Actelion obtains marketing approval for Epoprostenol "ACT" in Japan

Mon Feb 18, 2013 11:35am EST

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Actelion Pharmaceuticals Ltd / Actelion obtains marketing approval for Epoprostenol "ACT" in Japan
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ALLSCHWIL/BASEL, SWITZERLAND - 18 February 2013 - Actelion (SIX: ATLN) announced today that
Japan's Ministry of Health, Labor and Welfare granted approval for Epoprostenol "ACT" (0.5 mg and
1.5 mg) for the treatment of pulmonary arterial hypertension (PAH).

Satoshi Tanaka, Dr.med Sci. President of Actelion Japan and Chairman of Actelion South Korea
commented: "Unlike other epoprostenol formulations approved for PAH, Epoprostenol "ACT" has
greater stability. This provides unique benefits, such as a more flexible preparation of the
medication and infusion of the product within 24hrs at room temperature."

Satoshi Tanaka concluded: "By adding Epoprostenol "ACT" to our Japanese product portfolio we will
be able to offer PAH physicians an option for intravenous therapy on top of our oral endothelin
receptor antagonist Tracleer(R), the leading oral treatment option in Japan."

Actelion Pharmaceuticals Japan will now ensure that Epoprostenol "ACT" is made available to
patients as soon as possible.

Actelion already markets this product as Veletri(R) in the United States and during 2012 Actelion
received approval to market as Veletri(R) in Switzerland and in Canada under the trade name
Caripul(R). Regulatory review for this epoprostenol formulation is ongoing in the European Union.

 

###

 
Notes to the Editor

About Pulmonary Arterial Hypertension

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 symptoms of PAH are non-specific and can range from mild breathlessness and
fatigue during normal daily activity to symptoms of right heart failure and severe restrictions on
exercise capacity and ultimately reduced life expectancy.

PAH is one group within the classification of pulmonary hypertension (PH). This group includes
idiopathic PAH, heritable PAH and PAH caused by factors which include connective tissue disease,
HIV infection and congenital heart disease.

The last decade has seen significant advances in the understanding of the pathophysiology of PAH,
which has been paralleled with developments of treatment guidelines and new therapies. Drugs
targeting the 3 pathways that have been established in the pathogenesis of PAH are endothelin
receptor antagonists (ERAs), prostacyclins and phosphodiesterase-5 inhibitors. PAH treatments have
transformed the prognosis for PAH patients from symptomatic improvements in exercise tolerance 10
years ago to delayed disease progression today.  Improved disease awareness and evidence-based
guidelines developed from randomized controlled clinical trial data have highlighted the need for
early intervention, goal-oriented treatment and combination therapy.

Despite these advances in PAH, survival rates are unacceptably low and PAH remains incurable.

About Actelion Pharmaceuticals Japan

Actelion Pharmaceuticals Japan was established in 2001 to meet the medical needs of patients with
pulmonary arterial hypertension in Japan. Since its foundation the company has established a
significant presence in the pharmaceutical market and also provides clinical development for the
specific needs of the Japanese Health Authorities. The organization also has a central role for
East Asian cross-border clinical development activities, such as in South Korea. In 2012 Actelion
Pharmaceuticals Japan contributed 12% of Actelion's total product sales.

Actelion Ltd.

Actelion Ltd is a biopharmaceutical company with its corporate headquarters in Allschwil/Basel,
Switzerland. Actelion's first drug Tracleer(R), an orally available dual endothelin receptor
antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets
Tracleer(R) 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 2,400 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(R)).

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 http://www.actelion.com/ 

 

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vary materially from those described herein as anticipated, believed, estimated or expected.

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Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil Switzerland

ISIN: CH0010532478;

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