Actelion Pharmaceuticals Ltd : Actelion obtains marketing approval for
Epoprostenol "ACT" in Japan
Actelion Pharmaceuticals Ltd / Actelion obtains marketing approval for
Epoprostenol "ACT" in Japan . Processed and transmitted by Thomson Reuters
ONE. The issuer is solely responsible for the content of this announcement.
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^®, 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^® in the United States and
during 2012 Actelion received approval to market as Veletri^® in Switzerland
and in Canada under the trade name Caripul^®. 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
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
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 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 2,400 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®).
For further information please contact:
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
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Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil Switzerland
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