OREANDA-NEWS. Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced an agreement with the Medicines Patent Pool (MPP) to license its pediatric formulations of raltegravir for use in treating HIV-1 infection in infants and children from four weeks to under 12 years of age in developing countries. This is the MPP’s first agreement to provide access to an HIV integrase inhibitor for use in combination HIV therapy for infants and children in this age range. The agreement also allows for development of novel pediatric formulations of raltegravir and novel combinations. Raltegravir is marketed by Merck as ISENTRESS® (raltegravir). In the United States, ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients four weeks of age and older.

“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,” said Jackie Neilson, general manager and global commercial leader for the HIV Franchise, Merck. “This builds upon Merck’s three-decade long commitment to both innovation and access to address the global HIV epidemic.”

Raltegravir is the only integrase inhibitor approved for use in infants and children as young as four weeks in the United States and European Union. Pediatric formulations of raltegravir are available as chewable tablets (25 mg and 100 mg) and granules for oral suspension (single-use 100 mg packets).

Merck is providing the MPP a royalty-free license for the development of pediatric formulations of raltegravir—chewable tablets and granules for oral suspension—for infants and children from four weeks to under 12 years of age. The agreement is designed to improve access to raltegravir for pediatric populations in low- and middle-income countries with significantly high rates of pediatric HIV, totaling 92 countries. In addition to providing expanded access, the agreement allows for development of new pediatric formulations of raltegravir, in support of the “Global Pediatric Antiretroviral Commitment-to-Action” announced by the United States 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.

“MPP is pleased to have Merck on board as a new private sector partner working with us on pediatric programs,” said Greg Perry, executive director, MPP. “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.”

Despite efforts to eliminate pediatric HIV, it is estimated that there are 3.2 million children infected with HIV worldwide and almost 800 die every day because of lack of access to treatment and care. In fact, it is estimated that less than a quarter of all children infected with HIV worldwide are receiving antiretrovirals. Therefore, it is critical to develop innovative formulations to meet this unmet medical need while ensuring access to these therapies. As such, the World Health Organization (WHO) guidelines have listed raltegravir as an important product needed for certain pediatric populations.

For 30 years, Merck has demonstrated its commitment to improved access to HIV medicines through longstanding efforts including differential pricing, voluntary licensing, public-private partnerships, philanthropic programs, and continued research and development efforts in HIV.