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DEVELOPMENTAL
METHYLPHENIDATE PATCH
SCHEDULED FOR FDA ADVISORY COMMITTEE REVIEW
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Miami, FL and Philadelphia,
PA, October 27, 2005 -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN)
and Shire Pharmaceuticals Group plc
announced today that the amended New Drug Application (NDA) for MTS
(methylphenidate transdermal system) will be reviewed by the Food and
Drug Administration's Psychopharmacologic Drugs Advisory Committee
at their scheduled open session on December 2, 2005. MTS is a transdermal
patch designed for once-daily use to treat attention deficit hyperactivity
disorder (ADHD) in children aged 6 to 12 years. The NDA amendment has
been assigned a Prescription Drug User Fee Act (PDUFA) date of December
28, 2005.
About Noven
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 patches are being
developed in collaboration with Shire Pharmaceuticals Group plc,
Novartis
Pharma AG, P&G Pharmaceuticals, Endo Pharmaceuticals Inc. and
others. Noven is committed to expanding the universe of available
transdermal
therapies for the benefit of patients, partners and shareholders.
See www.noven.com for additional information.
About Shire
Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical
company with a strategic focus on meeting the needs of the specialist
physician and currently focuses on developing and marketing products
in the areas of central nervous system (CNS), gastrointestinal (GI),
renal diseases and human genetic therapies. Shire has operations
in the world's key pharmaceutical markets (US, Canada, UK, France,
Italy,
Spain and Germany) as well as a specialist drug delivery unit in
the US. For further information on Shire, please visit the Company's
website:
www.shire.com.
About
MTS and Methylphenidate
In pivotal clinical studies managed by Shire, MTS was generally well
tolerated and adverse events typically were mild to moderate, resolved
with continued therapy and were consistent with known effects of
methylphenidate. The most common adverse events reported by patients
who received MTS
in clinical trials were: nausea, vomiting, nasopharyngitis, weight
decreased, anorexia, decreased appetite, affect lability, insomnia,
tic, and nasal congestion.
Methylphenidate should not be administered to patients with: glaucoma;
tics, Tourette's syndrome or a family history of Tourette's syndrome;
current or recent use of Monoamine Oxidase Inhibitors (MAOIs).
Chronic abuse of methylphenidate may lead to dependence and careful
supervision
following withdrawal from abuse is warranted.
Methylphenidate should
not be given to patients with a history of drug dependence or alcoholism.
Methylphenidate should not be used for the prevention or treatment
of severe depression or normal fatigue states. Growth should be
monitored in patients treated with methylphenidate. Use with caution
in patients
with psychosis, history of seizures or EEG abnormalities, hypertension,
a history of drug dependence or alcoholism. Rare cases of visual
disturbances have been reported with methylphenidate use. Hematologic
monitoring
is advised during prolonged therapy.
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
the FDA and/or the advisory committee could determine that Noven's
amended NDA for MTS does not support approval or that MTS may not
ultimately be approved or commercialized; the possibility that
safety concerns
by the FDA and/or the advisory committee regarding the use of controlled
substances in patches may delay or prevent approval of MTS; risks
and uncertainties related to the fact that MTS is a novel delivery
system
for this controlled substance, which may result in new and additional
concerns for the advisory committee and/or the FDA; uncertainties
related to the FDA's discretion to approve or not approve a product,
as well
as the timing of any FDA approval for MTS, which is outside Noven's
control and may impact the success of product launch and market penetration;
any exercise of Shire's right to terminate the MTS development agreement;
and the likelihood that Noven's development strategy would change
if Shire were to terminate the agreement under certain circumstances,
or if MTS were not ultimately approved or were abandoned.
Contact:
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.
(305) 253-1916
Copyright © 2005 Noven
Pharmaceuticals, Inc. All rights reserved.
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