Healthcare Industry News: Vivelle-Dot
News Release - September 4, 2007
Noven Provides Update on Daytrana(TM) Methylphenidate Transdermal SystemProduct Licensee Shire Undertakes Voluntary Market Withdrawal of a Limited Portion of Daytrana(TM) Product
MIAMI--(HSMN NewsFeed)--Noven Pharmaceuticals, Inc. (NASDAQ: NOVN ) today provided an update on the Daytrana(TM) patch product for the treatment of the symptoms of Attention Deficit Hyperactivity Disorder (ADHD). Daytrana(TM), developed and manufactured by Noven, is licensed globally to Shire plc.
Shire has announced via separate press release that it is undertaking a voluntary market withdrawal of a limited portion of Daytrana(TM) product. Shire is taking this action primarily due to feedback from patients and caregivers who have experienced difficulty removing the release liner from some Daytrana(TM) patches.
In the first quarter of 2007, Noven and Shire implemented enhancements to the Daytrana(TM) release liner intended to improve ease of use of the patch, and product using the enhanced release liner is now in the trade channels. Shire and Noven are committed to improving the ease of use of Daytrana(TM) so patients can use Daytrana(TM) with the convenience they expect from this novel ADHD treatment option.
Based on preliminary information, the retail value of product being withdrawn is estimated to be in the $4 million to $6 million range.
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; 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.
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, please see www.daytrana.com.
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, has established itself as a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products. Its commercialized transdermal products include Vivelle-Dot®, the most prescribed estrogen patch in the U.S., and Daytrana(TM), the first and only patch approved for the treatment of ADHD. Transdermal products in development include an amphetamine patch for ADHD, a generic fentanyl patch for pain management, and undisclosed partnered products.
With the acquisition of JDS Pharmaceuticals, LLC in August 2007, Noven has expanded its business to become a broader-based specialty pharmaceutical company. The acquisition adds a psychiatry-focused marketing and sales infrastructure (including a targeted sales force, in-market products and category expertise) and substantially enhances Noven's late-stage product development pipeline.
Forward Looking Information
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 which 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 which are, in many instances, beyond Noven's control. These risks and uncertainties include: the risk that, going forward, product not subject to the withdrawal does not continue to improve ease of use of the product; ongoing risk to Noven and Daytrana(TM) associated with Noven's previously-announced Form 483; the risk that the estimated amount of product subject to the withdrawal may prove incorrect; the risk of supply interruptions resulting from delays or inability to obtain DEA methylphenidate quota to replace withdrawn product; the risk that the market withdrawal will inhibit Noven's ability to achieve the third Daytrana(TM) milestone payment under its agreement with Shire; the risk that any of the foregoing factors could adversely affect Noven's business, results of operations and/or financial position; and the possibility that Noven may incur significant costs relating to the Daytrana(TM) market withdrawal, which could adversely affect Noven's 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 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.
Source: Noven Pharmaceuticals
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