Shire Delivers Excellent Growth for the Year, With the new Product Portfolio Achieving Sales of ...(uary 9 2009 Shire announced that it had ...)

Date:2/19/2009

uary 9, 2009 Shire announced that it had received Paragraph IV Notice letters from Barr Laboratories, Inc. ("Barr") and Mylan Inc. ("Mylan") advising the filing of Abbreviated New Drug Applications for generic versions of 500 mg, 750mg, and 1 gm FOSRENOL. Shire is currently reviewing the detail of the Paragraph IV Notice letters from Barr and Mylan, and under the Hatch Waxman Act has 45 days to determine if it will file patent infringement suits. Pipeline FIRAZYR - for Hereditary angioedema ("HAE") in the US - In December 2008 Jerini AG ("Jerini") met with the US Food and Drug Administration ("FDA") to discuss the development of FIRAZYR for use in the US following the not approvable letter received from the FDA in April 2008. It was agreed that an additional clinical study would be required and a complete response to the not approvable letter would be filed after completion of this study. We expect this additional study to be initiated during the third quarter of 2009.

VYVANSE - for use in the treatment of attention deficit and hyperactivity disorder ("ADHD") in children in the European Union ("EU")

    - During Q4 2008, Phase 3 clinical trials designed to support
      registration for the treatment of ADHD in children in the EU commenced.


    INTUNIVTM - for use in the treatment of ADHD in children in the US

    - On January 27, 2009 Shire made a resubmission to the FDA of the New
      Drug Application to support registration for the treatment of ADHD in
      children.


    HGT-2610 for Krabbe Disease (Globoid Cell Leukodystrophy)

    - In November 2008 Shire announced that it was developing an enzyme
      replacement therapy for the treatment of Krabbe Disease, a lysosomal
      storage disorder. This program is in early preclinical development.


    Business

    - In November 2008 Shire settled 
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SOURCE  Shire Plc
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