Strides Arcolab in pact with Gilead to make & distribute generic version of its HIV drug

Strides Arcolab Limited has entered into a licensing agreement with Gilead Sciences, under which Gilead has extended non-exclusive rights to the Indian firm to manufacture and distribute Tenofovir Alafenamide (TAF), both as a single agent product and in combination with other drugs, as per a company release.

With this licence, Strides can distribute this drug to 112 countries which together account for more than 30 million people living with HIV.

As part of the licensing agreement, pending USFDA 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.

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 US and have not yet been determined safe or efficacious in humans.

Strides Arcolab, a Bangalore-based pharmaceutical company, focuses on development and manufacture of IP-led niche generics and bio-pharmaceuticals. It has eight manufacturing facilities presence in more than 75 countries in developed and emerging markets.

It counts private equity firm Apax Partners as a shareholder.

(Edited by Joby Puthuparampil Johnson)

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