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Highlights |
THE ACTELION ANNUAL REPORT 2003 |
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| 1997 |
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December 1997 - Recognizing the potential of the Endothelin Receptor Antagonist (ERA) bosentan (Tracleer®), the discovery team founds Actelion
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| 1998 |
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- Actelion research laboratories established in Allschwil, Switzerland
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| 1999 |
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September 1999 - Actelion starts investigations in patients with pulmonary arterial hypertension (PAH) with Tracleer®
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| 2000 |
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February 2000 - Actelion and Genentech sign licensing agreement for Veletri™ (tezosentan) in the US
- Actelion subsidiaries opened in US and Europe
April 2000 - Initial Public Offering (IPO); Actelion Ltd shares listed on the SWX New Market
November 2000 - New Drug Application (NDA) for Tracleer® in PAH is submitted to the US Food and Drug Administration
- Start of the RITZ study program, investigating Veletri™ in acute heart failure
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| 2001 |
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January 2001 - Canadian subsidiary opened
- Marketing application for Tracleer® is submitted to the European Medicines Evaluation Agency (EMEA). The same month, the European Commission grants Tracleer® orphan drug status
- Australian authorities grant Tracleer® orphan drug status
- RITZ-2 clinical trial with Veletri™ successfully completed
April 2001 - RITZ-1 clinical trials with Veletri™ completed without meeting primary endpoints
May 2001 - BREATHE-1 study with Tracleer® in PAH successfully completed
- Start of BREATHE-2 (Tracleer® in combination with epoprostenol in PAH patients) and BREATHE-3 (combination in children with PAH)
June 2001 - Australian subsidiary opened
September 2001 - Japanese subsidiary opened
November 2001 - US FDA approves Tracleer® for the treatment of primary PAH and PAH related to scleroderma (WHO class III and IV)
- Start of the clinical trial RAPIDS-1 investigating Tracleer® in digital ulceration secondary to scleroderma
December 2001 - Tracleer® launch in the US and in Canada
- Actelion grants commercial license to Neopharm to sell Tracleer® in Israel
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| 2002 |
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January 2002 - ENABLE study, assessing Tracleer® inchronic heart failure, completed without meeting primary endpoints
February 2002 - European Union’s Committee for Proprietary Medicinal Products (CPMP) recommends the approval of Tracleer® for the treatment of primary PAH and PAH secondary to scleroderma (WHO class III)
May 2002 - 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
June 2002 - Actelion starts to market Tracleer® tablets in Germany and the UK
- BREATHE-3 study completed without meeting primary endpoints
- Actelion holds its first “R&D Day” presenting its approach to drug discovery and its emerging drug pipeline
August 2002 - Positive results in the first study of Tracleer® in scleroderma-related digital ulcerations (RAPIDS-1)
September 2002 - Actelion listed in SWX Main Market (SWX: ATLN)
- Dose-optimization study with Veletri™ successfully completed
October 2002 - BREATHE-2 study successfully completed
- Australia’s regulatory authority TGA recommends Tracleer® for the treatment of PAH in both adults and children
November 2002 - Full enrollment of bridging study necessary to file for marketing approval of Tracleer® in PAH in Japan
- European Commission approval for Zavesca® (miglustat) in type 1 Gaucher’s disease. Worldwide license agreement signed by Actelion and Oxford GlycoSciences Plc (OGS)
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| 2003 |
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January 2003 - Tracleer® launch in Finland
- Start of clinical trials phase I with the first urotensin II receptor antagonist (palosuran) in man
- Initiation of Tracleer® study phase II in metastatic melanoma
- Tracleer® launch in Spain
February 2003 - Tracleer® launch in The Netherlands
March 2003 - Actelion starts launch of Zavesca® in the European Union
April 2003 - Actelion files New Drug Application for Tracleer® in Japan
- American Thoracic Society publishes abstract on positive long-term data with Tracleer® in patients with PPH
May 2003 - Tracleer® launch in Denmark
June 2003 - Zavesca® approved in Israel
- Collaboration with Discovery Partners International starts
- Actelion and Axovan AG enter research collaboration
August 2003 - Zavesca® approved by the US FDA
- Start of trials phase II/III with Tracleer® in interstitial lung disease (BUILD-1 & -2)
September 2003 - Results of Tracleer® in HIV patients with PAH presented at the ESC
- Actelion acquires Axovan AG
October 2003 - Actelion strengthens its finances by issuing a convertible bond
- Actelion presents research and development results in London and New York
- Start of clinical trial phase III with Tracleer® in digital ulcers (RAPIDS-2)
November 2003 - The construction of the Actelion Research Center is initiated in Allschwil
- Start of clinical trials phase II with palosuran in chronic renal failure
December 2003 - Actelion and Merck join forces in renin inhibitor project
- Tracleer® achieves reimbursement status in Australia
- Limited commercial launch of Tracleer® in Taiwan
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| 2004 |
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2004 - Zavesca® available for prescription in the US
- Actelion sells its stake in Hesperion to Cerep SA
- Actelion wins “Innovation Prize 2004”
- Actelion wins “James D. Watson Helix Award”
- Start of Tracleer® commercialization in Australia
Further highlights expected in 2004 - Tracleer® approval and launch in Japan
- Futility analysis of Veletri™ in acute heart failure (VERITAS-1 & -2)
- Results of Veletri™ trial phase II in hepatorenal syndrome
- Results of Tracleer® trial phase II in metastatic melanoma
- Start of clinical trial phase III with Tracleer® in PAH patients class II (EARLY)
- Renin inhibitor alliance with Merck advances
- Start of phase II/III program with clazosentan in subarachnoid hemorrhage
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