Noven Completes Successful Phase II Study of Once-a-day Transdermal Methylphenidate Patch

Phase III Studies for MethyPatch™ to Begin in Summer 2000

New Patch May Eliminate Broad Social Issues Presented by AD/HD Pill Therapies

-- Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) today announced that it successfully completed Phase II clinical trials evaluating MethyPatch™, Noven's once-a-day transdermal methylphenidate patch. Methylphenidate, the active ingredient in Novartis Pharmaceuticals Corporation's Ritalin® tablets, is the most commonly prescribed medication for Attention Deficit Hyperactivity Disorder (AD/HD). Presently, all AD/HD medications approved in the U.S. are delivered orally, and the majority of patients require more than one dose per day. Noven expects that the small patch, worn discreetly under clothing, would eliminate the stigma that many children suffer when receiving oral methylphenidate during the school day, and would substantially reduce the drug diversion and abuse issues that plague pill formulations.

Results of Noven's Phase II placebo-controlled dose-ranging study suggest that MethyPatch™ is effective in the treatment AD/HD, and that Noven may have the flexibility to offer MethyPatch™ in a broad range of once-a-day dosing strengths.

Noven's upcoming Phase III studies for MethyPatch™ are expected to begin by the third quarter of 2000 and will involve several hundred children at multiple test facilities throughout the United States. Noven's state-of-the-art manufacturing facility, certified by the Drug Enforcement Agency to manufacture products containing controlled substances, has already produced the product to be used in these studies. Noven expects to file a New Drug Application for MethyPatch™ in the first half of 2001.

Robert C. Strauss, Noven's President and Chief Executive Officer, commented: "Every day, millions of children, their parents, the school system and law enforcement agencies struggle with the issues presented by oral formulations of methylphenidate. We believe that, if approved, our MethyPatch™ transdermal methylphenidate system will alleviate and perhaps eliminate many of these social concerns. Consider the following:

  • Today, parents must deliver a supply of their child's methylphenidate pills to his or her school, and the school itself must devote considerable time and resources to delivering the medication during the school day. In contrast, MethyPatch™ is placed on the child at home by the parent before school, eliminating deliveries by the parent and relieving schools from the costly, time-consuming and undesired role of medication administrator.
  • Daily visits to the school nurse to receive oral medication can stigmatize children and embarrass them in front of their peers. MethyPatch™, applied before school and worn discreetly under clothing, assures that a child's privacy and dignity are maintained.
  • A pill cannot be "unswallowed" - once ingested, it medicates a child for the fixed duration of dosing, which is not always desirable. MethyPatch™, however, can be removed immediately if discontinuation of dosing is appropriate.
  • Delivered through the skin and directly into the bloodstream, MethyPatch™ puts a minimal amount of drug into a child's system to induce a full therapeutic effect. Pills generally require that substantially more drug be introduced into the system in order to overcome the first pass through the liver and gastrointestinal tract.
  • Across the country, methylphenidate pills are crushed and snorted by those who would abuse them. The medication in MethyPatch™ cannot be readily extracted, and you simply cannot snort a patch."

 

Mr. Strauss concluded: "For these and other reasons, we believe MethyPatch™ will be much more than just a long-acting methylphenidate product. We are confident that it will alleviate several broad-reaching social issues that cannot be addressed as effectively by any oral methylphenidate product on the market or in development. MethyPatch™ is expected to deliver all the benefits of methylphenidate - the benchmark therapy for AD/HD - while eliminating a host of serious concerns."

Up to 13% of school age children are believed to have full or partial AD/HD, resulting in a U.S. market of over $500 million for related therapies. Presently, a majority of affected children require more than one dose per day and must visit the school nurse to receive a midday dose. In 1999, over 10 million prescriptions were written in the U.S. for oral methylphenidate products.

MethyPatch™ is subject to issued and pending U.S. patents held by Noven. Like its other advanced products, including Vivelle-Dot™ and CombiPatch™, MethyPatch™ incorporates Noven's proprietary Dot Matrix™ adhesive technology that permits controlled and extended drug delivery through inconspicuous, comfortable and adherent transdermal patches.

About Noven
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leader in the development of transdermal and transmucosal drug delivery technologies. Together with Novartis Pharmaceuticals, Noven owns a women's health products company called Novogyne Pharmaceuticals. Noven's existing products include advanced estrogen transdermal delivery systems (including Vivelle-Dot™, licensed to Novogyne); combination estrogen/progestin transdermal delivery systems (including CombiPatch™, licensed to Aventis S.A., and Estalis®, licensed to Novartis Pharma AG); and the first transmucosal patch delivery system approved by the FDA (DentiPatch®). With a range of additional products in development, including MethyPatch™, Noven is committed to becoming the world's premier developer, manufacturer and marketer of transdermal and transmucosal drug delivery systems.

For additional information on Noven, visit the company's web site at www.noven.com. For information on Noven's Vivelle® and Vivelle-Dot™ products, visit www.vivelledot.com.

Ritalin® is a registered trademark of Novartis Pharmaceuticals Corporation.

Forward looking statements contained in this release are qualified by and subject to the risks and uncertainties specified below and those specified by Noven in its most recent filings with the Securities and Exchange Commission, including the risks that Noven's NDA filing may be delayed, that Noven may not receive FDA approval to market MethyPatch™, that Noven may not successfully commercialize MethyPatch™, that MethyPatch™ may not compete effectively against extended release oral formulations of methylphenidate and/or other AD/HD medications, including those that may reach the U.S. market prior to MethyPatch™, and that Noven's patents may not provide meaningful protection against other patch products that may be developed by competitors.