NOVEN
AND SHIRE ANNOUNCE POSITIVE CLINICAL DATA
FOR TRANSDERMAL ADHD TREATMENT
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Miami, FL, April
6, 2005 -- Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) today announced
positive preliminary results from clinical trials of its methylphenidate
transdermal system (MTS) which is being developed in conjunction with
Shire Pharmaceuticals Group plc for children with Attention Deficit
Hyperactivity Disorder (ADHD).
These trial results are expected to be included as part of an amendment
to the New Drug Application for the product currently pending at the
FDA. Both Noven and Shire believe that the studies will address the
issues raised by the FDA's review in April 2003. The FDA has
previously confirmed that the amendment will be reviewed within six
months after submission.
The two studies, a Phase 2 study involving 79 patients over a seven-week
period and a Phase 3 study involving 268 patients over a seven-week
period, examined MTS in children between the ages of 6 and 12 previously
diagnosed with ADHD. In these studies, use of MTS was well tolerated
and the objectives of both studies were achieved.
Shire is expected to release additional details of the trial results
following further analysis and as part of an R&D update in May
2005.
Robert Strauss, Noven’s President, CEO & Chairman, said:
"Today's news is an important step forward in the development of our
methylphenidate
patch. The next step is preparation of an amendment to the pending
New Drug Application, and we expect to be working closely with our
partner Shire to achieve that goal."
Matthew Emmens, Chief Executive Officer of Shire, said: "These
results demonstrate that MTS has the potential to provide significant
benefits for children with ADHD, especially those that have difficulty
taking oral medications and those that find a once-a-day patch more
appropriate for their lifestyle. As the ADHD market develops, new choices
of treatment are emerging, including specialized delivery systems (such
as MTS) to meet the needs of different patients. Shire aims to have
a range of medicines in its ADHD portfolio, with ADDERALL XR® being
the most prescribed treatment for ADHD in the U.S. If approved, this
product will be a strong addition and we look forward to advancing
its development further."
Shire acquired the worldwide sales and marketing rights to MTS from
Noven in February 2003.
Methylphenidate Transdermal System
The most common adverse events reported by patients who received the
methylphenidate transdermal system in previous clinical trials were:
application site reactions such as skin redness, insomnia (difficulty
sleeping), anorexia (loss of appetite), headache, abdominal pain, sudden
changes in emotions, viral infection (symptoms of a virus), vomiting,
weight loss, nervousness, twitching, increased cough, inflammation
of the nose, inflammation of the throat, irritability, overall body
discomfort, apathy (lack of interest or emotion), fever, anxiety, impaired
body movement, and accidental injury.
Preliminary evaluation of adverse events seen in the two trials referenced
in this press release included abdominal pain, anorexia (loss of appetite),
application site reactions, headache, insomnia, and nausea.
About Adderall XR
The most common adverse events in pediatric trials included loss of appetite,
insomnia, abdominal pain, and emotional lability. The most common adverse
events in the adult trial included dry mouth, loss of appetite, insomnia,
headache, and weight loss.
The effectiveness of ADDERALL XR for long-term use has not been systematically
evaluated in controlled trials. As with other psychostimulants indicated
for ADHD, there is a potential for exacerbating motor and phonic tics
and Tourette's syndrome. A side effect seen with the amphetamine class
is psychosis. Caution also should be exercised in patients with a history
of psychosis.
Abuse of amphetamines may lead to dependence. Misuse of amphetamine may
cause sudden death and serious cardiovascular adverse events. ADDERALL
XR generally should not be used in children or adults with structural
cardiac abnormalities. ADDERALL XR is contraindicated in patients with
symptomatic cardiovascular disease, moderate to severe hypertension,
hyperthyroidism and glaucoma, known hypersensitivity to this class of
compounds, agitated states, history of drug abuse, or current or recent
use of MAO inhibitors. ADDERALL XR should be prescribed with close physician
supervision.
About Shire Pharmaceuticals Group plc
Shire is a global specialty pharmaceutical company with a strategic focus
on meeting the needs of the specialist physician and currently focuses
on developing projects and marketing products in the areas of central
nervous system (CNS), gastrointestinal (GI), and renal diseases. Shire
has operations in the world’s key pharmaceutical markets (US,
Canada, UK, France, Italy, Spain and Germany) as well as a specialist
drug delivery
unit in the US. For further information on Shire, please visit www.shire.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 sold in
over 30 countries, and a range of new patches are being developed in
collaboration with Shire Pharmaceuticals Group plc, Novartis Pharma
AG, 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 word “believes,” “expects,” “will” 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 possibility that the FDA may determine that the clinical
study results do not adequately address the concerns raised in its 2003
letter; the risk that an amendment to the pending New Drug Application
may not be filed on a timely basis or at all, including the risk that
the filing of an amendment to the pending New Drug Application could
be delayed as a result of Shire’s continuing analysis of the study
data; the possibility that Shire’s continuing analysis of the study
data could reveal results that do not support approval of the methylphenidate
transdermal system; the risk that Noven and Shire may not agree on the
manner or timing with which to proceed with the filing of an amendment
to the pending New Drug Application; the timing of the FDA's review of
any amended NDA for the methylphenidate transdermal system as well as
any product approval, which are beyond Noven's control and which may
impact the success of product launch and market penetration; the possibility
that, even if approved, the methylphenidate transdermal system may not
be successfully commercialized due to competitive market conditions or
other factors, including physician/patient preferences for other therapies;
and the risk that Noven’s collaborations with Shire and others
may not result in the development and successful commercialization of
additional product. In addition to the risks and factors identified above,
reference is also made to the other risks and factors detailed in reports
filed by the Noven with the Securities and Exchange Commission. Noven
cautions that the foregoing list of factors is not exhaustive.
Contact:
Joseph
C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.
(305) 253-1916
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Copyright © 2005 Noven
Pharmaceuticals, Inc. All rights reserved. |