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Shire presentations at EAHAD 2018 demonstrate commitment to studying outcomes in patients with bleeding disorders

Shire presentations showcase heritage in Hematology

Zug, Switzerland – February 1, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, today announced the range of real-world and long-term research it will present at the 11th Annual Congress of the European Association of Haemophilia and Allied Disorders (EAHAD), taking place February 7-9 2018, in Madrid, Spain. Shire’s presence at EAHAD, with five presentations, showcases its heritage in bleeding disorders and dedication to studying hemophilia patient outcomes.

“Shire is committed to the ongoing fight to address the significant unmet patient need for personalized treatments in hemophilia,” said Dr. Peter Foertig, MD, Global Head Hematology Medical Affairs, Shire. “Our presentations at EAHAD represent years of real-world patient outcomes from our portfolio of hemophilia treatments and demonstrate Shire’s continued dedication to improving patient treatment through personalized care.”

Research presented at EAHAD will showcase Shire’s broad hematology portfolio, which covers a wide range of indications for rare bleeding disorders. In addition to presenting new research at the congress, Shire will share updates related to its ongoing innovation in patient-centric care at a symposium titled Advancing Patient-Centric Care Through Innovation.

Shire’s data presentations, to take place February 7-9 at EAHAD 2018, include:

  • Recombinant Von Willebrand Factor Administration: Dosing Considerations and Rapid Stabilization of Endogenous Plasma FVIII Levels in Patients with Severe Von Willebrand Disease (poster P117)
  • FEIBA Global Outcome study (FEIBA GO) first data read-out: Real-world Bleeding Frequency in Patients with Inhibitors on Prophylaxis with Activated Prothrombin Complex Concentrate (APCC) (poster P179)
  • Real world use of B-domain-deleted, porcine-sequence factor VIII (rpFVIII) in patients with Acquired Haemophilia A (AHA): Post-Marketing Safety (PMS) Studies in European Union (EU) and in the United States (US) (poster P181)
  • Rationale and Design of FEIBA STAR study: Revised Study Design (poster P180)
  • The International AHEAD Study: Beneficial Effects of Prophylaxis in Patients With Hemophilia A Are Maintained Over 4 Years (poster P006)

These presentations are intended for scientific discussion only.

The upcoming research presentations at EAHAD follow the recently announced launch of the Irish Personalized Approach to the Treatment of Hemophilia (iPATH) study. Instead of focusing on standardized treatments, the iPATH study seeks to take the next step in treatment and will investigate new personalized treatment approaches by tailoring care based on the needs of individual patients. The Novel Clinical Study to Improve Personalized Care for Hemophilia patients was launched in December 2017.

About FEIBA (Factor VIII Inhibitor Bypassing Activity)
FEIBA® (factor VIII inhibitor bypassing activity) is indicated for the treatment of spontaneous bleeding and cover of surgical interventions in haemophilia A patients with factor VIII inhibitors and in non-haemophiliacs with acquired factor VIII inhibitors as well as for prophylaxis in haemophilia A patients with high responding inhibitors and frequent joint bleeding.

Please consult the FEIBA Summary of Product Characteristics (SmPC) before prescribing, particularly in relation to dosing and treatment monitoring.

Contraindications are hypersensitivity to the product, disseminated intravascular coagulation (DIC) and acute thrombosis or embolism (including myocardial infarction).

The Adverse Drug Reactions (ADRs) occurring in the highest frequency (common, ≥ 1/100 to <1/10) were hypersensitivity, headache, dizziness, hypotension, rash, hepatitis B surface antibody positive.

Other symptoms of hypersensitivity reactions to plasma-derived products include lethargy and restlessness.

Additional Shire Product Information
For more information on antihaemophilic Factor VIII (recombinant), porcine sequence, please visit the EMA website.

For more information on von Willebrand factor (recombinant), please see the full Prescribing Information.

