(ASX:ANP) says it has received notification that the European Commission has designated ATL1102 as an orphan medicinal product for Duchenne muscular dystrophy (DMD).
The company said orphan designation was granted by the European Commission based on a positive opinion issued by the European Medicines Agency (EMA) Committee for Orphan Medicinal Products in November 2020.
This latest news follows the recent granting of both Orphan Drug Designation and Rare Pediatric Disease Designation for ATL1102 in DMD by the US FDA.
Orphan status in the EU brings development and marketing incentives, such as reduced fees on scientific advice and marketing authorisation application, and market exclusivity in Europe for ten years upon regulatory approval with an additional two years of exclusivity for its pediatric use in DMD.
Managing Director and CEO Mark Diamond, ANP said, “We are very pleased the EC has adopted the decision to designate ATL1102 for DMD as an Orphan Drug in the EU. We have now successfully achieved orphan drug designation in Europe and orphan drug and rare pediatric disease designations in the US, the world’s major pharmaceutical markets.
“We expect that the incentives that come from such designations including marketing exclusivity periods will be of very significant commercial value should ATL1102 be successful in its progress through development and ultimately achieve marketing approval.”