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Media Releases 2007
20 Dec 2007 · Actelion enters Phase III with novel orexin receptor antagonist almorexant – RESTORA program to confirm efficacy and safety in patients suffering from primary insomnia – RESTORA 1 with active reference arm initiated |
ALLSCHWIL, SWITZERLAND – 20 December 2007 – Actelion Ltd (SWX: ATLN) announced today that the company has initiated the comprehensive Phase III program RESTORA (REstore physiological Sleep with The Orexin Receptor Antagonist Almorexant) with its first-in-class orexin receptor antagonist, almorexant.
19 Dec 2007 · Phase III study initiated with Actelion-1 – Highly potent tissue-targeting
endothelin receptor antagonist – Largest study ever in PAH to demonstrate
morbidity/mortality benefits |
ALLSCHWIL, SWITZERLAND – 19 December 2007 – Actelion Ltd (SWX: ATLN) announced today the initiation of the phase III study SERAPHIN (Study with an Endothelin Receptor Antagonist in Pulmonary arterial Hypertension to Improve cliNical outcome) for its highly potent, tissue-targeting endothelin receptor antagonist (ERA) Actelion-1 (ACT-064992). The study is designed to evaluate the safety and efficacy of Actelion-1 in delaying disease progression and mortality in patients with pulmonary arterial hypertension (PAH).
18 Dec 2007 · 10 Year Anniversary of Actelion – Now full member of Interpharma, the Swiss Association of Pharmaceutical Research Companies |
ALLSCHWIL, SWITZERLAND – 18 December 2007 – Actelion Ltd (SWX: ATLN) announced today that the biopharmaceutical company with headquarters in Allschwil (just outside of Basel) is celebrating its 10 year anniversary. On that occasion, the company is becoming a full member of Interpharma, the association of Swiss pharmaceutical research companies.
17 Dec 2007 · Actelion provides update on bosentan in metastatic melanoma |
ALLSCHWIL, SWITZERLAND – 17 December 2007 – Actelion Ltd (SWX: ATLN) announced today that preliminary efficacy data generated in the proof-of-concept study evaluating bosentan (500mg bid) in the indication metastatic melanoma (stage 4) do not support the initiation of a full clinical development program in this indication. The observed safety profile was consistent with earlier findings in clinical studies that led to the approval of bosentan (Tracleer® 125mg bid) in pulmonary arterial hypertension (PAH).
05 Dec 2007 · Actelion/Merck & Co., Inc. Renin alliance achieves fourth milestone Dosing in Phase II initiated Actelion receives USD 10 million |
ALLSCHWIL, SWITZERLAND – 05 December 2007 – Actelion Ltd (SWX: ATLN) announced today that the renin alliance with Merck & Co., Inc. has achieved its fourth milestone. The alliance has started dosing in the Phase II program for its first compound, a new renin inhibitor. This triggers a milestone payment by Merck to Actelion of USD 10 million.
29 Nov 2007 · Management change at Actelion - Otto Schwarz to join as new Head of Business Operations |
ALLSCHWIL, SWITZERLAND – 29 November 2007 – Actelion Ltd (SWX: ATLN) announced today that Otto Schwarz will join the company as its new Head of Business Operations on 14 January 2008. He will succeed Christian Chavy who is leaving his position at that time to pursue other opportunities.
12 Nov 2007 · Pivlaz® (clazosentan) Phase III study initiated to demonstrate prevention of vasospasm-related morbidity and all-cause mortality after aneurysmal subarachnoid hemorrhage |
ALLSCHWIL, SWITZERLAND – 12 November 2007 – Actelion Ltd (SWX: ATLN) announced today the initiation of the phase III program, CONSCIOUS-2, for the endothelin receptor antagonist Pivlaz® (Clazosentan). The study is designed to evaluate the safety and efficacy of Pivlaz® in reducing vasospasm-related morbidity and all-cause mortality following aneurysmal subarachnoid hemorrhage (aSAH). In earlier studies, the use of Pivlaz® was associated with up to 65 percent reduction in vasospasm, a contraction of blood vessels in the brain.
19 Oct 2007 · Miglustat (Zavesca®) receives negative opinion from the European Committee for Medicinal Products for Human Use for extension of indication for Niemann Pick type C |
ALLSCHWIL, SWITZERLAND – 19 October 2007 - Actelion Ltd
(SWX: ATLN) announced today that the Committee for Medicinal Products for Human
Use (CHMP) has adopted a negative opinion for the extension of indication on the
use of miglustat (Zavesca®) in patients suffering from Niemann Pick type C
(NP-C), a rare genetic disease associated with multiple neurological
manifestations.
The company intends to request a re-examination of the CHMP opinion.
Accordingly, the CHMP would issue a final opinion in the first quarter of
2008
18 Oct 2007 · Actelion announces 9-months results for 2007 |
Total net revenues of CHF 946.4 million, up 38 percent – Tracleer® sales of CHF 846.5 m, up 30 percent – Number of Tracleer-treated PAH patients continues to grow - Quarter-on-quarter growth variation attributable to buying patterns – Cash EBIT of CHF 349.0 million, up 48 percent – Strong cash generation enables full funding of rapidly expanding late-stage pipeline
28 Sep 2007 · Miglustat enters Phase IIa for Cystic Fibrosis |
ALLSCHWIL, SWITZERLAND – 28 September 2007 – Actelion Ltd (SWX: ATLN) announced today that it has initiated a Phase IIa proof-of-concept clinical study with miglustat in Cystic Fibrosis (CF). It is the first time that miglustat is being tested in a clinical setting involving CF patients.
