Medicines Patent Pool Signs 7 New Sub-Licences For Generic HIV Drugs

The Medicines Patent Pool has announced seven new sub-licensing agreements to produce generic HIV medicines in order to make more affordable versions available to developing countries.

The 17 July announcement comes on the eve of the 20th International AIDS Conference in Melbourne, Australia.

The deals relate to the manufacture of atazanavir (ATV) and dolutegravir (DTG), include the first for the Medicines Patent Pool (MPP) with a Chinese generics manufacturer, Desano. It increases the total number of generics producers in agreements from six to ten companies.

The Geneva-based Medicines Patent Pool was created in 2010 and supported by UNITAID as a way to negotiate licences with holders of key patents on HIV medicines. The MPP has signed agreements with patent-holders Bristol Myers-Squibb, Gilead Sciences, F. Hoffmann-La Roche, the US National Institutes of Health and ViiV Healthcare for eight antiretrovirals (ARVs) and one medicine for an HIV opportunistic infection, it said.

“Increased generic competition will ultimately bring prices down and increase availability to allow national treatment programmes to treat many more people in their countries,” MPP Executive Director Greg Perry said in the announcement.

In addition to Desano, other new companies in the agreements are Cipla, Mylan, and Micro Labs. Collaborations were extended with Aurobindo, Laurus Labs and Emcure.

“Increasing access to second-line treatments for HIV is crucial as more people living with HIV develop resistance to first-line regimens,” the MPP said. “The WHO estimates there will be more than one million people on second-line treatment by 2016 and many more will need access to these new medicines.”

“This medicine offers new options for people living with HIV who are no longer able to take their first HIV regimens and its distribution in resource-poor settings is crucial,” Arvind Vasudeva, chief executive officer for formulations at Aurobindo, said in the statement.

Cipla Chief Medical Officer Jaideep Gogtay said: “Dolutegravir belongs to the new class of drugs – integrase inhibitors. This class of drugs brings new options for patients, has advantages over the existing drugs in terms of high efficacy and also brings down the viral loads rapidly.

Mylan President Rajiv Malik said, “DTG represents a significant advancement in HIV treatment as it does not require boosting when combined with other appropriate ARVs and has a good efficacy profile at very small doses.”

The MPP release did not go into detail on which countries would be affected, but NK Kothari, executive director at Micro Labs, was quoted as saying, “We hope to have a generic product available as soon as possible to strengthen HIV treatment options in hundreds of countries throughout Africa, Asia and Latin America.”