Gilead Sciences Inc. entered a licensing agreement with the Medicines Patent Pool, a United Nations-backed public health organization, to expand access to bictegravir after regulatory approval in the U.S.
Bictegravir is a novel investigational integrase strand transfer inhibitor for use in combination with other antiretroviral agents to treat HIV-1 infection in adults.
Under the agreement, the Medicines Patent Pool can sublicense rights to bictegravir to generic drug companies in India, China and South Africa to manufacture therapies containing the drug for distribution in 116 low- and middle-income countries.
The company also expanded its licensing agreements with Sun Pharmaceutical Industries Ltd., Strides Shasun Ltd., Mylan NV unit Mylan Laboratories Ltd. and Sequent Scientific Ltd. to include the drug, and products incorporating the compound, for distribution in the developing countries.
Under the voluntary licensing agreements, the manufacturers may produce the drug as a single agent or in fixed-dose combinations with other HIV medicines.
The company said competition among manufacturers has reduced the lowest price of a Gilead HIV generic therapy by 80% since 2006, to as low as $3.50 per patient per month.
Gilead said it has filed a new drug application with the U.S. Food and Drug Administration for an investigational, once-daily single tablet regimen containing bictegravir in combination with emtricitabine and tenofovir alafenamide. The marketing authorization application for the drug combination in the European Union is under evaluation by the European Medicines Agency.