Ventavis (Iloprost) in pulmonary arterial hypertension receives US approval for increased 20 mcg/ml strength formulation

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ALLSCHWIL, SWITZERLAND - 10 August 2009 - Actelion Ltd (SIX: ATLN)
announced today that the US Food and Drug Administration (FDA) has
approved a new 20 microgram per milliliter (mcg/ml) formulation of
Ventavis® as a therapy for New York Heart Association Class III and
IV pulmonary arterial hypertension (PAH). This new increased 20
mcg/ml strength formulation will deliver the same dose in half the
volume which is expected to reduce inhalation time and further
support patient compliance.

The approval was based on the submission of technical data showing
that the new formulation did not alter the functional characteristics
of the delivery system or the emitted dose to the patient.

Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion
commented: "This is another major improvement for Ventavis® in the US
and for the patients who use this important inhaled therapy for PAH.
The only inhaled prostacyclin therapy to show significant patient
improvement measured by both exercise capacity and improvement in
NYHA Functional Class. [1] In 2008, Actelion successfully implemented
an improved cleaning protocol for the device which significantly
reduced the time each patient spent on maintenance."

Jean-Paul added: "We have now been successful with this new
strengthened formulation offering additional convenience for US
patients using Ventavis®. We will continue our commitment to
Ventavis® as well as our portfolio of PAH programs in order to
achieve further improvements for the PAH community."

Dr. Harold Palevsky, Professor of Medicine at the University of
Pennsylvania School of Medicine, Chief of the Pulmonary, Allergy and
Critical Care Division, and Director of the Pulmonary Vascular
Disease Program at Penn Presbyterian Medical Center in Philadelphia
commented: "Ventavis is an important treatment option for many
patients with PAH. Decreasing the time required per inhalation will
allow these patients more time to focus on activities that are
important in their lives. In addition, the new formulation should
help maintain patient compliance, an important part of any PAH
therapy"

About Ventavis®
Ventavis® is indicated for the treatment of pulmonary arterial
hypertension (WHO Group 1) in patients with NYHA Class III or IV
symptoms.

In January 2007, Actelion announced the successful completion of its
cash tender offer for shares of CoTherix, Inc., thereby strengthening
its PAH franchise by adding Ventavis® to its product offerings in the
United States. Bayer Schering Pharma - the inventor of Ventavis® -
markets the drug as the first inhaled prostacyclin in Europe and
other countries outside the US.

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Notes to Editor:

About Pulmonary Arterial Hypertension (PAH)
Pulmonary arterial hypertension (PAH) is a chronic, life-threatening
disorder characterized by abnormally high blood pressure in the
arteries between the heart and lungs of an affected individual. The
function of the heart and lungs is severely compromised, manifested
by a limited exercise capacity, and, ultimately, a reduced life
expectancy. Approximately 100,000 people in Europe and the United
States are afflicted with either primary or secondary forms of the
disease related to conditions or tissue disorders that affect the
lungs, such as scleroderma, lupus, HIV/AIDS or congenital heart
disease.

PAH is associated with structural changes in both the pulmonary
vasculature and the right ventricle. Recent advances [2] in the
understanding of the pathogenic factors leading to the pulmonary
vascular disease have led to the development of new therapies
targeting specific pathways (the prostacyclin pathway; the endothelin
pathway; and the nitric oxide pathway) [3]. The available therapies
have positive effects in PAH, but they do not provide a cure, and in
many patients the disease will progress. PAH remains a serious
life-threatening condition [3,4]. Early recognition and an
understanding of the selection and timing of therapeutic options
remain critical elements in the optimal management of patients with
this disorder.

About Ventavis®
Ventavis® (iloprost) is an inhaled synthetic analog of prostacyclin
(PGI2) that produces potent pulmonary vasodilation and inhibits
platelet aggregation, among other benefits. Prostacyclin functions as
a hormone, binding to receptors on smooth muscle cells, thereby
affecting their function. Prostacyclin has multiple physiological
effects, including vasodilation, inhibition of platelet aggregation,
antiproliferation, anti-inflammation, and enhanced cardiac
contractility. Ventavis® is an inhaled synthetic prostacyclin which
has been shown to:

* Significantly increase (p = 0.0033) patient improvement after 12
weeks of treatment compared to baseline on a composite endpoint
of improved exercise capacity 30 minutes after dosing,
improvement of at least one NHYA class and no clinical
deterioration.
* Significantly improve 6-minute walk distance at week 12 with a
10% or greater increase in individual walk distance (p < 0.01).
* Significantly improve patients' functional class at week 12 (p =
0.03).

For patients with PAH (WHO Group 1) with NYHA Class III or IV
symptoms [1]

References

1. Ventavis® Prescribing Information
2. Farber HW; Loscalzo J. Mechanisms of disease: pulmonary arterial
hypertension. N. Eng. J. Med. 2004; 351:1655-65.
3. Humbert M; Sitbon O; Simonneau G. Treatment of pulmonary arterial
hypertension. N. Eng. J. Med. 2004;351:1425-36.
4. Humbert M; Morrell NW; Archer SL; et al. Cellular and molecular
pathobiology of pulmonary arterial hypertension. J. Am. Coll.
Cardiol. 2004; 43: Suppl. 12: 13S-24S.

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 2000 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:

Investor Contact
Roland Haefeli
Vice President, Head of Investor Relations & Corporate Communications
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
+1 650 624 69 36
http://www.actelion.com

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Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil
Switzerland

WKN: 936767; ISIN: CH0010532478; Index: SBIOM, SLIFE, SMCI, SMIEXP,
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