Shire plc Release:” New Phase 3 Data For Guanfacine Extended Release (GXR) To Be Presented At European Congress Of Psychiatry
Nyon, Switzerland – February 27, 2014 – Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that scientific data from two of its guanfacine extended release (GXR) European pivotal Phase 3 clinical studies are being presented at the 22nd European Congress of Psychiatry in Munich, Germany, March 1-4. Data being presented include efficacy studies with GXR for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) in children and adolescents. GXR is not licensed for use in the European Union.
The data will be presented as posters at the European Congress of Psychiatry, as follows:
- “Guanfacine XR (GXR) for children and adolescents with attention-deficit/hyperactivity disorder (ADHD): phase 3, randomized, double-blind, multicenter, placebo- and active-reference study” [A. Hervas, Spain; Clinicaltrials.gov identifier: NCT01244490; European and North American sites]
Oral poster presentation: Tuesday March 4, 08:00–09:30 CET - “Long-term maintenance of efficacy of extended-release guanfacine hydrochloride (GXR) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD): double-blind, placebo-controlled, multicentre, phase 3 randomized withdrawal study” [J. Newcorn, USA; Clinicaltrials.gov identifier: NCT01081145; European and North American sites]
Poster presentation: Tuesday March 4, 12:30–13:15 CET
Guanfacine extended release (GXR) contains the active substance guanfacine hydrochloride. It is a long-acting, non-stimulant medicine to be taken once a day. GXR is currently available as a prescription-only medicine (INTUNIV®) in the USA; approved for use as a monotherapy or adjunctively with a stimulant medication for ADHD in children and adolescents 6 -17 years of age inclusive. GXR (INTUNIV XR®) is approved in Canada for use in children only with ADHD as a monotherapy or adjunctively with a stimulant medication as part of a treatment programme. Side effects reported during GXR clinical trials were generally mild to moderate in severity, the most common being fatigue, headache, abdominal pain, and somnolence. GXR is not licensed for use in the European Union.
ADHD is a common psychiatric disorder1-3 and is recognised by the World Health Organization (WHO).4 Worldwide prevalence is estimated at 5.3 per cent for children/adolescents.5 While the exact origin of ADHD is not understood, it is thought to result from complex interactions between genetic and environmental factors.6-8 Environmental factors which may increase the risk of developing ADHD include low birth weight/prematurity and maternal smoking and/or alcohol use during pregnancy.8-9
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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 provide treatments in Neuroscience, Rare Diseases, Gastrointestinal and Internal Medicine, and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas.
FORWARD - LOOKING STATEMENTS - "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. 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;
- revenues from ADDERALL XR are subject to generic erosion and revenues from INTUNIV will become subject to generic competition starting in December 2014;
- the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payors in a timely manner for Shire's products may impact future revenues, financial condition and results of operations;
- Shire conducts its own manufacturing operations for certain of its Rare Diseases products and is reliant on third party contractors 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 development, approval and manufacturing of Shire’s products is subject to extensive oversight by various regulatory agencies and regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
- 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 impact 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 the distraction of senior management, 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, academic institutions, government entities and other organizations. Shire is undergoing a corporate reorganization and the consequent uncertainty could adversely impact 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 ViroPharma Incorporated 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 U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K.
1. Pliszka S & the AACAP Work Group on Quality Issues. Practice Parameter for the Assessment and Treatment of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry 2007; 46(7):894-921.
2. Bloom B, et al. Summary Health Statistics for U.S. Children: National Health Interview Survey, 2010. Vital Health Stat 10. 2011; (250):1-80.
3. McCarthy S, et al. The Epidemiology of Pharmacologically Treated Attention Deficit Hyperactivity Disorder (ADHD) in Children, Adolescents and Adults in UK Primary Care. BMC Pediatr. 2012; 12:78.
4. International Classification of Diseases, 10th ed., (ICD-10). World Health Organization 2007: Chapter 5,F90. http://apps.who.int/classifications/icd10/browse/2010/en#/F90-F98. Last accessed January 2014.
5. Polanczyk G, et al. The Worldwide Prevalence of ADHD: A Systematic Review and Metaregression Analysis. Am J Psych 2007;164:942–948.
6. Valera EM, et al. Meta-Analysis of Structural Imaging Findings in Attention-Deficit/Hyperactivity Disorder. Biol Psychiatry 2007; 61:1369.
7. Gizer IR, et al. Candidate Gene Studies of ADHD: A Meta-Analytic Review. Hum Genet 2009; 126:51-90.
8. Sagiv SK, et al. Pre- and Postnatal Risk Factors for ADHD in a Nonclinical Pediatric Population. J Atten Disord 2012; 17:47-57.
9. Heinonen K,Räikkönen K, Pesonen AK, et al. Behavioural symptoms of attention deficit/hyperactivity disorder in preterm and term children born small and appropriate for gestational age: a longitudinal study. BMC Pediatr 2010; 10: 91.
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