Healthcare Industry News: Shire Plc
News Release - March 10, 2006
FDA Declares Daytrana(TM) NDA Resubmission to Be Complete Class I ResponseMIAMI--(HSMN NewsFeed)--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(TM) (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.
Daytrana(TM), licensed globally to Shire Plc, is a developmental product for the treatment of attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years. The resubmission is intended to address the issues presented by the FDA in the December 23, 2005 Daytrana(TM) approvable letter, which included proposed revisions to labeling, as well as requests for data clarification, post-marketing surveillance, and post-marketing studies.
If Daytrana(TM) is ultimately approved, Noven would be entitled to receive a $50 million milestone payment from Shire, and would have the opportunity to earn additional milestone payments of up to $75 million depending on the level of Shire's commercial sales of the product. In addition, Noven expects to earn a profit on the manufacture and supply of finished product to Shire.
Daytrana(TM) is a trademark of Shire.
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 products are being developed in collaboration with Shire Plc, Novartis Pharma AG, P&G Pharmaceuticals, Endo Pharmaceuticals Inc. and others. See http://www.noven.com 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 "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(TM) 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(TM); 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(TM); the risk that Noven may encounter production issues and/or inefficiencies in the process of manufacturing commercial quantities of Daytrana(TM), 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(TM) that could adversely affect the commercial success of Daytrana(TM) 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.
Source: Noven Pharmaceuticals
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