Mylan expands hepatitis-C agreement with Gilead

Drug could become the first all-oral single tablet regimen for all hepatitis-C genotypes

US generics pharmaceuticals maker Mylan Inc today said that its subsidiary Mylan Laboratories Limited, based out of Hyderabad, is expanding its hepatitis C licensing agreement with Gilead Sciences, Inc.

The revised agreement includes the non-exclusive rights to manufacture and distribute the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir (Sovaldi)/GS-5816 tablet, once approved, in 91 developing countries.

The single tablet regimen is being evaluated in Phase 3 clinical studies for treatment of all six genotypes of hepatitis C, it said in a release.

Mylan president Rajiv Malik said,"We are proud to partner with Gilead, once again in our joint effort to quickly expand access to high quality, affordable medications to more than 100 million people living with hepatitis C in development countries. The potential to offer the sofosbuvir/GS-5816 regimen is particularly exciting, as it is an innovative compound that is being studies to treat all hepatitis C genotypes".

If approved by the regulatory authorities, the said drug would become the first all-oral single tablet regimen for all hepatitis-C genotypes, the release said.

This agreement is in addition to the licensing and technology transfer agreement that Mylan entered into with Gilead in September 2014, which grants Mylan the non-exclusive rights to manufacture and distribute sofosbuvir and ledipasvir/ sofosbuvir, it said.