For further information please contact:

Elizabeth 781 482 2713
Gwen 781 482 9649
Investor Relations
Christoph 795 432 359
Sun 617 588 8175
Robert 203 549 0874


About Shire

Shire is the global leader in serving patients with rare diseases. We strive to develop best-in-class therapies across a core of rare disease areas including hematology, immunology, genetic diseases, neuroscience, and internal medicine with growing therapeutic areas in ophthalmics and oncology. Our diversified capabilities enable us to reach patients in more than 100 countries who are struggling to live their lives to the fullest.

We feel a strong sense of urgency to address unmet medical needs and work tirelessly to improve people’s lives with medicines that have a meaningful impact on patients and all who support them on their journey.

Forward-Looking Statements

Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, projected revenues, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products, are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:

  • Shire’s products may not be a commercial success;
  • increased pricing pressures and limits on patient access as a result of governmental regulations and market developments may affect Shire’s future revenues, financial condition and results of operations;
  • Shire conducts its own manufacturing operations for certain of its products and is reliant on third party contract manufacturers to manufacture other products and to provide goods and services. Some of Shire’s products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of Shire’s 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 for some period of time;
  • the manufacture of Shire’s products is subject to extensive oversight by various regulatory agencies. Regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to, among other things, significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
  • certain of Shire’s therapies involve lengthy and complex processes, which may prevent Shire from timely responding to market forces and effectively managing its production capacity;
  • Shire has a portfolio of products in various stages of research and development. The successful development of these products 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 Shire’s ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely affect Shire’s revenues, financial conditions or results of operations;
  • Shire’s products and product candidates face substantial competition in the product markets in which it operates, including competition from generics;
  • adverse outcomes in legal matters, tax audits and other disputes, including Shire’s ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on the Company’s revenues, financial condition or results of operations;
  • inability to successfully compete for highly qualified personnel from other companies and organizations;
  • failure to achieve the strategic objectives, including expected operating efficiencies, cost savings, revenue enhancements, synergies or other benefits at the time anticipated or at all with respect to Shire’s acquisitions, including NPS Pharmaceuticals Inc., Dyax Corp. or Baxalta Incorporated may adversely affect Shire’s financial condition and results of operations;
  • Shire’s growth strategy depends in part upon its ability to expand its product portfolio through external collaborations, which, if unsuccessful, may adversely affect the development and sale of its products;
  • a slowdown of global economic growth, or economic instability of countries in which Shire does business, as well as changes in foreign currency exchange rates and interest rates, that adversely impact the availability and cost of credit and customer purchasing and payment patterns, including the collectability of customer accounts receivable;
  • failure of a marketed product to work effectively or if such a product is the cause of adverse side effects could result in damage to Shire’s reputation, the withdrawal of the product and legal action against Shire;
  • 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 significant legal costs and the payment of substantial compensation or fines;
  • Shire is dependent on information technology and its systems and infrastructure face certain risks, including from service disruptions, the loss of sensitive or confidential information, cyber-attacks and other security breaches or data leakages that could have a material adverse effect on Shire’s revenues, financial condition or results of operations;
  • Shire incurred substantial additional indebtedness to finance the Baxalta acquisition, which has increased its borrowing costs and may decrease its business flexibility;
  • Our ongoing strategic review of our Neuroscience franchise may distract management and employees and may not lead to improved operating performance or financial results; there can be no guarantee that, once completed, our strategic review will result in any additional strategic changes beyond those that have already been announced; and

a further list and description of risks, uncertainties and other matters can be found in Shire’s most recent Annual Report on Form 10-K and in Shire’s subsequent Quarterly Reports on Form 10-Q, in each case including those risks outlined in “ITEM 1A: Risk Factors”, and in Shire’s subsequent reports on Form 8-K and other Securities and Exchange Commission filings, all of which are available on Shire’s website.

All forward-looking 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 forward-looking 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 update or revise forward-looking statements, whether as a result of new information, future events or otherwise.

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