturers to develop paediatric formulations of dolutegravir without paying a royalty in 121 countries where most (99%) children with HIV live. Dolutegravir is currently approved for patients 12 years and older. However, this licence also includes a commitment for future lower dose tablets and age-appropriate formulations developed by ViiV Healthcare to meet the needs of younger children with HIV, if and when approved by a major regulatory authority.
Financial terms:
Latest news: * On April 25, 2016, ViiV Healthcare announced an extension of overall country coverage of its existing licence agreement for adults formulation of dolutegravir to the Medicines Patent Pool (MPP) to cover all lower middle income countries (LMICs). The existing licence 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 licence agreement1. 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 to benefit an additional 270,000 people living with HIV. 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 licence for some middle-income countries, where a small percentage of the net sales value is paid according to the gross national income (GNI) per capita.
