FDA Issues Approvable Letter For Daytrana™ Methylphenidate Transdermal System

-- Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter relating to Daytrana™ (methylphenidate transdermal system), a developmental product under FDA review for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years. Daytrana™ is licensed globally to Shire plc.

In its letter, the FDA states that it has completed its review of the amended New Drug Application (NDA) for Daytrana™ and has determined that it is approvable. The approvable letter contains proposed revisions to labeling, as well as requests for data clarification, post marketing surveillance, and post-marketing studies.

"We are pleased that the FDA has determined that Daytrana™ is approvable for the treatment of ADHD,” said Robert C. Strauss, Noven’s President, CEO & Chairman. "Noven and Shire will be working with the FDA as necessary to address the remaining issues and to advance the NDA toward final approval."

If the product is ultimately approved, Noven will receive a $50 million milestone payment from Shire, and may earn additional milestone payments of up to $75 million depending on the level of Shire’s commercial sales of the product. In addition, Noven expects to earn a profit on the manufacture and supply of finished product to Shire.

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 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. 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 product may not ultimately be approved; risks related to final product labeling, including the risk that warnings or limitations required by the FDA may adversely affect the commercial success of the product; risks related to post-marketing surveillance and studies; the risk of supply interruptions and other uncertainties relating to future DEA awards of methylphenidate procurement quota necessary for the production of Daytrana™; 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; and risks related to competition (including from other ADHD products marketed by Shire) and market acceptance of the product that could adversely affect the commercial success of Daytrana™ and could, among other things, limit Noven’s right to receive the additional milestone payments under its agreement with Shire. 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.

Contact:
Joseph C. Jones
Vice President – Corporate Affairs
305-253-1916