Noven To Commence Manufacture of Daytrana™ Methylphenidate Transdermal System

-- Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) announced today that it expects to commence the manufacture of launch supplies of Daytrana™ (methylphenidate transdermal system) this week.

Daytrana™, licensed globally to Shire plc, is an investigational transdermal patch designed for once-daily use to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years. An amended New Drug Application (NDA) for the product is currently pending at the U.S. Food and Drug Administration (FDA). The FDA regulatory review period under the Prescription Drug User Fee Act for Daytrana™ is scheduled to conclude December 28, 2005.

Earlier in December 2005, the U.S. Drug Enforcement Administration (DEA) granted Noven procurement quota (methylphenidate raw material) sufficient to manufacture launch supplies. Noven’s application for additional procurement quota is currently pending at the DEA.

If the amended NDA is approved, Noven will be entitled to a $50 million milestone payment from Shire, and may earn additional milestone payments totaling $75 million depending on commercial sales of the product. Noven also expects to earn a profit on the manufacture and supply of finished product to Shire. Under the agreements between Noven and Shire, Shire bears financial responsibility for Daytrana™ inventory if the product is not approved or cannot otherwise be sold.

Daytrana™ is a trademark of Shire.

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 sold in over 30 countries, and a range of new products are being developed in collaboration with Shire plc, Novartis Pharma AG, P&G Pharmaceuticals, Endo Pharmaceuticals Inc. and others. See 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. 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, notwithstanding the recommendations of the December 2, 2005 Advisory Committee, the FDA may determine that the amended NDA for Daytrana™ does not support approval; risks related to final product labeling (if the product is approved), including the risk that warnings or limitations required by the FDA may adversely affect the commercial success of the product; the risk that Daytrana™ may not ultimately be commercialized; the risk of supply interruptions and other uncertainties relating to future DEA awards of methylphenidate procurement quota necessary for the production of Daytrana™, which is outside Noven's control and may impact the success of product launch and market penetration, including the possibility that Noven may not have sufficient quota to manufacture additional launch quantities if requested by Shire; and the risk that Noven may encounter production issues and/or inefficiencies in the process of manufacturing commercial quantities of Daytrana™, which could adversely affect the success of product launch and Noven’s results of operations. 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, 2004 as well as other reports filed from time to time with the Securities and Exchange Commission.

Joseph C. Jones
Vice President – Corporate Affairs