12:00 AM
Jun 26, 2006
 |  BioCentury  |  Finance

What Actelion's investors want

Disappointing preliminary data from Actelion Ltd.'s Phase III CONSCIOUS-1 trial of clazosentan might re-open a debate on whether the European bellwether needs to fill its mid- to late-stage pipeline gap through in-licensing or M&A. But while investors may want to see the company do a better job of executing on its later stage compounds, they aren't clamoring for ATLN to rush out and pay inflated prices for pipeline stuffers.

Both the company and investors agree that Tracleer bosentan for pulmonary arterial hypertension should continue to generate revenue and profit growth. As such, although a good product deal would be desirable, neither the company nor investors think in-licensing or M&A is a necessity.

Last week, shares of Actelion (SWX:ATLN, Allschwil, Switzerland) lost CHF17.20 to CHF120 after the company reported that clazosentan demonstrated no overall clinical benefit even though the compound met the primary endpoint of preventing cerebral vasospasm after subarachnoid arterial hemorrhage (SAH) (see B10).

"Vasospasm is a surrogate endpoint. We must have a measurable clinical outcome benefit for this product to get approved," ATLN spokesperson Roland Haefeli told BioCentury. "Our ongoing analysis is trying to determine if there's a problem with the drug or trial design or the analysis before we make a decision" on the future of the compound. The analysis will be completed in the second half.

The disappointment has raised questions about ATLN's execution in the clinic.

"With the exception of Tracleer, it's clear that Actelion has missed the boat on their late stage products," said Nick Draeger, a buyside analyst at Adamant Biomedical Investments. "Veletri is toast, and clazosentan is disappointing."

Veletri tezosentan twice failed in Phase III for acute heart failure (AHF). After Veletri failed in 2001, the company ran a second set of Phase III trials, hoping that a lower dose would prove successful...

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