) 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
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
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
Gilead Sciences Inc.
Questcor Pharmaceuticals Inc.
), all of which carry a Zacks Rank #1 (Strong Buy).
ACTELION LTD (ALIOF): Get Free Report
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