0-29630
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98-0601486
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of principal executive offices)
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(Zip code)
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Registrant's telephone number, including area code
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+353 1 429 7700
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o
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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o
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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o
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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o
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 8.01.
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Other Events
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Item 9.01.
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Financial Statements and Exhibits
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99.1
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Press Release dated February 7, 2014
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Dated: February 7, 2014
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SHIRE PLC
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By:
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/s/ T May | ||
Name: | Tatjana May | ||
Title: | General Counsel |
EXHIBIT INDEX
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Number
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Description
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99.1
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Press release dated February 7, 2014
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Press Release
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www.shire.com
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·
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CNS stimulants (amphetamines and methylphenidate-containing products) have a high potential for abuse and dependence.
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Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
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Contraindications:
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Known hypersensitivity to amphetamines or other ingredients in Vyvanse. Anaphylactic reactions, Stevens - Johnson syndrome, angioedema, and urticaria have been observed in postmarketing reports.
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Concurrent administration of monoamine oxidase inhibitors (MAOI) or administration of Vyvanse within 14 days of the last MAOI dose. Hypertensive crisis can occur.
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Educate patients about abuse and periodically re-evaluate the need for Vyvanse.
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Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in children and adolescents with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Prior to treatment assess for the presence of cardiac disease. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Vyvanse treatment.
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CNS stimulants cause an increase in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
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Use of stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with preexisting psychosis. Clinical evaluation for bipolar disorder is recommended prior to stimulant use.
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CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Monitor weight and height in children during treatment with Vyvanse. Treatment may need to be interrupted in children not growing as expected.
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Stimulants used to treat ADHD, including Vyvanse, are associated with peripheral vasculopathy, including Raynaud's phenomenon. Careful observation for digital changes (e.g., numbness, pain, skin color change, or sensitivity to temperature, and rarely ulcerations and/or soft tissue breakdown) is necessary during treatment and may require further evaluation (e.g., referral).
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The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in clinical trials were:
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Children aged 6 to 12: decreased appetite, insomnia, upper abdominal pain, irritability, vomiting, decreased weight, nausea, dry mouth and dizziness;
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Adolescents aged 13 to 17: decreased appetite, insomnia, and decreased weight;
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Adults: decreased appetite, insomnia, dry mouth, diarrhea, nausea, anxiety and anorexia.
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Investor Relations
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||
Eric Rojas
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erojas@shire.com
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+1 781 482 0999
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Sarah Elton-Farr
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seltonfarr@shire.com
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+44 1256 894157
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Media
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||
Jessica Mann
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jmann@shire.com
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+44 1256 894 280
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Gwen Fisher
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gfisher@shire.com
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+1 484 595 9836
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Shire’s products may not be a commercial success;
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revenues from ADDERALL XR are subject to generic erosion;
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the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payors in a timely manner for Shire's products may impact future revenues and earnings;
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Shire relies on a single source for manufacture of certain of its products and a disruption to the supply chain for those products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis;
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Shire uses third party manufacturers to manufacture many of its products and is reliant upon third party contractors for certain goods and services, and any inability of these third party manufacturers to manufacture products, or any failure of these third party contractors to provide these goods and services, in each case in accordance with its respective contractual obligations, could adversely affect Shire’s ability to manage its manufacturing processes or to operate its business;
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the development, approval and manufacturing of Shire’s products is subject to extensive oversight by various regulatory agencies and regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
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the actions of certain customers could affect Shire 's ability to sell or market products profitably and fluctuations in buying or distribution patterns by such customers could adversely impact Shire’s revenues, financial conditions or results of operations;
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investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire’s activities in the highly regulated markets in which it operates may result in the distraction of senior management, significant legal costs and the payment of substantial compensation or fines;
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adverse outcomes in legal matters and other disputes, including Shire’s ability to obtain, maintain, enforce and defend patents and other intellectual property rights required for its
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any failure to achieve Shire’s strategic objectives with respect to the acquisition of ViroPharma Inc., including a failure to achieve targeted sales of CINRYZE, may adversely affect Shire’s financial condition and results of operations;
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