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Shire Delivers Record Quarterly Revenues and Non GAAP Diluted Earnings per ADS up 42%
Date:7/18/2014

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  • On June 12, 2014 Shire announced that it had agreed to a written request by the US Food and Drug Administration ("FDA") to conduct pediatric clinical studies to investigate the potential use of VYVANSE for the treatment of ADHD in preschool-age children, ages 4 to 5. Upon FDA confirmation of a timely submission and review of data that adheres to the requirements of the written request, Shire will be entitled to the benefits of the Best Pharmaceuticals for Children Act, including a six-month extension to the exclusivity afforded by Shire's patents for VYVANSE, which expire in 2023.
  • Pipeline 

    SHP 606 lifitegrast - for the treatment of Dry Eye disease

    • Following a meeting with the FDA, on May 16, 2014 Shire announced that it intends to submit a New Drug Application ("NDA") for lifitegrast in Q1 2015 as a treatment for the signs and symptoms of Dry Eye disease in adults. In parallel to preparing for the NDA submission, Shire is assessing the need to collect additional clinical data to further strengthen the filing, marketing claims and rest-of world-opportunity for lifitegrast.

    VASCUGEL® (SHP613) - for the treatment of Acute Vascular Repair

    • Shire made the decision in Q2 2014 to discontinue further development of VASCUGEL, intended to enhance blood vessel repair in patients undergoing hemodialysis. This decision was made based on portfolio prioritization as well as unexpected challenges and complexities with the development program. No new patients will be enrolled in the two Phase 2 trials, but those currently in the trials will be followed for at least 12 weeks for safety. In addition, the 64 patients enrolled in the Arteriovenous Fistula study will be followed for six months, per the study protocol. Once the studies are closed out Shire will analyze available data then make any further decisions
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    SOURCE Shire plc
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    Related medicine technology :

    1. Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc.
    2. arGEN-X Receives Two Preclinical Milestone Payments Under Collaboration With Shire
    3. Shire Extends Tender Offer for ViroPharma
    4. Shire Reports Top-Line Results on OPUS-2, a Phase 3 Study Investigating the Use of Lifitegrast (5.0% Ophthalmic Solution) in Adults With Dry Eye Disease
    5. MinuteClinic Opens First Clinic Locations in New Hampshire
    6. Block & Leviton LLP Investigates ViroPharma Inc. for Possible Breaches of Fiduciary Duty in Connection with Its Acquisition by Shire PLC.
    7. Shire to Present at the Bank of America Merrill Lynch Global Health Care Conference
    8. Shire to Present at the Morgan Stanley Global Healthcare Conference
    9. Shire Reports 7% Product Sales Growth: Anticipating Double Digit Non GAAP Earnings Growth in 2013
    10. Shire Announces Award Recipients for 2013 US ADHD Scholarship Program
    11. Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting
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