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 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 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®).
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