NOVEN SUBMITS ABBREVIATED NEW DRUG APPLICATION FOR FENTANYL TRANSDERMAL SYSTEM

Miami, FL, August 6, 2003 -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today announced that it has submitted an Abbreviated New Drug Application to the U.S. Food & Drug Administration seeking approval to market a generic version of Duragesic® (fentanyl transdermal system).

Duragesic®, distributed by Janssen Pharmaceutica, L.P. (a division of Johnson & Johnson), is a Schedule II transdermal patch containing fentanyl, an opioid analgesic. The product is indicated for the management of chronic pain, and had U.S. sales of over $900 million in 2002.

Duragesic® is expected to come off patent in mid-2004, but Janssen has been granted a six-month extension to the patent term due to completion of pediatric studies. Noven is in the process of selecting an industry partner to assist with commercialization. Noven believes that other companies are also developing generic versions of Duragesic®.

“Noven’s fentanyl patch is an important part of our strategy to leverage our transdermal technology and diversify our sources of revenue,” said Robert Strauss, Noven’s President, CEO & Chairman.

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 developer, manufacturer and marketer of transdermal drug delivery systems. For additional information, visit Noven’s website at www.noven.com.

Duragesic® is a registered trademark of Janssen Pharmaceutica, L.P.

This release contains forward-looking information related to the business of Noven that can be identified by the use of forward-looking terminology such as “believes”, “expects”, “hopes” and similar words and phrases. Such statements are qualified by and subject to the risks and uncertainties specified in Noven’s most recent filings with the Securities and Exchange Commission and those specified herein, including the risk that: we may fail to develop new products or establish new strategic collaborations, either of which would significantly limit our ability to leverage our technology, diversify our prospects and execute on our growth strategy; product development is inherently risky, and any project, including our fentanyl patch, could fail at any time or be delayed indefinitely; the timing of ANDA approval for our fentanyl patch could be affected by any number of issues that are beyond our control, including patent strategies by the innovator and strategies by generic competitors that could result in exclusivity; and with several companies expected to offer a generic version of Duragesic®, product pricing and other competitive factors may substantially diminish the market opportunity available to Noven.

Contact:
Investor & Media Contact
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.
(305) 253-1916

Product Licensing Inquiries
Pavan Handa
Executive Director - Business Development
(305) 964-3330

 


 

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