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Shire Global

Pipeline

Our Pipeline - as of Q2 2016

Click on each of the items below for more information
and to sort columns on the right by Phase.

Phase I

Phase II

Phase III

REGISTRATION

Adynovate: Hemophilia A*

Registration

Therapeutic Area: Hematology

Type of Molecule: Protein

* 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

Alpha-1-Antitrypsin: Acute GvHD*

Phase II

Therapeutic Area: Immunology

Type of Molecule: Protein

* Phase 3 ready program

BAX2200*

Phase III - Confirmatory

Therapeutic Area: Immunology

Type of Molecule: Protein

* Coherus Enbrel Biosimilar


BAX2923*

Phase III - Confirmatory

Therapeutic Area: Immunology

Type of Molecule: Antibodies (and derivatives)

* Momenta Humira Biosimilar


BAX826:Hemophilia A

Phase I

Therapeutic Area: Hematology

Type of Molecule: Protein

BAX930: Thrombotic Thrombocytopenic Purpura*

Phase I

Therapeutic Area: Hematology

Type of Molecule: Protein

* Phase 1/2

Calaspargase Pegol: Acute Lymphoblastic Leukemia

Phase III

Therapeutic Area: Oncology

Type of Molecule: Protein

Cinryze: AMR

Phase III

Therapeutic Area: Genetic Diseases

Type of Molecule: Protein

Cinryze: (Japan) HAE Prophylaxis

Phase III

Therapeutic Area: Genetic Diseases

Type of Molecule: Protein

Cinryze SC: HAE Prophylaxis

Phase III

Therapeutic Area: Genetic Diseases

Type of Molecule: Protein

Cuvitru: PID

Registration

Therapeutic Area: Immunology

Type of Molecule: Antibodies (and derivatives)

Firazyr: (Japan) Acute HAE

Phase III

Therapeutic Area: Genetic Diseases

Type of Molecule: Peptide

Hyqvia + Kiovig: Chronic Inflammatory Demyelinating Polyneuropathy

Phase III

Therapeutic Area: Immunology

Type of Molecule: Antibodies (and derivatives)

Imalumab: mCRC

Phase II

Therapeutic Area: Oncology

Type of Molecule: Antibodies (and derivatives)

Intuniv: (Japan) ADHD

Registration

Therapeutic Area: Neuroscience

Type of Molecule: Small Molecule

NATPAR: (EU) Hypoparathyroidism

Registration

Therapeutic Area: GI / Metabolic

Type of Molecule: Protein

Obizur: CHAWI Surgery

Phase III

Therapeutic Area: Hematology

Type of Molecule: Protein

Onivyde: (EU) Pancreatic Cancer, Post-Gemcitabine Progression

Registration

Therapeutic Area: Oncology

Type of Molecule: Small Molecule

Onivyde: (Japan) Pancreatic Cancer, Post-Gemcitabine Progression*

Phase II

Therapeutic Area: Oncology

Type of Molecule: Small Molecule

* Registration Study


Onivyde: Pancreatic Cancer, Line 1

Phase II

Therapeutic Area: Oncology

Type of Molecule: Small Molecule


Pacritinib: (EU) Myelofibrosis*

Registration

Therapeutic Area: Oncology

Type of Molecule: Small Molecule

* Program currently on full clinical hold in the US; under Regulatory review in EU

rC1-INH: (NMO)*

Phase I

Therapeutic Area: 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.

Revestive:(Japan) Adult Short Bowel Syndrome

Phase III

Therapeutic Area: GI / Metabolic

Type of Molecule: Peptide

SHP465: ADHD*

Phase III

Therapeutic Area: Neuroscience

Type of Molecule: Small Molecule

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

SHP555: Chronic Idiopathic Constipation (CIC)

Phase III

Therapeutic Area: GI / Metabolic

Type of Molecule: Small Molecule

SHP607: Neonatal Complications*

Phase II

Therapeutic Area: Ophthalmology

Type of Molecule: Protein

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

Learn more at ShireTrials.com Click Here

SHP609: Hunter IT*

Phase III

Therapeutic Area: Genetic Diseases

Type of Molecule: Protein

* Phase 2/3

Learn more at ShireTrials.com Click Here

SHP610: Sanfilippo A

Phase II

Therapeutic Area: Genetic Diseases

Type of Molecule: Protein

Learn more at ShireTrials.com Click Here

SHP611: MLD*

Phase I

Therapeutic Area: Genetic Diseases

Type of Molecule: Protein

* Phase 1/2

Learn more at ShireTrials.com Click Here

SHP620: CMV in transplant patients*

Phase II

Therapeutic Area: Oncology

Type of Molecule: Small Molecule

* Phase 3 ready program

SHP621: Eosinophilic Esophagitis (EoE)*

Phase III

Therapeutic Area: GI / Metabolic

Type of Molecule: Small Molecule

* Granted breakthrough designation by FDA

SHP625: Alagille Syndrome

Phase II

Therapeutic Area: GI / Metabolic

Type of Molecule: Small Molecule

Learn more at ShireTrials.com Click Here

SHP625: PFIC*

Phase II

Therapeutic Area: GI / Metabolic

Type of Molecule: Small Molecule

* Granted breakthrough designation for PFIC type 2

SHP626: Non-Alcoholic Steatohepatitis (NASH)

Phase II

Therapeutic Area: GI / Metabolic

Type of Molecule: Small Molecule

Learn more at ShireTrials.com Click Here

SHP631: Hunter Syndrome

Phase I

Therapeutic Area: Genetic Diseases

Type of Molecule: Protein

SHP640: Infectious Conjunctivitis*

Phase II

Therapeutic Area: Ophthalmology

Type of Molecule: Small Molecule

* Phase 3 ready program

SHP643: HAE Prophylaxis

Phase III

Therapeutic Area: Genetic Diseases

Type of Molecule: Antibodies (and derivatives)

SHP647: Crohn's Disease*

Phase II

Therapeutic Area: GI / Metabolic

Type of Molecule: Small Molecule

* Phase 3 pending regulatory feedback

SHP647: Ulcerative Colitis*

Phase II

Therapeutic Area: GI / Metabolic

Type of Molecule: Small Molecule

* Phase 3 pending regulatory feedback

SM101: Systemic Lupus Erythematosus (SLE)

Phase II

Therapeutic Area: Protein

Type of Molecule: Antibodies (and derivatives)

Vonvendi: von Willebrand Disease*

Phase 3

Therapeutic Area: Hematology

Type of Molecule: Protein

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

Vyvanse: (Japan) ADHD*

Phase III

Therapeutic Area: Neuroscience

Type of Molecule: Small Molecule

* Phase 2/3

Xiidra: Dry Eye Disease

Registration

Therapeutic Area: Ophthalmology

Type of Molecule: Small Molecule

Learn more at ShireTrials.com Click Here

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