NOVEN
ANNOUNCES RESULTS OF
DAYTRANA™ ADVISORY COMMITTEE MEETING
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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.
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.
Contact:
Joseph
C. Jones
Vice President – Corporate Affairs
(305) 253-1916
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Copyright © 2005 Noven
Pharmaceuticals, Inc. All rights reserved. |