Summary
Orphan Drugs to 2008- Understanding regulation & market opportunity in Europe is designed for executives to understand the market environment for orphan drugs. The content will help all global companies to better understand the opportunities presented by recent developments in Europe orphan drug legislation. Over the last four years the legislation has provided opportunities for big and small companies, employing deliberate or add-on orphan drug development programmes. As has been shown through the success of the more mature market environment for US orphan medicines, the impact of European measures is likely to be significant and is only just beginning to materialise.
The report uses detailed regulatory, company and primary source information in order to provide a detailed guide to employing orphan drug development and marketing strategies in Europe. The report looks first at the global opportunity for orphan medicines, before outlining the European regulations and procedures in full detail. In order to assess the impact of the legislation both designated and subsequently launched orphan drugs are analysed and profiled. Detailed case studies lead to a set of key conclusions and recommendations for all pharmaceutical and biotechnology companies.
The report contains detailed analysis of major orphan drugs:
Aldurazyme, Busilvex, Carbaglu,Fabrazyme, Glivec, Litak, PhotoBarr, Onsenal, Replagal, Somavert, Tracleer, Trisenox,Ventavis and Zavesca with details of:
- Disease description
- Prevalence and incidence of disease
- Development trials
- Pivotal clinical trials
- Development and regulatory timeline
- CPMP conclusions
- CPMP decision
- Post-marketing programme
- Steps taken after granting the Marketing Authorization
- Commercial impact
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