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Shire Global

Pipeline

Our Pipeline - as of July 2017

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Recent Approval

CINRYZE: Pediatric HAE Prophylaxis [EU]

Category: Genetic Diseases

Type of Molecule: Protein

Rare indication

Recent Approval

INTUNIV: ADHD [Japan]

Category: Neuroscience

Type of Molecule: Small Molecule

Recent Approval

MYDAYIS: ADHD

Category: Neuroscience

Type of Molecule: Small Molecule

Recent Approval

NATPAR: Hypoparathyroidism [EU]

Category: Internal Medicine

Type of Molecule: Protein

Rare indication

REGISTRATION

SHP489: ADHD [Japan]*

Category: Neuroscience

Type of Molecule: Small Molecule

* Phase 2/3

Phase III

SHP555: Chronic Constipation (US)

Category: Internal Medicine

Type of Molecule: Small Molecule

Phase II

SHP607: BPD and IVH*

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 II

SHP615: Seizures [Japan]

Category: Neuroscience

Type of Molecule: Small Molecule

Phase III

SHP616: AMR

Category: Genetic Diseases

Type of Molecule: Protein

Rare indication

Phase III

SHP616: HAE Prophylaxis

Category: Genetic Diseases

Type of Molecule: Protein

Rare indication

Phase III

SHP616: HAE Prophylaxis [Japan]

Category: Genetic Diseases

Type of Molecule: Protein

Rare indication

Phase III

SHP620: CMV infection in transplant patients

Category: Oncology

Type of Molecule: Small Molecule

Rare indication

Phase III

SHP621: Eosinophilic Esophagitis (EoE)*

Category: Internal Medicine

Type of Molecule: Small Molecule

Rare indication

* Granted breakthrough designation by FDA

Learn more at ShireTrials.com

Phase I

SHP623: rC1-INH (NMO)

Category: Immunology

Type of Molecule: Protein Replacement

Rare indication

Phase II

SHP625: Alagille Syndrome

Category: Internal Medicine

Type of Molecule: Small Molecule

Rare indication

Learn more at ShireTrials.com

Phase II

SHP625: PFIC*

Category: Internal Medicine

Type of Molecule: Small Molecule

Rare indication

* Granted breakthrough designation by FDA

Phase II

SHP626: Non-Alcoholic Steatohepatitis (NASH)

Category: Internal Medicine

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

SHP633: Adult Short Bowel Syndrome [Japan]

Category: Internal Medicine

Type of Molecule: Peptide

Rare indication

Phase III

SHP633: Pediatric SBS

Category: Internal Medicine

Type of Molecule: Peptide

Rare Indication

Phase I

SHP634: Hypoparathyroidism [Japan]

Category: Internal Medicine

Type of Molecule: Therapeutic Protein

Rare Indication

Phase I

SHP639: Glaucoma

Category: Ophthalmology

Type of Molecule: Peptide

Phase III

SHP640: Infectious Conjunctivitis

Category: Ophthalmology

Type of Molecule: Small Molecule

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: Internal Medicine

Type of Molecule: Antibodies (and derivatives)

Phase II

SHP647: Ulcerative Colitis

Category: Internal Medicine

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

* On clinical hold and working closely with the FDA to resolve their questions

Phase II

SHP655: Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

Category: Hematology

Type of Molecule: Protein

f.k.a. BAX930

Rare indication

Phase II

SHP659: Dry Eye Disease

Category: Ophthalmology

Type of Molecule: Small Molecule

Rare Indication

REGISTRATION

SHP660: 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.

Phase III

SHP663: Acute Lymphoblastic Leukemia (ALL)

Category: Oncology

Type of Molecule: Protein

Rare indication

REGISTRATION

SHP667: HAE [Japan]

Category: Genetic Diseases

Type of Molecule: Peptide

Rare indication

REGISTRATION

SHP667: Pediatric HAE

Category: Genetic Diseases

Type of Molecule: Peptide

Rare Indication

Phase III

SHP671: Chronic Inflammatory Demyelinating Polyneuropathy

Category: Immunology

Type of Molecule: Antibodies (and derivatives)

Rare indication

Phase III

SHP671: Pediatric PID

Category: Immunology

Type of Molecule: Therapeutic Protein

Rare Indication

Phase II

SHP673: Pancreatic Cancer, Post-Gemcitabine [Japan]*

Category: Oncology

Type of Molecule: Small Molecule

Rare indication

* Registrational Study

Phase II

SHP673: Pancreatic Cancer, 1st Line

Category: Oncology

Type of Molecule: Small Molecule

Rare indication


Phase I

SHP673: Small Cell Lung Cancer, 1st Line

Category: Oncology

Type of Molecule: Small Molecule

Rare Indication

REGISTRATION

SHP677: von Willebrand Disease

Category: Hematology

Type of Molecule: Protein

Rare indication

Phase I

SHP680: Cognitive Impairment Disorders

Category: Neuroscience

Type of Molecule: Small Molecule

Recent Approval

XIIDRA: Dry Eye [US]

Category: Ophthalmology

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