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Shire Global

Pipeline

Our Pipeline - as of April 2018

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REGISTRATION

SHP489: ADHD [Japan]

Category: Neuroscience

Type of Molecule: Small Molecule

REGISTRATION

SHP555: Chronic Idiopathic Constipation [US]

Category: GI / Internal Medicine

Type of Molecule: Small Molecule

* Program has completed phase 3/ pivotal trials and is awaiting further regulatory action

REGISTRATION

SHP606: Dry Eye [EU]

Category: Ophthalmics

Type of Molecule: Small Molecule

For more information

Phase II

SHP607: Chronic Lung Disease

Category: GI / Internal Medicine

Type of Molecule: Protein

Rare indication

* SHP607 originally studied 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

SHP 615: Convulsive Seizures [US]

Category: Neuroscience

Type of Molecule: Small Molecule

Phase III

SHP615: Convulsive Seizures [Japan]

Category: Neuroscience

Type of Molecule: Small Molecule

Phase III

SHP616: Antibody Mediated Rejection

Category: Immunology

Type of Molecule: Protein

Rare indication

Phase III

SHP616: HAE Prophylaxis [Japan]

Category: Immunology

Type of Molecule: Protein

Rare indication

Phase III

SHP616: Subcutaneous for HAE Prophylaxis

Category: Immunology

Type of Molecule: Protein

Rare indication

Phase III

SHP620: CMV infection in transplant patients

Category: Immunology

Type of Molecule: Small Molecule

Rare indication

* Granted breakthrough designation by FDA​

Phase III

SHP621: Eosinophilic Esophagitis (EoE)*

Category: GI / Internal Medicine

Type of Molecule: Small Molecule

Rare indication

* Granted breakthrough designation by FDA

Learn more at ShireTrials.com

Phase II

SHP625: Alagille Syndrome

Category: GI / Internal Medicine

Type of Molecule: Small Molecule

Rare indication

Learn more at ShireTrials.com

Phase II

SHP625: Progressive Familial Intrahepatic Cholestasis*

Category: GI / Internal Medicine

Type of Molecule: Small Molecule

Rare indication

* Granted breakthrough designation by FDA

Phase II

SHP626: Non-Alcoholic Steatohepatitis (NASH)

Category: GI / 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: GI / Internal Medicine

Type of Molecule: Peptide

Rare indication

Phase III

SHP633: Pediatric Short Bowel Syndrome

Category: GI / Internal Medicine

Type of Molecule: Peptide

Rare indication

Phase I

SHP634: Hypoparathyroidism [Japan]

Category: GI / Internal Medicine

Type of Molecule: Therapeutic Protein

Rare Indication

Phase I

SHP639: Glaucoma

Category: Ophthalmics

Type of Molecule: Peptide

Phase III

SHP640: Infectious Conjunctivitis

Category: Ophthalmics

Type of Molecule: Small Molecule

REGISTRATION

SHP643: HAE Prophylaxis*

Category: Immunology

Type of Molecule: Antibodies (and derivatives)

Rare indication

* Granted breakthrough designation by FDA

Phase II

SHP647: Crohn's Disease

Category: GI / Internal Medicine

Type of Molecule: Antibodies (and derivatives)

Phase III

SHP647: Ulcerative Colitis

Category: GI / Internal Medicine

Type of Molecule: Antibodies (and derivatives)

Phase II

SHP652: Systemic Lupus Erythematosus (SLE)*

Category: Immunology

Type of Molecule: Antibodies (and derivatives)

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

Rare indication

Phase I

SHP654: Hemophilia A, Gene Therapy

Category: Hematology

Type of Molecule: Protein

Rare Indication

Phase III

SHP655: Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

Category: Hematology

Type of Molecule: Protein

Rare indication

Phase II

SHP659: Dry Eye Disease

Category: Ophthalmics

Type of Molecule: Small Molecule

Rare Indication

2018 Approvals

SHP660: Hemophilia A [EU]

Category: Hematology

Type of Molecule: Protein

Rare indication

REGISTRATION

SHP663: Acute Lymphoblastic Leukemia (ALL)

Category: Oncology

Type of Molecule: Protein

Rare indication

* Program has completed phase 3/ pivotal trials and is awaiting further regulatory action

REGISTRATION

SHP667: HAE [Japan]

Category: Immunology

Type of Molecule: Peptide

Rare indication

Phase III

SHP671: Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Category: Immunology

Type of Molecule: Antibodies (and derivatives)

Rare indication

Phase III

SHP671: Pediatric Primary Immunodeficiency

Category: Immunology

Type of Molecule: Therapeutic Protein

Rare Indication

Phase III

SHP672: Congenital Hemophilia A with Inhibitors - Surgery

Category: Hematology

Type of Molecule: 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, 2nd Line

Category: Oncology

Type of Molecule: Small Molecule

Rare Indication

REGISTRATION

SHP677: von Willebrand Disease [EU]

Category: Hematology

Type of Molecule: Protein

Rare indication

Phase I

SHP680: Neurologic Conditions

Category: Neuroscience

Type of Molecule: Small Molecule

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