Noven Developing Transdermal Methylphenidate Patch For Attention Deficit Hyperactivity Disorder

First Transdermal Patch for ADHD Shows Promise in Initial Clinical Study

Once-A-Day Delivery System May Diminish Stigma and Abuse Associated with Oral Therapies

-- Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) today announced that it is developing a transdermal patch that delivers a therapeutic dose of methylphenidate for up to 24 hours. Methylphenidate, the active ingredient in Novartis Pharmaceuticals Corporation's Ritalin® tablets, is the most commonly prescribed medication for the treatment of the symptoms of Attention Deficit Hyperactivity Disorder (ADHD). Presently, all ADHD medications approved in the U.S. are delivered orally, and the vast majority of patients require more than one dose per day.

William E. Pelham, Ph.D., Professor of Psychology, Director of Clinical Training, and Director of the Attention Deficit Hyperactivity Disorder Program at the State University of New York (SUNY), Buffalo, recently completed a placebo-controlled crossover study to preliminarily evaluate Noven's methylphenidate patch. In the study, children diagnosed with ADHD underwent sequential multi-day regimens comparing Noven's patch to oral methylphenidate and to a placebo. The children exhibited a decrease in symptoms while wearing the patch that was similar to the decrease in symptoms exhibited while taking oral methylphenidate. Dr. Pelham expects to publish the results of the study within a year.

"We are very encouraged by the results observed in the children who participated in our study," said Dr. Pelham. "Everyday across the country, children like those studied must visit the school nurse or principal's office to receive a midday dose of ADHD medication. For these children, the stigma associated with this visit adds to the embarrassment and difficulty of dealing with ADHD, especially as they get older. A once-a-day therapy like Noven's patch has the potential to alleviate the issue of multiple daily doses and the problems that often accompany that practice."

Although its exact cause remains uncertain, ADHD is considered the most common psychiatric disorder affecting children. As many as five percent of school age children in the U.S. are believed to have ADHD, and between 1.5 million and 2.5 million children are taking medication for the disorder. Children with ADHD typically exhibit short attention spans, abnormally high activity levels, and impulsive behavior patterns. These children often cannot maintain the attention levels necessary to learn and comprehend in the classroom, and commonly have difficulty developing and maintaining normal social relationships with family members and friends. It is becoming increasingly understood that the symptoms of ADHD can frequently extend well into adulthood.

"Although the SUNY study is an important first step in our strategy to develop an improved therapy for ADHD, additional studies and regulatory filings will be required before the product can be commercialized," said Robert C. Strauss, Noven's President and Chief Executive Officer. "We are committed to its rapid development, for the patch would address many of the health and social issues faced by children with ADHD, as well as their parents, schools and communities. Our patch would help preserve a child's sense of privacy and dignity - applied once a day before school and under clothing, peers would not know that the child was on medication. With fewer students needing midday dosing at school, administrative burdens would be eased. For parents and physicians, our patch would provide unprecedented control over the duration of dosing - one dose could be continued for a full day, or could be discontinued instantly by simply removing the patch. Lastly, because of its nature and design, our patch would be far less susceptible to (and may work to eliminate) the product diversion and abuse issues that plague tablet formulations."

Noven expects to file a New Drug Application with the U.S. Food and Drug Administration relating to its methylphenidate patch in 2001, and is presently evaluating strategies to broadly commercialize the product assuming marketing approval is obtained. The patch and its related technologies are the subjects of issued U.S. patents and pending applications. Ritalin® and other medications indicated for the treatment of ADHD together had 1998 U.S. sales of about $500 million. Ritalin® is a registered trademark of Novartis Pharmaceuticals Corporation.

A methylphenidate patch is one of several groundbreaking transdermal systems developed by Noven. Earlier this month, Noven announced the U.S. launch of Vivelle-Dot™ (estradiol transdermal system), the world's smallest estrogen patch, approved for the treatment of menopause. Vivelle-Dot™, developed and manufactured by Noven, is marketed and sold by Novogyne Pharmaceuticals, a women's health care products company jointly owned by Noven and Novartis. In September 1998, Noven announced the U.S. launch of CombiPatch™ (estradiol/norethindrone acetate transdermal system), the nation's first two-drug patch, also approved for the treatment of menopause. CombiPatch™, developed and manufactured by Noven, is marketed and sold by Rhône-Poulenc Rorer.

Like Vivelle-Dot™ and CombiPatch™, the methylphenidate patch incorporates Noven's proprietary Dot Matrix™ adhesive technology, which combines the medication with the patch's adhesive, permitting controlled and extended drug delivery through patches that are remarkably inconspicuous, comfortable and adherent.

Mr. Strauss commented: "We believe that our proprietary patch technologies will permit us to formulate safe and effective transdermal versions of important medications that, according to conventional wisdom, cannot be put into a patch. Methylphenidate is a perfect example of this. And with fewer than ten compounds in transdermal systems presently available in the U.S., there is certainly no shortage of opportunities for us to choose from."

Mr. Strauss is scheduled to discuss Noven's business and prospects with conference invitees at the Warburg Dillon Read Global Specialty Pharmaceuticals Conference at the Pierre Hotel in New York on May 26, 1999.

Noven Pharmaceuticals Inc., headquartered in Miami, Florida, is a leader in the development of transdermal and transmucosal drug delivery systems and technologies. Noven's existing products include Vivelle® and Vivelle-Dot™ estrogen transdermal delivery systems (licensed to Novogyne Pharmaceuticals) and Menorest® (licensed to Rhône-Poulenc Rorer); CombiPatch™ and Estalis® estrogen/progestin transdermal delivery systems (licensed to Rhône-Poulenc Rorer); and DentiPatch®, the first transmucosal patch approved by the FDA (developed, marketed and sold by Noven). With a wide range of additional products in development, Noven is committed to becoming the world's premier developer, manufacturer, and marketer of transdermal and transmucosal drug delivery systems. For more information, visit Noven's Web site at

Forward looking statements contained in this release are qualified by and subject to the risks and uncertainties specified by Noven in its most recent filings with the Securities and Exchange Commission, including the risk that Vivelle-Dot™ and CombiPatch™ sales may be less than expected, and that other unanticipated events may adversely affect Noven’s financial results. Specifically, Noven’s products compete with the products of companies that have significantly greater financial and other resources.

Investor Contact:
James B. Messiry
Chief Financial Officer
Noven Pharmaceuticals, Inc.

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