NOVEN SIGNS PRODUCT DEVELOPMENT AGREEMENT WITH NOVARTIS

Work Underway on Extensions/Enhancements to
Combination HRT Patch Product Line

MIAMI, FL. - August 2, 2001 - Noven Pharmaceuticals, Inc. (Nasdaq:NOVN), a leader in the development of transdermal and transmucosal drug delivery technologies and products, today announced that it has signed a product development agreement with Novartis Pharma AG relating to the development of line extensions and product enhancements to the Combipatch™/Estalis® line of hormone replacement therapy (HRT) patches.

Under the agreement, Noven is responsible for product formulation and technical matters, and Novartis Pharma is responsible for related clinical and regulatory matters. Under the agreement, Noven receives certain payments as development milestones are achieved. Work on the projects is underway.

For competitive reasons, the parties have not disclosed the nature of the line extensions and product improvements, other than to say that they will provide physicians and patients who prefer transdermal combination hormone therapy with additional convenience and benefits.

"The new development agreement underscores Novartis Pharma's commitment to establishing and, importantly, maintaining our combination HRT patch as a leading product line," said Robert C. Strauss, Noven's President, CEO and Chairman. "It also helps confirm the value of Noven's proprietary Dot Matrix™ patch technology to domestic and international pharmaceutical companies seeking a competitive advantage in therapies suited to transdermal drug delivery."

In the U.S., Noven's combination patch is licensed to Novogyne Pharmaceuticals, a women's health company jointly owned by Noven and Novartis Pharmaceuticals Corporation, which markets the product under the trade name Combipatch™. In all territories outside the U.S. (other than Japan), the product is licensed to Novartis Pharma, which markets the product under the trade name Estalis®. The product is indicated for use in menopausal women with an intact uterus for the relief of moderate-to-severe vasomotor symptoms such as hot flashes, night sweats and vaginal dryness.

Noven's patented Dot Matrix™ technology (incorporated in Vivelle-Dot™, Estradot™, Combipatch™ and Estalis®) permits Noven to make patches that are generally smaller, more comfortable and more adherent than competitive patches.

About Noven
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leader in the development of transdermal and transmucosal drug delivery technologies and products. Noven's existing products include advanced estrogen transdermal delivery systems (including Vivelle-Dot™, licensed to Novogyne, and Estradot™, licensed to Novartis) and combination estrogen/progestin transdermal delivery systems (including Combipatch™, licensed to Novogyne, and Estalis®, licensed to Novartis). With a range of additional products in development, including MethyPatch®, a once-daily transdermal methylphenidate system for ADHD, 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.

Forward looking statements contained in this release are qualified by and subject to the risks and uncertainties specified in Noven's most recent filings with the Securities and Exchange Commission. Product development is an inherently uncertain process, and Noven's development of the combination patch line extensions/enhancements may not be successful. If Noven's development efforts are unsuccessful, development milestones will not be reached and Noven will not receive development payments. Even if technical development is successful, the products may not be approved for marketing or commercialized in a timely fashion or at all.


Investor & Media Contact:
Joseph C. Jones
Vice President, Corporate Affairs
Noven Pharmaceuticals, Inc.
(305) 253-1916

 

 

Copyright ©  2001 Noven Pharmaceuticals, Inc. All rights reserved.