Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced the acceptance for review of their once-daily ADHD medicinal product VENVANSE® (lisdexamfetamine dimesylate) by the Medicines Healthcare products Regulatory Agency (MHRA), UK. The MHRA have agreed to act as the Reference Member State for this Decentralised Procedure (DCP) which will initially include eight European countries.This application follows the successful completion of the European Phase 3 study of VENVANSE in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) last year.*
VENVANSE® is the first long-acting prodrug stimulant and is currently commercialized in the US, and Canada for the treatment of ADHD in children, adolescents and adults (under the tradename VYVANSE®) and in Brazil for the treatment of ADHD in children (under the trade name VENVANSE®).
“The regulatory submission of VENVANSE in Europe is an important milestone for Shire and for physicians in the EU who are seeking alternative treatments to help their patients diagnosed with ADHD,” said Mike Yasick, Senior Vice President of Shire’s ADHD business unit. “VENVANSE is an approved ADHD treatment in North and South America and has become an important resource for physicians when helping their patients manage their ADHD symptoms, We look forward to making this treatment available in Europe.”
* A randomised, double-blind, multicentre, parallel-group, placebo- and active controlled, dose-optimisation, safety and efficacy study in 336 children and adolescents aged 6 to 17 years (data from this study were publicly disclosed on October 21st at the AACAP congress 2011 in Toronto)
About lisdexamfetamine dimesylate1;2
VENVANSE (LDX) is available as a prescription-only medicine in the USA (brand name VYVANSE® ; approved for the treatment of ADHD in children and adolescents aged 6 to 17 and adults), Canada (brand name VYVANSE® (available for use in children and adolescents aged 6 to 17 and adults) and Brazil (VENVANSE™; approved for children aged 6-12 years)
LDX should be used as part of a total treatment program that may include counseling or other therapies.
LDX is a prodrug of dextroamfetamine. After oral administration, LDX is rapidly absorbed from the gastrointestinal tract and hydrolyzed primarily in whole blood to dextroamfetamine, which is responsible for the drug’s activity.
The safety and tolerability profiles of LDX are generally consistent with those of other CNS (central nervous system) stimulant medications, the most common side effects being decreased appetite, insomnia, abdominal pain, headache, and irritability.
About VYVANSE (from US safety information)
VYVANSE is a stimulant medication and federally controlled substance (CII) because it can be abused or lead to dependence. Keep VYVANSE in a safe place to prevent misuse and abuse. Selling or giving away VYVANSE may harm others, and is against the law. Misuse of stimulants may cause sudden death and serious cardiovascular adverfse events.
IMPORTANT SAFETY INFORMATION
|Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep in a safe place to prevent misuse and abuse. Selling or giving away Vyvanse may harm others, and is illegal. Vyvanse is a stimulant. Misuse of stimulants may cause sudden death and serious heart problems.|
This is not a complete summary of safety information. For additional safety information, please contact Shire’s medical information office at firstname.lastname@example.org.
ADHD is one of the most common psychiatric disorders in children and adolescents.3;4 Worldwide prevalence of ADHD is estimated at 5.3 percent.5
ADHD is a psychiatric behavioural disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development.6;7 The exact origin of ADHD is unknown, but scientists speculate the disorder may be caused, in part, by an imbalance of two neurotransmitters, dopamine (DA) and noradrenaline (NA), which are believed to play an important role in the ability to focus and pay attention to tasks.8 Adequate diagnosis requires the use of medical and special psychological, educational and social resources, utilising diagnostic criteria such as Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV-TR) or International Classification of Diseases 10 (ICD-10).6;7
Although there is no “cure” for ADHD, there are accepted treatments that specifically target its symptoms. A multimodal treatment approach that combines medication and behavioural modifications are found to be most effective in managing ADHD.9
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Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder, human genetic therapies, gastrointestinal diseases and regenerative medicine as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company’s website: www.shire.com.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein 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, the Company’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company’s Specialty Pharmaceuticals, Human Genetic Therapies and Regenerative Medicine products, as well as the ability to secure new products for commercialization and/or development; government regulation of the Company’s products; the Company’s ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company’s products; the Company’s ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company’s ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company’s filings with the Securities and Exchange Commission.