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New drug added to generic Sovaldi licensing

Published on 26/01/15 at 01:49pm
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Gilead has expanded the licensing of generic versions of its blockbuster hepatitis C treatment Sovaldi to include a new experimental pill.

The firm’s manufacturing partners will now be allowed to produce the protein inhibitor GS-5816, which is currently in Phase III studies investigating its use in combination with Sovaldi (sofosbuvir) for the treatment of all six genotypes of hepatitis C (HCV).

Gilead says that the compound would become the first all-oral, single tablet regimen treating every genotype of HCV if approved. Results from the Phase III trial are expected in the second half of 2015.

“Pan-genotypic hepatitis C treatments have the potential to radically change the treatment landscape in developing countries, removing the need for patients to undergo burdensome laboratory tests,” says Professor Abhijit Chowdhury, head of hepatology at the Institute of Post Graduate Medical Education and Research in Kolkata.

“Even if testing facilities are available, their cost is a barrier to treatment access, so a regimen that can be used for any genotype is going to be a real attribute in tackling this disease on a global level.”

Eight Indian generic manufactures are licensed to produce the medicine if it is approved, among them being Ranbaxy and Mylan. The generics will be distributed in 91 developing countries, which together account for 54% of the global including HCV population – including Cambodia, Indonesia, several African countries and India itself.

However, Gilead has come under fire for its generic licensing agreements in the past with patient groups and Médecins Sans Frontières calling them too restrictive – for example, they do not cover middle-income countries such as China, which has 30 million HCV patients.

Sovaldi’s high price in developed countries has also been a source of controversy – the drug’s $84,000 cost per course of treatment in the US has led to lawsuits, and it faced a rocky road on its road to NICE approval in the UK.

Meanwhile when Gilead launches the branded version of the drug in India, where it has recently been approved, it will cost just $900 per 12-week regimen.

Regulatory submissions have also been completed in several other countries, including Pakistan, Thailand, Brazil, Uganda, South Africa and Nigeria.

George Underwood

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