Noven Issued U.S. Patent for Transdermal Methylphenidate

NOVEN ISSUED U.S. PATENT FOR TRANSDERMAL METHYLPHENIDATE

Patent for Once-Daily Methylphenidate Patch for ADHD
Effective Through 2018
- - - - - - - - - - - - - - - - - - - - - -

MIAMI, FL. - May 23, 2001 - Noven Pharmaceuticals, Inc. (Nasdaq:NOVN),a leader in the development of transdermal and transmucosal drug delivery technologies and products, today announced that it has been issued a U.S. patent relating to the transdermal delivery of methylphenidate for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

U.S. Patent No. 6,210,705, entitled Compositions and Methods for Treatment of Attention Deficit Disorder and Attention Deficit/Hyperactivity Disorder with Methylphenidate, was issued in April 2001 and is effective through the year 2018. The patent includes a range of claims covering Noven's proprietary technology for delivering a therapeutically effective dose of methylphenidate, the benchmark medication for ADHD, for up to 24 hours via a transdermal patch. Noven holds over 20 additional U.S. patents relating to its products and technologies.

Noven's once-daily methylphenidate patch, known as MethyPatch^®, is currently in Phase III clinical trials for the treatment of ADHD, and Noven expects to file a New Drug Application (NDA) for the product in the first half of 2002.

"In 2003, we expect to be the only methylphenidate patch available in the near billion-dollar U.S. market for ADHD therapies," said Robert C. Strauss, Noven's President, Chief Executive Officer and Co-Chairman. "This broad patent, together with Noven's other patents covering this product, may help secure that unique and favorable position well into the next decade."

ADHD affects 3% to 5% of school-age children and an estimated 1.5 million children are currently on medication to treat this disorder. All presently approved ADHD medications are delivered orally. Noven's once-daily MethyPatch^® is expected to offer the safety and efficacy of immediate release oral methylphenidate products, while eliminating in-school dosing, minimizing drug abuse potential, and providing physicians and parents with the ultimate in dosing flexibility and control.

About Noven
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leader in the development of transdermal and transmucosal drug delivery technologies and products. Together with Novartis Pharmaceuticals, Noven owns a 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) and combination estrogen/progestin transdermal delivery systems (including Combipatch™, licensed to Novogyne, and Estalis^®, licensed to Novartis). With a range of additional products in development, including MethyPatch^®, a once-daily transdermal methylphenidate system for ADHD, Noven is committed to becoming the world's premier developer, manufacturer and marketer of transdermal and transmucosal drug delivery systems. For additional information on Noven, visit the company's web site at www.noven.com. For information on Noven's Vivelle and Vivelle-Dot products, visit www.vivelledot.com.

Forward looking statements contained in this release are qualified by and subject to the risks and uncertainties specified in Noven's most recent filings with the Securities and Exchange Commission, including the risk that some or all of the referenced patent claims may be invalid or unenforceable or may not preclude another company from developing a competitive patch, and that the MethyPatch^® clinical studies, NDA filing, product approval and/or product launch will be unsuccessful or delayed.

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

Back