The Medicines Patent Pool (MPP) and ViiV Healthcare announced an extension of their current licensing agreement to increase access to dolutegravir (DTG), a promising new antiretroviral, to cover all remaining lower middle-income countries. The amendment to the 2014 licence specifically allows generic medicine distribution in four countries with patents – Armenia, Moldova, Morocco and Ukraine – that were not covered in the initial agreement. MPP sub-licensees can now sell in countries that are home to 94 per cent of people living with HIV in the developing world.

The expansion comes on the heels of ViiV Healthcare majority shareholder GlaxoSmithKline’s March 31 announcement of its new approach to managing intellectual property based on country economic maturity, and its intention of broadening licensing for countries that fall under the lower middle-income category as defined by the World Bank.

As a result, the MPP licence for DTG adult formulations now includes 92 developing countries, including 59 middle-income nations. In addition, countries without patents in force are able to procure generic products from MPP sub-licensees, extending access to many more countries.

“This is great news for communities battling the epidemic in lower middle-income nations, specifically for Armenia, Moldova, Morocco and Ukraine where an estimated 270,000 people live with the virus,” said Greg Perry, executive director of the MPP. “We congratulate ViiV Healthcare, a longtime MPP partner, for taking this key step in expanding our already broad licence.”

In 2014, ViiV Healthcare granted MPP two non-exclusive licences for DTG: one for the production of the medicine for adults and another for children. Both licences permit generic manufacturers based anywhere in the world to manufacture DTG and to combine the medicine with other drugs to develop fixed-dose combinations (FDCs). To date, nine generic manufacturers have signed MPP sub-licences for DTG and are actively developing the treatment.

“ViiV Healthcare has worked with the Medicines Patent Pool for many years and we are pleased to continue our work with the organisation to further improve access to innovative medicines to address the burden of HIV,” said Dr. Dominique Limet, CEO of the company. “It is also a great testament to the success we have had working with the MPP that GSK is now looking at expanding this collaboration for access to medicines beyond HIV treatments.”

DTG is considered a significant advancement in HIV treatment. The medicine does not require boosting and has a good barrier to resistance, and efficacy and tolerability profile at very small doses. Moreover, the medicine can be used for patients that have never taken HIV therapy as well as for many that have developed resistance to their current regimens. The World Health Organization recommended DTG as an alternative first-line treatment for adults in 2015.

The DTG licences and amendment build on the MPP and ViiV Healthcare’s long-term partnership. In February 2013, ViiV Healthcare granted the MPP a paediatric licence for abacavir (ABC), a key WHO-recommended antiretroviral for children, for 121 countries.

“I salute this remarkable advancement,” said Philippe Douste-Blazy, chair of the Executive Board at UNITAID, MPP’s funder. “Five years ago when we started the Medicines Patent Pool, it was just a novel concept. Now the organisation is a key player in the global health community in helping speed life-saving medicines such as dolutegravir to low- and middle-income countries. Ensuring these medicines reach the poorest and most vulnerable citizens is our overriding goal.”

“This announcement comes at an important time for Ukraine, as we seek to ensure access to HIV treatment for those in need, and need access to the best possible medicines at the lowest possible prices. We welcome the inclusion of Ukraine in the licence,” said Ihor Perehinets, deputy minister, Ministry of Health of Ukraine.

“For people living with HIV in Morocco, access to new generation HIV medicines, like DTG, is crucial. DTG has great potential for improving treatment options in middle-income countries given its high effectiveness and low side effects. We welcome this announcement,” said Hakima Himmich, president of the Association de lutte contre le sida (ALCS).

“This is very good news for Moldova. New medicines with high efficacy and low side effects like dolutegravir can contribute to improving living conditions for people living with HIV. We look forward to working with all stakeholders in Moldova to make sure new and improved treatments become accessible to all people in need as soon as possible,” said Alexandr Curasov, executive director at the Positive Initiative in Moldova and Communities Delegation Board Member at the Global Fund to Fight AIDS, Tuberculosis and Malaria.

“We welcome the expansion of the Medicines Patent Pool licence, as dolutegravir is a promising new treatment. Taking into account the huge demand for treatment in Ukraine and the existing funding gap due to currency devaluation, we stress the urgent need for improving access to patented antiretrovirals like dolutegravir in Ukraine. The All-Ukrainian Network’s mission is to ensure access to HIV treatment for all people living with HIV, and this announcement is an important step in that direction,” said Dmytro Sherembey, head of Coordination Council of the All-Ukrainian Network of PLWHA.