8-K

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): December 2, 2005

Noven Pharmaceuticals, Inc.
__________________________________________
(Exact name of registrant as specified in its charter)

Delaware	0-17254	59-2767632
_____________________ (State or other jurisdiction	_____________ (Commission	______________ (I.R.S. Employer
of incorporation)	File Number)	Identification No.)
11960 S.W. 144th Street, Miami, Florida		33186
_________________________________ (Address of principal executive offices)		___________ (Zip Code)

Registrant’s telephone number, including area code: 305-253-5099

Not Applicable
______________________________________________
Former name or former address, if changed since last report

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[  ]  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[  ]  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[  ]  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[  ]  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01 Other Events.

On December 2, 2005, Noven Pharmaceuticals, Inc. issued a press release, a copy of which is filed herewith as Exhibit 99.1 and is incorporated herein by reference.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Noven Pharmaceuticals, Inc.
December 2, 2005	By:	/s/ Diane M. Barrett
		Name: Diane M. Barrett
		Title: Vice President and Chief Financial Officer

Exhibit Index

Exhibit No.	Description
99.1	Press Release of Noven Pharmaceuticals, Inc. dated December 2, 2005

EX-99.1

11960 Southwest 144^th Street
Miami, Florida 33186
(305) 253-5099
www.noven.com

F O R            I M M E D I A T E            R E L E A S E

NOVEN ANNOUNCES RESULTS OF
DAYTRANA™ ADVISORY COMMITTEE MEETING

Miami, FL – December 2, 2005 - Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) announced the results of the Psychopharmacologic Drugs Advisory Committee meeting held earlier today relating to Daytrana™ (methylphenidate transdermal system).

Daytrana™, licensed globally to Shire plc, is an investigational transdermal patch designed for once-daily use to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12 years. An amended New Drug Application (NDA) for Daytrana™ is currently pending at the U.S. Food and Drug Administration (FDA).

The FDA asked the Advisory Committee to vote on (i) whether the product has been shown to be effective for the treatment of ADHD, and (ii) whether the product has been shown to be acceptably safe in the treatment of ADHD. On the first question, the Committee voted unanimously in favor of the efficacy of the product. On the second question, the Committee voted unanimously in favor of the safety of the product, but recommended that the FDA require post-marketing surveillance and/or studies related to the product. The Advisory Committee also recommended to the FDA that consideration of oral ADHD products be given prior to use of the product, but by a vote of eleven to one rejected a proposal to limit use of the product to patients who cannot use oral methylphenidate products.

“We are pleased that the Committee’s vote was supportive of the efficacy and safety of the product,” said Robert C. Strauss, Noven’s President, CEO & Chairman. “We look forward to the FDA’s final decision on the approvability of the amended NDA.”

The regulatory review period under the Prescription Drug User Fee Act (PDUFA) for the amended NDA is scheduled to conclude on December 28, 2005. The FDA is not bound by the vote or recommendations of the Advisory Committee.

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 www.noven.com for additional information.

Contact:
Joseph C. Jones
Vice President – Corporate Affairs
(305) 253-1916

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. 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 FDA will determine that the amended NDA does not support approval; the risk that MTS may not ultimately be approved or commercialized; risks related to final product labeling (if the product is approved), including the risk that warnings or limitations required by the FDA may adversely affect the commercial success of the product; uncertainties relating to the timing of any DEA award of methylphenidate procurement quota necessary for the production of MTS, which is outside Noven’s control and may impact the success of product launch and market penetration.

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