04.09.2007 12:05:00
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Noven Provides Update on Daytrana(TM) Methylphenidate Transdermal System
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withdrawn is estimated to be in the $4 million to $6 million range.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.
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