NOVEN
PROVIDES UPDATE ON DAYTRANA™ METHYLPHENIDATE TRANSDERMAL
SYSTEM |
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Product
Licensee Shire Undertakes Voluntary Recall of a Limited Portion
of Daytrana™ Product
Miami, FL, June 9,
2008 -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today provided an
update on the status of Daytrana™, the only transdermal patch
indicated for the treatment of the symptoms of Attention Deficit Hyperactivity
Disorder (ADHD). Daytrana™, developed and manufactured by Noven,
is licensed globally to Shire Limited.
Concurrently with this press
release, Shire has announced that it is undertaking a voluntary recall
of two lots of Daytrana™. Shire is taking this action because
some Daytrana™ patches do not meet the product’s release
liner removal specification and, as a result, patients and caregivers
could have difficulties removing the liner when they peel the patch
open. The Daytrana™ prescribing information and medication guide
provide that, if a patch is damaged or the release liner is difficult
to remove, the patch should be discarded.
Shire indicated that the
voluntary recall is not due to safety issues, and that current supply
levels of Daytrana™ should be sufficient to ensure that patients
can continue to have their Daytrana™ prescriptions filled at
their local pharmacies. Noven continues to manufacture the product
and Shire continues to promote it in the United States.
Peter Brandt,
Noven's President and Chief Executive Officer, commented: "The
Daytrana™ product enhancements implemented in 2007 generally
improved the ease of use of Daytrana™ and substantially reduced
complaint rates, but they have not fully resolved the issue. We have
recently identified a probable root cause, as well as several possible
solutions, and testing is underway to confirm our belief that we are
headed toward resolution of this issue."
Noven and Shire will
continue ongoing quality assurance activities and data analysis of
Daytrana™, and additional voluntary actions are possible. The
parties continue to pursue additional product enhancements and to work
closely with the U.S. Food and Drug Administration to implement changes
that may further improve the ease of use of Daytrana™.
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; 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™.
Note: 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 redness or itching is common with Daytrana™. Allergic skin
rash may occur.
About Noven
Noven Pharmaceuticals, Inc. is a specialty
pharmaceutical company engaged in the research, development, manufacture,
marketing and sale of prescription pharmaceutical products. Noven’s
business and operations are focused in three principal areas – transdermal
drug delivery, the Novogyne joint venture, and its Noven Therapeutics
specialty pharmaceutical unit.
Safe Harbor Statement under the Private
Litigation Reform Act of 1995
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 that 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 that are, in many instances, beyond
Noven's control.
These risks and uncertainties include: the risk that
additional lots of Daytrana™ may be recalled by Shire due to product
failing to meet the release liner specification or otherwise; the risk
that Noven may not identify a definitive root cause of the release liner
issue or identify or be able to implement a solution to fully resolve
the issue; uncertainties related to the financial impact of the recall;
the risk that Noven’s response to the FDA’s January 2008
warning letter may not be acceptable to the FDA or adequately address
the FDA’s concerns, and in such case, the risk that the FDA may
take regulatory action against Noven, which may include fines, product
seizures or recalls, injunctions, suspension of production and/or the
withdrawal of product approval; and the risk that any adverse effect
to the market for Daytrana™ due to the foregoing or other factors
could adversely affect Noven’s reputation, results of operations
and/or its financial position, including limiting Noven’s ability
to achieve the additional milestone payment 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, 2007, 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.
Noven
Contact:
Joseph C. Jones
Vice President – Corporate
Affairs
(305) 253-1916
|
Media
Contact for Daytrana™:
Matthew
Cabrey
Shire Limited
(484) 595-8248 |
Copyright © 2008 Noven
Pharmaceuticals, Inc. All rights reserved. |