Company
2007 - 2006 - 2005 - 2004 - 2003 - 2002 - 2001
| 14 Jul | Actelion and GlaxoSmithKline enter into exclusive collaboration to realise the full potential of almorexant in sleep disorders and beyond |
| 08 Jul | SWX Swiss Exchange decides to add Actelion shares to the blue-chip SMI® (Swiss Market Index) - First trading day September 22, 2008 |
| 27 Jun | Bosentan (Tracleer®) receives positive EU opinion for treatment of patients with mildly symptomatic WHO Functional Class II PAH |
| 20 Jun | Pivotal PAH study published in The Lancet concludes that bosentan (Tracleer®) demonstrates benefits in patients with mildly symptomatic WHO FC II disease |
| 29 Feb | Actelion and Nippon Shinyaku to collaborate on novel PAH compound |
| 20 Dec | 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 |
| 19 Dec | Phase III study initiated with Actelion-1 – Highly potent tissue-targeting endothelin receptor antagonist – Largest study ever in PAH to demonstrate morbidity/mortality benefits |
| 18 Dec | 10 Year Anniversary of Actelion – Now full member of Interpharma, the Swiss Association of Pharmaceutical Research Companies |
| 17 Dec | Actelion provides update on bosentan in metastatic melanoma |
| 05 Dec | Actelion/Merck & Co., Inc. Renin alliance achieves fourth milestone – Dosing in Phase II initiated – Actelion receives USD 10 million |
| 12 Nov | Pivlaz® (clazosentan) Phase III study initiated to demonstrate prevention of vasospasm-related morbidity and all-cause mortality after aneurysmal subarachnoid hemorrhage |
| 28 Sep | Miglustat enters Phase IIa for Cystic Fibrosis |
| 03 Sep | EARLY: First PAH functional class II population study emphasizes need to diagnose and treat PAH early |
| & lt; strong>02 Sep | New data on orexin receptor antagonist almorexant shows therapeutic potential to restore normal physiological sleep in patients suffering from insomnia. |
| 11 Jun | Actelion announced that the European Commission has granted marketing approval for Tracleer® for the reduction of the number of new digital ulcers i n patients with systemic sclerosis and ongoing digital ulcer disease. |
| 31 May | Actelion announced that the one-to-five split of shares of Actelion will take effect on Wednesday, 6 June 2007. |
| 26 Mar | Actelion announced 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 | Actelion announced the initial results from the first-ever placebo-controlled study BENEFiT evaluating bosentan (Tracleer® ) in inoperable Chronic Thromboembolic Pulmonary Hypertension. The study met its primary objective, as treatment with bosentan was associated with a significant reduction in pulmonary vascular resistance. |
09 Jan | 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 |
| 18 Dec | Actelion announces that initial results from the double-blind, placebo-controlled, multicenter study EARLY (Endothelin Antagonist Trial in miLdly Symptomatic PAH patients, NYHA modified functional class II) indicate that six months of treatment with the dual endothelin receptor antagonist bosentan (Tracleer®) showed a signific ant reduction in pulmonary vascular resistance, a strong trend towards improved exercise capacity and a significant delay in the time to clinical worsening. |
| 11 Dec | Actelion has initiated a comprehensive Phase III program for Actelion-1, the first tissue targeting endothelin receptor antagonist (ERA). Initially, development will focus on pulmonary hypertension ( PH), with other cardiopulmonary indications expected to follow |
| 08 Dec | Actelion Ltd. announces Commencement of Cash Tender Offer for CoTherix, Inc. and HSR Clearance to Acquire CoTherix, Inc. |
| 20 Nov | Actelion announced that it has entered into a definitive agreement to acquire CoTherix, Inc., a biopharmaceutical company with its headquarters in Brisbane, California. CoTherix currently markets Ventavis® (iloprost), the only approved inhaled therapy for the treatment of Pulmonary Arterial Hypertension in the United States |
| 09 Oct | Actelion presents detailed analysis of CONSCIOUS-1 showing significant reduction of cerebral vasospasm in clazosentan-treated patients with aneurysmal subarachnoid hemorrhage |
| 17 Jul | Actelion and Roche enter into autoimmune disorder collaboration. Co-development for Actelion’s selective S1P1 receptor agonist in multiple indications with co-promotion and profit share |
| 06 Jul | Actelion/Merck Renin alliance achieves third milestone. Actelion receives USD 7 m following entry into man of a new renin inhi bitor |
19 Jun | Preliminary results of CONSCIOUS-1. Further data analysis needed to determine future development path |
23 May | ATS presentation highlights strong rationale for a morbidity/mortality study with bosentan in Idiopathic Pulmonary Fibrosis (IPF) |
| 08 Sep | Actelion hosts its 3rd Research and Development Day |
| 05 Sep | Tracleer Excellence Post Marketing Surveilla nce Program (TRAX PMSTM) confirms long-term safety profile in various pulmonary arterial hypertension subgroups |
| 09 Aug | Second study wit h bosentan (Tracleer®) demonstrating a statistically significant reduction of new digital ulcers in patients with systemic sclerosis |
| 12 Jul | Tracleer® study BREATHE-5 f irst ever to show benefits in Eisenmenger's syndrome |
| 08 Jun | Actelion Japan launches Tracleer® in PAH |
