NOVEN
PROVIDES UPDATE ON DAYTRANA™ |
BackMiami, FL, November
28, 2006 -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today provided
an
update
on production and prescription information related to its
Daytrana™ methylphenidate transdermal system.
Noven announced that the U.S. Drug Enforcement Administration (DEA)
has granted Noven additional methylphenidate quota for 2006 related
to the production of Daytrana™. The grant follows Noven’s
prior statements that it was seeking additional methylphenidate quota
for 2006 from the DEA in order to fulfill product orders from Shire
plc. Shire is the exclusive, global licensee of Daytrana™, which
was developed and is manufactured by Noven.
"We are very pleased to have been granted additional quota for
2006," said
Robert C. Strauss, Noven's President, CEO & Chairman. "This
grant should help us as we work to maintain a continuity of product
supply in the marketplace. It should also help us improve utilization
of our facilities during the 2006 fourth quarter through additional
production. Due to the time it takes to complete production, however,
we do not expect that the additional quota will meaningfully increase
our fourth quarter product revenues above our prior public guidance."
Methylphenidate, the active ingredient in Daytrana™, is a Schedule
II controlled substance regulated by the DEA. Manufacturers of products
containing such substances must apply under the DEA’s quota process
in order to receive the active ingredient required for production.
Noven also announced that total prescriptions for Daytrana™ (launched
in June 2006) increased approximately 22% in October 2006 (the most
recent month for which data is available) compared to September 2006,
while prescriptions for ADHD stimulant therapies as a class increased
approximately 8% for the same period.
About Daytrana™
Daytrana™ is the first and only transdermal medication approved
to treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD).
It is approved for children aged six to twelve years with ADHD. The
product combines the active ingredient methylphenidate with Noven’s
patented DOT Matrixä transdermal technology.
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™.
Daytrana™ was generally well tolerated in clinical studies. 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.
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 under development by Noven in collaboration with industry
partners. 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 words “expect,” “should,” 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 of supply interruptions of methylphenidate, which is necessary for the production of Daytrana™, including uncertainties relating to future DEA awards of methylphenidate procurement quota, which interruptions could negatively affect production, facility utilization and Noven’s revenues and gross margin in future periods as well as market acceptance for Daytrana™; the risk that Noven may encounter production inefficiencies or other issues in the process of manufacturing commercial quantities of Daytrana™, which could adversely affect the success of the product and Noven’s results of operations; the risk that only limited prescription data is presently available for Daytrana™ and such data may not be representative of the future market for the product; ongoing initiatives intended to reduce manufacturing costs and improve Daytrana™ gross margins may not result in further gross margin improvement; 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 ability to achieve the additional milestone payments under its agreement with Shire; and the possibility that the market for methylphenidate products may be negatively affected by the ongoing public debate in the United States regarding the appropriateness of using methylphenidate and other medications to treat children with ADHD, as well as the outcome of the FDA’s ongoing inquiry into the possible cardiac, psychiatric and other side effects of ADHD medications, and that the FDA’s inquiry could result in “black-box” warnings being added to the labeling for these medications. 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, 2005 as well as other reports filed from time to time by Noven with the Securities and Exchange Commission.
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Copyright © 2006 Noven Pharmaceuticals, Inc. All rights reserved.