03 Sep 2007 · EARLY: First PAH functional class II population study emphasizes need to diagnose and treat PAH early |
VIENNA, AUSTRIA – 03 September 2007 – At the 2007 European Society of Cardiology (ESC) congress in Vienna, Actelion Ltd (SWX: ATLN) has presented full results from a Phase IIIb trial1 which demonstrated that six months of treatment with bosentan (Tracleer®) in patients with mildly symptomatic WHO functional class II (FCII) Pulmonary Arterial Hypertension (PAH) significantly delayed time to clinical worsening and reduced the number of patients worsening to WHO functional class III/IV.
02 Sep 2007 · New data on orexin receptor antagonist almorexant shows therapeutic potential to restore normal physiological sleep in patients suffering from insomnia |
Pre-clinical and clinical data presented at the World Sleep Congress 2007 provides evidence for key role of orexin receptor antagonist almorexant to significantly restore relevant clinical parameters of sleep in a dose-dependent manner – Phase III program RESTORA planned to start by year-end
19 Jul 2007 · Actelion announces Half Year financial results 2007 |
Total net revenue increases to CHF 626.4 million, up 43% compared to the first six months of 2006 - Tracleer® sales of CHF 559.9 million - Cash EBIT up 59% to CHF 231.0 million - Rapidly expanding product pipeline - Multiple Phase III studies enrolling or about to enroll - Orexin-receptor antagonist data to be presented in early September - Phase II go/no-go decisions for renin inhibitor and S1P1 agonist ahead - Increased revenue and Cash EBIT guidance for FY 2007
11 Jun 2007 · Bosentan (Tracleer®) receives EU approval for reduction of number of new digital ulcerations in systemic sclerosis patients |
ALLSCHWIL, SWITZERLAND - 11 June 2007 - Actelion Ltd (SWX: ATLN) announced today that the European Commission has granted marketing approval for Tracleer® for the reduction of the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
31 May 2007 · Actelion Stock Split 1:5 effective Wednesday, 6 June 2007 |
ALLSCHWIL, SWITZERLAND - 31 May 2007 Actelion Ltd (SWX: ATLN) announced today that the one-to-five split in shares of Actelion (SWX: ATLN) will take effect on Wednesday, 6 June 2007.
04 May 2007 · Annual General Meeting of Shareholders in Basel, Switzerland |
ALLSCHWIL/BASEL, SWITZERLAND – 4 May 2007 – At today's Annual General Meeting of Actelion Ltd (SWX: ATLN), shareholders approved all resolutions.
19 Apr 2007 · Actelion announces first quarter results 2007 |
Total net revenue increases to CHF 290.4 million, up 38 percent compared to Q1 2006 - Tracleer® sales of CHF 260.4 million - Cash EBIT up 41% to CHF 101.3million - One-time IPRD charge results in US GAAP Operating loss - Increased revenue and Cash EBIT guidance for FY 2007
26 Mar 2007 · Bosentan (Tracleer®) receives positive EU opinion for reduction of new digital ulcerations in systemic sclerosis patients |
ALLSCHWIL, SWITZERLAND – 26 March 2007 – Actelion Ltd (SWX: ATLN) announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has issued a positive opinion on bosentan (Tracleer®) to extend the use of this dual endothelin receptor antagonist beyond Pulmonary Arterial Hypertension.
05 Mar 2007 · Positive study with bosentan (Tracleer®) in CTEPH |
First-ever placebo-controlled study in inoperable Chronic Thromboembolic Pulmonary Hypertension – Primary endpoint of reduction in pulmonary vascular resistance met – Six-minute-walk test unchanged – Significant effect on dyspnoea score and biological disease marker
22 Feb 2007 · Actelion announces Full Year 2006 financial results |
Total net revenue up 43% to CHF 945.7 million - Tracleer® sales up 42% to CHF 898.7 million - Operating income up 76% to CHF 268.2 million - Net income up 92% to CHF 241.1 million - Ongoing growth for marketed products forecasted - Rapidly expanding and maturing pipeline highlights opportunity for accelerated future growth
05 Feb 2007 · Successful Proof-of-Concept with Actelion’s Orexin Receptor Antagonist in patients suffering from primary insomnia – First demonstration of key role of Orexin System in humans suffering from sleep disorders |
29 Jan 2007 · Publication in Nature Medicine highlights potential of Actelion’s Orexin Receptor Antagonist as a novel mechanism to treat sleep disorders |
18 Jan 2007 · Actelion calls its Zero Coupon Convertible Bond 2003-2008 |
09 Jan 2007 · Actelion Ltd. Announces Successful Completion of its Cash Tender Offer for Shares of CoTherix, Inc. |
More than 97 percent of shares tendered – Deal to be consummated at the end of Tuesday, 9 January 2007
Last update: 09 Jan 2007
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