Daytrana, developed and manufactured by Noven, is licensed globally to Shire plc. Concurrently with this release, Shire has announced via press release that it is undertaking a voluntary market withdrawal and voluntary recall of certain lots of Daytrana product. Shire is taking this action because some Daytrana patches no longer meet the product's release liner removal specification and, as a result, patients and caregivers could have difficulties removing the release liner when they peel the patch open. The specific lots subject to this action are identified in Shire's press release and at http://www.daytrana.com.
Shire has advised that, because this action is not due to product safety issues, all Daytrana patches, including those in the lots subject to the withdrawal/recall, can continue to be used unless the release liner cannot be removed, or the patches are damaged while being opened. In this regard, 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.
Michael Price, Noven's Chief Financial Officer, said: "While this voluntary action is unfortunate, it was expected, and in 2008 we established a $3.8 million financial reserve specifically for existing Daytrana product at risk of being withdrawn or recalled. We expect that this reserve will be sufficient to cover our costs related to this withdrawal/recall. Accordingly, today's news should not materially affect our results of operations, and our financial guidance for 2009 remains unchanged."
Shire has indicated 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 Daytrana in the United States. Noven and Shire have notified the U.S. Food and Drug Administration (FDA) of this voluntary action.
Noven and Shire are committed to continuing their ongoing quality assurance monitoring and data analysis of Daytrana, and there may be additional voluntary actions. Shire and Noven continue to actively pursue enhancements to Daytrana and are working with the FDA to implement changes intended to enhance the product's usability.
Important Safety Information about Daytrana
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; or 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.
Talk to your health care provider if your child experiences slowing of growth (height and weight). Children should have their height and weight checked periodically while taking Daytrana. Your healthcare provider may stop Daytrana treatment if a problem is found during these check-ups.
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, manufacturing, 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 Noven Therapeutics, Noven's specialty pharmaceutical unit. Noven is committed to developing and offering products and technologies that meaningfully benefit patients, its customers and its industry partners. For more information, visit http://www.noven.com.
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 the financial reserve will prove to be insufficient to cover Noven's costs associated with Daytrana withdrawals/recalls; the risk that solutions currently in testing to address the Daytrana peel force issue may be delayed, unsuccessful, costly or take more time than expected to implement and the possibility that any implemented solution may not adequately resolve the issue; the risk that the FDA may not agree with the solutions currently in testing, which could delay or prevent their implementation; the risk that Shire's expectations regarding Daytrana supply levels could prove inaccurate; the risk that Noven's response to the FDA's January 2008 warning letter, which remains under FDA review, 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. 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, 2008, 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.