Actelion Pharmaceuticals US, Inc. has received subpoena relating to Tracleer
(Thomson Reuters ONE) -
Actelion Pharmaceuticals Ltd / Actelion Pharmaceuticals US, Inc. has received subpoena relating to Tracleer processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
SOUTH SAN FRANCISCO, USA and ALLSCHWIL, SWITZERLAND - 20 September 2010 -
Actelion Ltd. (SIX: ATLN) announced today that its fully owned US subsidiary
Actelion Pharmaceuticals US, Inc. has received a subpoena from the United States
Attorney's Office for the Northern District of California, requesting documents
relating, among others, to marketing and sales practices of Tracleer(®) in the
United States. Tracleer(®) is a prescription medication for the treatment of
patients with pulmonary arterial hypertension. The company intends to cooperate
with the investigation.
###
Notes to the Editor
About pulmonary arterial hypertension (PAH)
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 function of the heart and lungs
is severely compromised, manifested by a limited exercise capacity, and,
ultimately, a reduced life expectancy. Approximately 100,000 people in Europe
and the United States are afflicted with either primary or secondary forms of
the disease related to conditions or tissue disorders that affect the lungs,
such as scleroderma, lupus, HIV/AIDS or congenital heart disease.
About Tracleer® in Pulmonary Arterial Hypertension (PAH)
Tracleer® (bosentan), the first oral dual endothelin receptor antagonist, is
approved for the treatment of pulmonary arterial hypertension (PAH) and made
available by Actelion subsidiaries in the United States, the European Union,
Japan, Australia, Canada, Switzerland and other markets worldwide.
Requires attention to two significant safety concerns: Potential for serious
liver injury (including rare cases of liver failure and unexplained hepatic
cirrhosis in a setting of close monitoring) - Liver monitoring of all patients
is essential prior to initiation of treatment and monthly thereafter. High
potential for major birth defects - Pregnancy must be excluded and prevented by
two forms of birth control; monthly pregnancy tests should be obtained. Because
of these risks, Tracleer® is only supplied through controlled distribution.
About 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
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
http://www.actelion.com
[HUG#1445231]
--- End of Message ---
Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil Switzerland
ISIN: CH0010532478;
Media Release PDF:
http://hugin.info/131801/R/1445231/388652.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
Unternehmensinformation / Kurzprofil:
Datum: 20.09.2010 - 07:00 Uhr
Sprache: Deutsch
News-ID 42813
Anzahl Zeichen: 0
contact information:
Town:
Allschwil
Kategorie:
Business News
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