Gilead Sciences' ($GILD) highly anticipated investigational hep C drug sofosbuvir is moving down the road toward FDA approval after a panel of experts recommended it in a 15-0 vote last week. And Gilead is preparing to meet those big expectations with a $47 million expansion of its plant in Canada that is manufacturing the drug in anticipation of its commercial launch.
Gilead Alberta develops and manufactures Gilead's investigational medicines for a number of clinical research programs, and that included sofosbuvir. Last week, the company said it would expand the plant in Edmonton, Alberta, by 45,000 square feet of laboratory and research space, adding 80 positions to the 250 there that work in manufacturing and quality assurance, as well as research and development and analytical research. The company said the plant will manufacture sofosbuvir "for commercial use pending approval of the medicine by Health Canada and other regulatory authorities."
Ed Gudaitis, general manager of Gilead Sciences Canada, said it was the the division's hope that "Gilead's state-of-the-art facility in Alberta will play a central role in bringing this important therapeutic advance [sofosbuvir] to patients around the world."
Gilead got sofosbuvir in its $11 billion buyout of Pharmasset in 2011. The drug is expected to lead the market of drugs that will be used in cocktails to provide the first oral, interferon-free treatments for hepatitis C. Analysts have pegged peak annual sales at $5 billion-plus. But other drugs are on their way. In fact, the same FDA panel also recommended approval of Johnson & Johnson's ($JNJ) hep C treatment simeprevir two days before voting for Gilead's drug.
- here's the announcement