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Shire plc Submits Elvanse® (Lisdexamfetamine Dimesylate) For An Adult Licence In The UK, Denmark And Sweden


2/19/2014 9:33:03 AM

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Nyon, Switzerland – February 19, 2014 – Shire plc (LSE: SHP, NASDAQ: SHPG) today announced the acceptance for review of an application for an adult indication, for their once-daily Attention Deficit/Hyperactivity Disorder (ADHD) medication Elvanse® (lisdexamfetamine dimesylate), for newly diagnosed adult patients. The application was accepted by the Medicines Healthcare products Regulatory Agency (MHRA), UK. The MHRA have agreed to act as the Reference Member State for this Decentralised Procedure, which will include the UK, Denmark and Sweden.

Elvanse, the first long-acting prodrug stimulant for the treatment of ADHD, is currently licensed in 8 European countries for the treatment of children 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate.1

“The regulatory submission for the adult indication for Elvanse in Europe is a key milestone for both Shire and adults with ADHD,” said Perry Sternberg, Senior Vice President of the Neuroscience Business Unit at Shire. “ADHD is sometimes only diagnosed in adulthood and, in Europe, the choice of licensed medications for newly diagnosed adults with ADHD is currently limited. After receipt of regulatory approval, Elvanse will bring a new treatment option to adults with ADHD.”

It is estimated that anywhere between 1.0 to 7.3 percent of adults are affected by ADHD worldwide.2-6 ADHD may have a significant impact on an adults’ life, including educational and occupational achievement, criminal behaviour and relationships.7-14

Evidence for the submission is based on results from several clinical studies designed to evaluate the efficacy, effectiveness and safety of Elvanse in adults with ADHD.15-17

About Elvanse

Elvanse is indicated in 8 European countries as part of a comprehensive treatment programme for ADHD in children 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate.1 Elvanse is not indicated in all children with ADHD and the decision to use the drug must be based on a very thorough assessment of the severity and chronicity of the child’s symptoms in relation to the child’s age and potential for abuse, misuse or diversion.1

Please consult the Summary of Product Characteristics before prescribing Elvanse, particularly in relation to abuse and dependence, pre-treatment evaluation and ongoing monitoring, cardiovascular adverse events, psychiatric adverse events, tics, long-term suppression of growth (height and weight), seizures, visual disturbance, prescribing and dispensing, and use with other sympathomimetic drugs.1

Stimulants including Elvanse have a potential for abuse, misuse, dependence or diversion for non-therapeutic uses that physicians should consider when prescribing this product. Stimulants should be prescribed cautiously to patients with a history of substance abuse or dependence.1

Elvanse is available in the following countries:

- UK, Denmark, Germany and Sweden (2013). It has also received marketing authorisation (but is not yet available) in Spain, Finland and Norway

- Ireland (2013) under the brand name Tyvense®

- US (2007), Canada (2010) and Australia (2013) under the brand name Vyvanse®

- Brazil (2011) under the brand name Venvanse®

About ADHD

ADHD is a common psychiatric disorder18-20 and is recognised by the World Health Organization (WHO).21 Worldwide prevalence is estimated at 5.3 percent for children/adolescents22 and anywhere between 1.0 to 7.3 percent for adults.2-6 While the exact origin of ADHD is not understood, it is thought to result from complex interactions between genetic and environmental factors.23-25 Environmental factors which may increase the risk of developing ADHD include low birth weight/prematurity and maternal smoking and/or alcohol use during pregnancy.25-26

For further information please contact:

Media
Nicole Barraud nbarraud@shire.com
+41 22 419 40 56
Gwen Fisher gfisher@shire.com
+1 484 595 9836

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.

www.shire.com

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 the 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.
References

1. Elvanse® Summary of Product Characteristics (SPC), Shire Pharmaceuticals Limited 2013.
2. Simon V, Czobor P, Balint S, et al. Prevalence and correlates of adult attention-deficit hyperactivity disorder: meta-analysis. Br J Psychiatry 2009; 194: 204-211.
3. Kessler RC, Adler L, Barkley RA, et al. The prevalence and correlates of adult ADHD in the United States: results from the National Comorbidity Survey Replication. Am J Psychiatry 2006; 163: 716-723.
4. Fayyad J, De Graaf R, Kessler R, et al. Cross-national prevalence and correlates of adult attention-deficit hyperactivity disorder. Br J Psychiatry 2007; 190: 402-409.
5. de Zwaan M, Gruss B, Müller A, et al. The estimated prevalence and correlates of adult ADHD in a German community sample. Eur Arch Psychiatry Clin Neurosci 2012; 262: 79-86.
6. Polanczyk G, Laranjeira R, Zaleski M, et al. ADHD in a representative sample of the Brazilian population: estimated prevalence and comparative adequacy of criteria between adolescents and adults according to the item response theory. Int J Methods Psychiatr Res 2010; 19: 177- 184.
7. Biederman J, Faraone SV, Spencer TJ, et al. Functional impairments in adults with self-reports of diagnosed ADHD: A controlled study of 1001 adults in the community. J Clin Psychiatry 2006; 67: 524-540.
8. Bijlenga D, van der Heijden KB, Breuk M, et al. Associations between sleep characteristics, seasonal depressive symptoms, lifestyle, and ADHD symptoms in adults. J Atten Disord 2013; 17: 261-275.
9. Yoon SY, Jain UR, Shapiro CM. Sleep and daytime function in adults with attention- deficit/hyperactivity disorder: subtype differences. Sleep Med 2013; 14: 648-655.
10. Surman CB, Adamson JJ, Petty C, et al. Association between attention-deficit/hyperactivity disorder and sleep impairment in adulthood: evidence from a large controlled study. J Clin Psychiatry 2009; 70: 1523-1529.
11. Lichtenstein P, Halldner L, Zetterqvist J, et al. Medication for attention deficit-hyperactivity disorder and criminality. N Engl J Med 2012; 367: 2006-2014.
12. Torgersen T, Gjervan B, Rasmussen K. ADHD in adults: a study of clinical characteristics, impairment and comorbidity. Nord J Psychiatry 2006; 60: 38-43.
13. Barkley RA, Murphy KR, Dupaul GI, et al. Driving in young adults with attention deficit hyperactivity disorder: knowledge, performance, adverse outcomes, and the role of executive functioning. J Int Neuropsychol Soc 2002; 8: 655-672.
14. Lensing MB, Zeiner P, Sandvik L, et al. Quality of Life in Adults Aged 50+ With ADHD. J Atten Disord 2013 Mar 20. [Epub ahead of print]
15. Adler LA, Goodman DW, Kollins SH, et al. Double-blind, placebo-controlled study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2008 Sep;69(9):1364-73.
16. Weisler R, Young J, Mattingly G, et al. Long-term safety and effectiveness of lisdexamfetamine dimesylate in adults with attention-deficit/ hyperactivity disorder. CNS Spectr. 2009 Oct;14(10):573-85.
17. Brams M, Weisler R, Findling RL, et al. Maintenance of Efficacy of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder: Randomized Withdrawal Design. J Clin Psychiatry. 2012;73(7):977-983.
18. 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.
19. Bloom B, et al. Summary Health Statistics for U.S. Children: National Health Interview Survey, 2010. Vital Health Stat 10. 2011; (250):1-80.
20. 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.
21. 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.
22. Polanczyk G, et al. The Worldwide Prevalence of ADHD: A Systematic Review and Metaregression Analysis. Am J Psych 2007;164:942–948.
23. Valera EM, et al. Meta-Analysis of Structural Imaging Findings in Attention-Deficit/Hyperactivity Disorder. Biol Psychiatry 2007; 61:1369.
24. Gizer IR, et al. Candidate Gene Studies of ADHD: A Meta-Analytic Review. Hum Genet 2009; 126:51-90.
25. Sagiv SK, et al. Pre- and Postnatal Risk Factors for ADHD in a Nonclinical Pediatric Population. J Atten Disord 2012; 17:47-57.
26. 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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