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3 March 2015Asia

Natco to sell Sovaldi generics following Gilead deal

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.


More on this story

Asia
16 September 2015   The Indian Pharmaceutical Alliance has dropped its opposition to a patent application filed by Gilead Sciences covering its hepatitis C drug Sovaldi.

More on this story

Asia
16 September 2015   The Indian Pharmaceutical Alliance has dropped its opposition to a patent application filed by Gilead Sciences covering its hepatitis C drug Sovaldi.