Shire provides key R&D candidates update

Speaking at a recent webcast R&D briefing, Matthew Emmens, chief executive of UK drugmaker Shire Pharmaceuticals, stated that, "during 2005, Shire aims to build on [2004's] success with the planned filings of four key products that are intended to build its leadership position in the ADHD [attention-deficit hyperactivity disorder] market and expand its offerings in the GI [gastrointestinal] market." The company went on to provide an update of these four key candidates:

- MTS (methylphenidate transdermal system), a transdermal patch in development with the USA's Noven Pharmaceuticals (Marketletter June 21, 2004). A Phase II analog classroom study (n= 80) met its primary endpoint and showed significant improvement in performance and behavior versus placebo, with a similar safety profile to approved oral methylphenidate agents. A Phase III naturalistic evaluation (n=268) met its primary endpoint, demonstrating performance and behavior improvements vs placebo. Class II resubmission is scheduled for this quarter;

- SPD503 (guanfacine hydrochloride in extended-release tablets), is a non-stimulant, non-scheduled product with a differentiated mechanism of action for treating ADHD. Phase III safety and efficacy studies in children and adolescents aged six-17 met primary endpoints as determined by the ADHD Rating Scale. A filing is set for the fourth quarter;