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New Chief Executive Reports Q1 Results and Sets out Strategy for Growth
Date:5/2/2013

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  • In March 2013, Shire enrolled the first patient in its Phase 2 clinical program for VASCUGEL.
  • OTHER DEVELOPMENTS

    Legal Proceedings

    INTUNIV patent litigation

    • On April 25, 2013, Shire settled all pending litigation with Actavis, Inc., Actavis LLC, and Actavis Elizabeth LLC (collectively "Actavis") and Watson Laboratories, Inc.-Florida, Watson Pharma, Inc. and ANDA, Inc. (collectively "Watson") in connection with Actavis's and Watson's Abbreviated New Drug Applications ("ANDAs") for generic versions of INTUNIV for the treatment of ADHD.

      The settlement provides Actavis with a license to make and market Actavis's generic versions of INTUNIV in the United States on December 1, 2014, or earlier in certain limited circumstances. Such sales will require the payment of a royalty of 25% of gross profits to Shire during the 180 day period of Actavis's exclusivity. The settlement also provides Watson with a license to make and market Watson's generic versions of INTUNIV in the United States, 181 days after Actavis's launch of generic INTUNIV, or earlier in certain limited circumstances.

    Acquisition of SARcode Bioscience Inc. ("SARcode")

    • On April 17, 2013 Shire completed the acquisition of SARcode, a privately held biopharmaceutical company based in Brisbane, California. This acquisition brings a new Phase 3 compound, lifitegrast, currently under development for the signs and symptoms of dry eye disease, into Shire's portfolio. Shire anticipates launching lifitegrast in the United States as early as 2016 pending a positive outcome of the Phase 3 clinical development program and regulatory approvals. Shire is acquiring the global rights to lifitegrast and wil
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    SOURCE Shire plc
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