Medicines Patent Pool, ViiV Healthcare Sign Licence for The Most Recent HIV Medicine To Have Received Regulatory Approval
1 April 2014
Access to dolutegravir could improve millions of lives in developing countries
Geneva, 1 April 2014 – The Medicines Patent Pool (MPP) and ViiV Healthcare announced a new collaboration on HIV medicines today, signing two licensing agreements to increase access to dolutegravir (DTG), a promising new antiretroviral, for both adult and paediatric care. The agreements would allow generic manufacturers to produce low-cost versions of DTG for countries with the highest HIV burden, where 93% of adults and 99% of children living with HIV in the developing world reside.
Today’s announcement comes just two months after the European Medicines Agency approved the drug for adults and adolescents age 12-18, and eight months after the U.S. Food and Drug Administration’s approval. Historically, it has taken an average of seven to nine years for generic versions of new HIV treatment to reach developing countries after introduction in industrialized nations.
“By narrowing the gap between access to breakthrough new ARVs in developed versus developing countries, the ViiV-MPP agreement represents a significant public health achievement,” said Greg Perry, Executive Director, Medicines Patent Pool. “Dolutegravir is an innovative HIV therapy, and we will be working closely with generic manufacturers over the next few years to make it available to those most in need as quickly as possible.”
The agreements build on MPP-ViiV’s current partnership, announced in February 2013, which included a broad collaboration on paediatric ARVs and a licence for abacavir (ABC), a key WHO-recommended antiretroviral for children. ViiV is granting the MPP two licences for DTG, one for the production of the medicine for adults and the other for paediatrics. Both licences allow generic manufacturers based anywhere in the world the right to combine DTG with other drugs, including ABC, and develop fixed-dose combinations (FDCs), two or more active drugs in a single dosage form.
Through its collaboration with the MPP, ViiV is extending its voluntary licensing to public and nonprofit HIV programmes in six additional large middle-income countries (MICs), Egypt, India, Indonesia, the Philippines, Turkmenistan and Vietnam, offering a sliding scale royalty scheme based on per capita income. The company continues its practice of waiving all royalties in sub-Saharan Africa, least-developed countries and low-income countries, as well as in the 121 countries that will have access to low-cost DTG for paediatric use.
The licence also expands to future paediatric formulations currently in clinical development at ViiV. These formulations may be appropriate for hundreds of thousands of younger children representing one of the most vulnerable and under-served populations in the HIV community. Today, 647,000 children receive life-saving HIV medicines, only a quarter of those eligible for treatment. “UNITAID applauds today’s move by ViiV and the MPP to address the specific needs of children living with HIV,” said Philippe Douste- Blazy, Chair, UNITAID. “Incorporating palatable, child-friendly ABC and DTG options into paediatric HIV programmes could significantly enhance and prolong children’s lives.”
DTG is considered a significant advancement in HIV treatment. The medicine does not require boosting and has a good efficacy and tolerability profile at very small doses. Moreover, the medicine can be used in combination with other drugs for patients that have never taken HIV therapy as well as for the many that have developed resistance to their current regimens. The WHO has estimated that 9.7 million people are on first-line HIV treatment today and that more than one million people will be on second-line treatment by 2016.
“For people living with HIV, access to new generation HIV medicines, like DTG, could be a lifeline. DTG has great potential for improving treatment options in developing countries given its high effectiveness and low side effects,” said Nelson Otwoma, Executive Director of the National Empowerment Network of People living with HIV/AIDS in Kenya (NEPHAK). “I welcome the ViiV-MPP collaboration and other efforts to speed delivery of innovative ARVs to those who need them.”
About the Medicines Patent Pool
The Medicines Patent Pool is a United Nations-backed organisation founded in 2010 by UNITAID to increase access to HIV treatment and spur new innovation worldwide. The foundation offers a new public health approach to negotiating patent licences for the production of low-cost versions of existing medicines and works with manufacturers to encourage the development of needed new technologies such as FDCs and formulations suitable for children. To date, MPP has signed licensing agreements for eight antiretrovirals and six generic manufacturers have now licensed from the organisation.
Senior Consultant, Media and Communications
Medicines Patent Pool
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Other press release: ViiV Healthcare, Medicines Patent Pool Extend Licence For Dolutegravir To All Lower Middle-Income Countries (25 April 2016)
 MPP analysis based on U.S. FDA and World Health Organization public documents on approval and prequalification timelines.
 World Health Organization, March 14 Supplement to the 2013 Consolidated Guidelines of the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection.