Gilead to expand sofosbuvir plant days after positive US FDA review

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.