Actelion - A global biopharmaceutical leader
Actelion Ltd is a public company and listed on the Swiss stock exchange (SIX)
17 December 1997
Jean-Paul Clozel, Walter Fischli, Thomas Widmann, Martine Clozel, Andre Mueller
Actelion Ltd & Actelion Pharmaceuticals Ltd
Actelion has subsidiaries with marketing and sales in more than 30 countries, covering all key pharmaceutical markets worldwide.
Tracleer® (bosentan) is an oral dual endothelin receptor antagonist, which is currently licensed for the treatment of pulmonary arterial hypertension (WHO Group I), a chronic, life-threatening disorder which severely compromises the function of the lungs and heart.
In the United States, Tracleer® is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital systemic-to-pulmonary shunts (18%). Considerations for use: Patients with WHO class II symptoms showed reduction in the rate of clinical deterioration and a trend for improvement in walk distance. Physicians should consider whether these benefits are sufficient to offset the risk of liver injury in WHO class II patients, which may preclude future use as their disease progresses.
In Europe it is approved for treatment of PAH functional class III to improve exercise capacity and symptoms, as well as PAH functional class II, where some improvements have also been shown. In the EU Tracleer® is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
Regulatory review and approval for the inclusion of functional class II in the Tracleer® label is ongoing in additional markets.
Veletri® (Epoprostenol for Injection), an improved formulation of epoprostenol that is stable at room temperature, is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases.
Ventavis® (iloprost), an inhaled formulation of iloprost, is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration. Studies establishing effectiveness included predominately patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (65%) or PAH associated with connective tissue diseases (23%).
Zavesca® (miglustat) is the first and only oral medication approved for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease, and it may only be used in those patients for whom enzyme replacement therapy is unsuitable.
Zavesca® is also approved in the European Union for the treatment of progressive neurological manifestations in adult patients and pediatric patients with Niemann-Pick type C disease (NP-C). Zavesca® is the first treatment to be approved for patients with Niemann-Pick type C disease, a very rare, invariably progressive and eventually fatal neurodegenerative genetic disorder affecting both children and adults.