Shire Limited announced new study results on INTUNIV(TM) (guanfacine) Extended-Release Tablets published in the October Journal of Child and Adolescent Psychopharmacology. In this open-label safety study, there was no evidence of unique adverse effects with the combination of INTUNIV and amphetamine or methylphenidate relative to what was observed with either medication alone. The open-label study also assessed improvement of Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms using the ADHD Rating Scale-IV (ADHD-RS-IV). INTUNIV is a nonscheduled, once-daily selective alpha-2A agonist indicated for monotherapy treatment of ADHD in children and adolescents ages 6 to 17. Pivotal studies have shown that INTUNIV improved ADHD symptoms in children and adolescents with the disorder, and the publication of these safety data gives us insight into administering INTUNIV in combination with stimulant medications in the management of ADHD.

Shire Limited announced that the United States Food and Drug Administration has granted Priority Review for the New Drug Application for velaglucerase alfa, the company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease. Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists, and accelerates the target review timing from ten to six months. The FDA has issued an action date for the NDA of February 28, 2010 under the Prescription Drug User Fee Act. In the U.S., patients continue to be enrolled in an FDA-approved treatment protocol, under which Gaucher patients receive velaglucerase alfa prior to commercialization. Shire has also engaged with national and regional authorities outside the U.S. and patients are receiving velaglucerase alfa through pre-approval access programs. Shire confirms it is on track with its filing of the Marketing Authorization Application (MAA) in the EU for 2009.

Shire Limited announced on November 2, 2009 the Mr. David Stout will join the Board as a non-executive director with effect from October 31, 2009.