Shire presentations at EAHAD 2018 demonstrate commitment to studying outcomes in patients with bleeding disorders
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:
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NOTES TO EDITORS
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.
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;
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- 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;
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- 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;
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- 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.
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