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Shire Global

Pipeline

Our Pipeline - as of May 2017

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REGISTRATION

ADYNOVATE: Hemophilia A* [EU]

Category: Hematology

Type of Molecule: Protein

Rare indication

* Approved in the US for on-demand prophylaxis in adults and children and in perioperative management. EU is in registration for on-demand in adults.

Phase III

Alpha-1-ANTITRYPSIN: Acute GvHD

Category: Immunology

Type of Molecule: Protein

Rare indication

Phase III

CALASPARGASE PEGOL: Acute Lymphoblastic Leukemia (ALL)

Category: Oncology

Type of Molecule: Protein

Rare indication

Phase III

CINRYZE: HAE Prophylaxis [Japan]

Category: Genetic Diseases

Type of Molecule: Protein

Rare indication

Phase III

CINRYZE SC: HAE Prophylaxis

Category: Genetic Diseases

Type of Molecule: Protein

Rare indication

Recent Approval

CUVITRU: PID [US; EU]

Category: Immunology

Rare indication

Phase III

FIRAZYR: Acute HAE* [Japan]

Category: Genetic Diseases

Type of Molecule: Peptide

Rare indication

* Phase 2/3

Phase III

GATTEX: Adult Short Bowel Syndrome [Japan]

Category: GI / Metabolic

Type of Molecule: Peptide

Rare indication

Phase III

10% HYQVIA + KIOVIG: Chronic Inflammatory Demyelinating Polyneuropathy

Category: Immunology

Type of Molecule: Antibodies (and derivatives)

Rare indication

Recent Approval

INTUNIV: ADHD [Japan]

Category: Neuroscience

Type of Molecule: Small Molecule

Recent Approval

NATPAR: Hypoparathyroidism [EU]

Category: GI / Metabolic

Type of Molecule: Protein

Rare indication

Phase III

OBIZUR: CHAWI on demand

Category: Hematology

Type of Molecule: Protein

Rare indication

Phase III

OBIZUR: CHAWI Surgery

Category: Hematology

Type of Molecule: Protein

Rare indication

Phase II

ONIVYDE: Pancreatic Cancer, Post-Gemcitabine [Japan]*

Category: Oncology

Type of Molecule: Small Molecule

Rare indication

* Registration Study

Phase II

ONIVYDE: Pancreatic Cancer, 1st Line

Category: Oncology

Type of Molecule: Small Molecule

Rare indication


Recent Approval

ONIVYDE: Pancreatic Cancer, Line 2 [EU]

Category: Oncology

Rare indication

REGISTRATION

SHP465: ADHD

Category: Neuroscience

Type of Molecule: Small Molecule

Phase III

SHP555: Chronic Constipation (US)

Category: GI / Metabolic

Type of Molecule: Small Molecule

Phase II

SHP607: Complications of Prematurity

Category: Neuroscience

Type of Molecule: Protein

Rare indication

* SHP607 originally for RoP

Phase III

SHP609: Hunter IT*

Category: Genetic Diseases

Type of Molecule: Protein

Rare indication

* Phase 2/3

Learn more at ShireTrials.com

Phase I

SHP611: Metachromatic Leukodystrophy (MLD)

Category: Genetic Diseases

Type of Molecule: Protein

Rare indication

Learn more at ShireTrials.com

Phase III

SHP616: AMR

Category: Genetic Diseases

Type of Molecule: Protein

Rare indication

Phase III

SHP620: CMV in transplant patients

Category: Oncology

Type of Molecule: Small Molecule

Rare indication

Phase III

SHP621: Eosinophilic Esophagitis (EoE)*

Category: GI / Metabolic

Type of Molecule: Small Molecule

Rare indication

* Granted breakthrough designation by FDA

Phase I

SHP623: rC1-INH (NMO)*

Category: Immunology

Type of Molecule: Protein Replacement

Rare indication

* rC1-INH previously being developed as SHP623 for HAE prophylaxis. After Phase 1 completion will be developed for NMO.

Phase II

SHP625: Alagille Syndrome

Category: GI / Metabolic

Type of Molecule: Small Molecule

Rare indication

Learn more at ShireTrials.com

Phase II

SHP625: PFIC*

Category: GI / Metabolic

Type of Molecule: Small Molecule

Rare indication

* Granted breakthrough designation by FDA

Phase II

SHP626: Non-Alcoholic Steatohepatitis (NASH)

Category: GI / Metabolic

Type of Molecule: Small Molecule

Learn more at ShireTrials.com

Phase I

SHP631: Hunter CNS

Category: Genetic Diseases

Type of Molecule: Protein

Rare indication

Phase III

SHP640: Infectious Conjunctivitis*

Category: Ophthalmology

Type of Molecule: Small Molecule

* Phase 3 expected to start in 2017

Phase III

SHP643: HAE Prophylaxis*

Category: Genetic Diseases

Type of Molecule: Antibodies (and derivatives)

Rare indication

* Granted breakthrough designation by FDA

Phase II

SHP647: Crohn's Disease

Category: GI / Metabolic

Type of Molecule: Antibodies (and derivatives)

Phase II

SHP647: Ulcerative Colitis

Category: GI / Metabolic

Type of Molecule: Antibodies (and derivatives)

Phase II

SHP652: Systemic Lupus Erythematosus (SLE)

Category: Immunology

Type of Molecule: Antibodies (and derivatives)

f.k.a. SM101

Phase I

SHP655: Thrombotic Thrombocytopenic Purpura

Category: Hematology

Type of Molecule: Protein

f.k.a. BAX930

Rare indication

Phase I

SHP656: Hemophilia A

Category: Hematology

Type of Molecule: Protein

Rare indication

f.k.a. BAX826

Phase III

VONVENDI: von Willebrand Disease

Category: Hematology

Type of Molecule: Protein

Rare indication

Phase III

VYVANSE: ADHD [Japan]*

Category: Neuroscience

Type of Molecule: Small Molecule

* Phase 2/3

Recent Approval

XIIDRA: Dry Eye [EU]

Category: Ophthalmology

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