NOVEN
TO RECEIVE $25 MILLION DAYTRANA™ SALES MILESTONE |
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Miami, FL, July
31, 2007 -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today announced
that it has been advised by Shire plc that Shire’s net sales of Daytrana™ (methylphenidate
transdermal system) have triggered the second of three potential
$25 million milestone payments to Noven.
Daytrana™, licensed globally to Shire,
was launched in June 2006. Payment of the first milestone was triggered
upon Shire’s net sales of Daytrana™ exceeding $25 million in
2006. Payment of the milestone announced today was triggered upon Shire’s
net sales of Daytrana™ exceeding $50 million in the 12-months
preceding June 30, 2007.
Under the Daytrana™ transaction agreement, a third
$25 million milestone is payable upon Shire’s achievement of $75
million in annual net sales of Daytrana™. For purposes of the sales
milestones, Shire’s annual net sales are measured quarterly
on a trailing 12-month basis. From an accounting standpoint, Noven
expects to defer the sales milestones and recognize them as license
revenues over time.
About Daytrana™
Daytrana™ is a methylphenidate transdermal
system for the treatment of ADHD and is currently the only transdermal
product approved for ADHD therapy. It is approved for children aged
six to twelve years with ADHD.
Daytrana™ should not be used in patients
with allergy to methylphenidate or patch components; marked anxiety,
tension and agitation; glaucoma; tics, diagnosis or a family history
of Tourette's syndrome; seizures; or during or within 14 days after
treatment with monoamine oxidase inhibitors (MAOIs). Sudden death
has been reported in association with CNS stimulant treatment at
usual doses in children and adolescents with structural cardiac abnormalities
or other serious heart problems.
Sudden
deaths, stroke, and myocardial infarction have been reported in adults
taking stimulant drugs at usual doses in ADHD. Physicians should take a
careful patient history, including family history, and physical exam, to
assess the presence of cardiac disease. Patients who report symptoms of
cardiac disease such as exertional chest pain and unexplained syncope should
be promptly evaluated. Use with caution in patients whose underlying medical
condition might be affected by increases in blood pressure or heart rate.
New
psychosis, mania, aggression, growth suppression, and visual disturbances
have been associated with the use of stimulants. Use with caution
in patients with a history of: psychosis; EEG abnormalities; bipolar
disorder; depression. Growth and hematologic monitoring is advised
during prolonged treatment. Patients should avoid applying external
heat to the Daytrana™ patch.
Skin irritation or contact sensitization may occur.
Daytrana™ should
be given cautiously to patients with a history of drug dependence
and alcoholism. Chronic abuse can lead to marked tolerance and psychological
dependence. Frank psychotic episodes can occur, especially with parenteral
abuse. Careful supervision is required during withdrawal from abusive
use, since severe depression may occur. Withdrawal following chronic
therapeutic use may unmask symptoms of the underlying disorder.
Common adverse events reported
by patients who received Daytrana™ in
clinical trials were decreased appetite, insomnia, nausea, vomiting,
decreased weight, tics, affect lability, and anorexia, consistent
with adverse events commonly associated with the use of methylphenidate.
For Full Prescribing Information, go to www.daytrana.com.
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 approved
in over 30 countries and include Vivelle-Dot® (the
most prescribed estrogen patch in the U.S.) and Daytrana™ (the first and only patch approved for
ADHD). 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. Daytrana™ and DOT Matrix® are
trademarks of Shire Pharmaceuticals Ireland Limited and Noven, respectively.
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 word “expect” 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 past Daytrana™ results may not be indicative
of future Daytrana™ results; the risk that the market for Daytrana
as well as future sales of Daytrana™ could be adversely affected
by a number of factors, including as a result of: (i) supply interruptions
of methylphenidate, (ii) delays or inability to obtain necessary DEA
methylphenidate procurement quota, (iii) issues relating to difficulties
in removing the release liner from the Daytrana™ patch, (iv) the
resolution of the observations made by the FDA in the Form 483 that Noven
received in July 2007, and (v) new market entrants, including from other
ADHD products marketed or under development by Shire; the risk that any
adverse effect to the market for Daytrana™ due the foregoing or
other factors could adversely affect Noven’s results of operations
and/or its financial position, including limiting Noven’s ability
to achieve the additional milestone payments under its agreement with
Shire. For additional information regarding these and other risks associated
with Noven’s business, readers should refer to Noven’s Annual
Report on Form 10-K for the year ended December 31, 2006 as well as other
reports filed from time to time by Noven with the Securities and Exchange
Commission.
Contact:
Joseph C. Jones
Vice President – Corporate Affairs
(305) 253-1916
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Copyright © 2007 Noven
Pharmaceuticals, Inc. All rights reserved. |