Shire to Present New Research at 2016 American Psychiatric Association Annual Meeting

Shire to Present New Research at 2016 American Psychiatric Association Annual Meeting

May 11, 2016

Reinforces Long-Standing Commitment to Furthering Knowledge of B.E.D. and ADHD

Lexington, MA – May 11, 2016 – For US Audiences Only – Shire plc (LSE: SHP, NASDAQ: SHPG) will present new research on Binge Eating Disorder (B.E.D.) and Attention-Deficit/Hyperactivity Disorder (ADHD) at the upcoming 169th Annual Meeting of the American Psychiatric Association (APA) in Atlanta, GA, demonstrating its ongoing commitment to furthering the understanding and management of psychiatric disorders.

“The data being presented this year at APA will address several important topics within the adult psychiatry therapeutic area, including the characterization of eating behaviors in adults with binge eating disorder, as well as patterns of prescription medication use in two psychiatric disorders,” said Barry K. Herman, MD, MMM, DLFAPA, Global Medical Team Lead, Senior Medical Director for Shire. “These presentations underscore our long-standing commitment to furthering knowledge of psychiatric conditions and advancing research into the unmet needs of people with B.E.D. and ADHD.”

Posters presented during the conference will include:  

  • Poster Number P6-048; Monday, May 16, 2:00pm EDT: The Use and Value of the 7-Item Binge Eating Disorder Screener in Clinical Practice; Presented by Barry K. Herman, MD, MMM, DLFAPA
  • Poster Number P6-136; Monday, May 16, 2:00pm EDT: A Register-Based Case-Control Study of Prescription Medication Utilization in Binge Eating Disorder; Presented by Barry K. Herman, MD, MMM, DLFAPA
  • Poster Number P8-040; Tuesday, May 17, 2:00pm EDT: Medication Use among Commercially-insured Adults with Attention-Deficit/Hyperactivity Disorder (ADHD) in the US; Presented by Zhou Zhou, PhD

Poster Number P6-136 is part of a Shire-funded research partnership with scientists from the University of North Carolina at Chapel Hill; Karolinska Institutet in Stockholm, Sweden; and Shire. The partnership was established to optimize the Swedish National Registers’ extensive data to enhance researchers’ understanding of the critical dimensions of B.E.D. in adults, including the prevalence, correlates, comorbidity, course, treatment, and outcome of B.E.D. The partnership is an example of Shire’s dedication to research that advances the understanding of mental health disorders.

“Continued research on binge eating disorder in adults is crucial to expanding our understanding of the disorder,” said Cynthia Bulik, PhD, FAED, Distinguished Professor of Eating Disorders, Department of Psychiatry, University of North Carolina at Chapel Hill, and co-author of P6-136. “We value our collaboration with Shire to enhance efforts to educate health care professionals who evaluate adults living with B.E.D.”

About B.E.D.

Binge Eating Disorder (B.E.D.), recognized in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5®) as a distinct eating disorder in 2013, is defined as recurring episodes (on average, at least once weekly, for 3 months) of consuming an unusually large amount of food in a short time, compared with what others would consume under the same or similar circumstances. Adults with B.E.D. feel a sense of lack of control over eating during a binge eating episode and marked distress over their binge eating. They typically experience shame and guilt about their binge eating, among other symptoms, and may conceal their eating problems. Unlike people with other eating disorders, adults with B.E.D. don’t routinely try to “undo” their excessive eating with extreme actions like purging or over-exercising. Only a doctor or other qualified health care professional (HCP) can diagnose B.E.D. and determine an appropriate treatment plan.

B.E.D. is the most common eating disorder among US adults, and is more than twice as common as anorexia nervosa and bulimia nervosa combined. The disorder occurs in both men and women, is seen across racial and ethnic groups in US adults, and can occur in normal weight, overweight, and obese adults.

About ADHD

Attention-Deficit/Hyperactivity Disorder (ADHD) is a neurobehavioral disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development and is inconsistent with developmental level.

ADHD is one of the most common childhood psychiatric disorders. An estimated 11 percent
(6.4 million) of US school-aged children have been diagnosed with ADHD in their lifetime, based on the 2011/12 National Survey of Children’s Health, in which parents were asked if a health care practitioner had ever told them their child had ADD or ADHD. Although many people tend to think of ADHD as a childhood problem, 60% to 85% of children with ADHD may continue to meet the criteria for the disorder during their teenage years. Nearly 50% of children with ADHD may continue to meet the criteria for the disorder in adulthood, based on parent report. The disorder is estimated to affect 4.4 percent of US adults aged 18 to 44 based on results from the National Comorbidity Survey Replication. When this percentage is extrapolated to the full US population aged 18 and over, approximately 10.5 million adults are estimated to have ADHD. Drug treatment may not be appropriate for all patients with ADHD.

The specific etiology of ADHD is unknown. The diagnosis is made utilizing criteria specified in the DSM-5 or International Classification of Diseases, 10th revision (ICD-10).

While there is no cure for ADHD, there are accepted treatments that may help. These often include education, counseling, and/or medication. Only a health care professional (HCP) can accurately diagnose ADHD.

DSM-5® is a registered trademark of the American Psychiatric Association.

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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.

Forward-Looking Statements
Statements included herein that are not historical facts, including without limitation statements concerning our announced business combination with Baxalta and the timing and financial and strategic benefits thereof, our 20x20 ambition that targets $20 billion in combined product sales by 2020, as well as other targets for future financial results, capital structure, performance and sustainability of the combined company, the combined company’s 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:

  • the proposed combination with Baxalta may not be completed due to a failure to satisfy certain closing conditions, including any shareholder or regulatory approvals or the receipt of applicable tax opinions;
  • disruption from the proposed transaction with Baxalta may make it more difficult to conduct business as usual or maintain relationships with patients, physicians, employees or suppliers;
  • the combined company may not achieve some or all of the anticipated benefits of Baxalta’s spin-off from Baxter International, Inc. (“Baxter”) and the proposed transaction 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 proposed combination with Baxalta may adversely affect the combined 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 combined 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 combined company’s ability to sell or market products profitably, and fluctuations in buying or distribution patterns by such customers can adversely affect the combined company’s revenues, financial condition or results of operations;
  • investigations or enforcement action by regulatory authorities or law enforcement agencies relating to the combined 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 and other disputes, including the combined 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 combined 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 combined 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 combined company’s financial condition and results of operations;
  • the combined company will be 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 combined company’s revenues, financial condition or results of operations;
  • the combined 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 combined 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 (“SEC”), 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.