FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

Sovaldi Patent Challenger Natco Signs Licensing Deal With Gilead

March 9, 2015

Teaser: Natco will produce generic Sovaldi in India and 90 other countries.

Generics maker Natco Pharma has signed an authorized generic licensing deal with Gilead to produce its pricey blockbuster hepatitis C drug Sovaldi in India and 90 other developing countries. The agreement likely signals an end to Natco’s fight to have Sovaldi’s patent protection in India revoked.

Under the nonexclusive agreement, Natco will pay Gilead royalties in exchange for rights to generic Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir), as well as an investigational drug currently in clinical trials to treat all six genotypes of hepatitis C with a single tablet, Natco said.

The licensing deal is the same as others Gilead has signed with nearly a dozen other Indian generics makers, all of whom are allowed to set their own prices. Gilead provides the companies with the technical knowledge and legal rights to make and sell the hepatitis C treatments in the developing world, offsetting the cost of a drug with a $1,000-per-pill price tag in the U.S.

Gilead also recently signed a deal with Mylan’s Indian subsidiary to distribute branded Sovaldi in the country.

Though Natco hasn’t confirmed it will drop its Sovaldi challenge, Tahir Amin, co-founder of the U.S.-based nonprofit Initiative for Medicines, Access & Knowledge, which also is challenging the drug’s patent, says based on other licensing deals he’s seen, he anticipates the company will drop Gilead Pharmasset LLC vs. Union of India.

A Gilead spokesman says Natco’s position on Sovaldi’s patent application in India was not part of the licensing discussions. — Bryan Koenig