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Shire Product Pipeline

Disease AreaProject/CompoundDevelopment StatusTerritorial rights
Neuroscience
ADHD in children and adolescentsINTUNIVPhase 3 in EU (entered Phase 3 in Q2 2010)Global
Binge Eating Disorder (BED) in adultsLDX (lisdexamfetamine dimesylate)Phase 3 in US (entered Phase 3 in Q4 2012)Global
ADHD in children and adolescentsLDX (lisdexamfetamine dimesylate)Phase 2-ready in JapanGlobal(1)
ADHD in children and adolescentsINTUNIVPhase 3-ready in JapanGlobal(1)
 
Rare Diseases
Gaucher DiseaseVPRIVRegistration in JapanGlobal
ACE inhibitor-induced AngioedemaFIRAZYRPhase 3Global
HAE ProphylaxisCINRYZE Phase 3-ready in JapanGlobal
Hunter Syndrome with CNS symptomsSHP609 (HGT2310)Phase 2 / 3Global(2)
CMV in transplant patientsMaribavirPhase 2 
Sanfilippo A Syndrome (MPS IIIA)SHP610 (HGT1410)Phase 1 / 2 completed and preparation is underway for a Phase 2b trialGlobal
Metachromatic Leukodystrophy (“MLD”)SHP611 (HGT1110)Phase 1/ 2Global
HAE ProphylaxisCINRYZE IV (low vol) Phase 1Global
HAE ProphylaxisCINRYZE Subcutaneous formulationPhase 1 Global
Friedreich’s AtaxiaVP20629 Phase 1 
 
Gastrointestinal
Chronic Constipation (Males)RESOLOR (prucalopride)Phase 3 in EU (entered Phase 3 in Q4 2010) Europe
Chronic ConstipationSHP555 (prucalopride)Phase 3-ready in USUS
 
Other therapeutic area
Essential thrombocythaemiaXAGRIDRegistration in JapanGlobal
Dry eye diseaseSHP606 (lifitegrast)Phase 3Global
Chronic Iron-overloadSHP602 (FBS 0701)Phase 2Global
Prevention of retinopathy of prematurity (ROP)SHP607
Phase 2Global
Acute Vascular RepairSHP613Phase 2Global 

 

(1) Under co-development with Shionogi as a result of a license and collaboration agreement. 
(2) Genzyme has rights to manage marketing and distribution in Japan and certain other Asia Pacific countries under a license with Shire.