NOVEN
SUBMITS RESPONSE TO
LONDON & MEAD CITIZEN PETITION ON
FENTANYL PATCH
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Miami, FL, January
3, 2005 -- Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) today announced
that it has submitted comments to the U.S. Food & Drug Administration
(FDA) in response to a pending citizen petition intended to prevent
or delay the approval of certain generic versions of Johnson & Johnson’s
Duragesic® product (fentanyl transdermal system).
Noven’s comments address the issues raised in the citizen petition
submitted by the law firm of London & Mead in December 2004, and
otherwise offer insight into the characteristics of adhesive matrix
transdermal patches. A copy of Noven’s comments, and a link to
the subject citizen petition, are available on Noven’s website
at www.noven.com/cpresponse1.htm.
Noven’s fentanyl patch is a transdermal delivery system for the
management of chronic pain. An Abbreviated New Drug Application for
Noven’s patch is pending at the FDA. Marketing rights to the
product in the U.S. and Canada have been licensed to Endo Pharmaceuticals
Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc.
(NASDAQ: ENDP).
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a
leading developer of advanced transdermal drug delivery technologies
and prescription transdermal products. Noven’s prescription patches
are approved in over 30 countries, and a range of new patches are being
developed in collaboration with Novartis Pharma AG, Shire Pharmaceuticals
Group plc, Procter & Gamble Pharmaceuticals, Endo Pharmaceuticals
Inc. and others. Together with Novartis Pharmaceuticals Corporation,
Noven owns Novogyne Pharmaceuticals, a profitable women’s health
products company with 2003 sales of over $100 million. Among other
products, Novogyne markets and sells Noven’s Vivelle Dot® product
– the smallest estrogen patch in the world, and the most dispensed
transdermal estrogen product in the U.S. Noven is committed to expanding
the universe of available transdermal therapies for the benefit of
patients, partners and shareholders. See www.noven.com for additional
information.
This press release contains forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933
and Section 21E of the Securities Exchange Act of 1934. Actual
results, performance or achievements could differ materially from
those contemplated, expressed or implied by the forward-looking
statements contained herein. These forward-looking statements are
based largely on the current expectations of Noven and are subject
to a number of risks and uncertainties that are subject to change
based on factors which are, in many instances, beyond Noven’s
control. Reference is made to the risks and factors detailed in
Noven’s Annual Report on Form 10-K as well as other reports
filed by Noven with the Securities and Exchange Commission.
Investor & Media
Contact:
Joseph C. Jones
Vice President – Corporate Affairs
(305) 253-1916
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Copyright © 2004 Noven
Pharmaceuticals, Inc. All rights reserved. |