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

/span> for the treatment of DFU, following its approval by Health Canada as a class IV medical device for the treatment of DFU in September 2012.

VPRIV - for the treatment of Gaucher disease (Type 1)

  • On March 21, 2013 the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion regarding an update to the clinical efficacy and safety section of the VPRIV Summary of Product Characteristics to include information on long term clinical data relating to efficacy and safety in skeletal pathology from the TKT025 extension study in Type 1 Gaucher patients.

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Lisdexamfetamine dimesylate(1) ("LDX") - for the treatment of negative symptoms of schizophrenia ("NSS")

  • Shire has cancelled the NSS Phase 3 program after a review and prioritization of Shire's development portfolio and taking into account investment requirements for recent acquisitions. No patients had been dosed in the studies and this decision was not due to any safety issues with LDX in any patient population. Shire remains committed to continuing Phase 3 trials for MDD and BED and these are enrolling as expected.

(1) Currently marketed as VYVANSE in the US and ELVANSE® in certain territories in the EU for the treatment of ADHD.

HGT4510 - for Duchenne Muscular Dystrophy ("DMD")

  • In April 2013, following analysis of the results of toxicology studies, Shire discontinued development of HGT4510 and returned Shire's rights in the asset to Acceleron Pharma Inc. The development of HGT4510 was placed on clinical hold in February 2011, subject to the completion of the toxicology studies.

VASCUGEL® - for the treatment of end-stage renal disease.


    SOURCE Shire plc
    Copyright©2012 PR Newswire.
    All rights reserved

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