Actelion Provides Update on CRTH2 Program

ALLSCHWIL/BASEL, SWITZERLAND - 02 April 2012 - Actelion Ltd (SIX: ATLN) announced today that the company will re-direct its development efforts in the anti-inflammatory area, focusing on a potent follow-up CRTH2 antagonist currently in Phase I clinical development.

Two recently concluded studies with the first orally-active CRTH2 antagonist, setipiprant, in asthma (Phase IIb) and seasonal allergic rhinitis (Phase III profiling) did not confirm efficacy findings made in earlier studies. Accordingly, clinical development with this well-tolerated agent in these indications is being discontinued.

By focusing on the more potent follow-up compound, Actelion expects to further develop the understanding of the CRTH2 mechanism as a potential anti-inflammatory mode of action in allergic indications.

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Notes to the Editor

About setipiprant

Actelion's CRTH2 antagonist, setipiprant, blocks the effects of prostaglandin D2 (PGD2) role in inflammation and, in consequence, the amplification and maintenance of allergic reactions. It targets the allergic inflammation at the beginning of the cascade.

Earlier, positive data was obtained with setipiprant in an allergen challenge proof-of-mechanism study in patients with mild to moderate allergic asthma. In the 18-patient 2-period crossover double-blind placebo-controlled study, the compound was well tolerated and demonstrated efficacy versus placebo on the primary endpoint (FEV1) during the late allergic reaction (3-10 hours) after a bronchial allergen challenge.

A Phase II study with setipiprant in seasonal allergic rhinitis (SAR) met its primary endpoint with statistical significance (p<0.05). The two week study assessed the efficacy and tolerability of various doses of setipiprant in 579 adult patients with SAR ("hay fever") due to mountain cedar pollen. Treatment in the study was well tolerated across all treatment groups and no serious adverse events were reported.

Actelion Ltd.

Actelion Ltd is a biopharmaceutical company with its corporate headquarters in Allschwil/Basel, Switzerland. Actelion's first drug Tracleer®, an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer® through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union, Japan, Canada, Australia and Switzerland. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium - the single layer of cells separating every blood vessel from the blood stream. Actelion's over 2,500 employees focus on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) as part of the Swiss blue-chip index SMI (Swiss Market Index SMI®).

For further information please contact:

Roland Haefeli Senior Vice President, Head of Investor Relations & Public Affairs Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil +41 61 565 62 62 +1 650 624 69 36 www.actelion.com  

Posted: April 2012


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