Actelion obtains marketing approval for Epoprostenol "ACT" in Japan
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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(®), 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.
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:
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
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
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Source: Actelion Pharmaceuticals Ltd via Thomson Reuters ONE
[HUG#1678832]
Unternehmensinformation / Kurzprofil:
Datum: 18.02.2013 - 17:35 Uhr
Sprache: Deutsch
News-ID 230444
Anzahl Zeichen: 7895
contact information:
Town:
Allschwil
Kategorie:
Business News
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