Noven And Shire Sign Development Agreement For New ADHD Patch

-- Noven Pharmaceuticals, Inc. (Nasdaq: NOVN) today announced that it has signed an agreement with Shire Pharmaceuticals Group plc (Shire) for the development of a transdermal amphetamine patch for Attention Deficit Hyperactivity Disorder (ADHD).

The agreement marks the second collaboration between Noven and Shire. In early 2003, Shire licensed global rights to MethyPatch® (methylphenidate transdermal system, MTS), a developmental methylphenidate patch for ADHD. "We are very pleased to enter into a second development collaboration with Shire – the market share leader in ADHD – which could ultimately position Noven in the methylphenidate and amphetamine segments of the ADHD market," said Robert C. Strauss, Noven's President, CEO & Chairman.

Greg Flexter, Shire General Manager, North America, commented: "We are pleased that the methylphenidate transdermal system is proceeding under an agreed development plan. The amphetamine patch should offer an additional choice in this growing market and in this highly effective segment of ADHD treatments."

The agreement provides for payments to Noven of up to $5.0 million if certain development milestones are achieved. The parties are currently negotiating an agreement for the license and supply of the product to Shire.

In a separate release issued today, Noven provided an update on the development status of its methylphenidate transdermal system.

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 sold in over 30 countries, and a range of new patches are being developed in collaboration with Novartis Pharma AG, Shire Pharmaceuticals Group plc, P&G Pharmaceuticals, Endo Pharmaceuticals Inc. and others. With the most advanced and broadly applicable transdermal technology in its class, Noven is committed to expanding the universe of available transdermal therapies for the benefit of patients, partners and shareholders. See for additional information.

Except for historical information contained herein, the matters discussed in this press release contain 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 that involve substantial risks and uncertainties. When used in this press release, the words "expects", "may", "will”, “should” and similar expressions identify certain of such forward-looking statements. 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. These risks and uncertainties include: the possibility that the development of a transdermal amphetamine patch may not proceed on schedule or as expected; the possibility that Noven’s technologies may not be suitable for delivery of an amphetamine patch that meets Shire’s requirements; the possibility that Noven may be unsuccessful in achieving any or all of the milestone objectives under its agreement with Shire; the possibility that the parties may be unable to reach agreement on the terms of a license and supply agreement; the risk that a transdermal amphetamine patch may not ultimately be approved by the FDA or commercialized; and Noven’s success at managing the risks related to the foregoing. In addition to the risks and factors identified above, reference is also made to the other risks and factors detailed in reports filed by Noven with the Securities and Exchange Commission. Noven cautions that the foregoing list of factors is not exhaustive.

Investor & Media Contact

Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.