Gilead Licenses Generic Production of its HIV-1 Treatment
California-based Gilead Sciences Inc., has now announced a new licensing agreement with the Medicines Patent Pool (MPP), a United Nations-backed public health organization, to expand access to bictegravir (BIC) upon regulatory approval in the United States.
According to Gilead, the agreement allows the UN-backed public health organization to sub-license rights to bictegravir to generic drugmakers in India, China and South Africa to manufacture therapies containing the integrase strand transfer inhibitor for distribution in 116 low- and middle-income countries.
Further, Gilead said that it is also expanding existing licensing deals with Sun Pharmaceutical, Strides Shasun, Mylan and SeQuent Scientific to include bictegravir for distribution in 116 developing countries. “Under these voluntary licensing agreements, the manufacturers may produce bictegravir as a single agent or in fixed-dose combinations with other HIV medicines,” Gilead noted.
Bictegravir, which Gilead submitted a new drug application (NDA) to FDA as part of a fixed-dose combination with emtricitabine/tenofovir alafenamide (Descovy) for HIV this June, could serve in combination therapies “crucial for people living in resource-limited settings,” MPP executive director Greg Perry said.
“With this new license, we look forward to our long-running collaboration with Gilead Sciences continuing to deliver significant results,” Perry said.
Bictegravir is an investigational integrase strand transfer inhibitor for use in combination with other
antiretroviral agents for the treatment of HIV-1 infection in adults. Gilead has filed a New Drug Application to the U.S. Food and Drug Administration for an investigational, once-daily single tablet regimen containing Bictegravir (50mg) and emtricitabine/tenofovir alafenamide.Analysts initially believed bictegravir, if approved, was going to be a red-hot competitor to the GSK med but phase 3 data released last spring cooled those expectations somewhat. While four studies of the investigational integrase strand transfer inhibitor hit their primary endpoints by measuring up to Tivicay and other antiretroviral agents, they didn’t prove that bictegravir is superior.
“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.
