MPP is a United Nations-backed funding agency which is part of the World Health Organisation (WHO), and this is its first agreement to provide access to an HIV integrase inhibitor for use in combination HIV therapy to treat infants and children in this age group.
It means that generic manufacturers and other companies based anywhere in the world can develop, manufacture and sell low cost, paediatric versions of Isentress in 92 countries, including sub-Saharan Africa.
Under the deal, Merck is offering MPP a royalty-free license to develop pediatric formulations of raltegravir, chewable tablets and granules for oral suspension.
The deal will also see new pediatric formulations developed of raltegravir, in support of the ‘Global Pediatric Antiretroviral Commitment-to-Action’ announced by the US President’s Emergency Plan for AIDS Relief (PEPFAR), the Pediatric HIV Treatment Initiative (PHTI), and the Global Fund to Fight AIDS, Tuberculosis and Malaria, to accelerate the development of new, high-priority pediatric antiretroviral co-formulations.
In the US, Merck markets raltegravir as Isentress and is indicated in combination with other antiretroviral agents to treat HIV-1 infection in patients aged four weeks and older.
In the US and European Union (EU), raltegravir is the only integrase inhibitor approved for use in infants and children as young as four weeks.
Currently, pediatric formulations of raltegravir are available as chewable tablets in doses of 25mg and 100mg, and granules for oral suspension in single-use 100mg packets.