shire map
Select a
Location

Shire Global

Newsroom

Shire Obtains Injunction Against Roche to Address Incomplete and Misleading Statements Regarding Investigational Agent Emicizumab That May Impact Patient Safety

Berlin, Germany – July 9 2017 - Shire International GmbH has obtained a preliminary injunction in a court of Hamburg, Germany against F. Hoffmann-La Roche Ltd. (Roche) to address incomplete and misleading statements that may impact important issues of patient safety regarding the investigational treatment emicizumab.

Under the injunction, Shire seeks to prevent further dissemination of the inaccurate and misleading characterization of the serious adverse events that occurred in the HAVEN 1 Phase 3 trial of emicizumab, specifically the assertion that “all events occurred when repeated high aPCC (activated Prothrombin Complex Concentrate) doses were used concurrently with emicizumab.” The injunction also seeks to correct promotion of the primary data results relative to “treated bleeds” (a secondary endpoint) as compared to the primary endpoint of “number of bleeds over time” established at the outset of the trial.

Based on Roche’s publically available information to date (as of 7 July 2017), physicians, patients and caregivers may be misinformed about the appropriate management of breakthrough bleeds uncontrolled by emicizumab. In addition, through these actions, Shire believes Roche has unlawfully disparaged Shire’s proven bypassing agent, FEIBA (Anti-Inhibitor Coagulant Complex). Shire has issued multiple unheeded requests to Roche in an effort to resolve these concerns in an appropriate manner. As a result, Shire made the decision to seek court intervention.

Shire’s goal with this action is to ensure the hemophilia community receives sufficient, accurate information from Roche about the reported serious adverse events (SAEs) in the Phase 3 emicizumab trial, enabling physicians and their patients to make properly informed decisions about patient care.

As the global leader in rare hematology, Shire advocates in the interest of patient safety and continually defends the demonstrated 40-year safety profile of FEIBA.

The preliminary injunction is an interim measure which can be appealed by Roche.

International Safety Information FEIBA (Factor VIII Inhibitor Bypassing Activity)

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

Contraindications

Hypersensitivity to the product or any of the components, disseminated intravascular coagulation (DIC) and acute thrombosis or embolism (including myocardial infarction).

Special warnings and precautions for use

Thromboembolic events, including disseminated intravascular coagulation (DIC), venous thrombosis, pulmonary embolism, myocardial infarction, and stroke, have occurred in the course of treatment with FEIBA. At the first signs or symptoms of thromboembolic events, the infusion should be stopped immediately and appropriate diagnostic and therapeutic measures initiated.

FEIBA can precipitate allergic-type hypersensitivity reactions; these reactions can be severe and can be systemic (e.g., anaphylaxis with urticaria and angioedema, bronchospasm, and circulatory shock). Other infusion reactions, such as chills, pyrexia, and hypertension have also been reported.

If clinically significant changes in blood pressure or pulse rate, respiratory distress, coughing or chest pain occur, the infusion is to be discontinued immediately and appropriate diagnostic and therapeutic measures are to be initiated.

In vitro tests, such as aPTT, whole blood clotting time (WBCT) may not correlate with the clinical picture.

Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/ repeated receipt of human plasma-derived products including FEIBA.

Adverse Reactions

Common
(≥1/100 to <1/10)
Hypersensitivity, Headache, Hypotension, Rash, Hepatitis B surface antibody positive.
Not knownDisseminated intravascular coagulation (DIC), Increase of inhibitor titer (anamnestic response),Urticaria, Anaphylactic reaction, Paresthesia, Hypoaesthesia, Thrombotic stroke, Embolic stroke, Somnolence, Dizziness, Dysgeusia, Cardiac infarction, Tachycardia, Thrombosis, Venous thrombosis, Arterial thrombosis, Embolism, Hypotension, Hypertension, Flushing, Pulmonary embolism, Bronchospasm, Wheezing, Cough, Dyspnea, Vomiting, Diarrhea, Abdominal discomfort, Nausea, Sensation of numbness in the face, Angioedema, Urticaria, Pruritus, Pain at the injection site, Malaise, Feeling hot, Chills, Pyrexia, Chest pain, Chest discomfort, Blood pressure decreased.

 

NOTES TO EDITORS

For further information please contact:

Investor Relations  
Ian Karpikarp@shire.com+1 781 482 9018
Robert Coates rcoates@shire.com+44 1256 894874
   
Media  
Molly Poarchmolly.poarch@shire.com+1 312 965 3413

 

About Shire

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

www.shire.com

Forward-Looking Statements

Statements included herein that are not historical facts, including without limitation statements concerning 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 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 may decrease its business flexibility and increase borrowing costs; 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.

Cookie Use Notification

The site uses cookies to provide you with a more responsive and personalized service. By using this site you agree to our use of cookies as set out in our cookie notice. Please read our privacy notice for more information on the cookies we use and how to delete or block the use of cookies. LEARN MORE