Shire Pharmaceuticals Group Plc

Shire Announces Completion of Decentralized Procedure in Europe for Immunoglobulin Treatment Cuvitru

Zug, Switzerland (ots/PRNewswire) -

- Cuvitru (IG 20mg/ml solution for subcutaneous injection) builds on 
  company's broad portfolio of IG treatments gained through 
  combination with Baxalta   
- New option to treat primary and certain secondary 
  immunodeficiencies can help meet patient needs related to number of
  infusion sites and infusion time  

Shire plc (LSE: SHP, NASDAQ: SHPG) announced today the successful completion of a decentralized procedure (DCP) to support approval by 17 authorities in Europe for Cuvitru (IG 20mg/ml solution for subcutaneous injection), a treatment for pediatric and adult patients with primary and certain secondary immunodeficiency disorders, a group of disorders in which part of the body's immune system is missing or does not function properly.[1] It is estimated that as many as six million children and adults may be affected by primary immunodeficiencies (PI) worldwide.[1]

With the addition of Cuvitru following the completion of the combination with Baxalta, Shire has the broadest immunoglobulin (IG) portfolio with intravenous, conventional and subcutaneous treatment options. Cuvitru is a new IG treatment that does not contain proline; it offers patients a new therapeutic option to meet their needs, particularly related to the number of infusion sites and infusion time. With the completion of the DCP, the 17 authorities mutually recognize approvability based on a scientific assessment of the product, and local marketing authorizations in Europe are expected to begin later in 2016.

Regulatory evaluation for Cuvitru was based on the positive results of a Phase 2/3 study that evaluated the efficacy, safety, tolerability and pharmacokinetics of IGSC 20% in European patients with PI. The study met its primary endpoint that measured the rate of validated acute serious bacterial infections.

"With the completion of the assessment procedure, we can move forward with seeking country approvals of Cuvitru in Europe as we continue to build a comprehensive portfolio of IG treatments that can address the distinct needs of people with PI around the world," said Philip J. Vickers, Ph.D., Head of Research and Development, Shire.

Shire expects a regulatory decision for Cuvitru in the U.S. later this year in response to Baxalta's submission for licensing late in 2015 based on a separate Phase II/III study. The company expects to initiate additional global regulatory submissions in 2016.

About Primary Immunodeficiency

Primary immunodeficiencies (PI) are a group of more than 300 disorders in which part of the body's immune system is missing or does not function properly.[2] Normally, the immune system protects the body from pathogenic microorganisms like bacteria, viruses, and fungi, which can cause infectious diseases. When any part of a person's immune system is absent or dysfunctional, the individuals are susceptible to infections, and it may take longer to recover from infections. When a defect in the immune system is genetically determined, it is called primary immune deficiency.[3] It is estimated that as many as six million children and adults may be affected by PI worldwide.[1]

About Cuvitru 20mg/ml solution for subcutaneous injection in Europe

After marketing authorization, Cuvitru 20mg/ml solution for subcutaneous injection will be indicated as a subcutaneous administration (SCIg) replacement therapy in adults, and children and adolescents (0 - 18 years) in:

- Primary immunodeficiency syndromes with impaired antibody 
  production.
- Hypogammaglobulinaemia and recurrent bacterial infections in 
  patients with chronic lymphocytic leukaemia (CLL), in whom 
  prophylactic antibiotics have failed or are contra-indicated.
- Hypogammaglobulinaemia and recurrent bacterial infections in 
  multiple myeloma (MM) patients.
- Hypogammaglobulinaemia in patients pre- and post- allogeneic 
  haematopoietic stem cell transplantation (HSCT). 

Detailed Important Risk Information

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients.

Severe IgA deficiency and a history of hypersensitivity to human immunoglobulin treatment.

Cuvitru must not be given intravascularly or intramuscularly.

WARNINGS and PRECAUTIONS

If Cuvitru is accidentally administered into a blood vessel patients could develop shock.

The recommended infusion rate must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.

Certain adverse reactions may occur more frequently in patients who receive human normal immunoglobulin for the first time or, in rare cases, when the human normal immunoglobulin product is switched or when there has been a long interval since the previous infusion.

