Orphan Drug Designation
There are a number of commercial advantages associated with the fact that Cytovac’s ALECSAT therapy project targeted at brain cancer has achieved Orphan Drug Designation.
The potential for obtaining faster marketing approval of ALECSAT that will result in longer time on the market.
Moreover, orphan drug designation also gives market exclusivity; 10-years in the EU market – and 7 years in USA. Furthermore, certain countries operate with reduced tax and reduced charges from regulatory authorities.
