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Shire Global

Pipeline

Our Pipeline - as of Q3 2016

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REGISTRATION

Adynovate: Hemophilia A*

Select a Category: Hematology

Type of Molecule: Protein

f.k.a. BAX0855

* Adynovate is approved in the US for 2x prophylaxis and on-demand treatment in patients with Hemophilia A, in registration in the US for surgery and pediatrics, and in registration in the EU for all three indications

Phase III

Alpha-1-Antitrypsin: Acute GvHD

Select a Category: Immunology

Type of Molecule: Protein

f.k.a. BAX1337

Phase III

Calaspargase Pegol: Acute Lymphoblastic Leukemia

Select a Category: Oncology

Type of Molecule: Protein

f.k.a. BAX2303

Phase III

Cinryze: HAE Prophylaxis [Japan]

Select a Category: Genetic Diseases

Type of Molecule: Protein

Phase III

Cinryze SC: HAE Prophylaxis

Select a Category: Genetic Diseases

Type of Molecule: Protein

Phase III

Firazyr: (Japan) Acute HAE*

Select a Category: Genetic Diseases

Type of Molecule: Peptide

* Phase 2/3

Phase III

Hyqvia + Kiovig: Chronic Inflammatory Demyelinating Polyneuropathy

Select a Category: Immunology

Type of Molecule: Antibodies (and derivatives)

f.k.a. BAX1515

REGISTRATION

Intuniv: ADHD [Japan]

Select a Category: Neuroscience

Type of Molecule: Small Molecule

Phase II

SHP653: mCRC (Imalumab)

Select a Category: Oncology

Type of Molecule: Antibodies (and derivatives)

f.k.a. BAX2070

REGISTRATION

NATPAR: Hypoparathyroidism [EU]

Select a Category: GI / Metabolic

Type of Molecule: Protein

Phase III

Obizur: CHAWI Surgery

Select a Category: Hematology

Type of Molecule: Protein

f.k.a. BAX0802

Phase II

Onivyde: Pancreatic Cancer, Post-Gemcitabine Progression [Japan]*

Select a Category: Oncology

Type of Molecule: Small Molecule

f.k.a. BAX2398

* Registration Study

Phase II

Onivyde: Pancreatic Cancer, 1st Line

Select a Category: Oncology

Type of Molecule: Small Molecule

f.k.a. BAX2399


Phase III

Revestive: Adult Short Bowel Syndrome [Japan]

Select a Category: GI / Metabolic

Type of Molecule: Peptide

Phase III

SHP465: ADHD*

Select a Category: Neuroscience

Type of Molecule: Small Molecule

* SHP465 received positive Phase 3 data in April (children/adolescents study), June (adults study) 2016

Phase III

SHP555: Chronic Idiopathic Constipation (CIC)

Select a Category: GI / Metabolic

Type of Molecule: Small Molecule

Phase II

SHP607: Neonatal Complications*

Select a Category: Neuroscience

Type of Molecule: Protein

* SHP607 (Neonatal Complications) completed Phase 2 in June 2016

Learn more at ShireTrials.com

Phase III

SHP609: Hunter IT*

Select a Category: Genetic Diseases

Type of Molecule: Protein

* Phase 2/3

Learn more at ShireTrials.com

Phase I

SHP611: Metachromatic Leukodystrophy (MLD)*

Select a Category: Genetic Diseases

Type of Molecule: Protein

* Phase 1/2

Learn more at ShireTrials.com

Phase III

SHP616: AMR (Cinryze)

Select a Category: Genetic Diseases

Type of Molecule: Protein

Phase II

SHP620: CMV in transplant patients*

Select a Category: Oncology

Type of Molecule: Small Molecule

* Phase 3 ready program

Phase III

SHP621: Eosinophilic Esophagitis (EoE)*

Select a Category: GI / Metabolic

Type of Molecule: Small Molecule

* Granted breakthrough designation by FDA

Phase I

SHP623: rC1-INH (NMO)*

Select a Category: Immunology

Type of Molecule: Protein Replacement

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

Phase II

SHP625: Alagille Syndrome

Select a Category: GI / Metabolic

Type of Molecule: Small Molecule

Learn more at ShireTrials.com

Phase II

SHP625: PFIC*

Select a Category: GI / Metabolic

Type of Molecule: Small Molecule

* Granted breakthrough designation for PFIC type 2

Phase II

SHP626: Non-Alcoholic Steatohepatitis (NASH)

Select a Category: GI / Metabolic

Type of Molecule: Small Molecule

Learn more at ShireTrials.com

Phase I

SHP631: Hunter Syndrome

Select a Category: Genetic Diseases

Type of Molecule: Protein

Phase II

SHP640: Infectious Conjunctivitis*

Select a Category: Ophthalmology

Type of Molecule: Small Molecule

* Phase 3 ready program

Phase III

SHP643: HAE Prophylaxis

Select a Category: Genetic Diseases

Type of Molecule: Antibodies (and derivatives)

Phase II

SHP647: Crohn's Disease*

Select a Category: GI / Metabolic

Type of Molecule: Small Molecule

* Phase 3 pending regulatory feedback

Phase II

SHP647: Ulcerative Colitis*

Select a Category: GI / Metabolic

Type of Molecule: Small Molecule

* Phase 3 pending regulatory feedback

Phase II

SHP652: Systemic Lupus Erythematosus (SLE)

Select a Category: Immunology

Type of Molecule: Antibodies (and derivatives)

f.k.a. BAX1811

Phase I

SHP655: Thrombotic Thrombocytopenic Purpura*

Select a Category: Hematology

Type of Molecule: Protein

f.k.a. BAX930

* Phase 1/2

Phase I

SHP656: Hemophilia A

Select a Category: Hematology

Type of Molecule: Protein

f.k.a. BAX826

Phase III

Vonvendi: von Willebrand Disease [EU]*

Select a Category: Hematology

Type of Molecule: Protein

f.k.a. BAX0111

* Surgery study ongoing and pediatric/prophylaxis studies to start later this year

Phase III

Vyvanse: ADHD [Japan]*

Select a Category: Neuroscience

Type of Molecule: Small Molecule

* Phase 2/3

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