Actelion Ltd.
Actelion announces half-year results 2004 – Part 4 of 4
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Actelion announces half-year results 2004 – Part 4 of 4
Planning initiated for first efficacy study with bosentan in Metastatic Melanoma
In the summer of 2003, Actelion initiated a first pilot study evaluating in an
open-label, non-randomized setting the safety and efficacy of 500 mg bosentan
(Tracleer(R)) twice a day in 35 patients with stage IV metastatic malignant
melanoma. Patients with this advanced form of spreading skin cancer have an
average life expectancy of six to nine months.
In late July 2004, Actelion completed the analysis of the Tracleer(R) proof of
concept study in Metastatic Melanoma. The efficacy analysis supports the ongoing
clinical evaluation of Tracleer(R) in Metastatic Melanoma. The safety analysis
indicates that the drug is well tolerated even at doses four times higher than
what is prescribed today in the approved indication, pulmonary arterial
hypertension.
In due time, the principal investigator will publish study findings in an
appropriate, peer-reviewed manner. Together with clinical experts in the field,
Actelion has initiated work on the design of a first efficacy study involving
this time randomization and placebo-control in an adjuvant setting.
For documentation purposes – table Q1 2004 vs. Q2 2004
In CHF thousands Results Q2 2004 Results Q1 2004 Variance in %
Net Revenues 113’937 101’053 12’884 +13
Operating Expenses 98’606 81’299 17’307 +21
Operating Profit/Loss 15’331 19’754 -4’423 -22
Net Profit/Loss 11’330 27’715 -16’385 -59
Basic EPS in CHF 0.52 1.27 -0.75 -59
Cash & cash equivalents 244’831 283’409 -38’578 -14
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Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate headquarter 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 as well as Australia, Canada 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 focuses on the discovery,
development and marketing of innovative drugs for significant unmet medical
needs. Actelion shares are traded on the SWX Swiss Exchange (ticker symbol:
ATLN).
For further information please contact:
Actelion Ltd, Gewerbestrasse 16, CH-4123 Allschwil
Investor Contact Roland Haefeli +41 61 487 34 58
+1 650 624 6936
Media Contact Peter Engel +41 61 487 36 28
+1 650 624 6996
http://www.actelion.com
Conference Call
Actelion will host an Investor Conference Call and discussion/Q&A on Tuesday, 27
July 2004, 15.30 CET / 09.30 a.m. EST / 14.30 GMT
Dial: +41 (0)91 610 56 00 (Europe)
+1 866 291-4166 (U.S.)
+44 207 107 06 11 (U.K.)
Webcast – Live and replay on demand
Actelion webcasts its Investor Conference Call. On the Web, you may either
follow the call live or have the call replayed later on demand.
To access the webcast live, simply visit the link on our homepage
http://www.actelion.com/ 5-10 minutes before the conference is due to start.
Approximately 60 minutes after the call has ended, the archived investor webcast
will be available for replay on our website “Investors/Past Events”.
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end of message, (c)DGAP 27.07.2004
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WKN: 936767; ISIN: CH0010532478; Index:
Listed: Freiverkehr in Berlin-Bremen, Frankfurt, München und Stuttgart; SWX
Swiss Exchange
270702 Jul 04
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