The Medicines Patent Pool (MPP), an organization founded by UNITAID, and backed by the United Nations, signed today (24th February 2015) a licensing agreement with the American pharmaceutical company MSD (Merck Sharp & Dohme), known as Merck in the United States and Canada, for paediatric formulations of raltegravir- a key medicine approved for children living with HIV, one month of age and older.
This new license would allow generic manufacturers and other companies based anywhere in the world to develop, manufacture and sell low cost, paediatric versions of raltegravir in countries with the highest burden of disease, which are home to 98% of the children living with HIV. “MPP is pleased to have MSD on board as a new private sector partner working with us on paediatric programmes,” said Greg Perry, Executive Director of MPP. “Raltegravir adds to our arsenal of paediatric licences 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.”
The MSD licence will be applicable in 92 low- and middle-income countries, with significantly high rates of paediatric HIV, including India. Under the terms of the agreement, generic manufacturers will have the right to reformulate raltegravir formulations for use in combination with other HIV medicines and for distribution in resource-limited settings.
“PEPFAR applauds the new MSD license as part of international efforts to greatly improve the lives of infants and children living with HIV/AIDS,” said Ambassador Deborah L. Birx, M.D., U.S. Global AIDS Coordinator and U.S. Representative for Global Health Diplomacy. “Without antiretroviral treatment (ART), 50% of infants living with HIV will die by the age of two, and 80% by the age of five. We need a range of optimal and affordable paediatric antiretroviral drugs to scale up treatment and put the right medicines in the right formulations in the hands of caregivers globally.”
The World Health Organization recommends raltegravir as a component of paediatric third-line treatment. Its recent extended approval for infants as young as one month old suggests its potential in filling an important gap in paediatric care. The medicine’s current availability as chewable tablets and granules for oral suspension could potentially ease implementation in paediatric programmes. The medicine is currently in clinical studies for potential use in newborns.
“This agreement with 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,“ said Jackie Neilson, General Manager and Global Commercial Leader for the HIV Franchise, MSD. “This builds upon MSD’s three-decade long commitment to both innovation and access to address the global HIV epidemic.”
MPP works with a range of stakeholders- people living with HIV (PLHIV), governments, industry and international organisations, and to date it has signed agreements for 12 antiretrovirals (ARVs) for countries home to 87-94% of PLHIV in the developing world and for 1 medicine for an HIV opportunistic infection. Only two months ago it had signed a licence with AbbVie for paediatric versions of lopinavir and ritonavir.
MPP, together with UNITAID, the Drugs for Neglected Diseases initiative (DNDi) and the Clinton Health Access Initiative (CHAI), is a partner in the Paediatric HIV Treatment Initiative (PHTI) to accelerate the development of appropriate paediatric Fixed Dose Combinations for resource-limited settings.
Citizen News Service - CNS
24 February 2015
