Actelion's Tracleer Misses Primary Endpoint


Actelion Ltd. (ALIOF) failed to meet its primary endpoint in a phase IV study (COMPASS-2) on Tracleer. The randomized, double-blind, placebo-controlled, event-driven COMPASS-2 study evaluated the effect of Tracleer on the time to  first morbidity or mortality event in patients with symptomatic pulmonary arterial hypertension (PAH) already treated with Revatio.

The primary endpoint was to demonstrate that Tracleer prolonged the time to first morbidity or mortality event in patients with symptomatic PAH already receiving Revatio. Tracleer showed a risk reduction of 17% as compared to 43% in the primary endpoint.

However, this study provided important information for the scientific community. The University of Michigan will perform all the necessary analyses to fully understand the outcome of the study.

Tracleer is available in U.S., the EU, Japan, Australia, Canada, Switzerland and other markets worldwide for the treatment of PAH. Tracleer sales in 2013 were CHF 1,532 million, up 5% y/y in local currency. The increase was due to solid underlying global unit growth driven by Japan, Germany, PAH emerging markets and the digital ulcer indication in Europe.

Actelion possesses a leading franchise in PAH with three products for this indication besides Tracleer, namely, Ventavis, Veletri and Opsumit. Opsumit was approved by the U.S. Food and Drug Administration on Oct 18, 2013 and the drug was launched in Nov 2013. Health Canada, EU and Australia also approved this drug in Nov 2013, Dec 2013 and Feb 2014, respectively.

Actelion carries a Zacks Rank #2 (Buy). Investors looking for better-ranked stocks in the biopharma sector may consider companies like Gilead Sciences Inc. (GILD), Shire (SHPG) and Questcor Pharmaceuticals Inc. (QCOR), all of which carry a Zacks Rank #1 (Strong Buy).

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