Strides Arcolab has entered into a licensing agreement with Gilead Sciences, Inc. under which Gilead has extended non-exclusive rights to Strides to manufacture and distribute Tenofovir Alafenamide (TAF).
Further, the manufacturing and distribution rights for TAF will be both as a single product and in combination with other drugs, according to a company statement.
The licence being granted to Strides extends to 112 countries, which together account for more than 30 million people living with HIV.
Non-nucleoside reverse transcriptase inhibitors (NNRTIs) form the backbone of antiretroviral treatment for many HIV-infected individuals. The unique antiviral activity, high specificity, and low toxicity associated with this class of agents make them a frequent choice for first-line therapy, according to healthcare experts.
TAF is a novel nucleotide reverse transcriptase inhibitor that has demonstrated high antiviral efficacy at a dose 10 times lower than Gilead’s Viread (tenofovir disoproxil fumarate), as well as an improved renal and bone safety profile.
However, TAF and TAF-based regimens are investigational products in the US and have not yet been determined safe or efficacious in humans.
As part of the licensing agreement, which is pending US Food and Drug Administration (US FDA) approval of the Gilead product, Strides will receive a technology transfer from Gilead, enabling Strides to manufacture low-cost versions of TAF for developing countries.