ALLSCHWIL and BASEL, Switzerland, Dec. 15, 2003 (PRIMEZONE) -- Actelion:
-- Reimbursement status achieved in Australia -- Labeling questions received from Japanese regulator -- Limited commercial launch on a named-patient basis in Taiwan
Actelion Ltd (SWX:ATLN) has announced today that its lead product, Tracleer(r) in pulmonary arterial hypertension, has made further progress to market in Australia, Japan and Taiwan. This dual endothelin receptor antagonist is already commercialized successfully in the United States, the European Union, Canada and Switzerland as well as Israel.
In Australia, the committee in charge of reviewing the health economic justification for new medicines (PBAC) has recommended that the Australian Federal Government list and reimburse Tracleer(r) on the national Pharmaceuticals Benefits Scheme (PBS), as a cost effective therapy for adults and children older than 3 years of age suffering from either primary pulmonary hypertension (PPH) or from PAH associated with systemic scleroderma (WHO Class III/IV).
Once the decision has been made operational in practice by the Australian Federal Health Department in the coming months, Actelion will immediately make Tracleer(r) available on a commercial basis. In the meantime, Actelion will continue its compassionate use program that has already significantly benefited more than 150 Australian PAH patients.
In Japan, the regulatory authority has asked Actelion to provide additional information related to the potential labeling, product specification and testing methods as well as the related pharmacovigilance system. These questions follow the legally prescribed six-month review process that was applied for the first time in Japan for designated orphan drugs, such as Tracleer(r). Actelion has immediately started to provide the required information to the authorities in charge and looks forward to concluding the regulatory process in Japan in the coming months.
In Taiwan, Tracleer(r) was granted orphan drug status in the fall of 2003. As a consequence, Actelion's Taiwanese distribution partner, Excelsior Biopharmaceutical Ltd., has now been authorized to immediately commence the commercial launch of Tracleer(r) on a named-patient basis, pending full national regulatory approval and reimbursement decisions.
About Tracleer(r) in pulmonary arterial hypertension
Tracleer(r), the first oral dual endothelin receptor antagonist, has demonstrated its efficacy in two pivotal, placebo-controlled studies. Tracleer(r) has shown statistically significant improvements in the primary efficacy endpoint of exercise capacity with patients achieving a significantly greater, and clinically meaningful increase in walking distance compared to placebo.
Clinical trials have also demonstrated Tracleer(r)'s efficacy in significantly decreasing dyspnea (shortness of breath), one of the most debilitating symptoms for people with PAH. Additionally, treatment with Tracleer(r) is also associated with a significant delay in disease progression (the time to clinical worsening). Clinical worsening is defined as combined endpoint of death, hospitalization or discontinuation due to worsening PAH, or initiation of epoprostenol therapy.
In clinical trials, approximately 11% of PAH patients receiving Tracleer(r) experienced abnormal but reversible liver enzyme elevations. It is therefore important that patients undergo monthly liver monitoring. Due to the risk of birth defects, women who are pregnant, or woman of childbearing age, who do not use a reliable method of contraception, must not take Tracleer(r).
About Pulmonary Arterial Hypertension
Around 100,000 people in Europe and the US currently suffer from pulmonary arterial hypertension, which includes PPH or PAH related to other diseases such as scleroderma, a degenerative connective tissue disease. Early diagnosis is important for PAH patients. Unfortunately, diagnosis can often be delayed because initial symptoms are unspecific (i.e. breathlessness) and therefore go undetected or are attributed to other diseases.
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 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).
Reminder: Actelion Corporate Reporting Calendar for the year 2004
2 March 2004 FY 2003 results (Media and Analyst
Conference in Zurich)
27 April 2004 Q1 2004 results (Media Release/Webcast)
30 April 2004 Annual General Assembly of the
Shareholders (Basel)
27 July 2004 Half Year 2004 results (Media
Release/Webcast)
26 October 2004 9 months 2004 results (Media
Release/Webcast)