Gilead Announces New License Agreement With the Medicines Patent Pool for Access to Bictegravir

Gilead Sciences, Inc. 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. BIC is a novel investigational integrase strand transfer inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. Through this agreement, MPP can sub-license rights to BIC to generic drug companies in India, China and South Africa to manufacture therapies containing BIC for distribution in 116 low- and middle-income countries.

Gilead has also expanded its licensing agreements with Sun Pharmaceutical Industries Limited, Strides Shasun Limited, Mylan Laboratories Limited and SeQuent Scientific Limited to include BIC, and products incorporating the compound, for distribution in 116 developing countries.

Under these voluntary licensing agreements, the manufacturers may produce BIC as a single agent or in fixed-dose combinations with other HIV medicines. BIC is the fifth HIV agent to be licensed in Gilead’s agreements with the MPP and generic manufacturers. Gilead and the MPP recently expanded the geographic scope of the licensing agreements for Gilead’s other HIV therapies to include Malaysia, Philippines, Ukraine and Belarus.

“These agreements allow for our licensees to provide generic versions of our latest therapies to people living with HIV in the developing world,” said Gregg H. Alton, Executive Vice President for Corporate and Medical Affairs at Gilead Sciences. “Today, more than 10 million people in resource-limited countries are on Gilead-based HIV therapies, which would not be possible without these strong alliances.”

Voluntary licensing agreements are a key component of Gilead’s efforts to increase access to the company’s therapies in the developing world. Competition among manufacturers has reduced the lowest price of a Gilead HIV generic therapy by 80 percent since 2006, to as low as $3.50 per patient per month. Ninety-nine percent of people taking Gilead’s HIV therapies in developing countries receive generic medicine.

Gilead has filed a New Drug Application to the U.S. Food and Drug Administration for an investigational, once-daily single tablet regimen containing BIC (50mg) and emtricitabine/tenofovir alafenamide (200mg/25mg) (BIC/FTC/TAF). In the European Union, the company’s Marketing Authorization Application for BIC/FTC/TAF has been fully validated and is now under evaluation by the European Medicines Agency.

BIC in combination with FTC/TAF as a single tablet regimen is an investigational treatment that has not been determined to be safe or efficacious and is not approved anywhere globally.