EU orphan exclusivity statue is different from US orphan exclusivity. EU has maintenance clause where granted orphan exclusivity not only compared to treatment availability/benefit at the time of orphan exclusivity grant, but also to treatment availability/benefit to current situation. Currently, both old treatment availability of Cerezyme and new treatment option of Elelyso have changed from the time of grant.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.