Healthcare Industry News: Transdermal
News Release - June 29, 2006
Noven Confirms Availability of Daytrana(TM) Methylphenidate Transdermal SystemMIAMI--(HSMN NewsFeed)--June 29, 2006--Noven Pharmaceuticals, Inc. (NASDAQ:NOVN ) today confirmed that Shire plc has launched Daytrana(TM) (methylphenidate Transdermal system), the first and only Transdermal medication approved to treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD) in children aged six to twelve years, and that the product is now available in retail pharmacies. Shire, the market leader in ADHD, is the exclusive, global licensee of Daytrana(TM), which was developed and is manufactured by Noven.
"As an organization, we greatly appreciate the opportunity to work with our partner Shire to assure a successful product launch," said Robert C. Strauss, Noven's President, CEO & Chairman. "It is gratifying to know that Noven's science and technologies, as well as the efforts and dedication of our employees, have contributed to the availability of the first patch therapy for ADHD."
The U.S. Food and Drug Administration approved Daytrana(TM) on April 6, 2006. The product was developed by Noven and combines the active ingredient, methylphenidate, with Noven's patented DOT Matrix(TM) Transdermal technology. This Transdermal delivery system was designed to provide continuous release of medication throughout the day. The patch is designed to stay on during the normal daily activities of a child such as swimming, exercising or bathing.
Important Safety Information
Daytrana(TM) was generally well tolerated in clinical studies. As with other products containing methylphenidate (the active ingredient in Daytrana(TM)), common side effects reported with Daytrana(TM) were decreased appetite, insomnia, nausea, vomiting, weight loss, tics, and affect lability (mood swings). Abuse of methylphenidate may lead to dependence.
Parents or caregivers should tell the child's physician about any heart conditions their child or family members may have. Also parents and caregivers should tell the doctor if their child has a history of high blood pressure, problems with alcohol or drugs, depression, bipolar disorder, abnormal thoughts/behaviors, visual disturbances, or seizures. Inform the doctor immediately if the child develops symptoms that suggest heart problems, such as chest pain or fainting. Aggression, new abnormal thoughts/behaviors, mania, and growth suppression have been associated with use of drugs of this type. Methylphenidate should not be taken by children with significant agitation; glaucoma; tics, family history or diagnosis of Tourette's syndrome; or current/recent use of MAO inhibitors (a type of antidepressant). Daytrana(TM) should not be used by children allergic to methylphenidate or other ingredients in Daytrana(TM).
Daytrana(TM) 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 Full Prescribing Information on Daytrana(TM) system, please visit http://www.ADHDSupport.com or http://www.DAYTRANA.com or call Shire Medical Affairs at 1-800-828-2088, option 4.
Daytrana(TM) and DOT Matrix(TM) are trademarks of Shire Pharmaceuticals Ireland Limited and Noven, respectively.
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leading developer of advanced Transdermal drug delivery technologies and prescription Transdermal products. Noven's prescription patches are approved in over 30 countries and include Vivelle-Dot(TM) (the most prescribed estrogen patch in the U.S.) and Daytrana(TM) (the first and only patch approved for the treatment of ADHD). A range of new patches is being investigated and developed in collaboration with Shire plc, P&G Pharmaceuticals, Endo Pharmaceuticals Inc. and others. Noven is committed to expanding the universe of available Transdermal therapies for the benefit of patients, partners and shareholders. See http://www.noven.com for additional 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. When used in this press release, the words "expects" and similar expressions identify certain of such forward-looking statements. 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 Noven may encounter production issues and/or inefficiencies in the process of manufacturing commercial quantities of Daytrana(TM), which could adversely affect the success of the product and Noven's results of operations; risks related to post-marketing surveillance and studies; risks related to competition (including from other ADHD products marketed or under development by Shire) and market acceptance of Daytrana(TM) that could adversely affect the commercial success of Daytrana(TM) and could, among other things, limit Noven's right to receive the additional milestone payments under its agreement with Shire; the possibility that the market for methylphenidate products may be negatively affected by the outcome of the FDA's ongoing inquiry into possible cardiac, psychiatric and other side effects of ADHD medications, a 2005 study by researchers at the M.D. Anderson Cancer Center that found adverse chromosomal effects on 12 children treated with oral methylphenidate, as well as ongoing public debate in the United States regarding the appropriateness of using methylphenidate and other medications to treat children with ADHD; the possibility that the FDA's ongoing inquiry into possible side effects of ADHD medication could result in "black-box" warnings being added to the labeling for these medications; and the risk of supply interruptions and other uncertainties relating to future DEA awards of methylphenidate procurement quota necessary for the production of Daytrana(TM). For additional information regarding these and other risks associated with this product and Noven's business, readers should refer to Noven's Annual Report on Form 10-K for the year ended December 31, 2005 as well as the quarterly and periodic reports filed from time to time by Noven with the Securities and Exchange Commission.
Source: Noven Pharmaceuticals
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