New treatment option available to adults with ADHD in the UK

Shire launches Elvanse Adult ®Description: BT_1000x858px (lisdexamfetamine dimesylate), the first licensed stimulant treatment for adults with ADHD in the UK

Basingstoke, UK  – 26 August 2015 – Shire plc (LSE: SHP, NASDAQ: SHPG) today launched Elvanse Adult® – the first licensed stimulant indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in adults.1 This provides clinicians involved in the treatment of adults with ADHD with an additional treatment option in an environment where choice is currently limited.

While commonly thought of as a childhood condition, ADHD persists to adulthood in a reported 50-66% of individuals diagnosed with the disorder in childhood.2-5 In the UK adult ADHD is thought to affect between 3 and 4% of adults.6

"As a psychiatrist working with adult ADHD for 20 years, I recognise the many ways that ADHD impacts on the lives of adults and the importance of optimising treatment – fine-tuning medication to the unique characteristics and treatment response of each individual with ADHD. The availability of therapies, such as Elvanse Adult is a welcome addition to the options available to prescribers to help adults with ADHD effectively control their symptoms" said Professor Philip Asherson, Professor in Molecular Psychiatry at King's College London and Honorary Consultant Psychiatrist at The Maudsley Hospital.

Unlike other treatments currently available for ADHD in adults, the prodrug technology of Elvanse Adult means that the inactive molecule is gradually converted in the blood, making the active part of the medicine, d-amfetamine (d-AMF), available in the body over a period of time. As a result of the prodrug technology, Elvanse Adult capsules cannot be mechanically manipulated (e.g. crushed) to release d-AMF. 1,7-10


"Shire is answering the need for a wider choice of effective medications for adults living with ADHD, who previously have had limited options" said Peter Gillberg, Acting Head of Medical Affairs, Shire UK. "We are committed to improving access to Elvanse Adult, ensuring that adults with ADHD continue to benefit from advances in treatment."

About Elvanse Adult
Elvanse Adult is indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in adult patients.1

Elvanse Adult is not indicated in all adult patients and the decision to use the medicinal product must take into consideration the profile of the patient, including a thorough assessment of the severity and chronicity of the patient's symptoms, the potential for abuse, misuse or diversion and clinical response to any previous pharmacotherapies for the treatment of ADHD.1 Treatment must be under the supervision of a specialist in behavioural disorders.

The active part of Elvanse Adult, d-amfetamine (d-AMF), is thought to work by increasing the neurotransmitters, dopamine and noradrenaline, in the synaptic space between neurons. These chemicals are stored in nerve cells in the brain, and their presence in the synaptic space controls the transmission of messages. This process is responsible for efficient activity, attention and concentration.11

Elvanse Adult safety information
Pre-treatment evaluation
Prior to prescribing, it is necessary to conduct a baseline evaluation of a patient's cardiovascular status including blood pressure and heart rate. A comprehensive history should document concomitant medications, past and present co-morbid medical and psychiatric disorders or symptoms, family history of sudden cardiac/unexplained death, and accurate recording of pre‑treatment weight. Consistent with other stimulants, the potential for abuse, misuse or diversion of Elvanse Adult should be considered prior to prescribing.1

Ongoing monitoring
Psychiatric and cardiovascular status should be continually monitored. Patients should be monitored for the risk of diversion, misuse, and abuse of Elvanse Adult.1

Long-term use
Pharmacological treatment of ADHD may be needed for extended periods. The physician who elects to use Elvanse Adult for extended periods (over 12 months) should re-evaluate the usefulness of Elvanse Adult at least yearly, and consider trial periods off medication to assess the patient's functioning without pharmacotherapy.1

Contraindications
Hypersensitivity to sympathomimetic amines or any of the excipients, concomitant use of monoamine oxidase inhibitors (MAOI) or within 14 days after MAOI treatment (hypertensive crisis may result), hyperthyroidism or thyrotoxicosis, agitated states, symptomatic cardiovascular disease, advanced arteriosclerosis, moderate to severe hypertension, glaucoma.1

Special warnings and precautions for use
Stimulants including Elvanse Adult have a potential for abuse, misuse, or diversion that physicians should consider when prescribing this product. The risk of misuse may be greater in adults (especially young adults) than in paediatric use. Stimulants should be prescribed cautiously to patients with a history of substance abuse or dependence.1

