ViiV Healthcare will license adult and pediatric versions of the antiretroviral dolutegravir (DTG) to generic manufacturers at low cost for developing-world countries with the highest HIV burden, through its 14-month-old partnership with the Medicines Patent Pool (MPP), the partners said today.
The licensing agreements, intended to increase access to DTG, follow by two months the European Medicnies Agency’s approval of DTG for adults and adolescents aged 12–18—and eight months after approval by the FDA. That is far faster than the average of seven to nine years it has historically taken for generic versions of new HIV treatment to reach developing countries after introduction in industrialized nations.
“The ViiV-MPP agreement represents a significant public health achievement," Greg Perry, executive director, Medicines Patent Pool, said in a statement. "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."
Viiv – a joint venture of GlaxoSmithKline, Pfizer and Shionogi—and MPP launched their partnership in February 2013 by establishing collaborations focused on pediatric antiretrovirals, including a license for abacavir (ABC), which is recommended by the World Health Organization.
Viiv granted separate licenses: One allowing generic production of DTG for adults, the other for children. 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.
Through its collaboration with the MPP, ViiV is extending its voluntary licensing to public and nonprofit HIV programs in Egypt, India, Indonesia, the Philippines, Turkmenistan, and Vietnam, offering a sliding scale royalty plan 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 pediatric use.
The pediatric license also expands to future pediatric formulations currently in clinical development at ViiV. At present, 647,000 children—only a quarter of those eligible for treatment—receive HIV medicines, WHO reported in its March 14 Supplement to the 2013 Consolidated Guidelines of the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection.
DTG does not require boosting and has a good efficacy and tolerability profile at very small doses, making the antiretroviral a significant advancement in HIV treatment. DTG 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.
"Incorporating palatable, child-friendly ABC and DTG options into pediatric HIV programs could significantly enhance and prolong children's lives," added Philippe Douste-Blazy, chair of UNITAID. The global health initiative, half-funded by a surcharge on airline tickets, is designed to boost funding for greater access to treatments and diagnostics for HIV/AIDS, malaria and tuberculosis in low-income countries.
UNITAID founded MPP in 2010 to increase access to HIV treatment and spur new innovation worldwide, with support from the United Nations. To date, MPP has signed licensing agreements for eight antiretrovirals, with six generic manufacturers licensing production of drugs from the organization.