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Noven Seeking U.S. Marketing Approval from FDA for Transdermal ADHD Patch
Miami, FL, June 27,
2002 – 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.
About
Noven
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.
Investor
& Media Contact:
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.
(305) 253-1916
Copyright © 2002 Noven Pharmaceuticals, Inc. All rights reserved.