Stockwatch: Lax Approval Requirements Yield Blockbusters That Don’t Work

I met the management of InterMune Inc. almost 20 years ago when it was a mid-sized US biotechnology company that had three approved products, two of them interferons. Virtually all of InterMune’s revenues came from one product − Actimmune (interferon gamma 1b), originally licensed from Genentech Inc. in 1998. 

Actimmune was approved for two rare congenital disorders, but the vast majority of its sales were off-label in idiopathic pulmonary fibrosis (IPF). These were further fueled by the release of “promising” results in IPF from an investigator-sponsored Phase II study . In 2000, InterMune announced it would start an accelerated Phase II/III program later that same year