Healthcare Industry News: Vivelle-Dot
News Release - June 20, 2007
Noven & Shire to Develop New Transdermal Patch For ADHDShire Exercises Option to Develop Amphetamine Patch; Noven Receives $5.9 Million Milestone Payment
MIAMI--(HSMN NewsFeed)--Noven Pharmaceuticals, Inc. (NASDAQ:NOVN ) today announced that Shire plc has exercised its option under agreements with Noven to acquire the exclusive development rights to a new transdermal patch for ADHD to be formulated by Noven. In connection with this exercise, Noven received a $5.9 million milestone payment from Shire.
As previously announced, Noven successfully completed a Phase I study of an amphetamine transdermal system (ATS) under development for the treatment of ADHD. Shire has requested modifications to the original patch formulation in order to align ATS with its future direction in ADHD. In addition to the milestone payment received, Noven will be compensated by Shire for its continuing development efforts.
"Noven and Shire have worked collaboratively since 2003 to develop and commercialize patches for ADHD, with Daytrana(TM) representing the first patch approved in the category," said Jeffrey F. Eisenberg, Noven's Senior Vice President - Strategic Alliances. "We are very pleased to see this alliance expanded to include a Noven patch expected to be aligned with Shire's ADHD portfolio."
Shire is the global licensee of Daytrana(TM), a methylphenidate transdermal system for the treatment of ADHD. Daytrana(TM), developed and manufactured by Noven, was launched by Shire in June of 2006 and is currently the only transdermal product approved for ADHD therapy.
Daytrana(TM) should not be used in patients with allergy to methylphenidate or patch components; marked anxiety, tension and agitation; glaucoma; tics, diagnosis or a family history of Tourette's syndrome; seizures; or during or within 14 days after treatment with monoamine oxidase inhibitors (MAOIs).
Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses in ADHD. Physicians should take a careful patient history, including family history, and physical exam, to assess the presence of cardiac disease. Patients who report symptoms of cardiac disease such as exertional chest pain and unexplained syncope should be promptly evaluated. Use with caution in patients whose underlying medical condition might be affected by increases in blood pressure or heart rate.
New psychosis, mania, aggression, growth suppression, and visual disturbances have been associated with the use of stimulants. Use with caution in patients with a history of: psychosis; EEG abnormalities; bipolar disorder; depression. Growth and hematologic monitoring is advised during prolonged treatment. Patients should avoid applying external heat to the Daytrana(TM) patch. Skin irritation or contact sensitization may occur.
Daytrana(TM) should be given cautiously to patients with a history of drug dependence and alcoholism. Chronic abuse can lead to marked tolerance and psychological dependence. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder.
Common adverse events reported by patients who received Daytrana(TM) in clinical trials were decreased appetite, insomnia, nausea, vomiting, decreased weight, tics, affect lability, and anorexia, consistent with adverse events commonly associated with the use of methylphenidate.
For Full Prescribing Information, go to 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 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). Noven is committed to expanding the universe of available transdermal therapies for the benefit of patients, partners and shareholders. See www.noven.com for additional information. Daytrana(TM) is a trademark of Shire Pharmaceuticals Ireland Limited.
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 word "expect" 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 the development of ATS may not be successful or achieve the desired results or be delayed; the risk that Shire decides for any reason not to proceed with the ATS project; the risk that Shire may have different or conflicting priorities than Noven's, which may adversely impact its ability or willingness to assist in the development and commercialization of ATS or to continue the development program; and the possibility that Noven's current development priorities could render Noven unable to advance Noven's other development projects or increase the cost of advancing those projects. 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.
Source: Noven Pharmaceuticals
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