Whack-a-mole begins as Natco Sovaldi copies sprout in Nepal, Bangladesh

Want Sovaldi (sofosbuvir), the hepatitis C drug selling in the United States for $1,000 per pill, for just $10 a pill? Go to Bangladesh or some other country where the drug is about to be produced and sold free of the control of Sovaldi's owner, Gilead Sciences ($GILD). You can also head to Kathmandu and get a licensed copy at a rate that is also a fraction of the U.S. cost.

Less than a week after signing a nonexclusive licensing agreement with Gilead Sciences to manufacture and sell generic versions of its chronic hepatitis C medicines, India's Natco Pharma has Gilead products for sale in Nepal. According to local press reports, Natco launched generic copies of Sovaldi in Nepal last week, the first Indian drugmaker to use the license in this fashion and a move that is likely to set a benchmark on pricing. Natco did not immediately respond to a request for comment.

The licensing deal includes sofosbuvir, ledipasvir/sofosbuvir and the investigational NS5A inhibitor GS-5816, which is being evaluated in Phase III clinical studies as part of a single tablet regimen that combines the compound and sofosbuvir for the treatment of all 6 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 March 2 release.

"Under the license, Natco can set its own price for the generic products it produces, paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other essential business activities."

Natco had last year tried to block Gilead's patent in India and the firm is one of the most aggressive in the use of compulsory licenses, including winning one for Bayer's Nexavar in India.

However, it seems Gilead never obtained a patent for its drug in Bangladesh, so local drugmaker Incepta Pharmaceuticals made its own generic of the drug and launched it last month. Managing Director Abdul Muktadir said his company is also to market the drug at a similar low price elsewhere in Southeast Asia and in Africa in countries where Gilead does not have a Sovaldi patent.

After taking a lot of fire for charging $84,000 per 12-week regimen of the drug, Gilead licensed the drug in 91 mostly poor countries. But Malaysia and Thailand were not among the 91 and their people are stuck paying higher prices.

In addition to Incepta's plan for non-patent countries, the World Health Organization has been discussing with the company the possibility of putting its generic in its prequalification program, a certification that opens it to bulk purchases by poor nations receiving WHO funds.

Gilead refers to Incepta's generic as one of the "unauthorized generic versions" of Sovaldi but suggested it could not or would not do anything about it when it added it was focused next door on its India and its licensees getting their versions to market as soon as possible. Gilead had not responded to a query on the status by publication. Incepta also did not respond to an email seeking comment on its plans.

- here's the Natco release
- and Bloomberg's story