Miami, FL, April 1, 2002
Noven Announces Success of Phase III Study For Once-Daily Methypatch
Study Results Demonstrate Efficacy of Once-Daily Methylphenidate Patch for ADHD
MethyPatch New Drug Application Expected to be Filed with FDA Mid-Year 2002
-- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today announced that it has completed an initial review of the primary efficacy data from its recently completed Phase III clinical trial for once-daily MethyPatch® (transdermal methylphenidate system). The data indicate that MethyPatch, which incorporates Noven's patented DOT Matrix™ patch technology, is highly effective in the treatment of the symptoms of Attention Deficit Hyperactivity Disorder (ADHD). With the results from this pivotal trial, Noven expects to file a New Drug Application for MethyPatch with the U.S. Food and Drug Administration (FDA) in mid-2002.
The double-blind, placebo-controlled, multi-center trial, which ended in March 2002, involved over 200 patients between the ages of 6 and 12. The primary outcome measure was teacher ratings of patient attention and behavior using the IOWA Conners Rating Scale, a standard rating scale used for this condition in classroom and other settings. By this measure, MethyPatch offered highly statistically significant improvement (p less than .001) in patient attention and behavior compared to placebo.
Participating clinical investigators are expected to present full study results in late 2002 at a scientific forum to be announced in the coming months.
"MethyPatch is central to Noven's strategy of entering important therapeutic markets with products that we market ourselves, and these successful study results move us much closer to that goal," said Robert C. Strauss, Noven's President, CEO & Chairman. "We will now focus on completion of our MethyPatch New Drug Application, which we expect to submit to the FDA this summer, and on the advancement of other Noven products entering clinical trials."
If approved by the FDA, Noven expects MethyPatch will reach the U.S. market in the second half of 2003, and that it will be the first transdermal therapy available for ADHD.
MethyPatch is designed to offer a safe and effective method of delivering methylphenidate, while eliminating in-school or midday dosing and providing physicians and parents with unique flexibility in managing ADHD for the individual child. The recent Phase III study was part of a MethyPatch clinical trial program sponsored by Noven that spanned several years and included over 700 subjects in centers across the country.
MethyPatch combines methylphenidate - an established ADHD therapy - with Noven's patented DOT Matrix patch technology, which is the delivery platform underlying Noven's Vivelle-Dot® and CombiPatch® hormone replacement patches. DOT Matrix technology permits Noven to deliver predictable therapeutic doses of a range of prescription therapies through discreet, comfortable and 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.
A public telephone conference with management relating to the MethyPatch clinical results will be broadcast live via the Internet at http://www.noven.com beginning at 5:00 p.m. Eastern time this afternoon, April 1. Thereafter, a rebroadcast of the call will be accessible at the same website. A taped replay of the conference call will be available by telephone from April 1 at 9:00 p.m. Eastern time until the evening of April 3 by calling 800-475-6701 (from within the U.S.) or 320-365-3844 (from outside the U.S.) and entering the access code 634091. This conference call may contain forward-looking or material information in addition to that contained in this press release.
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 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 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 "indicate," "intends,"' "expect," "is designed to" 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 in this press release, including the risk that results of the study, when fully analyzed, may not support an NDA filing, that MethyPatch may not be approved or, if approved, that it may not be the first transdermal ADHD therapy on the market or 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 Noven may not be successful in entering new markets with products that it markets itself. FDA will examine data from the recently completed Phase III study together with data from other MethyPatch studies sponsored by Noven, and there can be no assurance that FDA will deem all of such data sufficient to approve the product for marketing or to authorize the product's use in the manner described by Noven. 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.
Financial & Company Contact:
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.