Miami, FL, February 7, 2002
Noven Completes Patient Enrollment For Methypatch Phase III Clinical Trial
-- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN), today announced that it has completed patient enrollment for a Phase III clinical trial of MethyPatch®, Noven's once-daily transdermal methylphenidate system for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Noven completed enrollment of over 200 patients between the ages of 6 and 12 in its double-blind, placebo-controlled, multi-center MethyPatch clinical trial. Patient screening and enrollment began in October 2001.
"We are pleased to conclude enrollment for our MethyPatch clinical trial,"' said Robert C. Strauss, Noven's President, Chief Executive Officer & Chairman. "We expect results from the study to be available in the second quarter of 2002."
Noven's once-daily MethyPatch is designed to offer the safety and efficacy of immediate release oral methylphenidate products, while giving physicians and parents unique flexibility in managing ADHD, eliminating in-school dosing, and providing the ability to discontinue dosing as needed by removing the patch. The product combines methylphenidate - 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.
ADHD is characterized by developmentally inappropriate impulsivity, inattention and hyperactivity. 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 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 http://www.noven.com.
This release contains forward-looking statements related to the business of Noven that can be identified by the use of forward-looking terminology such as "we expect" and "is designed to."' 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, including the risk that the Phase III trial may not conclude on schedule or that the results of the study may not support an NDA filing; and 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. There are several other once-daily ADHD medications on the market, and other products that may have improved safety and efficacy profiles are also in development.
Investor & Media Contact:
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.