Gilead to license hepatitis C drug to Indian generics firms

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Gilead to license hepatitis C drug to Indian generics firms

Generics/News | Posted 21/02/2014 0 Post your comment

Gilead Sciences (Gilead) has announced plans to license its breakthrough hepatitis C drug Sovaldi (sofosbuvir) to at least three Indian generics manufacturers. The announcement made in February 2014, comes three months after the company faced a ‘patent opposition’ filed at India’s Patent Office, which aimed to block them from gaining a patent for Sovaldi in India.

The Hepatitis C Trust understands that a final announcement on the arrangements will be made within a couple of months. Mr Gregg Alton, Gilead’s Executive Vice President, Corporate and Medical Affairs, said the imported and locally made versions would cost less than the current standard of care with existing generics, estimated at US$2,500 for six months.

Gilead is expected to charge around US$80,000 for one treatment course of sofosbuvir in the US. ‘Even if offered at a fraction of this price in developing countries, this drug will be priced out of reach,’ read a response from international aid agency Médecins Sans Frontières when they put their weight behind the patent opposition in 2013; ‘This opposition was filed to ensure that affordable generic versions of sofosbuvir can be produced to help the millions of people infected with chronic hepatitis C in developing countries access the drug’.

Gilead’s latest plans will cover about 60 low- and middle-income countries, according to a report from the Hepatitis C Trust. The company has said it will continue to defend patents while enabling generics production in India. It is likely to take at least two years before sofosbuvir is available in India, phase III clinical trials will be run at 15 sites across the country to test the drug on the local population.

Gilead has said it is working with between three and five companies in order for them to compete against each other to get the cost of the drug down. A company spokesperson told Reuters that they will work with partners in multiple sectors around the world to ensure Gilead’s access programme reaches as many patients as possible.

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, 2]. The cost of treatment is prohibitive in many developing countries, where the burden of disease is the highest.

References

1. Milani B, Gaspani S. Pathway to affordable, quality-assured sources of pegylated interferon alpha for treating hepatitis C. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(4):194-203. doi:10.5639/gabij.2013.0204.053

2. GaBI Online - Generics and Biosimilars Initiative. Improving access to HCV treatment in developing countries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 21]. Available from: www.gabionline.net/Biosimilars/Research/Improving-access-to-HCV-treatment-in-developing-countries

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Source: Hepatitis C Trust, Médecins Sans Frontières, Reuters