Naglazyme® — Competitive Intelligence Brief

Naglazyme® (Naglazyme®) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Enzyme replacement therapy. Area: Rare genetic disease / Lysosomal storage disorder.

marketed Enzyme replacement therapy Arylsulfatase B (ARSB) Rare genetic disease / Lysosomal storage disorder Small molecule

Target snapshot

Naglazyme® (Naglazyme®) — Masonic Cancer Center, University of Minnesota. Naglazyme is a recombinant human arylsulfatase B enzyme that breaks down glycosaminoglycans accumulated in mucopolysaccharidosis VI (MPS VI).

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Naglazyme® TARGET	Naglazyme®	Masonic Cancer Center, University of Minnesota	marketed	Enzyme replacement therapy	Arylsulfatase B (ARSB)
Fabrazyme (agalsidase beta)	Fabrazyme (agalsidase beta)	Genzyme, a Sanofi Company	marketed	Enzyme replacement therapy (ERT); recombinant enzyme	α-galactosidase A (GLA gene product); substrate: globotriaosylceramide (GL-3)
ALGLUCOSIDASE ALFA (MYOZYME)	ALGLUCOSIDASE ALFA (MYOZYME)	Genzyme, a Sanofi Company	marketed	Enzyme replacement therapy	Acid alpha-glucosidase (GAA)
Myozyme® (alglucosidase alfa)	Myozyme® (alglucosidase alfa)	Genzyme, a Sanofi Company	marketed	Enzyme replacement therapy	Acid alpha-glucosidase (GAA); lysosomal glycogen
Pancreatic Enzyme	Pancreatic Enzyme	University of Oxford	marketed	Pancreatic enzyme replacement therapy (PERT)
Cerezyme® / Imiglucerase	Cerezyme® / Imiglucerase	Sanofi	marketed	Enzyme replacement therapy	Glucocerebrosidase (β-glucosidase)
creon 35.000 Ph.U (R)	creon 35.000 Ph.U (R)	Hospital Clinico Universitario de Santiago	marketed	Pancreatic enzyme replacement therapy

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Enzyme replacement therapy class)

1. BioMarin Pharmaceutical · 5 drugs in this class
2. Sanofi · 3 drugs in this class
3. JCR Pharmaceuticals Co., Ltd. · 2 drugs in this class
4. Genzyme, a Sanofi Company · 2 drugs in this class
5. Pfizer Inc. · 1 drug in this class
6. Shire · 1 drug in this class
7. Alexion Pharmaceuticals, Inc. · 1 drug in this class
8. University of Missouri-Columbia · 1 drug in this class
9. Eurofarma Laboratorios S.A. · 1 drug in this class
10. ISU Abxis Co., Ltd. · 1 drug in this class