Noven Discloses Development Programs for Fentanyl And Dextroamphetamine Transdermal Systems

Bioequivalence Study Completed for Fentanyl Patch

Dextroamphetamine Patch for ADHD to Enter Human Clinical Trial

-- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN), a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products, today announced development programs for two new transdermal systems.

Fentanyl. Noven has completed bioequivalence studies comparing its developmental fentanyl transdermal system to Duragesic®, a Schedule II opioid analgesic transdermal system for chronic pain distributed by Janssen Pharmaceutica, L.P., a division of Johnson & Johnson. U.S. sales for Duragesic® exceeded $900 million in 2002. Noven believes it is one of several companies developing a generic version of Duragesic®. Duragesic® is expected to come off patent in July 2004, but Janssen has been granted an additional six months pediatric exclusivity, which would effectively prevent the launch of a generic version until January 2005.

Noven’s fentanyl transdermal patch utilizes a solid-state drug/adhesive matrix, as opposed to the liquid reservoir delivery system used in Duragesic®. Noven has also developed transdermal formulations for several additional pain management compounds.

"We expect to file an Abbreviated New Drug Application for our fentanyl patch with the Food and Drug Administration in the second half of 2003, and we are actively exploring opportunities with companies interested in marketing the product," said Robert Strauss, Noven's President, CEO & Chairman.

Dextroamphetamine. Noven also announced that it expects to begin human clinical trials of a long-acting dextroamphetamine transdermal system for Attention Deficit Hyperactivity Disorder (ADHD) in the summer of 2003. The dextroamphetamine patch adds to Noven’s ADHD therapy development program, which includes a methylphenidate transdermal system (MethyPatch®), currently under FDA review. In February 2003, Noven announced that Shire Pharmaceuticals Group plc, the market-share leader in ADHD therapy, had agreed to acquire global marketing rights to MethyPatch.

"Our developmental dextroamphetamine patch has the potential to be the first transdermal therapy in the $700 million U.S. market for amphetamine-based ADHD products,” said Strauss. “It would give Noven product entries in both the methylphenidate and amphetamine segments of the ADHD therapy market.”

Growth Strategy. Strauss added: "Our fentanyl and dextroamphetamine patches should advance our strategy to leverage our DOT Matrix™ transdermal technology across a diverse range of products and therapeutic categories. These products, along with the roughly 20 other transdermal products that Noven has formulated, should position Noven for growth from diverse sources in the years ahead."

DOT Matrix technology permits Noven to deliver predictable therapeutic doses of a wide range of prescription drugs through discreet, comfortable and adherent patches that are well suited to active lifestyles.

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, including MethyPatch® for ADHD, 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

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", "may", "could", "potential", "would", "should" 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 dextroamphetamine or fentanyl patches, 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; 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; the Shire transaction may not close; and MethyPatch may not be approved or, if approved, it may not be successfully commercialized by Shire due to competitive market conditions or other factors, including physician/patient preferences for other ADHD therapies.

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Noven Pharmaceuticals, Inc.

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