Spotlight Series on Hepatitis C


Gilead Licenses Generic Version of Improved Sovaldi in India, Agrees to Sovaldi Discount in Germany

January 30, 2015

A new pan-genotypic version of the hepatitis C (HCV) drug Sovaldi (sofosbuvir) will be licensed to Indian generic drug manufacturers, according to Gilead Sciences, the drug's manufacturer. The announcement comes even before the completion of phase-3 trials of one of the new drug's ingredients, GS-5816, later this year. GS-5816 will be combined with sofosbuvir in a single tablet to be taken once a day for 12 weeks. The generic licensing agreement is contingent on regulatory approval of the new medication in India.

Unlike previous sofosbuvir-based medications, which work only against specific HCV genotypes, the GS-5816 combination can be used for any of the virus' six genotypes. "Developing countries are home to a diverse mix of hepatitis C genotypes, and the development of a medicine that has the potential to cure any patient, regardless of genotype, could help accelerate access to treatment," said Gregg H. Alton, an executive vice president at Gilead.

Gilead has been widely criticized for the $1,000 per pill it charges for Sovaldi in the U.S. The company has negotiated steep discounts in several countries, including India and Germany. Four German state insurers will receive the drug at an as-yet-undisclosed discount, Reuters reported. "Thirty-five percent of those on statutory health insurance are already benefitting from the discount agreements," Carsten Nowotsch, the head of Gilead's German operations, said according to the German business weekly Wirtschafts Woche.

Sovaldi is sold in India -- where one of Gilead's patent applications for the drug was just denied -- for $300 per bottle, less than one-tenth of the U.S. price, the Wall Street Journal reports. The company's agreement with the Indian drug makers does not cover distribution of sofosbuvir or the new GS-5816-based medication in China, where 30 million people suffer from hepatitis C.

Gilead is also not allowed to sell its generic version in middle-income countries, such as Brazil, Russia and Thailand, according to the Times of India.

Barbara Jungwirth is a freelance writer and translator based in New York.

Follow Barbara on Twitter: @reliabletran.

Copyright © 2015 Remedy Health Media, LLC. All rights reserved.

Reader Comments:

Comment by: Seer Clearly (Denver, CO) Sat., Jan. 31, 2015 at 12:47 pm UTC
Did you know there are laws in the US that prevent insurance companies from negotiating with drug companies? Supposedly this is to prevent collusion, but the net result (which the drug companies I'm sure don't complain about) is that NOBODY gets a discount, since our government isn't interested or empowered to negotiate with them. Then there's Germany which has Single Payer as part of a two-tier health insurance system, which empowers the government to negotiate with drug companies: hence the discount. And India, where the government by default 'negotiates' (a la 'Fifth Element') by allowing drug companies to manufacture generic copies - so they get the biggest discounts. Get the picture? We've been sold down the river by a government that is on the side of corporate interests, not us. And us, the idiots, keep voting Status Quo politicians in that support the Corporatocracy. And that Corporatocracy kills. It's killing millions by denying treatment. I have two close friends dying of Hep C - that are denied Harvoni simply because it's (very) expensive and would put the insurance company out of business. I'm hopping mad. Clearly our politicians prefer to kills us than give up their lucrative and corrupt support from the drug companies. Vote the scoundrels out! Picket their houses! It's our lives we're talking about here!
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