Noven Pharmaceuticals Inc. Provides Update on Daytrana(TM) Methylphenidate Transdermal System; Shire Pharmaceuticals Group plc Undertakes Voluntary Recall of Two Lots
Concurrently with this press release, Shire has announced that it is undertaking a voluntary recall of two lots of Daytrana™. Shire is taking this action because some Daytrana™ patches do not meet the product’s release liner removal specification and, as a result, patients and caregivers could have difficulties removing the liner when they peel the patch open. The Daytrana™ prescribing information and medication guide provide that, if a patch is damaged or the release liner is difficult to remove, the patch should be discarded.
Shire indicated that the voluntary recall is not due to safety issues, and that current supply levels of Daytrana™ should be sufficient to ensure that patients can continue to have their Daytrana™ prescriptions filled at their local pharmacies. Noven continues to manufacture the product and Shire continues to promote it in the United States.
Peter Brandt, Noven’s President and Chief Executive Officer, commented: “The Daytrana™ product enhancements implemented in 2007 generally improved the ease of use of Daytrana™ and substantially reduced complaint rates, but they have not fully resolved the issue. We have recently identified a probable root cause, as well as several possible solutions, and testing is underway to confirm our belief that we are headed toward resolution of this issue.”
Noven and Shire will continue ongoing quality assurance activities and data analysis of Daytrana™, and additional voluntary actions are possible. The parties continue to pursue additional product enhancements and to work closely with the U.S. Food and Drug Administration to implement changes that may further improve the ease of use of Daytrana™.
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™.
Note: 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 redness or itching is common with Daytrana™. Allergic skin rash may occur.
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacture, marketing and sale of prescription pharmaceutical products. Noven’s business and operations are focused in three principal areas – transdermal drug delivery, the Novogyne joint venture, and its Noven Therapeutics specialty pharmaceutical unit.
Safe Harbor Statement under the Private Litigation Reform Act of 1995
Except for historical information contained herein, the matters discussed in this press release contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve substantial risks and uncertainties. Statements that are not historical facts, including statements that are preceded by, followed by, or that include, the words “believes,” “anticipates,” “plans,” “expects” or similar expressions and statements are forward-looking statements. Noven’s estimated or anticipated future results, product performance or other non-historical facts are forward-looking and reflect Noven’s current perspective on existing trends and information. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein. These forward-looking statements are based largely on the current expectations of Noven and are subject to a number of risks and uncertainties that are subject to change based on factors that are, in many instances, beyond Noven's control.
These risks and uncertainties include: the risk that additional lots of Daytrana™ may be recalled by Shire due to product failing to meet the release liner specification or otherwise; the risk that Noven may not identify a definitive root cause of the release liner issue or identify or be able to implement a solution to fully resolve the issue; uncertainties related to the financial impact of the recall; the risk that Noven’s response to the FDA’s January 2008 warning letter may not be acceptable to the FDA or adequately address the FDA’s concerns, and in such case, the risk that the FDA may take regulatory action against Noven, which may include fines, product seizures or recalls, injunctions, suspension of production and/or the withdrawal of product approval; and the risk that any adverse effect to the market for Daytrana™ due to the foregoing or other factors could adversely affect Noven’s reputation, results of operations and/or its financial position, including limiting Noven’s ability to achieve the additional milestone payment under its agreement with Shire. For additional information regarding these and other risks associated with Noven’s business, readers should refer to Noven’s Annual Report on Form 10-K for the year ended December 31, 2007, as well as other reports filed from time to time with the Securities and Exchange Commission. Unless required by law, Noven undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Noven Pharmaceuticals, Inc., Miami Joseph C. Jones, Vice President – Corporate Affairs 305-253-1916 or Media Contact for Daytrana™: Shire Limited Matthew Cabrey, 484-595-8248
Source: Noven Pharmaceuticals, Inc.