|
|
 |
| |
Tracleer® - Worldwide Marketing
|
THE ACTELION ANNUAL REPORT 2002 |
|
|
|
| |
|
|
|
|
|
|
|
United States
|
| |
- Tracleer® first introduced in this key market in December 2001
- Actelion US successfully reached out to physicians as well as patients
- Active participation in all major cardiology, pulmonology and rheumatology congresses (ACC, ISHLT, ATS, ACR, CHEST and AHA) with symposia highlighting Tracleer® in primary PAH and PAH related to scleroderma (class III and IV)
- Focused activities on PAH centers of excellence, scleroderma centers, teaching hospitals and community-based pulmonologists, cardiologists and rheumatologists
- Actelion US honored with the “Corporation of the Year Award” from the Pulmonary Hypertension Association (PHA) and the “Corporate Leadership Award” from the National Organization for Rare Disorders (NORD) for the development of Tracleer®
- Successful implementation of the unique Tracleer® Access Program (TAP), which facilitates prescribing and reimbursement for physicians and patients, and ensures appropriate safety measures are taken
|
|
|
| |
|
|
|
|
|
|
|
Europe
|
| |
- Tracleer® received marketing authorization in the European Union for all 15 EU member states. The marketing authorization was also recognized by Norway and Iceland
- Market introductions started in June with the launch of Tracleer® in the UK and Germany
- Implementation of the post-marketing surveillance project TRAX PMS to collect demographic information on Tracleer® patients
- Launch of the educational website www.TRAXglobal.com, which gives healthcare professionals easy access to important information about definition, diagnosis and treatment of PAH
- By end of 2002, Actelion operations were marketing and supporting Tracleer® in Austria, France, Germany, Greece, Ireland, Italy, Spain, Sweden, Switzerland and the UK
- In early 2003, Tracleer® to be marketed in Belgium, Denmark, Iceland, Luxembourg, The Netherlands, Norway and Portugal
|
|
|
| |
|
|
|
|
|
|
|
Canada
|
| |
- Following regulatory approval in December 2001, Tracleer® was successfully launched across Canada. By the end of 2002, all Canadian provinces had granted reimbursement for Tracleer® – a remarkable achievement by industry standards
|
|
|
| |
|
|
|
|
|
|
|
Australia
|
| |
- In October 2002, Australia’s Drug Evaluation Committee (ADEC) recommended Tracleer® for the treatment of PAH in adults and children
- Very strong link established with the physician and patient community through a well-received compassionate-use program
- By end of 2002, there were already over 100 Australian patients enrolled, including many children
- Reimbursement discussions continue and launch is planned for 2003
|
|
|
| |
|
|
|
|
|
|
|
Japan
|
| |
- Affiliate established
- Tracleer® efficacy-bridging study with over 20 patients enrolled
- Tracleer® successfully passed the evaluation for designation as an “orphan drug” at the First Committee on Drugs of Pharmaceutical Affairs Council
- NDA for Tracleer® to be filed in spring 2003
|
|
|
| |
|
|
|
|
|
|
|
Others
|
| |
- In Israel, where Tracleer® is licensed to Neopharm, the product was registered in mid-2002 and launch is planned for early 2003 after successful conclusion of reimbursement discussions
- Actelion Brazil established
- Other regions such as Eastern Europe, Southeast Asia and Latin America are under evaluation
|
|
|
|
