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Biotech / Medical : InterMune (nasdaq)ITMN -- Ignore unavailable to you. Want to Upgrade?


To: IRWIN JAMES FRANKEL who wrote (345)1/7/2003 10:30:29 AM
From: tuck  Read Replies (1) | Respond to of 508
 
The take from Mr. Gothcha (as he is occasionally known here):

>>Doubts Surface About InterMune's Actimmune By Adam Feuerstein <mailto:adam.feuerstein@thestreet.com> Senior Writer 01/07/2003 09:35 AM EST

Intermune's top-selling drug, Actimmune, now appears to be less effective than previously thought, according to follow-up data released by the company Tuesday.

In August, the Brisbane, Calif.-based company released results <http://www.thestreet.com/tech/adamfeuerstein/10039685.html> from a 330-patient study of Actimmune that it said proved the drug to be the first and only successful treatment for patients who suffer from idiopathic pulmonary fibrosis, a fatal disorder that causes lungs to fill with scar tissue.

InterMune continued to follow these patients for another three to five months. The analysis of that data was released Tuesday and it shows that the previously reported survival advantage for patients taking Actimmune has decreased, compared to patients who took a placebo. These results are sure to fire up the already-heated debate <http://www.thestreet.com/tech/adamfeuerstein/10040362.html> over Actimmune's efficacy and its revenue potential. Doctors who treat IPF patients, for the most part, have said that they would increase their use of Actimmune based on the original study results. These doctors, when asked, said they were less focused on actual numbers from the study. Instead, they were happy to see a drug, for the first time, show an ability to prolong the lives of their terminally ill patients.

Whether that sanguine outlook remains once these new findings are digested remains an open question, and one that has investors nervous. InterMune shares are off more than 13% in preopen trading Tuesday. InterMune executives will give a presentation and take questions at the J.P. Morgan H&Q Healthcare conference later today.

According to the follow-up data released Tuesday, the overall survival advantage in the Actimmune-treated patients compared to placebo patients fell to 25% from 40%. The difference is not statistically significance, but then, the original data were also not statistically significant. InterMune, however, was basing most of its original claims of efficacy on a much stronger analysis of a sub-group of patients in the study who had mild to moderate forms of idiopathic pulmonary fibrosis. But here too, the new data appears weaker.

The survival advantage in these Actimmune-treated patients fell to 49% from 70%, compared to patients taking placebo. The new results are still statistically significant, although less so than before.

"We believe the preliminary survival data from the follow-up observation period continue to support the hypothesis of a treatment benefit in IPF patients treated with Actimmune," said InterMune CEO Scott Harkonen in a statement.

Along with the data, InterMune also said Tuesday that it expects total 2002 revenue to be at the upper end of its previous forecast of $105 million to $110 million, driven mainly by strong sales of Actimmune. But the company, in its statement, did not reiterate its previous forecast for future, peak Actimmune sales in the range of $400 million to $500 million, based on the original study results. Whether the company still believes it can achieve this goal will certainly be a central question posed to InterMune executives at today's H&Q conference.

InterMune's shares were recently down $4.22 to $23.40 on the Instinet preopen session.<<

Cheers, Tuck