Natco Pharma has signed a non-exclusive licensing agreement with US-based Gilead Sciences to manufacture and sell generic versions of its chronic hepatitis C medicines. The agreement allows Natco to manufacture and sell generic versions of Sovaldi and combination therapies using the active ingredient in the medicine in 91 developing countries, the company said.
The medicines include sofosbuvir, ledipasvir/sofosbuvir and 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.
“Under the licence, Natco can set its own price for the generic products it produces, paying a royalty on sales to Gilead,” the company said.
Reports say that Sovaldi, chemically known as sofosbuvir, is a far more effective and better-tolerated treatment than older injection products which fetched about $1.7 billion in sales for Gilead Sciences.
Gilead has been facing serious opposition in India over its efficacy. On January 13, 2015, India’s patent office rejected the patent application for Sovaldi, using Section 3(d) of the Patents Act, on the grounds that it does not offer any significant improvement and delivers only minor changes.
Earlier, Gilead had in 2014 entered into licensing agreements with seven India-based firms, including Cipla, Ranbaxy and Cadila for the hepatitis C drugs to make them available in 91 developing countries.