The Pediatric HIV Treatment Initiative was launched today at an event on Capitol Hill. The initiative plans to foster the development, manufacture, and distribution of pediatric formulations of antiretroviral therapies for the treatment of HIV/AIDS. It will draw on the Medicines Patent Pool’s existing relationships to obtain the necessary intellectual property rights and production know-how from branded firms, and transfer the technology to generic firms. It then plans to coordinate large-scale purchases to ensure the medicines get to children in need. The Pediatric HIV Treatment Initiative is a joint project of the Medicines Patent Pool, the Drugs for Neglected Diseases Initiative, and UNITAID.
Chip Lyons (Elizabeth Glaser Pediatric AIDS Foundation) opened the event, noting that only 500,000 children out of a population of 3.2 million in need are able to receive treatment. Holly Wong (Department of Health and Human Services) described how this relatively small market has failed to incentivize production of appropriate formulations of antiretrovirals, including fixed dose combinations. The resulting medicines are difficult to take and may be poorly tested. There is less uptake of the medicines, so children in need of treatment are half as likely to receive it as adults. The Pediatric HIV Treatment Initiative (PHTI), therefore, needs to make sure drugs are both appropriate and affordable.
Greg Perry (Medicines Patent Pool) said that the PHTI will promote both intellectual property licensing and knowledge pooling between branded and generic firms to promote the development and manufacture of the needed formulations. The Medicines Patent Pool has already licensed needed patents from Gilead, ViiV, and Bristol Myers Squibb. It is currently in talks with AbbVie and MSD (Merck) for their relevant patents. Johnson and Johnson has is interested in the project and is in contact with the Medicines Patent Pool about transferring know-how for the production of off patent medicines. Once the generic formulations are in the pipeline, PHTI will then work with organizations that finance purchases and distribution of medicines to make sure there is a market for the drugs.
Marc Lallemant (Drugs for Neglected Diseases Initiative, DNDi) said that there are only two options for treating HIV/AIDS in children, and both are problematic. Nevirapine based regimens have low efficacy and lead to high viral loads and greater resistance. Lopinavir+ritonavir based regimens are administered in a foul-tasting liquid form that is difficult to administer to children and are hard to correctly dose. DNDi and Cipla have been jointly developing an affordable four-in-one fixed dose combination (LPV/r+3TC+AZT or ABC) that has no taste, is suitable for infants, and does not require a cold chain. They hope to have it completed by 2015. But there are big issues in developing this type of pediatric product, even if one has the patent rights licensed. The different drugs’ molecules may not be compatible with each other. They may mature at different speeds. It is not clear what portion of each is needed in each dose, and this changes for children at different stages of growth. There may be different absorption points for the different drugs in the combination product. It is not clear how to solubilize all of the drugs and mask their taste.
Clifford Samuel (Gilead) described his company’s work with the patent pool, and its other efforts to make sure people in need of its products are able to access them. The company has its own branded distribution in 130 low and middle income countries. It has generic licensing agreements with 16 Indian generic firms and one south African firms, and its scientists share production know-how with the generic producers to help facilitate production. These licensing agreements produce drugs that reach 5.6 million people. They look forward to working with the PHTI.
Anna Giesleman from PEPFAR stressed the large gap between the percentages of adults in need of antiretroviral therapy and the percentage of children in need of antiretroviral therapy who receive it. She said that PEPFAR aims to double the number of children on treatment in the next two years. To achieve this goal, PEPFAR will support pooled procurement with the Global Fund. It will also try to determine the appropriate dosages for adolescents, who are “neither big children nor little adults.”
Chip Lyons asked the panelists when they thought the new pediatric formulations would actually become available. Lallemant said that Cipla has already prepared a dossier for FDA approval, but that the approval process will take time. Clifford said that it may be 18 to 24 months before we see new formulations of their products, but he said that Gilead scientists will work with licensees to transfer know-how to help licensees develop their generic products. He also said that there is a need for mechanisms that can forecast the needed quantity – producers need to know their demand. Antiretroviral scale-up for adults wasn’t possible until PEPFAR came along as a large scale buyer – today we need the same thing for pediatric formulations. Perry agreed and said that the MPP is going to get purchasers involved as quickly as possible. They also want to consult with the FDA as soon as possible to make sure the registration process will be as quick as it can be.
