Noven and Shire Announce Positive Clinical Data For Transdermal ADHD Treatment

-- 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

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 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.

Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.