Safety Is Now the Hot Topic in Actimmune Debate

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There's been a lot of debate over whether or not InterMune's (ITMN:Nasdaq - news - commentary - research - analysis) drug, Actimmune, is a truly effective treatment for the fatal lung disease, idiopathic pulmonary fibrosis. But few people have questioned Actimmune's safety -- until now.

The April issue of the American Journal of Respiratory and Critical Care Medicine carries a case report detailing four European patients with advanced IPF who died from respiratory failure after being treated with Actimmune. Three of the patients died shortly after starting therapy with the drug.

Although not conclusive, there is ample evidence to suggest that Actimmune was the cause of the severe side-effects seen in the patients, according to the article's authors, who conclude their report by recommending that doctors stop giving the drug to patients with advanced IPF.

An accompanying editorial in the same issue of the medical journal says the four patient deaths "raise concerns that need to be addressed by further studies examining the potential role of [Actimmune] in the management of IPF."

Because the journal report and editorial were just published, it is not certain what effect this may have on Actimmune sales. But the new information raises the risk that doctors will curtail their use of the drug if they believe it could cause severe harm -- even kill -- some of their IPF patients, instead of helping them.

InterMune medical officer Dr. James Pennington says the new information, while important, should have no impact on Actimmune or the way doctors use it because the IPF patients who died were sicker than those who typically benefit from Actimmune therapy.

"We read the article with great interest and we're not sitting on any data that would refute or confirm the observations," Pennington said. "But in our study we didn't include patients with such severe disease and therefore didn't see any similar episodes."

If nothing else, the new safety concerns are sure to ratchet up the controversy over Actimmune, which has turned InterMune into one of the more volatile battleground stocks in the biotech sector. With the first quarter in the books, InterMune investors -- both long and short -- will be paying close attention to upcoming Actimmune sales figures.

InterMune was trading at $20.97 per share in recent Tuesday trading.

Recall that Actimmune is approved by the Food and Drug Administration, but not as a treatment for IPF, a fatal disorder that causes lungs to fill with scar tissue. Yet InterMune has strongly encouraged off-label use of the drug by doctors treating IPF patients, based on data from a phase III study released last August. A subset of patients in this study with mild to moderate forms of IPF lived longer after taking Actimmune, compared to those taking a placebo. (The overall endpoint of the study was not met, however, which InterMune shorts have used to question Actimmune's efficacy.)

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Adam Feuerstein writes regularly for RealMoney.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. He invites you to send your feedback.