The Medicines Patent Pool (MPP) has announced a licence with Gilead Sciences for bictegravir (BIC), now under review in the United States and the European Union as part of a once-daily, single-tablet HIV regimen. The licence allows manufacturers to develop and sell generic medicines containing BIC, if approved in the United States, in 116 low- and middle-income countries where more than 30 million people live with HIV.
“Bictegravir-containing combinations could offer improved, simplified treatment options, crucial for people living in resource-limited settings,” said Greg Perry, executive director of the Medicines Patent Pool. “With this new licence, we look forward to our long-running collaboration with Gilead Sciences continuing to deliver significant results.”
Bictegravir is an integrase inhibitor in the same class as dolutegravir (DTG) and elvitegravir (EVG), also licensed to the MPP. A once-daily, single-tablet regimen containing BIC along with emtricitabine (FTC) and tenofovir alafenamide (TAF), BIC/FTC/TAF is currently under investigation in adults as well as children. In phase 3 studies, BIC/FTC/TAF demonstrated high rates of viral suppression with no treatment-emergent resistance through 48 weeks among treatment-naïve adults and among adults with undetectable viral loads who switched regimens.
“The once-daily, single-tablet BIC/FTC/TAF regimen has the potential to simplify the management of HIV, and we are committed to promoting its access globally,” said Gregg Alton, executive vice president at Gilead Sciences. “MPP licensees with the rights to manufacture certain of Gilead’s agents, including TAF and now BIC, will be able to produce the single tablet for low- and middle-income countries shortly after its approval in the United States.”
The MPP and Gilead are also expanding the geographical scope of licences on other HIV products, enabling generic medicines to be supplied to additional countries. Belarus, the Philippines, Malaysia and Ukraine are now added to the MPP-Gilead HIV collaboration for the first time through the expansion of the licences on TAF, cobicistat (COBI) and tenofovir disoproxil fumarate (TDF).
“We’re tremendously pleased with the MPP and Gilead’s collaborative efforts over the many years to improve health outcomes in low- and middle-income countries,” said Lelio Marmora, executive director of Unitaid, MPP’s funder. “Through their joint HIV licensing programme, millions stand to benefit from quality-assured generics of new optimised treatment regimens.”
The two parties signed their first voluntary licence in 2011, which was amended in 2014 and 2015, and covers five Gilead compounds: TDF, EVG, COBI, FTC and TAF. The new amendment permits manufacturers located in India, China and South Africa to manufacture bictegravir in such countries and sell products containing the compound in 116 countries, including 74 middle-income nations. It expands the number of countries in which a licensee may sell products containing TDF or TAF (from 112 to 116), EVG (from 100 to 109) and COBI (103 to 116).
The Medicines Patent Pool has now signed sublicences with 13 generic companies to manufacture and sell products containing TDF, EVG, COBI, FTC and TAF. To date, MPP sublicensees have distributed more than four billion doses of products containing TDF to 124 low- and middle-income countries.
Gilead Sciences submitted a new drug application for the single-tablet regimen containing BIC/FTC/TAF to the US Food and Drug Administration on 12 June. The European Medicines Agency validated a marketing application on 13 July.