We focus our development resources on projects within our core therapeutic areas of Neuroscience, Rare Diseases, Gastrointestinal and Regenerative Medicine, as well as early development projects in additional therapeutic areas.
Total R&D expenditures of $965.5 million, $770.7 million and $661.5 million were incurred in the years ended December 31, 2012, 2011 and 2010 respectively.
|Disease Area||Project/Compound||Development Status||Territorial rights|
|ADHD in children and adolescents||INTUNIV||Phase 3 in EU (entered Phase 3 in Q2 2010)||Global|
|Adjunctive therapy in Major Depressive Disorder (MDD)||LDX (lisdexamfetamine dimesylate)||Phase 3 in US (entered Phase 3 in Q4 2011)||Global|
|Binge Eating Disorder (BED) in adults||LDX (lisdexamfetamine dimesylate)||Phase 3 in US (entered Phase 3 in Q4 2012)||Global|
|ADHD in children and adolescents||LDX (lisdexamfetamine dimesylate)||Phase 2-ready in Japan||Global(1)|
|ADHD in children and adolescents||INTUNIV||Phase 3-ready in Japan||Global(1)|
|ACE inhibitor-induced Angioedema||FIRAZYR||Registration in Europe|
Phase 3 ready in US
|Hunter Syndrome with CNS symptoms||SHP609 (HGT2310)||Phase 1/ 2 completed and preparation is underway for a Phase 3 trial||Global(2)|
|Sanfilippo A Syndrome (MPS IIIA)||SHP610 (HGT1410)||Phase 1/ 2 completed and preparation is underway for a Phase 2b trial||Global|
|Metachromatic Leukodystrophy (“MLD”)||SHP611 (HGT1110)||Phase 1/ 2||Global|
|Chronic Constipation (Males)||RESOLOR (prucalopride)||Phase 3 in EU (entered Phase 3 in Q4 2010)||Europe|
|Chronic Constipation||SHP555 (prucalopride)||Phase 3-ready in US||US|
|Refractory gastroesophageal reflux disease (“rGERD”)||SHP557||Phase 2||Europe and North America|
|Acute Vascular Repair||SHP613||Phase 2||Global|
|Other therapeutic area|
|Essential thrombocythaemia||XAGRID||Phase 3 in Japan (entered Phase 3 in Q4 2010)||Global|
|Dry eye disease||SHP606 (lifitegrast)||Phase 3||Global|
|Chronic Iron-overload||SHP602 (FBS 0701)||Phase 2||Global|
|Prevention of retinopathy of prematurity (ROP)||SHP607||Phase 2||Global|
(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.