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Shire Reports 7% Product Sales Growth: Anticipating Double Digit Non GAAP Earnings Growth in 2013
Date:7/25/2013

targeted launch date is November 2013.

SPD602 - for the treatment of transfusion-dependent iron overload

  • In June 2013 data from an on-going  phase 2 study was presented at the 18th Congress of the European Hematology Association.  Seventy-two-week data  in patients with hereditary anemias indicate that the safety, tolerability and efficacy profile of SPD602 supports its continued development. Full data from the ongoing phase 2 proof-of-concept program will be available mid-2014.

SPD557 - for the treatment of refractory gastroesophageal reflux disease ("rGERD")

  • This program has been discontinued following review of headline data from the proof-of-concept study which did not support continued development.

SPD554 (selective α2A agonist) - for the treatment of various central nervous system disorders

  • This program has been discontinued as part of ongoing portfolio prioritization assessments.

OTHER DEVELOPMENTS

Legal Proceedings

LIALDA patent litigation

  • On May 9, 2013 Shire announced that it had prevailed in its litigation against Watson Pharmaceuticals Inc., Watson Laboratories, Inc.-Florida, Watson Pharma, Inc. and Watson Laboratories, Inc. (collectively "Watson", now "Actavis") in connection with their ANDA for a generic version of Shire's LIALDA. Following a bench trial, the US Court for the Southern District of Florida upheld the validity of US Patent No. 6,773,720 and ruled that the proposed generic product infringes that patent. Actavis has appealed this ruling to the Court of Appeals of the Federal Circuit.

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