Medicines Patent Pool Nails Down Another Key Paediatric Drug

The UN-backed Medicines Patent Pool (MPP) today announced it has struck a licence with MSD, the North American-based Merck pharmaceutical company, to boost access to and innovation on raltegravir, a child-approved HIV medicine. The outcome is particularly significant because it opens options for very young children.

The new licence is publicly available here.

“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 said in a press release today.

“The licence is significant for several reasons,” Greg Perry, Executive Director, MPP, told Intellectual Property Watch. “Raltegravir has played a key role in the medical response to HIV/AIDS as the world’s first integrase inhibitor. It was approved for adults in 2007, and remains to date the only HIV integrase inhibitor approved for use in children younger than 12 years of age. It also is one of very few options for very young children living with HIV. In January 2014, RAL was approved for use in children as young as four weeks, thus making it an important alternative for infants and toddlers.”

The drug is typically a third-line treatment, an MPP spokesperson said, but could be an alternative to another recently licensed drug by MPP with AbbVie (IPW, Public Health, 1 December 2014), especially because it can provided to very young children, and because it is in tablet and powder form not containing high levels of alcohol nor requiring refrigeration.

The licence also is significant as it allows manufacturers to further develop RAL, making improvements in the antiretroviral, the spokesperson said.

“The World Health Organization recommends raltegravir as a component of paediatric third-line treatment,” MPP said in the press release. “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.”

According to the release, “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.”

The list of developing countries in Exhibit A of the agreement includes a number of major emerging economies, such generic drug powerhouse India, as well as Egypt, Kenya, Nigeria and South Africa. But it does not appear to include others, such as Brazil, China or Thailand.

The agreement makes explicit that apart from the terms of the agreement, Merck does not relinquish any of its patent rights over the compound or any related products, and reserves the right to bring cases for patent infringement.