Noven Submits Response To London & Mead Citizen Petition On Fentanyl Patch

-- 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

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 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.

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