Imiglucerase GZ437843 — Competitive Intelligence Brief

Imiglucerase GZ437843 (Imiglucerase GZ437843) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Enzyme replacement therapy. Area: Rare genetic disease / Lysosomal storage disorder.

phase 3 Enzyme replacement therapy Glucocerebrosidase (β-glucosidase) Rare genetic disease / Lysosomal storage disorder Small molecule

Target snapshot

Imiglucerase GZ437843 (Imiglucerase GZ437843) — Sanofi. Imiglucerase is a recombinant glucocerebrosidase enzyme that breaks down glucocerebroside, a lipid that accumulates in Gaucher disease.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Imiglucerase GZ437843 TARGET	Imiglucerase GZ437843	Sanofi	phase 3	Enzyme replacement therapy	Glucocerebrosidase (β-glucosidase)
alpha-1-Proteinase Inhibitor	alpha-1-Proteinase Inhibitor	Institute for Human Genetics and Biochemistry	marketed	Protease inhibitor / Enzyme replacement therapy	Neutrophil elastase
Panzytrat 25.000 FIP-E units of Lipase	Panzytrat 25.000 FIP-E units of Lipase	Foundation for Liver Research	marketed	Pancreatic enzyme replacement therapy	Triglycerides and dietary lipids
Elelyso	Taliglucerase Alfa	Pfizer Inc.	marketed	Enzyme replacement therapy	Glucocerebroside (substrate); mannose receptors on cell surface
Cerezyme® / Imiglucerase	Cerezyme® / Imiglucerase	Sanofi	marketed	Enzyme replacement therapy	Glucocerebrosidase (β-glucosidase)
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)
Naglazyme®	Naglazyme®	Masonic Cancer Center, University of Minnesota	marketed	Enzyme replacement therapy	Arylsulfatase B (ARSB)

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