MPP, MSD sign licensing agreement for paediatric formulations of raltegravir

Company joins five other MPP patent holders in efforts to improve HIV paediatric care

The Medicines Patent Pool (MPP) announced a licence today with MSD, known as Merck in the United States and Canada, for paediatric formulations of raltegravir, a key medicine approved for children living with HIV four weeks of age and older. With the new licence, generic manufacturers and other companies based anywhere in the world can develop, manufacture and sell low cost, paediatric versions of raltegravir in countries with the highest burden of disease, where 98 percent of children with HIV in the developing world live.

"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, 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."

"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, 50 percent of infants living with HIV/AIDS will die by the age of two, and 80 percent by the age of five. We need a range of optimal, 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 a month 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."

The agreement comes just two months after MPP signed a licence with AbbVie for paediatric versions of lopinavir and ritonavir and supports the work of the Paediatric HIV Treatment Initiative (PHTI), a collaboration among MPP, UNITAID, the Drugs for Neglected Diseases initiative (DNDi) and the Clinton Health Access Initiative (CHAI), to develop better, adapted HIV paediatric medicines. In December, PEPFAR, the Global Fund and the PHTI joined together in a Global Paediatric Antiretroviral Commitment-to-Action to ensure that new PHTI formulations will be made widely available. The PHTI has recognized raltegravir as an important product for children who fail on their first-line regimens.

The MSD licence territory focuses on low- and middle-income nations with significantly high rates of paediatric HIV, totalling 92 countries. Under the terms of the agreement, generic manufacturers have the right to reformulate raltegravir formulations for use in combination with other HIV medicines and for distribution in resource-limited settings.