New deal allows generics makers license to sell HIV drug

Isentress, which contains raltegravir potassium, is used to treat HIV. A new licensing agreement will allow makers of generic drugs to develop and sell the antiretroviral medication in low- and middle-income countries. Photo by: Damien Persohn

Children living with HIV in 92 countries may soon have access to a lower-cost antiretroviral treatment.

The Medicines Patent Pool has struck a licensing agreement with Merck, allowing the development of generic formulations of the pharmaceutical giant’s oral ART drug raltegravir, or RAL. The deal involves formulations targeting babies and children from 4 weeks to 12 years old.

MPP is a U.N.-backed organization that has been negotiating for improved production of HIV medicines and technologies in low-income settings by getting pharma companies to allow for the development of low-cost, generic alternatives of their patented drugs.

Studies have shown RAL’s effectiveness in slowing the spread of HIV in the body or bringing the virus down to undetectable levels. While the drug has been approved for use by adults and children, access has been problematic because of supply constraints and high costs.

In richer countries, RAL is available for $5,000 per patient per year. Humanitarian groups can obtain the drug at a lower — albeit still expensive — price of $1,000 per patient per year. International medical group Medecins Sans Frontieres, for instance, procures RAL at $1,700 per patient per year for its HIV treatment programs in India.

The steep cost of the drug has made it difficult for countries and organizations to scale up treatment of HIV, including among children. There are currently 3.2 million children worldwide living with HIV, but only 760,000 received ARV treatments in 2013.

Business and procurement opportunities

Officially announced Tuesday, the licensing agreement allows manufacturers of generic drugs to develop, produce and sell low-cost versions of pediatric RAL ahead of the drug’s patent expiration in 2022. The lower-cost version of the drug can be sold in 92 low- and middle-income countries which together account for 98 percent of the disease burden among children.

While these countries are mostly in sub-Saharan Africa, the agreement also covers Latin American states such as Bolivia and El Salvador, the Caribbean nation of Haiti, and Asian countries such as Indonesia and the Philippines. Middle-income countries like India and South Africa, where HIV incidence rates are still high, are also in the list.

The deal provides MPP a new drug to add to its portfolio of ARV treatments, and comes two months after MPP struck a similar licensing agreement with AbbVie for the pediatric versions of its lopinavir and ritonavir drugs.

Drug manufacturers interested in becoming an RAL sublicensee may submit expressions of interest via MPP’s website.

Sublicensees need to comply with international standards on good manufacturing practices. Before the generic drugs are allowed to be sold in the market, they must first gain pre-qualification and regulatory approval from the World Health Organization, MPP Head of Communications Katie Moore explained to Devex.

Many of MPP’s current sublicensees for its other negotiated ARV treatments are from the United States, China and India. MPP does not provide technical assistance funding, but acts as a “middleman” to ensure smooth transfer of technology between the pharmaceutical company and the generic drug manufacturers “under the terms of some of our licenses,” the MPP official further clarified.

Generic drugs are priced lower than their original versions, but their introduction to the market can also result in an overall reduction in prices for the drug. Following a similar licensing agreement with pharmaceutical company Gilead Science, which makes popular ARV drug tenofovir, generic TDF pushed prices down by as much as 87 percent since it was offered in 2011.

MPP estimates the global health community has saved more than $40 million in procurement costs to date, mainly to purchase TDF and drugs that contain TDF, as part of the licensing agreement.

The deal is a welcome development for programs such as the U.S. President’s Emergency Plan for AIDS Relief and the Global Fund to Fight AIDS, Tuberculosis and Malaria, both of which procure large amounts of ARV drugs for their HIV treatment programs. The availability of generics means these programs could save millions in public funding while being able to reach more people with lifesaving treatment.

Global health nongovernmental organizations could benefit as well, as “sublicensees have a right to develop new pediatric formulations of raltegravir in support of global health NGOs’ efforts to develop better, adapted formulations for children,” Moore concluded.

What other HIV treatment drugs would you like to see negotiated under MPP? Let us know by leaving a comment below.

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About the author

  • Ravelo jennylei

    Jenny Lei Ravelo

    Jenny Lei Ravelo is a Devex Senior Reporter based in Manila. She covers global health, with a particular focus on the World Health Organization, and other development and humanitarian aid trends in Asia Pacific. Prior to Devex, she wrote for ABS-CBN, one of the largest broadcasting networks in the Philippines, and was a copy editor for various international scientific journals. She received her journalism degree from the University of Santo Tomas.