Update on the DUAL Program in Digital Ulcers in Systemic Sclerosis
(Thomson Reuters ONE) -
Actelion Pharmaceuticals Ltd /
Update on the DUAL Program in Digital Ulcers in Systemic Sclerosis
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ALLSCHWIL, SWITZERLAND - 02 December 2013 - Actelion Ltd (SIX: ATLN) announced
today that following a scheduled meeting the independent Data Monitoring
Committee (DMC) has recommended that the Phase III DUAL-2 study should be
terminated. The DMC determined that there were no unexpected safety findings but
that additional data are unlikely to result in a positive primary outcome
measure.
The DUAL studies (DUAL-1 and DUAL-2) investigate the effect of treatment with
macitentan (3mg and 10mg) compared to placebo on the reduction of the number of
new digital ulcers in patients with systemic sclerosis and ongoing digital
ulcers. There are no more patients in DUAL-1 receiving study treatment and this
study will be completed as planned.
Actelion will now collect and analyze data from both studies. Data will be made
available in the future.
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NOTES TO THE EDITOR
MACITENTAN
Macitentan is an orally available endothelin receptor antagonist (ERA) that
resulted from a tailored drug discovery process with the target of developing an
ERA to address efficacy and safety.
ABOUT THE SAFETY AND TOLERABILITY PROFILE
The most common adverse reactions observed in patients treated to date with
macitentan are anemia, nasopharyngitis / pharyngitis, bronchitis, headache,
influenza, and urinary tract infection.
Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate headquarters in
Allschwil/Basel, Switzerland. Actelion first drug Tracleer® (bosentan), 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 2,300 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/1746886/588150.pdf
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(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 GlobeNewswire
[HUG#1746886]
Unternehmensinformation / Kurzprofil:
Datum: 02.12.2013 - 07:00 Uhr
Sprache: Deutsch
News-ID 321509
Anzahl Zeichen: 5394
contact information:
Town:
Allschwil
Kategorie:
Business News
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"Update on the DUAL Program in Digital Ulcers in Systemic Sclerosis"
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