Noven To Receive $25 Million Daytrana™ Sales Milestone

-- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today announced that it has been advised by Shire plc that Shire’s net sales of Daytrana™ (methylphenidate transdermal system) have triggered the second of three potential $25 million milestone payments to Noven.

Daytrana™, licensed globally to Shire, was launched in June 2006. Payment of the first milestone was triggered upon Shire’s net sales of Daytrana™ exceeding $25 million in 2006. Payment of the milestone announced today was triggered upon Shire’s net sales of Daytrana™ exceeding $50 million in the 12-months preceding June 30, 2007.

Under the Daytrana™ transaction agreement, a third $25 million milestone is payable upon Shire’s achievement of $75 million in annual net sales of Daytrana™. For purposes of the sales milestones, Shire’s annual net sales are measured quarterly on a trailing 12-month basis. From an accounting standpoint, Noven expects to defer the sales milestones and recognize them as license revenues over time.

About Daytrana™
Daytrana™ is a methylphenidate transdermal system for the treatment of ADHD and is currently the only transdermal product approved for ADHD therapy. It is approved for children aged six to twelve years with ADHD.

Daytrana™ 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™ patch. Skin irritation or contact sensitization may occur.

Daytrana™ 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™ 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

About Noven
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™ (the first and only patch approved for ADHD). Noven is committed to expanding the universe of available transdermal therapies for the benefit of patients, partners and shareholders. See for additional information. Daytrana™ and DOT Matrix® are trademarks of Shire Pharmaceuticals Ireland Limited and Noven, respectively.

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 past Daytrana™ results may not be indicative of future Daytrana™ results; the risk that the market for Daytrana as well as future sales of Daytrana™ could be adversely affected by a number of factors, including as a result of: (i) supply interruptions of methylphenidate, (ii) delays or inability to obtain necessary DEA methylphenidate procurement quota, (iii) issues relating to difficulties in removing the release liner from the Daytrana™ patch, (iv) the resolution of the observations made by the FDA in the Form 483 that Noven received in July 2007, and (v) new market entrants, including from other ADHD products marketed or under development by Shire; the risk that any adverse effect to the market for Daytrana™ due the foregoing or other factors could adversely affect Noven’s results of operations and/or its financial position, including limiting Noven’s ability to achieve the additional milestone payments under its agreement with Shire. 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, 2006 as well as other reports filed from time to time by Noven with the Securities and Exchange Commission.

Joseph C. Jones
Vice President – Corporate Affairs