Shire Voluntarily Withdraws a Limited Portion of Daytrana (Methylphenidate Transdermal System) Patches
Patches that are easier to use are available for patients and their families
PHILADELPHIA, September 4, 2007 /PRNewswire-FirstCall/ -- Shire plc , the global specialty biopharmaceutical company, announced today the voluntary market withdrawal of a limited amount of the ADHD patch Daytrana; only Daytrana packages with an expiration date of March 31, 2009 or earlier and Daytrana packages with lot numbers 2563511, 2563611, and 2570411 are impacted by this voluntary market withdrawal. Shire is taking this proactive step not due to safety and efficacy issues, but due to feedback from patients and caregivers who have experienced difficulty removing the release liner from some Daytrana patches.
Shire expects the Daytrana patches not subject to the market withdrawal, and which have been manufactured using an enhanced process, to offer patients and caregivers improved ease of use when peeling the release liner off the patches. The current supply levels of Daytrana are sufficient to ensure that patients will have their Daytrana prescriptions filled at their local pharmacy with the easier to use Daytrana patch.
All Daytrana patches, including those that are part of the voluntary market withdrawal, can continue to be used unless the release liner cannot be removed, or the patches are damaged while being opened. Patients and their caregivers who have questions regarding Daytrana patches should call Shire customer service at 1-800-828-2088, option 1. Pharmacies that have questions regarding this voluntary market withdrawal of Daytrana should call 1-888-216-6674.
Shire has notified the U.S. Food and Drug Administration of this voluntary market withdrawal. Daytrana is licensed globally to Shire by Noven Pharmaceuticals, Inc.
Important Safety Information
Tell your doctor about any heart conditions, including structural abnormalities, your child or a family member may have. Inform your doctor immediately if the child develops symptoms that suggest heart problems, such as chest pain or fainting.
Daytrana should not be used if the child has: significant anxiety, tension, or agitation; allergies to methylphenidate or other ingredients of Daytrana; glaucoma; discontinued in the last 14 days or is taking a monoamine oxidase inhibitor (MAOI); tics, or family history or diagnosis of Tourette's syndrome.
Tell your doctor before using Daytrana if the child: is being treated for or has symptoms of depression (e.g. sadness, worthlessness, or hopelessness) or bipolar disorder; has family history of tics; has abnormal thoughts 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 your doctor immediately if the child develops any of these conditions/symptoms while using Daytrana.
In clinical studies, side effects were generally mild to moderate. The most common side effects reported with Daytrana were decreased appetite, sleeplessness, sadness/crying, twitching, weight loss, nausea, vomiting, tics, and affect lability (mood swings). Aggression, new abnormal thoughts/behaviors, mania, and growth suppression have been associated with use of drugs of this type. Tell your doctor if the child has blurred vision while using Daytrana.
Abuse of Daytrana can lead to dependence.
Daytrana should be applied daily to clean, dry skin, which is free of any cuts or irritation. Skin irritation or allergic skin rash may occur.
For additional information, including Full Prescribing Information, please visit www.Daytrana.com.
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 and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
Shire's focused strategy is to develop and market products for specialty physicians. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.
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, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization; the impact of competitive products, including, but not limited to the impact of those on Shire's Attention Deficit and Hyperactivity Disorder ("ADHD") franchise; patents, including but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including but not limited to the expected product approval date of INTUNIV(TM) (guanfacine) extended release (ADHD); Shire's ability to secure new products for commercialization and/or development; Shire's ability to benefit from its acquisition of New River Pharmaceuticals Inc.; the successful development of JUVISTA(R) (human TGF B 3) and other risks and uncertainties detailed from time to time in Shire plc's filings with the Securities and Exchange Commission, particularly Shire plc's Annual Report on Form 10-K for the year ended December 31, 2006.
CONTACT: Investor Relations, Clea Rosenfeld, rest of the world,+44-1256-894-160, or Eric Rojas, North America, +1-484-595-8252; or Media,Jessica Mann, rest of the world, +44-1256-894-280, or Matthew Cabrey, NorthAmerica, +1-484-595-8248, all for Shire plc
Ticker Symbol: (NASDAQ-NMS:SHPGY),(Toronto:SHQ.)
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Posted: September 2007