Strides Arcolab to make and distribute Gilead's TAF

Indian generics drugmaker Strides Arcolab Limited (BSE: 532531) has entered into a licensing agreement with US biotech major Gilead Sciences (Nasdaq: GILD) under which Gilead has extended non-exclusive rights to Strides to manufacture and distribute tenofovir alafenamide (TAF), both as a single agent product and in combination with other drugs.

The license being granted to Strides extends to 112 countries, which together account for more than 30 million people living with HIV.

Will allow production of low-cost versions of TAF

As part of the licensing agreement, pending US Food and Drug Administration approval of the Gilead product, Strides will receive a technology transfer from Gilead, enabling it to manufacture low-cost versions of TAF for developing countries.

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.

TAF and TAF-based regimens are investigational products in the USA and have not yet been determined safe or efficacious in humans.

Last year, the Medicines Patent Pool signed six new sub-licenses with Aurobindo, Cipla, Desano, Emcure, Hetero Labs and Laurus Labs for generic manufacture of tenofovir alafenamide, for which MPP signed a license with Gilead Sciences (The Pharma Letter September 25, 2014).