Miami, FL, June 27, 2002
Noven Submits New Drug Application For Once-Daily MethyPatch®
Noven Seeking U.S. Marketing Approval from FDA for Transdermal ADHD Patch
-- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today announced that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for MethyPatch® (transdermal methylphenidate system), Noven's once-daily methylphenidate patch for Attention Deficit Hyperactivity Disorder (ADHD).
Noven is seeking marketing approval of MethyPatch for the treatment of ADHD. The MethyPatch NDA is supported by data from a double-blind, placebo-controlled, multi-center Phase III trial completed in March 2002 that involved over 200 patients between the ages of 6 and 12, as well as several other clinical studies. Clinical investigators who participated in the recent Phase III trial are expected to present full study results in late 2002 at a scientific forum to be announced in the coming months. The 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.
"We are pleased to have filed our MethyPatch NDA on schedule," said Robert C. Strauss, Noven's President, CEO & Chairman, "and to be advancing this unique ADHD therapy towards commercialization."
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-aged 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 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 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 "expect" 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 the Phase III trial data may not be presented at the time or in the manner expected, that Noven's NDA may not be accepted by FDA, 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. FDA will examine data from the most recent 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. The timing of any FDA approval is outside the control of 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.
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.