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.
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