ACE BioSciences enzyme gets EU Orphan Drug Designation Approval

The European Commission (EU) has on January 15, 2015 granted ACE BioSciences A/S (a subsidiary of Zymenex Holding A/S) Orphan Drug Designation for its recombinant human enzyme rhAGA for the treatment of the rare, lysosomal disease Aspartylglucosaminuria. Orphan designation qualifies the sponsor of the product for fee reductions, protocol assistance, centralized application procedure and access to 10 years marketing exclusivity once authorized, according to the Orphan Drug Regulation. Zymenex has previously received Orphan Drug Designation in both the EU and US for other lysosomal enzyme products Metazym for the treatment of Metachromatic Leukodystrophy and Lamazym for the treatment of alpha-Mannosodisis and Galaczym for the treatment of Krabbe Disease.

Zymenex A/S Roskildevej 12 C
3400 Hillerød, DK
Tel  +45 48250054
Fax  +45 48251054
Affiliate Sweden Agavägen 58
181 55 Lidingö, S
Tel  +46 8 7670203
Fax  +46 8 7670233

© 2004 Zymenex A/S