Please consult the Elvanse Adult Summary Product Characteristics (SPC) before prescribing, particularly in relation to abuse and dependence, cardiovascular adverse events, psychiatric adverse events, tics, long-term effect on weight, seizures, visual disturbance, prescribing and dispensing, and use with other sympathomimetic drugs.1

Side effects
Very common
(frequency ≥1/10):
Decreased appetite, insomnia, dry mouth and headache.1
Common
(≥1/100 to <1/10):
Agitation, anxiety, libido decreased, psychomotor hyperactivity, bruxism, dizziness, restlessness, tremor, tachycardia, palpitation, dyspnoea, diarrhoea, constipation, upper abdominal pain, nausea, hyperhidrosis, erectile dysfunction, irritability, fatigue, feeling jittery, blood pressure increased and weight decreased.1
Uncommon
(≥1/1000 to <1/100):
Hypersensitivity, logorrhea, depression, tic, affect lability, dysphoria, euphoria, dermatillomania, mania, somnolence, dyskinesia, vision blurred, vomiting, urticaria, rash and pyrexia.1

Please consult the SPC for rare (≥1/10000 to <1/1000); very rare (<1/10000), not known (cannot be estimated from the available data) side effects with Elvanse Adult.1

For further information please contact:

Media

 

Peter Gillberg M.D.,Ph.D.  

Head of Medical Affairs

          

Jenny Wilson
Communications Lead, Neuroscience Business Unit

Scott Santiamo
Communications Lead,
Neuroscience and Ophthalmic Business Units
Shire

+46 (0)734 151901


+44 (0)7738 981728


+1 484 343 2576
[email protected]

 

[email protected]

 

[email protected]

 

 


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® 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 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.     Elvanse Adult Summary of Product Characteristics, Shire Pharmaceuticals Limited.

2.     Lara C. et al. Childhood Predictors Of Adult Attention-Deficit/Hyperactivity Disorder: Results From The World Health Organization World Mental Health Survey Initiative. Biological Psychiatry. 2009;65:46-54.

3.     Faraone SV. et al. The Age-Dependent Decline Of Attention Deficit Hyperactivity Disorder: A Meta-Analysis Of Follow-Up Studies. Psychological Medicine. 2006;36:159-165.

4.     Barkley RA. et al. The Persistence Of Attention-Deficit/Hyperactivity Disorder Into Young Adulthood As A Function Of Reporting Source And Definition Of Disorder. Journal of Abnormal Psychology. 2002;111:279-289.

5.     Ebejer JL. et al. Attention Deficit Hyperactivity Disorder In Australian Adults: Prevalence, Persistence, Conduct Problems And Disadvantage. PLoS One. 2012;7:e47404.

6.     NICE. The NICE guideline on diagnosis and management of ADHD in children, young people and adults. Available at: https://www.nice.org.uk/guidance/cg72/resources/cg72-attention-deficit-hyperactivity-disorder-adhd-full-guideline-2 [Last accessed: 28 July 2015]

7.     Pennick M. Absorption of Lisdexamfetamine Dimesylate and its Enzymatic Conversion to d-Amphetamine. Neuropsychiatric Disease and Treatment. 2010;6:317-327

8.     Sharman J, Pennick M. Lisdexamfetamine prodrug activation by peptidase-mediated hydrolysis in the cytosol of red blood cells. Neuropsychiatric Disease and Treatment. 2014;10:2275-2280.

9.     Ermer J et al. Lisdexamfetamine Dimesylate: Linear Dose-Proportionality, Low Intersubject and Intrasubject Variability, and Safety in an Open-Label Single-Dose Pharmacokinetic Study in Healthy Adult Volunteers. Journal of Clinical Psychiatry. 2010;73:977-983.

10.  Jasinski D, Krishnan S. Abuse Liability and Safety of Oral Lisdexamfetamine Dimesylate in Individuals with a History of Stimulant Abuse. Journal of Psychopharmacology. 2009;23:419-427.

11.  Hodgkins P. et al. Amfetamine and methylphenidate medications for attention-deficit/hyperactivity disorder: complementary treatment options. European Child Adolescent Psychiatry 2012; 21: 477-492

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