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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 Limited
is expanding its hepatitis C licensing agreement with Gilead Sciences, Inc. to
include the non-exclusive rights to manufacture and distribute the
investigational NS5A inhibitor GS-5816 and single tablet regimen of
sofosbuvir(Sovaldi^®)/GS-5816, once approved, in 91 developing countries. The
single tablet regimen is being evaluated in Phase 3 clinical studies for the
treatment of all six genotypes of hepatitis C.


If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would
become the first all-oral single tablet regimen for all hepatitis C genotypes.
A pan-genotypic therapeutic option is particularly important for developing
countries, where genotype testing is often unreliable or not readily

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 the more than 100 million people living with
hepatitis C in developing countries.^1 The potential to offer the
sofosbuvir/GS-5816 regimen is particularly exciting, as it is an innovative
compound that is being studied to treat all hepatitis C genotypes – a medical
advancement that could significantly increase access to treatment."

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 in 91 developing countries. Mylan also partners with
Gilead on expanding access to high quality, affordable antiretrovirals for the
treatment of HIV/AIDS in India and other developing countries.

Posted-In: News FDA


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