India-based generic drug maker Natco Pharma has signed a non-exclusive licensing agreement with Gilead Sciences that allows Natco to make and sell generic versions of hepatitis C drugs including Sovaldi (sofosbuvir), it was announced yesterday (March 2).
The news comes just over a month after the Indian Patent Office refused to issue a patent covering the Californian pharmaceutical company’s drug Sovaldi, which in the US costs $84,000 for a 12-week course of treatment, or $1,000 per pill.
Natco was one of the parties to oppose Gilead’s Indian patent application, along with not-for-profit group Initiative for Medicines, Access & Knowledge, and the Delhi Network of Positive People.
Under the agreement, Natco will manufacture and distribute sofosbuvir, combination treatement Harvoni (ledipasvir/sofosbuvir), and its investigational NS5A inhibitor GS-5816. Natco will pay royalties to Gilead in return, although the rate has not been disclosed.
The NS5A inhibitor, which is in phase three of clinical studies, combines GS-5816 and sofosbuvir in a single tablet to treat of all six genotypes of hepatitis C.
“This agreement allows Natco to expand access to these chronic hepatitis C medicines in 91 developing countries,” Natco said in a statement.
Gilead already has licensing agreements with at least seven other India-based generic drug makers that allow them to make and distribute Sovaldi and Harvoni in developing countries.
Gilead did not respond to LSIPR’s request for comment.