Gilead Sciences has licensed manufacturing rights for its human immunodeficiency virus type 1 (HIV-1) treatment bictegravir (BIC) to the Medicines Patent Pool (MPP), which can sublicense those rights to generic drug makers in India, China, and South Africa for distribution in 116 low- and middle-income countries.
Within those countries, Gilead added, it has expanded its licensing agreements with Sun Pharmaceutical Industries, Strides Shasun, Mylan Laboratories, and SeQuent Scientific to include BIC and products incorporating the drug.
The value was not disclosed for the agreement, which would take effect upon BIC receiving FDA approval. 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.
The FDA is reviewing Gilead’s New Drug Application for a once-daily single tablet regimen containing BIC (50 mg) and emtricitabine/tenofovir alafenamide (200 mg/25 mg) (BIC/FTC/TAF). Gilead is also awaiting European Medicines Agency review of its Marketing Authorization Application for BIC/FTC/TAF.
Gilead said 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.
“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,” Gregg H. Alton, Gilead EVP for corporate and medical affairs, said in a statement.
Ninety-nine percent of patients treated with Gilead’s HIV therapies in developing countries receive generic versions, according to the company.
Gilead says its voluntary licensing agreements are a key component of its efforts to increase access to its therapies in developing countries. The company cites the 80% drop in the lowest price of a Gilead HIV generic therapy since 2006, to $3.50 per patient per month, through competition among manufacturers.
In the U.S., though, Gilead has weathered criticism over the high cost of its hepatitis C virus treatment Sovaldi® (sofosbuvir)—specifically the drug’s $84,000-per-treatment course price tag, which drew the wrath of some in Congress.
Launched in the U.S. in 2013, Sovaldi rocketed to blockbuster status a year later with $10.283 billion in sales. Sovaldi sales fell each year since, driven by falling cost and competition that began late in 2014—when Gilead reached agreements with seven generic drug makers in India to sell cheaper versions of the treatment in developing countries.