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Product Status
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THE ACTELION ANNUAL REPORT 2002 |
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Foundation for long-term growth
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The successful launch of Tracleer®, which began in the United States and Canada in December 2001 and expanded to Europe in 2002, has established Actelion as the world leader in endothelin science.
Tracleer® (bosentan), the first orally available dual endothelin receptor antagonist, is already being used by 5,000 patients for treatment of pulmonary arterial hypertension (PAH) – a rare disease that has an “orphan drug” designation. With sales revenues of CHF 121.8 million, Tracleer® has become one of the most successful drug launches ever from a biopharmaceutical company, a mere five years after Actelion’s founding. The rapid growth in sales also highlights the long-term potential of Tracleer® in PAH.
This remarkable achievement is based on Actelion’s simple but effective approach – great people bringing a great product to patients and physicians who desperately need it. Actelion has played a major role in increasing awareness of PAH in the medical community, assisting physicians in understanding the complexity of its diagnosis, and educating prescribers and patients on the effective and appropriate use of Tracleer®.
Actelion has made substantial progress in making Tracleer® available in all key markets worldwide. In Australia, approval for Tracleer® was obtained in late 2002 and reimbursement discussions initiated, with launch planned for 2003. In Japan the enrollment of an efficacy-bridging study was completed and preparations were made for a New Drug Application (NDA) to be filed in spring 2003.
New clinical trials initiated in the past year have broadened Actelion’s medical experience with Tracleer®. These studies are expected to become the basis for new indications for the use of Tracleer®. Actelion has also generated and reported to regulatory authorities worldwide data about the use of the drug in the marketplace. Both clinical trials and post-marketing surveillance have further strengthened the body of evidence indicating that Tracleer® – with appropriate monitoring of liver enzymes and pregnancy avoidance messaging – is an effective medicine for the treatment of PAH.
Actelion’s success as a company is also the result of its decision to keep full marketing rights for Tracleer® in key countries. While the brand name, the logo and the medical information about the product are the same worldwide, the marketing strategy is implemented locally according to local standards and customs. The success of this business model allowed Actelion to license in Zavesca® (miglustat), an “orphan drug” developed by Oxford GlycoSciences (OGS) for the treatment of lipid-storage disorders.
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