11th Aug 2010 07:00
Shire agrees to divest Daytrana® (methylphenidate transdermal system) CII to Noven Pharmaceuticals, Inc.; Shire's 2010 earnings outlook unchanged
Dublin, Ireland - August 11, 2010 - Shire plc , theglobal specialty biopharmaceutical company, announced the divestiture of Daytrana® (methylphenidate transdermal system) to Noven Pharmaceuticals, Inc.Daytrana, which is approved and marketed in the US for the treatment ofAttention Deficit Hyperactivity Disorder (ADHD) in children and adolescents,will continue to be available for patients through Noven.Shire's divestiture agreement grants Noven global marketing rights for Daytranaand is effective October 1, 2010. The book value of the assets to be disposedis approximately $95 million (or a gross, pre-amortization value ofapproximately $150 million). Shire's 2010 outlook of Non GAAP earnings trendingtowards $4.00 per ADS which was recently announced in its second quarterearnings press release is unchanged.
Noven developed and manufactures Daytrana, and Noven licensed Daytrana to Shire in 2003. The US Food and Drug Administration (FDA) approved Daytrana as a treatment for ADHD in children and adolescents in April 2006 and June 2010, respectively.
For further information please contact:
Investor Eric Rojas ([email protected]) +1 781 482 0999 Relations Media Jessica Mann ([email protected]) +44 1256 894 280 Matthew Cabrey ([email protected]) +1 484 595 8248 IndicationDaytrana is a prescription central nervous system (brain) stimulant medicineused to treat ADHD in people 6 to 17 years old. Daytrana may help increaseattention and decrease impulsive and hyperactive behavior. Daytrana should beused as a part of a total treatment program for ADHD that may includecounseling or other therapies.Important Safety InformationIMPORTANT: Daytrana is a controlled substance (CII) because it can be abused or lead to dependence. Keep Daytrana in a safe place to protect it from theft. Selling or giving away Daytrana may harm others and is against the law.
Tell the prescribing doctor if your child has ever abused or been dependent on alcohol, prescription medicines or street drugs.
Daytrana should not be used if your child is very anxious, tense, or agitated;has an eye problem called glaucoma; has tics (repeated movements or sounds thatcannot be controlled) has a diagnosis or family history of seizures or has adiagnosis or family history of Tourette's syndrome; or have had an abnormalbrain wave test (EEG); is taking a monoamine oxidase inhibitor (MAOI) medicineor has discontinued an MAOI medicine in the last 2 weeks; is pregnant orbreastfeeding; is allergic to methylphenidate or any other ingredients ofDaytrana.
Serious heart problems have been reported with Daytrana or other stimulant medicines including:
* sudden death in people with heart problems or heart defects * stroke and heart attack in adults * increased blood pressure and heart rate Tell the doctor if your child or a family member has any heart problems, heartdefects, or increased blood pressure and heart rate. Remove the Daytrana patchand call the doctor right away if your child has any signs of heart problemssuch as chest pain, shortness of breath, or fainting while using Daytrana.
Serious mental (psychiatric) problems have been reported with Daytrana or other stimulant medicines including:
* new or worse aggressive behavior, hostility, anger or irritability
* new or worse bipolar illness or mania (an extreme increase in activity or
talking)
* new or worse psychosis (hearing or seeing things that are not real, being
suspicious, or distrustful, believing things that are not true)
* other unusual or extreme changes in behavior or mood
Tell the doctor about any mental problems your child or family members have including suicide or depression, bipolar illness, mania, or psychosis. Call the doctor right away if your child has any new or worsening mental symptoms or problems while using Daytrana.
Serious side effects such as seizures (this usually happens in people with ahistory of seizures), slowing of growth (weight and height), eyesight changesor blurred vision have been reported with Daytrana. Allergic skin rash mayoccur. Stop using Daytrana and see the doctor right away if swelling, bumps, orblisters happen at or around where the patch is applied.If the patch is worn longer than 9 hours in a day, or if more than 1 patch isworn at a time, too much Daytrana has been used. Your child should not use hairdryers, heating pads, electric blankets, heated water beds or other heatsources while wearing a Daytrana patch. This could cause too much medicine topass into your child's body and cause serious side effects.Your child should have his or her height and weight checked often while takingDaytrana and your doctor may stop treatment if a problem is found during thesecheck-ups.
Most common side effects seen with Daytrana include skin problems (redness, small bumps, itching) where the patch is applied, poor appetite, nausea, vomiting, stomach pain, weight loss, tics, trouble sleeping, mood swings, and dizziness.
Please see Full Prescribing Information ( http://www.daytrana.com/prescribing-information/) and Medication Guide (http://www.daytrana.com/medication-guide/) including Warning regarding abuse and dependence.
You are encouraged to report negative side effects of prescription drugs to theFDA. Visit www.FDA.gov/medwatchor call 1-800-FDA-1088.
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 Centers for Disease Control and Prevention (CDC).
ADHD is a psychiatric behavioral disorder that manifests as a persistentpattern of inattention and/or hyperactivity-impulsivity that is more frequentand severe than is typically observed in individuals at a comparable level ofdevelopment. The specific etiology of ADHD is unknown and there is no singlediagnostic test for this disorder. Adequate diagnosis requires the use ofmedical and special psychological, educational and social resources, utilizingdiagnostic criteria such as Diagnostic and Statistical Manual of MentalDisorders-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 behavioral modification, and/or medication.
SHIRE PLC
Shire's strategic goal is to become the leading specialty biopharmaceuticalcompany that focuses on meeting the needs of the specialist physician. Shirefocuses its business on attention deficit hyperactivity disorder (ADHD), humangenetic therapies (HGT) and gastrointestinal (GI) diseases as well asopportunities in other therapeutic areas to the extent they arise throughacquisitions. Shire's in-licensing, merger and acquisition efforts are focusedon products in specialist markets with strong intellectual property protectionand global rights. Shire believes that a carefully selected and balancedportfolio of products with strategically aligned and relatively small-scalesales 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-lookingstatements. Such forward-looking statements involve a number of risks anduncertainties and are subject to change at any time. In the event such risks oruncertainties materialize, the Company's results could be materially adverselyaffected. The risks and uncertainties include, but are not limited to, risksassociated with: the inherent uncertainty of research, development, approval,reimbursement, manufacturing and commercialization of the Company's SpecialtyPharmaceutical and Human Genetic Therapies products, as well as the ability tosecure and integrate new products for commercialization and/or development;government regulation of the Company's products; the Company's ability tomanufacture its products in sufficient quantities to meet demand; the impact ofcompetitive therapies on the Company's products; the Company's ability toregister, maintain and enforce patents and other intellectual property rightsrelating to its products; the Company's ability to obtain and maintaingovernment and other third-party reimbursement for its products; and otherrisks and uncertainties detailed from time to time in the Company's filingswith the Securities and Exchange Commission. # # # Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PXPress Release www.shire.com
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