NOVEN
PROVIDES UPDATE ON DAYTRANA™
METHYLPHENIDATE TRANSDERMAL
SYSTEM |
|
Product
Licensee Shire Undertakes Voluntary Market Withdrawal
of a Limited
Portion of Daytrana™ Product
Miami, FL, September
4, 2007 -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today provided
an update on the Daytrana™ patch
product for the treatment of the symptoms of Attention Deficit Hyperactivity
Disorder (ADHD). Daytrana™, developed and manufactured by Noven,
is licensed globally to Shire plc.
Shire has announced via separate
press release that it is undertaking a voluntary market withdrawal
of a limited portion of Daytrana™ product. Shire is taking this
action primarily due to feedback from patients and caregivers who have
experienced difficulty removing the release liner from some Daytrana™ patches.
In
the first quarter of 2007, Noven and Shire implemented enhancements
to the Daytrana™ release liner intended to improve ease of use
of the patch, and product using the enhanced release liner is now in
the trade channels. Shire and Noven are committed to improving the
ease of use of Daytrana™ so patients can use Daytrana™ with
the convenience they expect from this novel ADHD treatment option.
Based
on preliminary information, the retail value of product being withdrawn
is estimated to be in the $4 million to $6 million range.
Important
Safety Information
Tell your doctor about any heart conditions, including
structural abnormalities, your child or a family member may have. Inform
your doctor immediately if the child develops symptoms that suggest
heart problems, such as chest pain or fainting.
Daytrana should not
be used if the child has: significant anxiety, tension, or agitation;
allergies to methylphenidate or other ingredients of Daytrana; glaucoma;
discontinued in the last 14 days or is taking a monoamine oxidase inhibitor
(MAOI); tics, or family history or diagnosis of Tourette’s syndrome.
Tell
your doctor before using Daytrana if the child: is being treated for
or has symptoms of depression (e.g. sadness, worthlessness, or hopelessness)
or bipolar disorder; has family history of tics; has abnormal thoughts
or visions, hears abnormal sounds, or has been diagnosed with psychosis;
has had seizures or abnormal EEGs; has or has had high blood pressure;
or exhibits aggressive behavior or hostility. Tell your doctor immediately
if the child develops any of these conditions/symptoms while using Daytrana.
In
clinical studies, side effects were generally mild to moderate. The most
common side effects reported with Daytrana were decreased appetite, sleeplessness,
sadness/crying, twitching, weight loss, nausea, vomiting, tics, and affect
lability (mood swings). Aggression, new abnormal thoughts/behaviors,
mania, and growth suppression have been associated with use of drugs
of this type. Tell your doctor if the child has blurred vision while
using Daytrana.
Abuse of Daytrana can lead to dependence.
Daytrana should
be applied daily to clean, dry skin, which is free of any cuts or irritation.
Skin irritation or allergic skin rash may occur.
For additional information,
please see www.daytrana.com.
About Noven
Noven Pharmaceuticals, Inc.,
headquartered in Miami, Florida, has established itself as a leading
developer of advanced transdermal drug delivery technologies and prescription
transdermal products. Its commercialized transdermal products include
Vivelle-Dot®,
the most prescribed estrogen patch in the U.S., and Daytrana™,
the first and only patch approved for the treatment of ADHD. Transdermal
products in development include an amphetamine patch for ADHD, a generic
fentanyl patch for pain management, and undisclosed partnered products.
With
the acquisition of JDS Pharmaceuticals, LLC in August 2007, Noven has
expanded its business to become a broader-based specialty pharmaceutical
company. The acquisition adds a psychiatry-focused marketing and sales
infrastructure (including a targeted sales force, in-market products
and category expertise) and substantially enhances Noven’s late-stage
product development pipeline.
Forward
Looking 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. Statements that are not
historical facts, including statements which are preceded by, followed
by, or that include, the words "believes," "anticipates," "plans," "expects" or
similar expressions and statements, are forward-looking statements. Noven’s
estimated or anticipated future results, product performance or other
non-historical facts are forward-looking and reflect Noven’s current
perspective on existing trends and information. 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, going forward, product not subject to the withdrawal does not continue
to improve ease of use of the product; ongoing risk to Noven and Daytrana™ associated
with Noven’s previously-announced Form 483; the risk that the estimated
amount of product subject to the withdrawal may prove incorrect; the
risk of supply interruptions resulting from delays or inability to obtain
DEA methylphenidate quota to replace withdrawn product; the risk that
the market withdrawal will inhibit Noven’s ability to achieve the
third Daytrana™ milestone payment under its agreement with Shire;
the risk that any of the foregoing factors could adversely affect Noven’s
business, results of operations and/or financial position; and the possibility
that Noven may incur significant costs relating to the Daytrana™ market
withdrawal, which could adversely affect Noven’s results of operations
and/or its financial position. 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 as well as other reports
filed from time to time with the Securities and Exchange Commission.
Unless required by law, Noven undertakes no obligation to publicly update
or revise any forward-looking statements, whether as a result of new
information, future events, or otherwise.
Investor
Contact:
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.
(305) 253-1916
Media
Contact for Daytrana™:
Matthew Cabrey
Shire plc
(484) 595-8248
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Copyright © 2007 Noven
Pharmaceuticals, Inc. All rights reserved. |