NOVEN
CONFIRMS AVAILABILITY OF
DAYTRANA™ METHYLPHENIDATE TRANSDERMAL
SYSTEM
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Miami, FL, June 29,
2006 -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today confirmed
that Shire plc has launched Daytrana™ (methylphenidate transdermal
system), the first and only transdermal medication approved to treat
the symptoms of Attention Deficit Hyperactivity Disorder (ADHD) in
children aged six to twelve years, and that the product is now available
in retail pharmacies. Shire, the market leader in ADHD, is the exclusive,
global licensee of Daytrana™, which was developed and is manufactured
by Noven.
"As an organization, we greatly appreciate the opportunity to
work with our partner Shire to assure a successful product launch,"
said Robert C. Strauss, Noven’s President, CEO & Chairman. “It
is gratifying to know that Noven's science and technologies,
as well as the efforts and dedication of our employees, have contributed
to the availability of the first patch therapy for ADHD."
About Daytrana™
The U.S. Food and Drug Administration approved Daytrana™ on April
6, 2006. The product was developed by Noven and combines the active
ingredient, methylphenidate, with Noven’s patented DOT Matrix™ transdermal technology. This transdermal delivery system was designed
to provide continuous release of medication throughout the day. The
patch is designed to stay on during the normal daily activities of
a child such as swimming, exercising or bathing.
Important Safety Information
Daytrana™ was generally well tolerated in clinical studies. As
with other products containing methylphenidate (the active ingredient
in Daytrana™), common side effects reported with Daytrana™ were
decreased appetite, insomnia, nausea, vomiting, weight loss, tics,
and affect lability (mood swings). Abuse of methylphenidate may lead
to dependence.
Parents or caregivers should tell the child’s physician about
any heart conditions their child or family members may have. Also parents
and caregivers should tell the doctor if their child has a history
of high blood pressure, problems with alcohol or drugs, depression,
bipolar disorder, abnormal thoughts/behaviors, visual disturbances,
or seizures. Inform the doctor immediately if the child develops symptoms
that suggest heart problems, such as chest pain or fainting. Aggression,
new abnormal thoughts/behaviors, mania, and growth suppression have
been associated with use of drugs of this type. Methylphenidate should
not be taken by children with significant agitation; glaucoma; tics,
family history or diagnosis of Tourette’s syndrome; or current/recent
use of MAO inhibitors (a type of antidepressant). Daytrana™ should
not be used by children allergic to methylphenidate or other ingredients
in Daytrana™.
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 Full Prescribing Information on Daytrana™ system, please
visit www.ADHDSupport.com or www.DAYTRANA.com or call Shire Medical
Affairs at 1-800-828-2088, option 4.
Daytrana and DOT Matrix are trademarks of Shire Pharmaceuticals Ireland
Limited and Noven, respectively.
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 the treatment of ADHD). A range of
new patches is being investigated and developed in collaboration with
Shire plc, 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.
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 words “expects” 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 Noven may encounter production issues and/or inefficiencies
in the process of manufacturing commercial quantities of Daytrana™,
which could adversely affect the success of the product and Noven’s
results of operations; risks related to post-marketing surveillance and
studies; risks related to competition (including from other ADHD products
marketed or under development by Shire) and market acceptance of Daytrana™ that
could adversely affect the commercial success of Daytrana™ and
could, among other things, limit Noven’s right to receive the additional
milestone payments under its agreement with Shire; the possibility that
the market for methylphenidate products may be negatively affected by
the outcome of the FDA’s ongoing inquiry into possible cardiac,
psychiatric and other side effects of ADHD medications, a 2005 study
by researchers at the M.D. Anderson Cancer Center that found adverse
chromosomal effects on 12 children treated with oral methylphenidate,
as well as ongoing public debate in the United States regarding the appropriateness
of using methylphenidate and other medications to treat children with
ADHD; the possibility that the FDA’s ongoing inquiry into possible
side effects of ADHD medication could result in “black-box” warnings
being added to the labeling for these medications; and the risk of supply
interruptions and other uncertainties relating to future DEA awards of
methylphenidate procurement quota necessary for the production of Daytrana™.
For additional information regarding these and other risks associated
with this product and Noven’s business, readers should refer to
Noven’s Annual Report on Form 10-K for the year ended December
31, 2005 as well as the quarterly and periodic 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 © 2006 Noven
Pharmaceuticals, Inc. All rights reserved. |