Generic hepatitis drug to be made available to 80 countries

Generics/General | Posted 12/09/2014 post-comment0 Post your comment

Originator pharma company Gilead Sciences (Gilead) is reportedly close to reaching a deal with generics makers to bring low cost versions of its hepatitis C drug Sovaldi (sofosbuvir) to about 80 developing countries including India, Indonesia, and Pakistan, as well as Egypt, Mongolia, South Africa, and Vietnam.

Sovaldi Sofosbuvir hep drug V14I12

Sofosbuvir works by inhibiting the RNA polymerase that the hepatitis C virus uses to replicate its RNA. In combination with other therapies, sofosbuvir can effectively cure hepatitis in 90% of patients.

According to Bloomberg, Gilead is close to completing the licensing deal which will permit generics makers to make generic sofosbuvir and one more candidate combining Sovaldi with another of Gilead’s hepatitis treatments. The deal could come into effect from the middle of September 2014. Gilead is currently in talks with five or six generics makers, including Indian generics makers Cipla and Mylan.

The World Health Organization estimates that about 3% of the world’s population has been infected with the hepatitis C virus and that more than 170 million chronic carriers are at risk of developing liver cirrhosis, liver cancer or both. Around 350,000 people are thought to die from the virus each year [1].

Gilead also plans to sell the brand-name version of Sovaldi in India for US$900 for 12 weeks of therapy. In the US, the drug sells for US$1,000 a pill, or US$84,000 for 12 weeks. Patients normally stay on the drug for 12 or 24 weeks.

The news follows a July 2014 announcement by Gilead that the company had made a new agreement with the Medicines Patent Pool (MPP) to expand access to Gilead’s investigational drug tenofovir alafenamide for the treatment of HIV and hepatitis B, depending on its US Food and Drug Administration approval. Under this agreement, the MPP can sub-license tenofovir alafenamide to generics companies in China and India, who may manufacture and distribute it in 112 developing countries.

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1.   GaBI Online - Generics and Biosimilars Initiative. Improving access to HCV treatment in developing countries []. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 12]. Available from:

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Source: Bloomberg, Gilead

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