Orphan designation provides NewLink with access to multiple incentives for drug development in EU.
Incentives include decreased development costs, right to use to the centralized authorization procedure, 10-year market exclusivity besides condensed marketing authorization application, pre-marketing inspections and multiple post-approval fees.
NewLink Genetics CEO and chairman Dr. Charles Link said, "As emphasized during National Pancreatic Cancer Awareness Month in November, there is a desperate need for new treatment options for this disease and the European Commission’s decision to grant orphan drug designation to algenpantucel-L should help us to address this unmet medical need."
The company is presently studying Algenpantucel-L in IMPRESS trial in stage I and stage II surgically-resected pancreatic cancer patients.
Algenpantucel-L earlier gained orphan drug designation and Fast-track status in the US.