Potential complications can often be avoided by:

- initially injecting the product slowly
- ensuring that patients are carefully monitored for any symptoms 
  throughout the infusion period. In particular, patients naive to 
  human normal immunoglobulin, patients switched from an alternative 
  immunoglobulin product or when there has been a long interval since
  the previous infusion should be monitored during the first infusion
  and for the first hour after the first infusion, in order to detect
  potential adverse signs. 

All other patients should be observed for at least 20 minutes after administration.

In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. Suspicion of severe hypersensitivity or anaphylactic-type reactions requires immediate discontinuation of the injection. The treatment required depends on the nature and severity of the adverse reaction.

In case of shock, standard medical treatment for shock should be implemented.

Thromboembolic events (e.g. myocardial infarction, cerebral vascular accident, deep vein thrombosis, and pulmonary embolism), renal dysfunction/failure, aseptic meningitis syndrome, hemolysis and interference with serological testing have been observed with IG administered intravenously and cannot be excluded with use of Cuvitru. Thrombotic events and hemolysis have also been reported in association with the subcutaneous administration of immunoglobulin products.

Human normal immunoglobulin is produced from human plasma and may carry a risk of transmitting infectious agents.

Shire, Baxalta and Cuvitru are trademarks of Shire plc, its subsidiaries or affiliates.

References

1. Bousfiha AA et al. Primary immunodeficiency diseases worldwide: more common than generally thought. J Clin Immunol. 2013 Jan;33(1):1-7.

2. Picard C, Al-Herz W, et al. Primary Immunodeficiency Diseases: an Update on the Classification from the International Union of Immunological Societies Expert Committee for Primary Immunodeficiency. J Clin Immunol. 2015 Nov;35(8):696-726.

3. IDF Patient & Family Handbook for Primary Immunodeficiency Diseases. 5th edition. Blaese. 2013.

NOTES TO EDITORS

About Shire

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

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.

http://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:

- disruption from the acquisition and integration of Baxalta 
  Incorporated ("Baxalta") may make it more difficult to conduct 
  business as usual or maintain relationships with patients, 
  physicians, employees or suppliers;
- the company may not achieve some or all of the anticipated benefits
  of Baxalta's spin-off from Baxter International, Inc. ("Baxter") 
  and the acquisition may have an adverse impact on Baxalta's 
  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
  acquisition of Baxalta may adversely affect the company's 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 third-party payers in a timely manner 
  for the company's 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 company's ability
  to sell or market products profitably, and fluctuations in buying 
  or distribution patterns by such customers can adversely affect the
  company's revenues, financial condition or results of operations;
- investigations or enforcement action by regulatory authorities or 
  law enforcement agencies relating to the company'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;
- adverse outcomes in legal matters, tax audits and other disputes, 
  including the company'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;
- Shire is undergoing a corporate reorganization and was the subject 
  of an unsuccessful acquisition proposal and the consequent 
  uncertainty could adversely affect the company's ability to attract
  and/or retain the highly skilled personnel needed to meet its 
  strategic objectives;
- failure to achieve the strategic objectives with respect to Shire's
  acquisition of NPS Pharmaceuticals Inc. or Dyax Corp. ("Dyax") may 
  adversely affect the company's financial condition and results of 
  operations;
- the company 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 the company's revenues, 
  financial condition or results of operations;
- the company may be unable to retain and hire key personnel and/or 
  maintain its relationships with customers, suppliers and other 
  business partners;
- difficulties in integrating Dyax or Baxalta into Shire may lead to 
  the 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 Shire's, Dyax's or Baxalta's filings with the Securities and Exchange Commission, including those risks outlined in "ITEM 1A: Risk Factors" in Shire's and Baxalta's Annual Reports on Form 10-K for the year ended December 31, 2015.

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 republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Contact:

please contact:
Investor Relations
Sarah Elton-Farr seltonfarr@shire.com +44 1256 894157
Ian Karp ikarp@shire.com +1 781 482 9018
Robert Coates rcoates@shire.com +44 1256 894874

Media
Gwen Fisher gfisher@shire.com +1 484 595 9836
Debbi Ford debbi.ford@shire.com +1 224 727 2079

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