Phase III Trial For Noven's Methypatch® Underway; Methypatch® Clinical Data Presented At AACAP Meeting

-- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN), today announced that it has begun patient screening and enrollment for a new Phase III clinical study of MethyPatch®, and that MethyPatch clinical data was recently presented at the 48th Annual Meeting of the American Academy of Child and Adolescent Psychology (AACAP). MethyPatch is Noven's once-daily transdermal methylphenidate system for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

New Trial Underway
"With the Food and Drug Administration's review of our new Phase III protocol completed, and with our pre-trial clinical investigators meetings behind us, we are pleased to have begun patient screening and enrollment for our MethyPatch pivotal study," said Robert C. Strauss, Noven's President, CEO and Chairman. "Target enrollment for this double-blind, placebo-controlled, multi-center study is about 200 patients, and we expect to conclude the study in the first quarter of 2002.

Noven's once-daily MethyPatch is designed to offer the safety and efficacy of immediate release oral methylphenidate products, while eliminating in-school dosing and providing physicians and parents the ability to discontinue dosing as needed by removing the patch. The product combines methylphenidate, which is an established ADHD therapy, with Noven's patented DOT Matrix™ patch technology, which is the delivery platform behind the commercial success of Vivelle-Dot™ and CombiPatch® hormone replacement patches. DOT Matrix technology permits Noven to deliver therapeutic doses of a range of prescription therapies through discreet, comfortable and highly adherent patches that are well suited to active lifestyles.

MethyPatch Symposium
Noven also announced that MethyPatch was the subject of a symposium held on October 27, 2001, at the American Academy of Child & Adolescent Psychiatry (AACAP) Annual Meeting.

Presenters included Mario A. Gonzalez, Ph.D., President & CEO, GloboMax Americas LLC; Donald R. Jasinski, M.D., Chief, Center for Chemical Dependents, John Hopkins Bayview Medical Center; William E. Pelham, Ph.D., Professor of Psychology, Center of Children and Families, State University of New York at Buffalo; and Laurence L. Greenhill, M.D., Clinical Professor of Child Psychology, Columbia University.

The primary objective of the symposium was to review the results of a series of pharmacokinetic and pharmacodynamic studies involving MethyPatch, culminating in a multi-center, randomized, double-blind, parallel-group, multi-dose, placebo-controlled Phase III study completed in early 2001.

The Phase III study compared MethyPatch applied once daily in the morning to placebo transdermal systems in over 200 children with ADHD between the ages of 6 and 12. The primary outcome measure was teacher ratings of patient behavior using the IOWA Conners Rating Scale (IO Scale). Secondary outcome measures were parent ratings using the IO Scale and clinician ratings using the Clinical Global Index.

As measured by teachers, the study demonstrated improved behavior on MethyPatch as compared to placebo, but the improvement was not statistically significant. As measured by both parents and clinicians, the study demonstrated highly statistically significant improvement in ADHD symptoms on MethyPatch versus placebo. The study also demonstrated that MethyPatch was a well-tolerated delivery platform for methylphenidate, with an adverse event profile similar to that seen in oral methylphenidate studies. Additional presentations at the symposium considered the pharmacokinetics, abuse potential and other aspects of MethyPatch.

Noven has indicated that its recently initiated Phase III study includes additional dosage strengths and a modified dose titration schedule as compared to the Phase III study presented at the AACAP meeting.

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.

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 Corporation, Noven owns a highly 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®, Noven is committed to becoming the world's premier developer, manufacturer and marketer of transdermal and transmucosal drug delivery systems. For additional information, visit Noven's website at

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 completion of the MethyPatch Phase III study may be delayed due to slower than expected enrollment or other factors; that the study may not be successful or may not provide sufficient information to support a New Drug Application; that MethyPatch may not be approved or, if approved, that it may not be successfully commercialized due to competitive market conditions or other factors, including physician/patient preferences for other ADHD therapies; and that other studies may not confirm or support the study results presented at the AACAP symposium.

Investor & Media Contact:
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.