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Actelion obtains marketing approval for Epoprostenol "ACT" in Japan
Actelion obtains marketing approval for Epoprostenol "ACT" in Japan
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For best results when printing this announcement, please click on the link below: http://pdf.reuters.com/htmlnews/8knews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20130218:nHUGcWSd 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(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/ The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Press Release PDF http://hugin.info/131801/R/1678832/548043.pdf ---------------------------------------------------------------------------------------------------- This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that: (i) the releases contained herein are protected by copyright and other applicable laws; and (ii) they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Actelion Pharmaceuticals Ltd via Thomson Reuters ONE HUG#1678832 --- End of Message --- Actelion Pharmaceuticals Ltd Gewerbestrasse 16 Allschwil Switzerland ISIN: CH0010532478;