NOVEN
ANNOUNCES FDA APPROVAL OF DAYTRANA™
METHYLPHENIDATE TRANSDERMAL SYSTEM
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Miami, FL, April
6, 2006 -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) announced today
that the U.S. Food and Drug Administration (FDA) has approved Daytrana™ (methylphenidate
transdermal system) as a new therapeutic option for the treatment of
Attention Deficit Hyperactivity Disorder (ADHD) in children aged six
to twelve years. Shire plc, the global licensee of Daytrana™ and
market-share leader in the ADHD category, is expected to launch the
product in the first half of 2006.
"The approval of Daytrana™, the first non-oral medication for
ADHD, is outstanding news for Noven, Shire and patients,” said
Robert C. Strauss, Noven’s President, CEO & Chairman. “For
Noven, the approval advances our goal of commercializing our patented
transdermal technology in diverse therapeutic markets with strong partners.
For Shire, it adds an important new methylphenidate product to their
portfolio of ADHD products, and reaffirms their position as the ADHD
support company. And for patients, parents and physicians, Daytrana™ represents
a new once-daily therapy for children diagnosed with ADHD."
Upon receipt of FDA approval, Noven became due to receive a $50 million
milestone payment from Shire. Noven also has the opportunity to earn
additional milestone payments of up to $75 million depending on the
level of Shire’s commercial sales of the product, and expects
to earn a profit on the manufacture and supply of finished product
to Shire.
Daytrana™ combines the active ingredient methylphenidate with
Noven’s patented DOT Matrix™ transdermal drug delivery
technology. Daytrana™ and DOT Matrix™ are trademarks of
Shire and Noven, respectively.
About Daytrana™
Daytrana™ is a Schedule II controlled substance. Daytrana™ was
generally well tolerated in clinical studies. As with other products
containing methylphenidate (the active ingredient in Daytrana™),
common side effects reported in children who received Daytrana™ were
decreased appetite, insomnia, nausea, vomiting, weight loss, tic, and
affect lability (mood swings).
Daytrana™ should not be used by children with allergies to methylphenidate
or other ingredients in Daytrana™. The patch should be applied
daily to clean, dry skin, which is free of any cuts or irritation.
Avoid applying external heat to the patch. Skin irritation or allergic
skin rashes may occur.
Methylphenidate should not be taken by children with significant anxiety,
tension, or agitation; glaucoma; tics; Tourette's syndrome, or family
history of Tourette's syndrome; or current/recent use of MAO inhibitors
(a type of antidepressant). Abuse of methylphenidate may lead to dependence.
Tell your healthcare professional if your child has had problems with
alcohol or drugs or has had depression, abnormal thoughts/behaviors,
visual disturbances, seizures, high blood pressure, or heart conditions
including structural abnormalities. For additional information, please
visit www.daytrana.com.
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 a range of new patches are being
developed in collaboration with Novartis Pharma AG, Shire plc, P&G
Pharmaceuticals, Endo Pharmaceuticals Inc. and others. Together with
Novartis Pharmaceuticals Corporation, Noven owns Novogyne Pharmaceuticals,
a women’s health products company with over $120 million in annual
sales. Among other products, Novogyne markets and sells Noven’s
Vivelle-Dot™ product – the smallest estrogen patch in
the world, and the most prescribed transdermal estrogen therapy in
the
U.S. 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: risks related to the timing of the launch
of Daytrana™ by Shire; 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 timing and/or success of product launch and Noven’s
results of operations; risks related to post-marketing surveillance
and studies; risks related to competition (including from other
ADHD products marketed 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. |