- Shire's experimental drug for adult attention-deficit/hyperactivity disorder (ADHD) proved superior to a placebo in treating the condition, according to topline study results released Wednesday.
- The drug, called SHP465, met both its primary and secondary goals, setting up Shire to resubmit an application for approval with the Food and Drug Administration by the end of this year.
- Shire has a strong presence in the ADHD market with the drugs Vyvanse and Intuniv already approved to treat the disorder. Winning approval form the FDA for SHP465 would further cement patent protection for Shire's ADHD franchise.
ADHD was once thought to be a disorder mainly affecting children and adolescents. But as many as 10.5 million adults are estimated to have ADHD in the U.S., according to Shire.
Shire already has an edge in the ADHD marketplace with Vyvanse, its top-selling ADHD drug, grossing over $1.5 billion per year. Johnson & Johnson's Concerta and Novartis' Ritalin also have a strong market presence.
But the good news on SHP465 was tempered by the failure of an experimental drug for a rare eye condition in extremely premature infants, which Shire announced Thursday morning.
The drug, known as SHP607, failed to reduce the severity of retinopathy of prematurity, the primary endpoint for the Phase 2 study. SHP607 did, however, help with severe complications also related to premature birth.
Shire plans to discuss a potential path forward for a Phase 3 study focusing on complications of prematurity with the regulatory authorities.
The setback for SHP607 failed to dent the stock gains seen Wednesday. Shares of Shire were up slightly in early trading Thursday, after rising by 2% the day before.
Shire's CEO Flemming Ornskov has repeatedly reiterated his company's goal to generate $10 billion in annual sales by 2020. The company bought Baxalta for $32 million in January and is continuing work on integration of the acquisition.