725 Chesterbrook Boulevard Wayne, PA 484 595 8110 www.shire.com
Press Release
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, PA – September 4, 2007 – Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ), 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.
For further information please contact:
Investor Relations
Cléa Rosenfeld (Rest of the World)
+44 1256 894 160
Eric Rojas (North America)
+1 484 595 8252
Media
Jessica Mann (Rest of the World)
+44 1256 894 280
Matthew Cabrey (North America)
+1 484 595 8248
Registered in England 5492592 Registered Office as above
Notes to editors
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 PLC
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
2
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™ (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® (human TGFβ3) 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.
3
Here is the other notice I received:
Important information regarding the voluntary market withdrawal of a limited portion of DaytranaTM (methylphenidate transdermal system) patches
Dear DaytranaTM Patients and Caregivers:
Shire wants to advise you of the company’s decision to implement a voluntary market withdrawal of limited portions of the DaytranaTM patches. 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 DaytranaTM patches.
Shire expects the remaining supply of DaytranaTM will offer patients and caregivers improved ease of use when peeling the release liner off the 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. The current supply levels of DaytranaTM are sufficient, ensuring that those patients who currently use DaytranaTM and those patients looking for an alternative ADHD treatment option will be able to have their prescriptions filled with DaytranaTM patches with an improved ease of use.
Are the affected lots safe and effective?
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 DaytranaTM patches. All DaytranaTM patches, including those affected by the voluntary market withdrawal, can be used unless the release liner cannot be removed or the patches are damaged.
How do I know if my current supply of DaytranaTM is affected by this voluntary market withdrawal?
Only those DaytranaTM packages that have an expiration date of March 31, 2009 or earlier or lots 2563511, 2563611, or 2570411 are affected by this voluntary market withdrawal. All DaytranaTM patches including those affected by the voluntary market withdrawal can continue to be used unless the patches are damaged when opening or the release liner cannot be removed.
What should parents and caregivers of patients prescribed DaytranaTM do with their packages of DaytranaTM if they meet the criteria for the voluntary market withdrawal?
They have two options:
a. If the release liners can be easily removed and the patches are not damaged, use the patches as directed.
b. Or, if the patches cannot be used, call the Shire Customer Service/ DaytranaCare line at 1-800-828-2088, option 1.
Please describe what you mean by "damaged."
If it appears to you that anything about a patch looks unusual, please do not use. Damaged patches should be discarded according to the directions in the DaytranaTM package insert.
Please see Important Safety Information on the following page and accompanying Full Prescribing Information.
D824 08/07
What changes have been made to DaytranaTM?
We have increased the release coating on the release liner. No changes to the medication, itself, have been made.
At Shire our patients always come first and Shire is dedicated to providing you with the information you need to make informed decisions related to your child’s care. If you have further questions after reviewing this information, please call us at 1-800-828-2088, option 1.
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.
I got the email too, but we don't have any difficult ones right now.
Here is a link to the pdf file
http://www.daytrana.com/PDFs/DaytranaInfo.pdf