Noven Announces Results of Daytrana(TM) Advisory Committee Meeting

Daytrana(TM), licensed globally to Shire plc, is aninvestigational transdermal patch designed for once-daily use to treatattention deficit hyperactivity disorder (ADHD) in children aged 6 to12 years. An amended New Drug Application (NDA) for Daytrana(TM) iscurrently pending at the U.S. Food and Drug Administration (FDA).

The FDA asked the Advisory Committee to vote on (i) whether theproduct has been shown to be effective for the treatment of ADHD, and(ii) whether the product has been shown to be acceptably safe in thetreatment of ADHD. On the first question, the Committee votedunanimously in favor of the efficacy of the product. On the secondquestion, the Committee voted unanimously in favor of the safety ofthe product, but recommended that the FDA require post-marketingsurveillance and/or studies related to the product. The AdvisoryCommittee also recommended to the FDA that consideration of oral ADHDproducts be given prior to use of the product, but by a vote of elevento one rejected a proposal to limit use of the product to patients whocannot use oral methylphenidate products.

"We are pleased that the Committee's vote was supportive of theefficacy and safety of the product," said Robert C. Strauss, Noven'sPresident, CEO & Chairman. "We look forward to the FDA's finaldecision on the approvability of the amended NDA."

The regulatory review period under the Prescription Drug User FeeAct (PDUFA) for the amended NDA is scheduled to conclude on December28, 2005. The FDA is not bound by the vote or recommendations of theAdvisory Committee.

Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is aleading developer of advanced transdermal drug delivery technologiesand prescription transdermal products. Noven's prescription patchesare sold in over 30 countries, and a range of new products are beingdeveloped in collaboration with Shire plc, Novartis Pharma AG, P&GPharmaceuticals, Endo Pharmaceuticals Inc. and others. Seehttp://www.noven.com for additional information.

Except for historical information contained herein, the mattersdiscussed in this press release contain forward-looking statementswithin the meaning of Section 27A of the Securities Act of 1933 andSection 21E of the Securities Exchange Act of 1934 that involvesubstantial risks and uncertainties. Actual results, performance orachievements could differ materially from those contemplated,expressed or implied by the forward-looking statements containedherein. These forward-looking statements are based largely on thecurrent expectations of Noven and are subject to a number of risks anduncertainties that are subject to change based on factors which are,in many instances, beyond Noven's control. These risks anduncertainties include: the possibility that FDA will determine thatthe amended NDA does not support approval; the risk that MTS may notultimately be approved or commercialized; risks related to finalproduct labeling (if the product is approved), including the risk thatwarnings or limitations required by the FDA may adversely affect thecommercial success of the product; uncertainties relating to thetiming of any DEA award of methylphenidate procurement quota necessaryfor the production of MTS, which is outside Noven's control and mayimpact the success of product launch and market penetration.