Mylan Expands Pact With Gilead For HEP-C Drug

Published: 28th January 2015 06:01 AM  |   Last Updated: 28th January 2015 06:01 AM   |  A+A-

HYDERABAD: Mylan Inc said its subsidiary Mylan Laboratories Ltd was expanding its hepatitis C licensing agreement with Gilead Sciences, Inc. The pact is to include the non-exclusive rights to manufacture and distribute the investigtional NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir (Sovaldi®), once approved, in 91 developing countries. “The potential to offer the sofosbuvir/GS-5816 regimen is exciting, as it is an innovative compound that is being studied to treat all hepatitis C genotypes,” said Rajiv Malik, President, Mylan. The single tablet regiment 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 hepatits C genotypes. A pan-genotypic therapeutica option is particularly important for developing countries, where genotype testing is often unreliable or not readily available.  

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