Gilead expands licensing pact with Indian firms for hepatitis C drug

US-based Gilead Sciences Inc has announced that it has expanded its hepatitis C generic licensing agreements to include the investigational NS5A inhibitor GS- 5816, which is being evaluated in phase 3 clinical studies as part of a single tablet regimen that combines the compound and sofosbuvir for the treatment of all six genotypes of hepatitis C. The expanded agreements will allow Gilead’s India-based partners to manufacture GS-5816 and the single tablet regimen of sofosbuvir/GS- 5816, once approved, for distribution in 91 developing countries, which together account for 54 percent of the total worldwide population of individuals infected with the hepatitis C virus (HCV).
 
The amended agreements expand on Gilead’s existing generic licensing partnerships for hepatitis C, announced in September 2014, under which partners may produce sofosbuvir and the single tablet regimen of ledipasvir/sofosbuvir. Eight Indian-based generic manufacturers now hold licenses to manufacture Gilead’s HCV medicines - Biocon Ltd, Cadila Healthcare Ltd, Cipla Ltd, Hetero Labs Ltd, Mylan Laboratories Ltd, Ranbaxy Laboratories Ltd, Sequent Scientific Ltd and Strides Arcolab Ltd.
 
Sofosbuvir recently received regulatory approval in India (January 2015), and regulatory submissions have been completed in additional countries, including Pakistan, Thailand, Brazil, Uganda, South Africa and Nigeria.
 
If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first pan-genotypic, all-oral single tablet regimen for HCV. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available.
 
“Today’s announcement marks an important milestone in Gilead’s effort to make effective hepatitis C treatment accessible to as many patients, in as many places, as quickly as possible. Developing countries are home to a diverse mix of hepatitis C genotypes, and the development of a medicine that has the potential to cure any patient, regardless of genotype, could help accelerate access to treatment,” said Gregg H Alton, executive vice president, corporate and medical affairs, Gilead Sciences.
 
Professor Abhijit Chowdhury, head of hepatology, Institute of Post Graduate Medical Education and Research, Kolkata, commented, “Pan-genotypic hepatitis C treatments have the potential to radically change the treatment landscape in developing countries, removing the need for patients to undergo burdensome laboratory tests. Even if testing facilities are available, their cost is a barrier to treatment access, so a regimen that can be used for any genotype is going to be a real attribute in tackling this disease on a global level.”