Gilead to expand sofosbuvir plant days after positive US FDA review

By Gareth Macdonald

- Last updated on GMT

Gilead to expand sofosbuvir plant days after positive US FDA review
Gilead to expand sofosbuvir plant days after positive US FDA review

Related tags Food and drug administration

Gilead will spend $47m (Eur 34m) to expand a Canadian plant at which it produces biopharmaceuticals for trials, including its Ph III hep C drug candidate sofosbuvir.

The plant in Edmonton, Canada produces clinical trial supplies of Gilead's candidate antivirals - including sofosbuvir - as well as several developmental cancer treatments. The firm plans to add additional lab and production space.

Gilead currently employs 250 at the site and - when the 45,000 sqft expansion is completed - plans to hire 80 additional staff according to Robin Nicol, vice-president and general manager.

This expansion represents an important opportunity to recruit highly trained clinical and technical professionals in Alberta​."

Hep c race

Gilead acquired sofosbuvir in 2011 when it paid $11bn for biotech firm Pharmasset. News of the investement follows just a day after the US Food and Drug Administration (FDA) released a positive assessment of the antiviral.

In the document​ the US regulatory said: "The currently available data support a favorable benefit-risk assessment for the use of sofosbuvir as part of a combination regimen for the treatment of chronic hepatitis C.

"In the HCV GT 2 and 3 populations, the sofosbuvir and ribavirin combination regimen provides the first all-oral, interferon-free treatment, as well as a shorter treatment duration and improved safety profile compared to the current standard of care interferon-based regimen​."

Most observers suggest that an oral alternative to injection-based Hep C treatment would quickly dominate the market and the positive review indicates that sofosbuvir could be a real contender.

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