Navigation Links
Shire Withdraws European Application for DAYTRANA(TM) (Methylphenidate Transdermal System)

DUBLIN, March 16 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has decided to withdraw the European Marketing Authorization Application (MAA) for DAYTRANA(TM) (methylphenidate transdermal system) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). A request from European regulators to conduct an additional clinical study on DAYTRANA in a European patient population combined with the recently announced planned acquisition of the worldwide rights (excluding the US, Canada and Barbados) to EQUASYM(R) IR and XL (methylphenidate hydrochloride) for the treatment of ADHD are the basis for this decision.

The decision to withdraw the MAA does not impact Shire's commitment to DAYTRANA in the U.S. where the product has been used as a pediatric treatment for ADHD since 2006.

EQUASYM IR and XL will provide Shire with an entry to the European ADHD market upon completion of the transaction, which subject to customary completion conditions, is anticipated in Q2 2009. EQUASYM XL is approved and currently marketed for the treatment of ADHD in children over 6 years of age, and is available in 10 countries outside of the US, Canada and Barbados including Denmark, Finland, Germany, Ireland, Netherlands, Norway, Sweden, UK, Mexico and South Korea. Shire will be working to progress a number of additional planned launches for EQUASYM XL in European and ROW markets.

EQUASYM will allow Shire to build on its status as the leader in the United States ADHD market with patients and customers in Europe, and establishes a solid bridge for Shire's other ADHD treatments, including VYVANSE(TM) (lisdexamfetamine dimesylate), its flagship ADHD product, in territories outside of the United States. VYVANSE is approved in the US for the treatment of ADHD in children aged 6-12 and adults. Shire continues to enroll patients in two European ADHD trials for VYVANSE.

Shire remains committed to providing a variety of medicines for the treatment of ADHD to benefit ADHD patients and their families around the world.

Notes to editors

About ADHD

ADHD is one of the most common psychiatric disorders in children and adolescents. Worldwide prevalence of ADHD is estimated at 5.3 percent (with large variability), according to a comprehensive systematic review of this topic published in 2007 in the American Journal of Psychiatry. In the United States, approximately 7.8 percent of all school-aged children, or about 4.4 million children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC). The disorder is also estimated to affect 4.4 percent of US adults aged 18-44 (approx 9.8 million) based on results from the National Comorbidity Survey Replication.

ADHD is a psychiatric behavioral 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. The specific aetiology of ADHD is unknown and there is no single diagnostic test for this syndrome. Adequate diagnosis requires the use of medical and special psychological, educational and social resources, utilizing diagnostic criteria such as Diagnostic and Statistical Manual(TM)-IV (DSM-IV) or International Classification of Diseases 10 (ICD-10).

Although there is no "cure" for ADHD, there are accepted treatments that specifically target its symptoms. Standard treatments include educational approaches, psychological, or behavioural modification, and medication.


Tell the doctor about any heart conditions, including structural abnormalities, that you, your child, or a family member, may have. Inform the doctor immediately if you or your child develops symptoms that suggest heart problems, such as chest pain or fainting.

Vyvanse should not be taken if you or your child has advanced disease of the blood vessels (arteriosclerosis); symptomatic heart disease; moderate to severe high blood pressure; overactive thyroid gland (hyperthyroidism); known allergy or unusual reactions to drugs called sympathomimetic amines (for example, pseudoephedrine); seizures; glaucoma; a history of problems with alcohol or drugs; agitated states; taken a monoamine oxidase inhibitor (MAOI) within the last 14 days.

Tell the doctor before taking Vyvanse if you or your child is being treated for or has symptoms of depression (sadness, worthlessness, or hopelessness) or bipolar disorder; has abnormal thought or visions, hears abnormal sounds, or has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or has had high blood pressure; exhibits aggressive behavior or hostility. Tell the doctor immediately if you or your child develops any of these conditions or symptoms while taking Vyvanse.

Abuse of amphetamines may lead to dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events. These events have also been reported rarely with amphetamine use.

Vyvanse was generally well tolerated in clinical studies. The most common side effects reported in studies of Vyvanse were: children - decreased appetite, difficulty falling asleep, stomachache, and irritability; adult - decreased appetite, difficulty falling asleep, and dry mouth.

Aggression, new abnormal thoughts/behaviors, mania, growth suppression, worsening of motion or verbal tics, and Tourette's syndrome have been associated with use of drugs of this type. Tell the doctor if you or your child has blurred vision while taking Vyvanse.


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 (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases 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:


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 Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate 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.

    For further information please contact:


    Jessica Mann (Rest of the World)

    Matthew Cabrey (Specialty Pharma)

