Shire Receives European Approval for INTUNIV®▼ (Guanfacine Hydrochloride Prolonged Release Tablets) as a Non-stimulant A

Publicado 21/09/2015 8:01:56CET

Side effects

Very common

(frequency

greater than or

equal to1/10): Somnolence, headache, abdominal pain and fatigue.

Decreased appetite, depression, anxiety, affect lability,

insomnia, middle insomnia, nightmare, sedation, dizziness,

lethargy, bradycardia, hypotension, orthostatic

Common hypotension, vomiting, diarrhoea, nausea, constipation,

(greater than or abdominal/stomach discomfort, dry mouth, rash, enuresis,

equal to1/100 to irritability, blood pressure decreased and weight

<1/10): increased

Hypersensitivity, agitation, hallucination, convulsion,

syncope/loss of consciousness, dizziness postural,

atrioventricular block first degree, tachycardia, sinus

Uncommon arrhythmia, pallor, asthma, dyspepsia, pruritis,

(greater than or pollakiuria, asthenia, chest pain, blood pressure

equal to1/1000 to increased, heart rate decreased and alanine

<1/100): aminotransferase increased.

Please consult the SPC for rare (greater than or equal to1/10000 to <1/1000) side effects with Intuniv.

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 provide 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.

http://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(R) and INTUNIV(R) 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.

REFERENCES: 

1) Intuniv Summary of Product Characteristics. Shire Pharmaceuticals Ireland Limited.

2015.

2) HERVAS A, et al. (2014) Efficacy and safety of extended-release guanfacine

hydrochloride in children and adolescents with attention-deficit/hyperactivity

disorder: a randomized, controlled, phase III trial. Eur Neuropsychopharmacol.

24:1861-72.

3) NEWCORN JH, et al. (2014) 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. Poster presented at the 22nd

European Congress of Psychiatry; Munich, Germany.

4) WILENS TE, et al. (2014) A multicentre, placebo-controlled trial of guanfacine

extended release in adolescents with attention-deficit/hyperactivity disorder. Poster

presented at the 3rd EUNETHYDIS International Conference on ADHD; Istanbul, Turkey.

5) POLANCZYK G, et al. (2007) The worldwide prevalence of ADHD: a systematic review and

metaregression analysis. Am J Psychiatry. 164:942-8.

6) WILLCUTT EG. (2012) The prevalence of DSM-IV attention-deficit/hyperactivity disorder:

a meta-analytic review. Neurotherapeutics. 2012;9:490-9.

7) American Psychiatric Association. (2013) Diagnostic and statistical manual of mental

disorders: DSM-5 (5th ed.). Arlington, VA: American Psychiatric Publishing.

8) International Classification of Diseases, 10th ed. (ICD-10). World Health Organization

2007. Chapter 5, F90. Available at:

http://apps.who.int/classifications/icd10/browse/2010/en#/F9... Last accessed

September 2015.

9) LANGLEY K, et al. (2007) Effects of Low Birth Weight, Maternal Smoking in Pregnancy

and Social Class on the Phenotypic Manifestation of Attention Deficit Hyperactivity

Disorder and Associated Antisocial Behaviour: Investigation in a Clinical Sample. BMC

Psychiatry. 7:26.

10) FARAONE S, et al. (2005) Molecular Genetics of Attention Deficit Hyperactivity

Disorder. BioPsych 57:1313-1323.

11) NIGG J, et al. (2010) Measured Gene-by-environment Interaction in Relation to

Attention-deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry.

49:863-873.

 

For further information, please contact: 

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Media 

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Gwen Fisher 

gfisher@shire.com 

+1-484-595-9836 

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Deborah Hibbett 

dhibbett@shire.com 

+41-41-288-4359

 

 

Investors 

EmptyBreak:MARKER 

Sarah Elton-Farr 

seltonfarr@shire.com 

+44(0)1256 894157

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