Gilead Licenses HIV Drug to Medicines Patent PoolBy
Gilead Sciences has signed a licensing agreement with the Medicines Patent Pool (MPP), a United Nations-backed public health organization, to expand access to its human immunodeficiency virus (HIV) drug, bictegravir (BIC), upon regulatory approval in the US.
BIC is an investigational integrase strand transfer inhibitor for use in combination with other antiretroviral agents for treating 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.
Gilead has also expanded its licensing agreements with Sun Pharmaceutical Industries, Strides Shasun, Mylan, and SeQuent Scientific to include BIC and products incorporating the compound, for distribution in 116 developing countries.
Under these agreements, the manufacturers may produce BIC as a single agent or in fixed-dose combinations with other HIV medicines.
Gilead has filed a new drug application to the US Food and Drug Administration for an investigational, once-daily single tablet regimen containing BIC (50 mg) and emtricitabine/tenofovir alafenamide (200 mg/25 mg) (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.
Source: Gilead Sciences