| 23 May | Clinical development of palosuran in diabetic nephropathy stopped after proof-of-conce pt program for lack of efficacy |
| 11 Apr | The Japanese Ministry of Health, Labor and Welfare grants formal approval for Tracleer for all forms of PAH |
15 Mar | Actelion receives USD 5 m following selection of first compound to enter full pre-clinical development |
05 Jan | Zavesca® (miglustat) capsules, the first oral treatment option for type I Gaucher disease, now available in the United States |
| Tracleer® launched in many EU countries in 2003 |
Jan | Entry-into-man of the first urotensin II receptor antagonist |
31 Mar | Tracleer® approved in Brazil |
08 Apr | Actelion files New Drug Application for T racleer® in Japan |
| 23 Apr | American Thoracic Society publishes abstract on positive long-term survival data with Tracleer® (bosentan) in patients with primary pulmonary hyp ertension |
| 19 May | Analysis of long-term follow-up data of primary pulmonary hypertension patie nts from Tracleer® pivotal registration studies suggests that the use of this oral dual endothelin receptor antagonist is associated with im proved survival |
| Jun | Zavesca approved in Israel |
| 02 Jun | Collabo ration with Discovery Partners begins |
| 17 Jun | Actelion & Axovan AG enter research collaboration |
| 31 Jul | Zavesca approved by the US FDA |
| 30 Sep | Actelion acquires Axovan |
| 1 Oct | Actelion stengthens its finances by issuing a convertible bond |
| 29-30 Oct | Actelion presents the research and development status in London and New York |
| 9 Nov | The building of the Actelion Research Center is inititated on Hagenmattweg in Allschwil. |
| 03 Dec | Actelion and Merck join forces in Renin Inhibitor project |
| 31 Dec | Tracleer® approved in Hong Kong |
Jan | ENABLE study, assessing Tracleer® in chronic heart failure, completed without meeting primary endpoints |
22 Feb | European Union's Committee for Proprietrary Medicinal Products (CPMP) recommends the approval of Tracleer® for the treatment of primary PAH and PAH secondary to scleroderma (WHO class III) |
| 28 Feb | Swiss regulatory authority, Swissmedic, approves Tracleer® for the treatment of primary pulmonary arterial hypertension |
15 May | European Commission grants marketing authorization for Tracleer® for treatment of PAH. Marketing authorization is valid for all 15 EU member states and is also recognized by Norway and Iceland |
| 13 May | Berna Biotech and Hesperion create clinical development partnership for new vaccines |
| 20 May | The New England Journal of Medicine publishes landmark study highlighting efficacy of Tracleer in life-threatening lung condition |
| 23 May | Actelion initiates major clinical trial programs to expand the use of Tracleer, with particular with focus on scleroderma |
| 05 Jun | Actelion holds its first "R&D Day" presenting its approach to drug discovery and its emerging drug pipeline |
| 05 Jun | Actelion reports positive data for BREATHE-3 clinical study |
| 06 Jun | Actelion starts introduction of Tracleer® in the EU |
| 26 Jul | Actelion and OGS announce marketing and distribution partnership for Zavesca |
| 30 Jul | Actelion joins Interpharma as associate member |
Aug | Positive results in the first study of Tracleer in scleroderma-related digital ulcerations (RAPIDS-1) |
| Sep | BREATHE-2 STUDY successfully completed |
Dose-optimization study with Veletri successfully completed | |
| Oct | BREATHE-2 STUDY successfully completed |
Australia's regulatory authority TGA recommends Tracleer® for the treatment of PAH in both adults and children | |
| Nov | Full enrollment of bridging study necessary to file for marketing approval of Tracleer in PAH in Japan |
12 Nov | Tracleer® approved in Australia |
| European Commission approval for Zavesca (migulstat) in type 1 Gaucher disease. Worldwide license agreement signed by Actelion and Oxford GlycoSciences Plc (OGS) |
27 Feb | EU Marketing Authorization Application submission for Tracleer® for the treatme nt of PAH; Initiation of centralized review procedure |
12 Apr | Actelion's first Annual General Meeting of Shareholders |
May | Actelion files the application for Tracleer® for the treatment of PAH with Swiss regulatory authority (IKS); granted fast-track review by IKS in March |
| 02 May | BREATHE-1 Tracleer® (bosentan) study in patients with pulmonary arterial hypertension completed - meeting primary endpoints |
| 20 May | US NDA supplementary submission (BREATHE-1 data) |
| 20 Jun | Actelion four-to-one stock split effective |
| 20 Jun | Actelion invited to FDA Advisory Board Meeting |
| 25 Jun | R.W. Johnson Pharmaceutical Research Institute (PRI) extends research collaboration agreement with Actelion for an additional year |
| 10 Aug | FDA Advisory Committee votes unanimously to recommend approval of Tracleer(bosentan) for treatment of PAH |
| Sept | Start of regulatory review for Tracleer® in PAH in Australia |
| 17 Sep | Tracleer receives 'approvable' letter from FDA |
| 20 Nov | US FDA approves Tracleer for treatment of PAH |
| 03 Dec | Canadian health authorities approve Tracleer |
| 05 Dec | Commercial launch of Tracleer in the US |
10 Dec | Actelion grants commercial license to Neopharm Ltd to market Tracleer® for PAH in Israel |
