"Study addresses key U.S. Food and Drug Administration FDA requirement keeping SHP on track for potential  U.S. launch   Topline data revealed SHP met primary endpoint showing ADHD symptom improvement in children and adolescents p.   Key secondary endpoint also met showing higher proportion of patients were rated improved p.   Data add to overall robust clinical development program for SHP  Shire plc LSE SHP httpstudio.financialcontent.comprnewsPageQuoteTickerSHPNASDAQ SHPG httpstudio.financialcontent.comprnewsPageQuoteTickerSHPG today announces positive topline results from a fourweek Phase  randomized doubleblind multicenter placebocontrolled doseoptimization safety and efficacy study SHP in children and adolescents aged  years with AttentionDeficitHyperactivity Disorder ADHD. SHP triplebead mixed amphetamine salts  MAS is an investigational oral stimulant medication being evaluated in the U.S. as a potential treatment for ADHD a therapeutic area with significant need for additional treatment options. The primary efficacy analysis of study  demonstrated that SHP administered as a daily morning dose was superior to placebo on the change from baseline in ADHDRSIV ADHD rating scale total score with a Least Squares LS mean difference from placebo at Week  of .  CI . to . p. suggesting a significant improvement in ADHD symptoms. SHP was also superior to placebo in the key secondary efficacy analysis on the clinical global impression improvement scale CGII with an LS mean difference from placebo at Week  of .  CI . to . p. indicating a significantly higher proportion of patients were rated improved on the CGII rating scale. The CGII is a standardized assessment tool that allows clinicians to rate the severity of ADHD illness change over time and efficacy of medication. Treatmentemergent adverse events   for SHP  were decreased appetite headache insomnia irritability nausea weight decrease and dizziness. Adverse events were generally mild to moderate in severity and similar to those observed in previous SHP studies and with other amphetamine compounds. The completion of SHP addresses an FDA requirement to evaluate the safety and efficacy of SHP in children and adolescents prior to filing a Class  resubmission of the medicine for FDA approval. We are pleased with the positive results of the SHP study said Philip J. Vickers Ph.D. Head of Research  Development Shire. These results represent an important step toward a new treatment option for patients with ADHD. Shire looks forward to including these data as part of the FDA resubmission and is eager to continue advancing this clinical program.   Dr. Matthew Brams M.D. Clinical Assistant Professor at Baylor College of Medicine and principal investigator for study  added The study of SHP in children and adolescents is an essential next step to progressing the clinical program. Im excited about these positive data from SHP because of the benefit that this potential new treatment option may provide for patients with ADHD. Overall Robust SHP Clinical Development Program to Support Class  Resubmission   Including study  and previous studies Shire now has a robust database of  clinical studies evaluating SHP in more than  subjects. Once the pharmacokinetic study and an additional safety and efficacy Phase  trial in adults currently under way are complete later this year Shire plans to add these study results to its existing SHP data set to submit a Class  resubmission for FDA approval of the medicine for treatment of ADHD. SHP remains on track for potential U.S. launch in the second half of . In previous adolescent and adult clinical studies SHP demonstrated a statistically significant difference versus placebo at  hours post dosing with onset of action starting  hours post dosing as measured by the Permanent Product Measure of Performance PERMP. PERMP was not measured in the SHP study. Protection for Shires ADHD Franchise Extends to   There are patents supporting Shires overall ADHD franchise in the U.S. that extend to . With a launch planned for the second half of   Shire expects that SHP following potential FDA approval will have three years of HatchWaxman exclusivity and at least three patents listed in the FDA Orange Book expiring as late as May . NOTES TO EDITORS  Shire enables people with lifealtering conditions to lead better lives. Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs. We focus on providing treatments in Rare Diseases Neuroscience Gastrointestinal and Internal Medicine and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas such as Ophthalmics. http ForwardLooking Statements  Statements included herein that are not historical facts including without limitation statements concerning our announced business combination with Baxalta and the timing and financial and strategic benefits thereof our x ambition that targets  billion in combined product sales by  as well as other targets for future financial results capital structure performance and sustainability of the combined company the combined companys future strategy plans objectives expectations and intentions the anticipated timing of clinical trials and approvals for and the commercial potential of inline or pipeline products are forwardlooking statements. Such forwardlooking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize Shires results could be materially adversely affected. The risks and uncertainties include but are not limited to the following  the proposed combination with Baxalta may not be completed due to a failure to satisfy certain closing conditions including any shareholder or regulatory approvals or the receipt of applicable tax opinions  disruption from the proposed transaction with Baxalta may make it more difficult to conduct business as usual or maintain relationships with patients physicians employees or suppliers  the combined company may not achieve some or all of the anticipated benefits of Baxaltas spinoff from Baxter International Inc. Baxter and the proposed transaction may have an adverse impact on Baxaltas existing arrangements with Baxter including those related to transition manufacturing and supply services and tax matters  the failure to achieve the strategic objectives with respect to the proposed combination with Baxalta may adversely affect the combined companys financial condition and results of operations  products and product candidates may not achieve commercial success  product sales from ADDERALL XR and INTUNIV are subject to generic competition  the failure to obtain and maintain reimbursement or an adequate level of reimbursement by thirdparty payers in a timely manner for the combined companys products may affect future revenues financial condition and results of operations particularly if there is pressure on pricing of products to treat rare diseases  supply chain or manufacturing disruptions may result in declines in revenue for affected products and commercial traction from competitors regulatory actions associated with product approvals or changes to manufacturing sites ingredients or manufacturing processes could lead to significant delays an increase in operating costs lost product sales an interruption of research activities or the delay of new product launches  the successful development of products in various stages of research and development is highly uncertain and requires significant expenditures and time and there is no guarantee that these products will receive regulatory approval  the actions of certain customers could affect the combined companys ability to sell or market products profitably and fluctuations in buying or distribution patterns by such customers can adversely affect the combined companys revenues financial condition or results of operations  investigations or enforcement action by regulatory authorities or law enforcement agencies relating to the combined companys activities in the highly regulated markets in which it operates may result in significant legal costs and the payment of substantial compensation or fines  adverse outcomes in legal matters and other disputes including the combined companys ability to enforce and defend patents and other intellectual property rights required for its business could have a material adverse effect on the combined companys revenues financial condition or results of operations  Shire is undergoing a corporate reorganization and was the subject of an unsuccessful acquisition proposal and the consequent uncertainty could adversely affect the combined companys ability to attract andor retain the highly skilled personnel needed to meet its strategic objectives  failure to achieve the strategic objectives with respect to Shires acquisition of NPS Pharmaceuticals Inc. or Dyax Corp. Dyax may adversely affect the combined companys financial condition and results of operations  the combined company will be dependent on information technology and its systems and infrastructure face certain risks including from service disruptions the loss of sensitive or confidential information cyberattacks and other security breaches or data leakages that could have a material adverse effect on the combined companys revenues financial condition or results of operations  the combined company may be unable to retain and hire key personnel andor maintain its relationships with customers suppliers and other business partners  difficulties in integrating Dyax or Baxalta into Shire may lead to the combined company not being able to realize the expected operating efficiencies cost savings revenue enhancements synergies or other benefits at the time anticipated or at all and other risks and uncertainties detailed from time to time in Shires  Dyaxs or Baxaltas filings with the Securities and Exchange Commission SEC including those risks outlined in ITEM A Risk Factors in Shires and Baxaltas Annual Reports on Form K for the year ended December  . All forwardlooking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forwardlooking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law we do not undertake any obligation to republish revised forwardlooking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events."