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Harvoni

Gilead Sciences, Inc.

Drug Names(s): sofosbuvir/GS-5885, PSI-7977/GS-5885, GS-7977/GS-5885, Sofosbuvir + Ledipasvir fixed dose combination (FDC)

Description: GS-7977/GS-5885 is a single pill combination of the prodrug GS-7977 and the NS5A replication inhibitor GS-5885.

GS-7977, a chirally pure isomer form of PSI-7851, is a prodrug of a nucleotide analog polymerase inhibitor of the hepatitis C virus (HCV), while GS-5885 is a HCV NS5A replication inhibitor.

Deal Structure: Gilead and India-Based Generic Pharmaceutical Manufacturers
In September 2014, Gilead announced that the company has signed non-exclusive licensing agreements with seven India-based generic pharmaceutical manufacturers to expand access to its chronic hepatitis C medicines in developing countries. The agreements allow the companies Cadila Healthcare Ltd., Cipla Ltd., Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd., Sequent Scientific Ltd. and Strides Arcolab Ltd. to manufacture sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 91 developing countries.

Under the licensing agreements, the Indian companies receive a complete technology transfer of the Gilead manufacturing process to enable them to scale up production as quickly as possible. The licensees also set their own prices for the generic product they produce, paying a royalty on sales to Gilead to support product registrations, medical...See full deal structure in Biomedtracker


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