KENILWORTH, N.J.—Merck, known as MSD outside of the United States and Canada, has announced an agreement with the Medicines Patent Pool (MPP) under which it will 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. Merck currently markets raltegravir as ISENTRESS. The compound is the only integrase inhibitor approved for use in infants and children as young as four weeks in the United States and European Union.
“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,” commented Jackie Neilson, general manager and global commercial leader for the HIV Franchise at Merck. “This builds upon Merck’s three-decade long commitment to both innovation and access to address the global HIV epidemic.”
Under the agreement, MPP will receive a royalty-free license for the development of pediatric formulations of raltegravir (chewable tablets and granules for oral suspension). The agreement allows for the development of novel pediatric formulations of raltegravir as well as novel combinations, in support of the “Global Pediatric Antiretroviral Commitment-to-Action” announced by President Obama's Emergency Plan for AIDS Relief, the Pediatric HIV Treatment Initiative and the Global Fund to Fight AIDS, Tuberculosis and Malaria, to hasten the development of new pediatric antiretroviral co-formulations.
Current estimates state that some 3.2 million children are infected with HIV worldwide, with less than a quarter of those children receiving antiretrovirals, which leads to almost 800 deaths every day.
“MPP is pleased to have Merck on board as a new private sector partner working with us on pediatric programs,” Greg Perry, executive director at MPP, said in a press release. “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.”
This news follows a day after Merck announced another collaboration, this one with privately held NGM Biopharmaceuticals Inc. The multi-year collaboration will seek to research, discover, develop and commercialize novel biologic therapies across a number of therapeutic areas. The agreement is subject to the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
“NGM has developed a uniquely powerful research program that has permitted identification of novel, and quite consequential, pathways for metabolic regulation,” Dr. Roger M. Perlmutter, president of Merck Research Laboratories, noted in a statement. “Through this new collaboration, we hope to apply Merck’s well-established translational capabilities to advance innovative biologics that address the needs of patients suffering from diabetes, metabolic dysregulation and malignancy.”
Per the agreement, Merck will pay NGM $94 million up front, in addition to purchasing a 15-percent equity stake in the company for $106 million. Merck will also commit up to $250 million to fund all of NGM's efforts under the initial five-year term of the collaboration, with the potential for further funding if certain conditions are met. The collaboration involves a number of NGM's preclinical drug candidates, and under the agreement, NGM will lead the research and development of the existing candidates and has the right to identify and pursue other discovery-stage programs as it chooses. Merck will have the option of licensing all resulting NGM programs after human proof-of-concept trials. If Merck exercises that option, it will lead global product development and commercialization for the resulting products.
Before Merck begins a Phase 3 study for a licensed program, NGM can choose to either receive milestones and royalty payments or to co-fund development and participate in a global cost and revenue share arrangement of up to 50 percent. NGM also has the option of participating in the co-promotion of any co-funded program in the United States. Merck will have an option of extending the agreement for two additional two-year terms.
“This collaboration brings together our biology-driven research and development product platform with Merck’s late-stage development and commercialization expertise, while also enabling NGM to explore exciting new drug targets,” added Dr. Jin-Long Chen, founder and chief scientific officer of NGM. “Both companies' commitment to scientific excellence and willingness to creatively combine our strengths was key to establishing this relationship.”