Healthcare Industry News: DAYTRANA
News Release - April 6, 2006
Noven Announces FDA Approval of Daytrana(TM) Methylphenidate Transdermal SystemMIAMI--(HSMN NewsFeed)--April 6, 2006--Noven Pharmaceuticals, Inc. (NASDAQ:NOVN ) announced today that the U.S. Food and Drug Administration (FDA) has approved DAYTRANA(TM) (methylphenidate transdermal system) as a new therapeutic option for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged six to twelve years. Shire plc, the global licensee of DAYTRANA(TM) and market-share leader in the ADHD category, is expected to launch the product in the first half of 2006.
"The approval of DAYTRANA(TM), the first non-oral medication for ADHD, is outstanding news for Noven, Shire and patients," said Robert C. Strauss, Noven's President, CEO & Chairman. "For Noven, the approval advances our goal of commercializing our patented transdermal technology in diverse therapeutic markets with strong partners. For Shire, it adds an important new methylphenidate product to their portfolio of ADHD products, and reaffirms their position as the ADHD support company. And for patients, parents and physicians, DAYTRANA(TM) represents a new once-daily therapy for children diagnosed with ADHD."
Upon receipt of FDA approval, Noven became due to receive a $50 million milestone payment from Shire. Noven also has the opportunity to earn additional milestone payments of up to $75 million depending on the level of Shire's commercial sales of the product, and expects to earn a profit on the manufacture and supply of finished product to Shire.
DAYTRANA(TM) combines the active ingredient methylphenidate with Noven's patented DOT Matrix(TM) transdermal drug delivery technology. DAYTRANA(TM) and DOT Matrix(TM) are trademarks of Shire and Noven, respectively.
DAYTRANA(TM) is a Schedule II controlled substance. 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 in children who received DAYTRANA(TM) were decreased appetite, insomnia, nausea, vomiting, weight loss, tic, and affect lability (mood swings).
DAYTRANA(TM) should not be used by children with allergies to methylphenidate or other ingredients in DAYTRANA(TM). The patch should be applied daily to clean, dry skin, which is free of any cuts or irritation. Avoid applying external heat to the patch. Skin irritation or allergic skin rashes may occur.
Methylphenidate should not be taken by children with significant anxiety, tension, or agitation; glaucoma; tics; Tourette's syndrome, or family history of Tourette's syndrome; or current/recent use of MAO inhibitors (a type of antidepressant). Abuse of methylphenidate may lead to dependence. Tell your healthcare professional if your child has had problems with alcohol or drugs or has had depression, abnormal thoughts/behaviors, visual disturbances, seizures, high blood pressure, or heart conditions including structural abnormalities. For additional information, please visit http://www.DAYTRANA.com.
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 a range of new patches are being developed in collaboration with Novartis Pharma AG, Shire plc, P&G Pharmaceuticals, Endo Pharmaceuticals Inc. and others. Together with Novartis Pharmaceuticals Corporation, Noven owns Novogyne Pharmaceuticals, a women's health products company with over $120 million in annual sales. Among other products, Novogyne markets and sells Noven's Vivelle-Dot(TM) product - the smallest estrogen patch in the world, and the most prescribed transdermal estrogen therapy in the U.S. 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: risks related to the timing of the launch of DAYTRANA(TM) by Shire; 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 timing and/or success of product launch and Noven's results of operations; risks related to post-marketing surveillance and studies; risks related to competition (including from other ADHD products marketed 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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