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Gilead Licenses Generic Sovaldi

India-based generic manufacturers to expand access to Hep C drugs

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By: Kristin Brooks

Managing Editor, Contract Pharma

Gilead Sciences, Inc. has signed non-exclusive licensing agreements with seven India-based generic manufacturers to expand access to its chronic hepatitis C medicines in developing countries. Cadila Healthcare Ltd., Cipla Ltd., Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd., Sequent Scientific Ltd. and Strides Arcolab Ltd. will be able to manufacture sofosbuvir (brand name Sovaldi) and the investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 91 developing countries.
 
The companies will receive a complete technology transfer of the Gilead manufacturing process for scale up production. The licensees establish their own prices for the generic product they produce, paying Gilead royalties on sales. The licenses also allow the manufacture of sofosbuvir or ledipasvir in combination with other chronic hepatitis C medicines.
 
“Hepatitis C is a significant public health issue worldwide, and Gilead is working to make its chronic hepatitis C medicines accessible to as many patients, in as many places, as quickly as possible. In developing countries, large-volume generic manufacturing and distribution is widely regarded as a key component in expanding access to medicines. These agreements are essential to advancing the goals of our humanitarian program in these countries,” said Gregg H. Alton, executive vice president, Corporate and Medical Affairs, Gilead Sciences.

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