US-based pharmaceutical firm Merck has entered an agreement with the Medicines Patent Pool (MPP) to provide its paediatric formulations of raltegravir to treat HIV-1 infection in infants and children from four weeks to below 12 years of age in developing countries.
Raltegravir paediatric formulations are available as chewable tablets, including 25mg and 100mg, and granules for oral suspension, comprising single-use 100mg packets.
As part of the agreement, Merck will provide a royalty-free licence to MPP to develop paediatric formulations of raltegravir, including chewable tablets and granules for oral suspension for infants and children from four weeks to below 12 years of age.
Merck HIV franchise global commercial leader and general manager Jackie Neilson said: "This agreement with the MPP has been established to provide access to raltegravir to HIV-infected children in developing countries where the burden of HIV infection is highest, including sub-Saharan Africa."
The agreement has been signed to enhance access to raltegravir for paediatric populations in around 92 low and middle-income countries, which are said to include high-rates of paediatric HIV.
Merck is marketing raltegravir as Isentress, which is indicated in combination with other antiretroviral agents to treat HIV-1 infection in patients four weeks of age and older in the US.
The deal will also allow to develop new paediatric formulations of raltegravir, in support of the Global Paediatric Antiretroviral Commitment-to-Action announced by the US President’s Emergency Plan for AIDS Relief (PEPFAR), the Paediatric HIV Treatment Initiative (PHTI), and the Global Fund to fight AIDS, tuberculosis and malaria.
MPP executive director Greg Perry said: "Raltegravir adds to our arsenal of pediatric licenses in supporting better options for children in low and middle-income countries and can benefit the most neglected sub-segment: infants and toddlers less than three years of age."
Image: Scanning electron micrograph of HIV-1 budding (in green) from cultured lymphocyte. Photo: courtesy of C Goldsmith.