Miami, FL, March
10, 2006 -- Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) announced today that
the U.S. Food and Drug Administration (FDA) has declared the February
resubmission to the pending New Drug Application for Daytrana™ (methylphenidate
transdermal system) to be a complete Class I response to the approvable
letter previously issued by the FDA for the product. The FDA has assigned
April 9, 2006 as the user fee goal date for the FDA to complete its
review of the resubmission. 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 “would”, “expects” 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 risk that the Daytrana™ resubmission may not be sufficient to support approval and that the product may not ultimately be approved; risks related to final product labeling, including the risk that warnings or limitations required by the FDA may adversely affect the commercial success of Daytrana™; risks related to post-marketing surveillance and studies; the risk of supply interruptions and other uncertainties relating to future DEA awards of methylphenidate procurement quota necessary for the production of Daytrana™; the risk that Noven may encounter production issues and/or inefficiencies in the process of manufacturing commercial quantities of Daytrana™, which could adversely affect the success of product launch and Noven’s results of operations; risks related to competition (including from other ADHD products marketed by Shire) and market acceptance of Daytrana™ that could adversely affect the commercial success of Daytrana™ and could, among other things, limit Noven’s right to receive the additional milestone payments under its agreement with Shire; the possibility that the market for methylphenidate products may be negatively affected by the outcome of the FDA’s ongoing inquiry into the possible side effects of ADHD medications, the FDA Drug Safety and Risk Management Advisory Committee’s recent recommendation that ADHD medications carry a “black-box” warning about possible cardiac events, a 2005 study by researchers at the M.D. Anderson Cancer Center that found adverse chromosomal effects on 12 children treated with oral methylphenidate, as well as ongoing public debate in the United States regarding the appropriateness of using methylphenidate and other medications to treat children with ADHD. For additional information regarding these and other risks associated with this product and Noven’s business, readers should refer to Noven’s Annual Report on Form 10-K as well as other reports filed from time to time with the Securities and Exchange Commission.
Copyright © 2006 Noven Pharmaceuticals, Inc. All rights reserved. |
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