NOVEN PROVIDES PRODUCT DEVELOPMENT UPDATE

Back

Miami, FL, December 8, 2003 -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today provided an update on the status of its MethyPatch^® and fentanyl transdermal patch products.

Regarding MethyPatch^®, Noven's developmental methylphenidate transdermal system for Attention Deficit Hyperactivity Disorder, the U.S. Food & Drug Administration (FDA) has responded to a previously submitted draft protocol for a proposed additional MethyPatch clinical study. Noven submitted the protocol for FDA review and comment in October 2003. The FDA’s response included specific recommendations regarding the proposed study design.

Noven and Shire Pharmaceuticals Group plc (Shire), the product’s global licensee, are working together to review and respond to the FDA’s comments with respect to the study design. "We appreciate the Agency's prompt review of the MethyPatch protocol and the specific guidance they have provided, and we expect our dialogue with them to continue," said Robert C. Strauss, Noven's President, CEO & Chairman.

Regarding Noven's developmental transdermal fentanyl system for chronic pain, the FDA has accepted for filing Noven’s Abbreviated New Drug Application (ANDA) for the product. Acceptance for filing means that the Agency has made a threshold determination that the application is sufficiently complete to permit a substantive review. Noven previously indicated that FDA had requested additional information regarding certain inactive ingredients used in Noven’s product as a condition to further review, and that Noven had responded to that request. Noven’s fentanyl ANDA was submitted on July 30, 2003, and was accepted for filing as of October 1, 2003. If approved, the product would be the generic equivalent of Johnson & Johnson’s Duragesic^® (fentanyl transdermal system). Contract negotiations relating to the license of the product to a third party are continuing.

"Through MethyPatch, our fentanyl patch, the P&G Pharmaceuticals collaboration and other new products, we are committed to leveraging our patented transdermal technology in new therapeutic categories through a range of strategic alliances," said Strauss.

About Noven
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products. Together with Novartis Pharmaceuticals Corporation, Noven owns a profitable women’s health products company called Novogyne Pharmaceuticals. Noven’s existing products include advanced estrogen transdermal delivery systems (including Vivelle-Dot^®, licensed to Novogyne, and Estradot^®, licensed to Novartis Pharma AG) and combination estrogen/progestin transdermal delivery systems (including CombiPatch^®, licensed to Novogyne, and Estalis, licensed to Novartis Pharma AG). With a range of additional products in development, Noven is committed to becoming the world’s premier transdermal drug delivery company. For additional information on Noven, visit www.noven.com.

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, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risks and uncertainties. When used in this press release the word “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 Pharmaceuticals, Inc. (the “Company”) and are subject to a number of risks and uncertainties that are subject to change based on factors which are, in many instances, beyond the Company’s control, including but not limited to risks and uncertainties associated with: economic, competitive, regulatory and other factors affecting the Company and its operations, markets, products and services; the inability of the Company and Shire to agree upon revisions to the MethyPatch protocol on a timely basis or at all; the results of Noven’s and Shire’s review of the FDA’s response, including the possibility that the parties may determine that they are unable or unwilling to accept FDA’s recommendations; the results of FDA's review of the revised MethyPatch protocol, including the risk that FDA may determine that the revised protocol and/or proposed clinical strategy are not acceptable or do not address FDA's concerns; the possibility that the additional study may not be commenced in a timely manner or at all due to FDA concerns or otherwise; the possibility that, even if approved by the FDA, the study will not be successfully conducted; the possibility that the study will not produce results that support approval, even if the study is revised to address the FDA’s concerns; the possibility that the cost of the additional study and related expenses may be higher than anticipated or may exceed the total amount of license revenues available to offset such costs and expenses; the possibility that the method of accounting for the $25 million received from Shire could change under certain circumstances, including if the parties' MethyPatch development strategy changes; the results of FDA's review of the fentanyl patch ANDA, including the risk that FDA may determine that the ANDA is not approvable; the possibility that the Company's fentanyl development program may not proceed on schedule or as expected; the possibility that the Company may be unsuccessful in negotiating definitive agreements with development partners for licensing of the fentanyl product or the application of its transdermal patch technology to new products on acceptable terms or at all; the possibility that, even if approved, the Company's MethyPatch, fentanyl patch or other products may not be successfully commercialized due to competitive market conditions or other factors, including physician/patient preferences for other therapies; and the Company’s success at managing the risks relating to the foregoing. In addition to the risks and factors identified above, reference is also made to the other risks and factors detailed in reports filed by the Company with the Securities and Exchange Commission. The Company cautions that the foregoing list of factors is not exhaustive.

Back

Copyright ©  2003 Noven Pharmaceuticals, Inc. All rights reserved.