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Shire plc: Core Portfolio of Products Delivers 20% Sales Growth
Date:8/5/2009

en aged 6 to 12 from the first time point measured (1.5 hours) through 13 hours post-dose. VYVANSE is now the first and only oral ADHD stimulant treatment to have 13 hour post-dose efficacy data for pediatric patients included in its product labeling. - By July 24, 2009 VYVANSE had achieved a US ADHD market share of 12.3% based on weekly prescription volumes. ADDERALL XR - for the treatment of ADHD - On April 2, 2009 Teva announced that it had commenced commercial shipment of its authorized generic version of ADDERALL XR. In Q2 2009 sales of ADDERALL XR declined by 77% to $67 million. A decline in ADDERALL XR sales subsequent to generic launch was anticipated and was already reflected in our guidance framework.

Pipeline

INTUNIV(TM) - for the treatment of ADHD in children and adolescents in the US.

    - On May 19, 2009 Shire announced that a randomized placebo controlled
      trial had met its primary objective, evaluating the effects of INTUNIV
      on oppositional symptoms in children aged 6 to 12 years with a
      diagnosis of ADHD and the presence of oppositional symptoms.

    - The Prescription Drug User Fee Act date ("PDUFA") for INTUNIV was July
      27, 2009. Shire has received a Complete Response Letter from the FDA
      for INTUNIV. Shire and the FDA were not able to reach agreement on
      final product labeling in time to meet the PDUFA date. The FDA did not
      identify safety concerns regarding INTUNIV, request new clinical data or
      additional analyses in the Complete Response Letter. Shire and the FDA
      will continue to work together to resolve the remaining labeling
      language over the next 4-8 weeks and we anticipate launch in the fourth
      quarter of 2009 as planned.

    VYVANSE - for the treatment of non ADHD indications in adults

    - Shire is conducting Phase 2 pilot cli
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SOURCE Shire Plc
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