NOVEN
DISCLOSES DEVELOPMENT PROGRAMS FOR |
BackBioequivalence Study Completed for Fentanyl Patch
Dextroamphetamine Patch for ADHD to Enter Human Clinical Trials
Miami, FL, March
24, 2003 -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN), a leading
developer of advanced transdermal drug delivery technologies and prescription
transdermal products, today announced development programs for two
new transdermal systems.
Fentanyl. Noven has completed bioequivalence studies comparing its
developmental fentanyl transdermal system to Duragesic®, a Schedule
II opioid analgesic transdermal system for chronic pain distributed
by Janssen Pharmaceutica, L.P., a division of Johnson & Johnson.
U.S. sales for Duragesic® exceeded $900 million in 2002. Noven
believes it is one of several companies developing a generic version
of Duragesic®. Duragesic® is expected to come off patent
in July 2004, but Janssen has been granted an additional six months
pediatric exclusivity, which would effectively prevent the launch
of a generic version until January 2005.
Noven’s fentanyl transdermal patch utilizes a solid-state drug/adhesive
matrix, as opposed to the liquid reservoir delivery system used in
Duragesic®. Noven has also developed transdermal formulations
for several additional pain management compounds.
"We expect to file an Abbreviated New Drug Application for our fentanyl
patch with the Food and Drug Administration in the second half of
2003, and we are actively exploring opportunities with companies
interested in marketing the product," said Robert Strauss,
Noven's President, CEO & Chairman.
Dextroamphetamine. Noven also announced that it expects to begin
human clinical trials of a long-acting dextroamphetamine transdermal
system for Attention Deficit Hyperactivity Disorder (ADHD) in the
summer of 2003. The dextroamphetamine patch adds to Noven’s
ADHD therapy development program, which includes a methylphenidate
transdermal system (MethyPatch®), currently under FDA review.
In February 2003, Noven announced that Shire Pharmaceuticals Group
plc, the market-share leader in ADHD therapy, had agreed to acquire
global marketing rights to MethyPatch.
"Our developmental dextroamphetamine patch has the potential to be
the first transdermal therapy in the $700 million U.S. market for
amphetamine-based ADHD products,” said Strauss. “It would
give Noven product entries in both the methylphenidate and amphetamine
segments of the ADHD therapy market.”
Growth Strategy. Strauss
added: "Our fentanyl and dextroamphetamine patches should advance
our strategy to leverage our DOT Matrix™ transdermal
technology across a diverse range of products and therapeutic categories.
These products, along with the roughly 20 other transdermal products
that Noven has formulated, should position Noven for growth from
diverse sources in the years ahead."
DOT Matrix technology permits Noven to deliver predictable therapeutic
doses of a wide range of prescription drugs through discreet, comfortable
and adherent patches that are well suited to active lifestyles.
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 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® for
ADHD, 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.
Duragesic® is a registered trademark of Janssen Pharmaceutica,
L.P.
This release contains forward-looking information
related to the business of Noven that can be identified by the use
of forward-looking
terminology such as "believes", "expects", "may", "could", "potential",
"would", "should" 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 those specified
herein, including the risk that: we may fail to develop new products
or establish new strategic collaborations, either of which would
significantly limit our ability to leverage our technology, diversify
our prospects and execute on our growth strategy; product development
is inherently risky, and any project, including our dextroamphetamine
or fentanyl patches, could fail at any time or be delayed indefinitely;
the timing of ANDA approval for our fentanyl patch could be affected
by any number of issues that are beyond our control, including patent
strategies by the innovator and strategies by generic competitors
that could result in exclusivity; with several companies expected
to offer a generic version of Duragesic, product pricing and other
competitive factors may substantially diminish the market opportunity
available to Noven; the Shire transaction may not close; and MethyPatch
may not be approved or, if approved, it may not be successfully commercialized
by Shire due to competitive market conditions or other factors, including
physician/patient preferences for other ADHD therapies.
Contact:
Investor & Media Contact
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.
(305) 253-1916
Product Licensing
Inquiries
Pavan Handa
Executive Direcor – Business Development
Noven Pharmaceuticals, Inc.
(305) 964-3330
Copyright © 2003 Noven Pharmaceuticals, Inc. All rights reserved.