Shire and Shionogi Announce Positive Topline Results for INTUNIV® Evaluated in Phase 3 Clinical Trial in Adults with ADHD

Zug, Switzerland  – September 20, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG) and its partner in Japan, Shionogi & Co., Ltd, announced that a Phase 3 study evaluating INTUNIV® (guanfacine hydrochloride prolonged release) in adult patients with attention deficit hyperactivity disorder (ADHD) in Japan has positive topline results, and the study met the primary endpoint. This is the first clinical trial evaluating INTUNIV in adult patients (18 years old and over) with ADHD.

“The positive topline results of this Phase 3 study provide us with important data and insights regarding the clinical profile of INTUNIV in adult patients with ADHD,” said Brigitte Robertson, M.D., VP and Head of Global Clinical Development, Neuropsychiatry, Shire. “We are evaluating the full data set, and excited to advance the development of INTUNIV as a non-stimulant treatment option for adults with ADHD in Japan, building on the established efficacy and safety data for ADHD in child and adolescent patients.”

INTUNIV, a non-stimulant and selective alpha-2A adrenergic receptor agonist¹ is currently approved as a treatment for child and adolescent patients (6 to 17 years old) in Japan. INTUNIV is being evaluated in Japan as a potential treatment option for ADHD in adults, a therapeutic area with significant need. Japan is the third largest ADHD market, growing at more than 20% annually.

For more information please see the full press release on Shire's website.