Regulation and market opportunity in Europe explained.
(PRWEB) January 5, 2004 -- Urch Publishing launches a wide-ranging report on the orphan drug sector in Europe which provides a comprehensive overview of this growing pharmaceutical market. "Orphan Drugs to 2008 - Understanding regulation & market opportunity in Europe"(www.urchpublishing.com/publications/discovery/orphan_drug.html)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. In the four years since orphan drug legislation has been in place, 204 projects have been granted orphan status by the European Medicines Evaluation, says Steve Seget the reports aurthor, and of these 15 had received a successful marketing authorised by June 2004," he added.
The report contains detailed analysis of major orphan drugs Aldurazyme, Busilvex, Carbaglu, Fabrazyme, Glivec, Litak, PhotoBarr, Onsenal, Replagal, Somavert, Tracleer, Trisenox, Ventavis and Zavesca.
The 155 page 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 research methodology applied throughout Orphan Drugs to 2008 - Understanding regulation & market opportunity in Europe has been to reference detailed secondary research sources, primarily cross-tabulating data taken directly from the Committee for Orphan Medicinal Products, the relevant body representing the European Medicines Evaluation Agency on matters relating to orphan drug designation. Some wider insight and experience has been used to compliment the key secondary research sources and, where necessary, primary sources within relevant regulatory bodies and industrial organisations have been referenced.
Urch Publishing Ltd is an independent business information publisher dedicated to delivering quality information products to the global pharmaceuticals industry. For more information contact Urch Publishing on +44 (0) 20 7060 7474 or e-mail press@urchpublishing.com.
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