SOURCE Shire Plc
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Shire Strives to Increase Adherence Among Chronic Kidney Disease Stage 5 Patients
2. Shire Enhances its Orphan Drug Pipeline With the Acquisition of a New Clinical Candidate for Metachromatic Leukodystrophy
3. Shire to Present Additional Scientific Data on ADHD Treatment Portfolio at American Psychiatric Association Annual Meeting
4. Shires Investigational Nonstimulant ADHD Treatment INTUNIV(TM) (Guanfacine Extended Release) Demonstrated Significant Efficacy in Reducing ADHD Symptoms at All Measured Time Points Up to 24 Hours Postdose
5. Shire Announces Approval of ELAPRASE(R) (idursulfase) in Brazil
6. Shire to add New Orphan Drug to its HGT Portfolio - EU Launch Imminent
7. Lilly Withdraws Application for Additional U.S. Indication for Cymbalta(R) for Chronic Pain
8. CV Therapeutics Announces Eight Abstracts Accepted for Presentation at the European Society of Cardiology Congress 2007
9. Boston Scientific Announces Schedule for European Society of Cardiology Congress 2007
10. European Experts Recommend Pregnant and Nursing Women Take More DHA - Every Day
11. Genasense(R) Data in Melanoma to be Presented in Opening Session at First Worldwide Melanoma Center Meeting of the European Association of Dermato-Oncology
Post Your Comments:
(Date:10/9/2015)... , October 9, 2015 ClinicalKey ... 7-9   Elsevier , ... and services, today launched ClinicalKey for Nursing , a ... tailored to meet the unique needs of nursing professionals. Attendees ... Atlanta , Oct. 7-9, will have the opportunity ...
(Date:10/9/2015)... 9, 2015 Eli Lilly and Company (NYSE: ... and approximately 50 new jobs to its research and development ... New York, New York . ... space will include a translational immuno-oncology hub and a Lilly ... collaborative access to cutting-edge drug discovery capabilities, including chemistry and ...
(Date:10/9/2015)... 2015 Der " JCA-Mauvernay Award ... Kondo und Dr.   Junko Takita    --> ... geht an Dr.   Yutaka Kondo und Dr. ... " JCA-Mauvernay Award   2015 " geht ... Takita    ™ , das weltweit tätige Schweizer Biopharmazieunternehmen, ...
Breaking Medicine Technology:
... DIEGO, May 2, 2012  Trovagene, Inc. (Pink Sheets: ... initiated development of a diagnostic test to determine the ... from urine specimens. The proprietary test (U.S. patent application ... determination of carrier status in males. The ...
... 2, 2012 Official journal of the American ... world-leading provider of scientific, technical and medical information products and ... the American Association for Geriatric Psychiatry (AAGP) to ... ( AJGP ) beginning in January 2013. ...
Cached Medicine Technology:
(Date:10/9/2015)... ... , ... With the FCPX LUT Vibrance pack from Pixel Film Studios, editors ... Lookup Table that contains a mathematical formula for modifying an image. The LUT changes ... with 60 vibrant CUBE LUT files. , Inspired by many YouTube make-up ...
(Date:10/9/2015)... ... 09, 2015 , ... Dentist in Huntington Beach , ... that uses clear, plastic aligners. This alternative to braces has become wildly popular ... patients to complete treatment in privacy. Additionally, Invisalign aligners are removable, so patients ...
(Date:10/9/2015)... Stockton, CA (PRWEB) , ... October 09, 2015 ... ... year anniversary of their “Agents of Change” program, a community improvement initiative that ... The newest charity to benefit from the assistance of Confidence Plus Insurance is ...
(Date:10/9/2015)... ... October 09, 2015 , ... ViewPoint Center, a teen mental health hospital ... mental illness, the stigma associated with mental illness causes many to hide away in ... importance of supporting teens with mental illness , providing teens with comprehensive diagnostic ...
(Date:10/9/2015)... ... , ... Most people assume that Chinese food is more nutritious than American ... T’ai Chi Master and integrative medicine guru Steven Aung, MD agrees with that assessment, ... that they potentially complement one another, with each supplying nutritional elements the other may ...
Breaking Medicine News(10 mins):
... Sales and Marketing Veteran to Drive International Retail Expansion, ... Group and New WrinkleFree Brand Line ExtensionIRVINE, Calif., Jan. ... developer and distributor of medically developed and efficacy-based skin ... mass market retail locations throughout the U.S., announced today ...
... The following statement can be attributed to Michael ... has consistently said two things: We are not ... But we have urged public policy makers to ... merger without conditions, because without conditions the merger ...
... (Nasdaq: OMCL ), a leading provider of system solutions to acute healthcare ... quarter 2008 financial results. , What: Omnicell ... webcast, When: January ... Lipps, chairman, president and chief executive officer, ...
... Maine, Jan. 21 IDEXX Laboratories, Inc. (Nasdaq: ... quarter and full-year financial results for Friday, January 30, at ... conference call beginning at 9:00 a.m. (eastern) on that day. ... through a link on the IDEXX Web site, ...
... can lead to failure, , , WEDNESDAY, Jan. 21 (HealthDay ... a common cause of kidney transplant failure may help ... polyomavirus nephropathy, which affects about 9 percent of kidney ... adults but can cause serious problems for people with ...
... CAMBRIDGE, Mass. -- Schizophrenia may blur the boundary between ... that is involved in self-reflection, and thus causing an ... brain imaging study has found. , The traditional ... and emotions that characterize the disease are caused by ...
Cached Medicine News:
... 4 Dot with 955R Red/Green glasses ... presence of binocular vision. Consists of ... discs: two green, one red and ... any distance. Patient wears red/green glasses ...
20 foot distance 22-1/2" X 11-1/2". This test for illiterate patients has HOTV letters on one side and Allen figures on the other....
Angled 30 degree shaft. 13 mm from tip to bend with 2.5 mm hook curved tip. Polished finished. Overall length excluding hub: 35 mm, 1.4 inches....
McIntyre-Binkhorst, length 18 mm....
Medicine Products: