InterMune Professes to Educate as It Profits
Biotech firm InterMune(ITMN Quote) might have a hot drug on its hands. Actimmune, already approved for the treatment of two very rare diseases affecting about 1,000 people total in the U.S., shows evidence of also being effective for the treatment of a fatal lung disease -- this one with a larger, and more profitable, U.S. patient base of 50,000.
The Brisbane, Calif.-based biotech firm is undertaking a late-stage clinical trial to treat the lung ailment known as idiopathic pulmonary fibrosis, with results due at the end of the year. But InterMune doesn't have to wait for Food and Drug Administration approval. Because Actimmune already is an approved drug, doctors can prescribe it to their IPF patients, a practice known as off-label use.
The FDA doesn't allow the marketing of a drug for off-label use. Companies can only provide educational material to physicians and patients. In the case of IPF, InterMune is doing that -- in a way that's raising the hackles of some in the IPF community. The company is the behind-the-scenes backer of a nonpartisan foundation -- the Coalition for Pulmonary Fibrosis -- that purports to educate the public and doctors about IPF, but which critics say is tied to the company's attempts to sell Actimmune. ...
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