Mylan Expands Hepatitis C Licensing Agreement with Gilead to Include Investigational Pan-Genotypic Agent

Mylan Inc.(Nasdaq: MYL) today announced that its subsidiary Mylan Laboratories Limitedis expanding its hepatitis C licensing agreement with Gilead Sciences, Inc. toinclude the non-exclusive rights to manufacture and distribute theinvestigational NS5A inhibitor GS-5816 and single tablet regimen ofsofosbuvir(Sovaldi^®)/GS-5816, once approved, in 91 developing countries. Thesingle tablet regimen is being evaluated in Phase 3 clinical studies for thetreatment of all six genotypes of hepatitis C.MylanIf approved by regulatory authorities, the sofosbuvir/GS-5816 regimen wouldbecome the first all-oral single tablet regimen for all hepatitis C genotypes.A pan-genotypic therapeutic option is particularly important for developingcountries, where genotype testing is often unreliable or not readilyavailable.Mylan President Rajiv Malik said, "We are proud to partner with Gilead, onceagain, in our joint effort to quickly expand access to high quality,affordable medications to the more than 100 million people living withhepatitis C in developing countries.^1 The potential to offer thesofosbuvir/GS-5816 regimen is particularly exciting, as it is an innovativecompound that is being studied to treat all hepatitis C genotypes – a medicaladvancement that could significantly increase access to treatment."This agreement is in addition to the licensing and technology transferagreement that Mylan entered into with Gilead in September 2014, which grantsMylan the non-exclusive rights to manufacture and distribute sofosbuvir andledipasvir/sofosbuvir in 91 developing countries. Mylan also partners withGilead on expanding access to high quality, affordable antiretrovirals for thetreatment of HIV/AIDS in India and other developing countries.