New Shire research to be presented at World Congress on ADHD highlights treatment portfolio, pipeline and caregiver experiences

May 26, 2015

Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that new data advancing the understanding of attention deficit/hyperactivity disorder (ADHD) will be presented at the 5th World Congress on ADHD in Glasgow, UK, May 28 – 31. These data will include findings from the company’s portfolio of approved and investigational medicines for ADHD, and from the CAPPA study measuring the social and professional impact of the disorder among caregivers in Europe.

“For many years now Shire’s commitment to advancing our understanding of ADHD has been driven by a passion to improve the experiences of those living with the disorder,” said Philip J. Vickers, Ph.D., Head of Research and Development, Shire. “We will continue to honor this commitment at the 2015 World Congress on ADHD by sharing research from our evolving portfolio of ADHD medications and important findings characterizing the real world impact of the disorder on patients and caregivers across Europe.”

Shire data to be presented at the World Congress on ADHD include the following highlights:

Abstract title

Author

Timings

Healthcare use in children with ADHD in France: results from the QUEST survey

C. Hervé, et al.

Poster presentation: Friday 29 May 2015,

16.00 – 17.30 BST

The impact of comorbid conditions on caregivers’ work, social and family activities: results from the CAregiver Perspective on Pediatric ADHD (CAPPA) study in Europe

K. Chen, et al.

Poster presentation: Friday 29 May 2015,

16.00 – 17.30 BST

Safety outcomes from a phase 4, open-label, multicentre, 2-year study of LDX in children/adolescents with ADHD

A. Zuddas, et al.

Poster presentation: Saturday 30 May 2015, 16.00 – 17.30 BST

Real-world treatment outcomes in adults with attention deficit/hyperactivity disorder treated with lisdexamfetamine versus atomoxetine following methylphenidate treatment

A. Joseph, et al.

Poster presentation: Friday 29 May 2015,

16.00 – 17.30 BST

 

Cost-effectiveness of guanfacine extended-release for the treatment of children and adolescents with attention deficit/hyperactivity disorder (ADHD) in the UK

A. Joseph, et al.

Poster presentation: Friday 29 May 2015,

16.00 – 17.30 BST

 

Clinical efficacy of guanfacine extended release among children with primarily inattentive subtype of attention-deficit/hyperactivity disorder: results from four phase 3 studies

M. Huss, et al.

Poster presentation: Friday 29 May 2015,

16.00 – 17.30 BST

 

 

Clinical response and symptomatic remission in adolescents with attention- deficit/hyperactivity disorder receiving guanfacine extended release in a phase 3 study

TE. Wilens, et al.

Poster presentation: Saturday 30 May 2015, 16.00 – 17.30 BST

 

Randomized, Double-Blind, Active- and Placebo-Controlled Trials of Lisdexamfetamine Dimesylate in Adolescents With Attention-Deficit/Hyperactivity Disorder

JH. Newcorn, et al.

Poster presentation: Friday 29 May 2015,

16.00 – 17.30 BST

 

 

 

About ADHD

ADHD is a common psychiatric disorder and is recognised by the World Health Organization (WHO). The core symptoms are inattention, hyperactivity and impulsivity. Worldwide prevalence is estimated to be between 5.29% and 7.1%, and just under 5% in Europe for children and adolescents (<18 years). While the exact origin of ADHD is not known, studies have indicated that ADHD is typically associated with structural and functional brain abnormalities.

For further information please contact:

Media

 

 

Scott Santiamo

ssantiamo@npsp.com

+1 908 450 5599

Deborah Hibbett

dhibbett@shire.com

+41 (41) 288 4359

NOTES TO EDITORS

Shire enables people with life-altering conditions to lead better lives.

Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.

We focus on providing treatments in Rare Diseases, Neuroscience, Gastrointestinal and Internal Medicine and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmics.

www.shire.com

THE “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included in this announcement that are not historical facts 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, that:

  • Shire’s products may not be a 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 Shire's products may affect 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 the Shire’s products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of the 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 significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
  • 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;
  • 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;
  • adverse outcomes in legal matters 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 Shire’s revenues, financial condition or results of operations;
  • Shire faces intense competition for highly qualified personnel from other companies and organizations. Shire is undergoing a corporate reorganization and was the subject of an unsuccessful acquisition proposal and the consequent uncertainty could adversely affect Shire’s ability to attract and/or retain the highly skilled personnel needed for Shire to meet its strategic objectives;
  • failure to achieve Shire’s strategic objectives with respect to the acquisition of NPS Pharmaceuticals, Inc. may adversely affect Shire’s financial condition and results of operations;

and other risks and uncertainties detailed from time to time in Shire’s filings with the US Securities and Exchange Commission, including its most recent Annual Report on Form 10-K.

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