Noven Announces Filing of Marketing Application For Lower-Dose Combination Hormone Patch In Sweden

Novartis Sverige AB Seeks Swedish Marketing Authorization for New Estalis Strength

-- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today announced that Novartis Sverige AB, a Swedish affiliate of Novartis Pharma AG (Novartis), has filed for marketing authorization in Sweden of a second, lower-dose version of Noven’s combination estradiol/norethindrone acetate transdermal system.

The product, marketed under the brand name Estalis®, was developed by Noven and is licensed to Novartis in most markets outside the U.S. It is indicated for use in menopausal women with an intact uterus for the treatment of postmenopausal symptoms and the prevention of postmenopausal osteoporosis. The Swedish application seeks marketing authorization for the 50/140 microgram/day (0.05/0.14 mg/day) dosage strength; a higher 50/250 microgram/day (0.05/0.25 mg/day) strength is already approved in most European countries.

The filing marks the first application in the European Union by Novartis for the 50/140 dosage strength of Estalis. Sweden will serve as the Reference Member State for the application seeking broader marketing authorization for this dosage strength in the European Union under the Mutual Recognition Procedure (MRP).

"The Swedish filing is a significant step towards approval of a broader Estalis product line to better meet the needs of patients and physicians in the European Union," said Robert C. Strauss, Noven's President, Chief Executive Officer & Chairman.

In the U.S., the combination patch is licensed to Novogyne Pharmaceuticals, a women's health products company jointly owned by Noven and Novartis Pharmaceuticals Corporation. Novogyne markets the product under the brand name CombiPatch®. CombiPatch is approved in two dosage strengths: 50/140 and 50/250 micrograms/day (0.05/0.14 mg/day and 0.05/0.25 mg/day).

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 existing products include advanced estrogen transdermal delivery systems (including Vivelle-Dot®, licensed to Novogyne Pharmaceuticals, and Estradot®, licensed to Novartis Pharma AG) and combination estrogen/progestin transdermal delivery systems (including CombiPatch®, licensed to Novogyne, and Estalis®, licensed to Novartis Pharma AG). With a range of additional products in development, including MethyPatch® (methylphenidate transdermal system) for ADHD, Noven is committed to becoming the world's premier developer, manufacturer and marketer of transdermal drug delivery systems. For additional information on Noven, visit the company's web site at

This release contains forward-looking statements related to the business of Noven that can be identified by the use of forward-looking terminology such as "will serve", "towards" and similar words and phrases. Such statements are qualified by and subject to the risks and uncertainties specified in Noven's most recent filings with the Securities and Exchange Commission and those specified herein, including the risk that the lower-dose strength Estalis may not receive marketing authorization in Sweden or in the European Union on a timely basis or at all, and that, even if approval is received, the product may not be successfully commercialized. Estalis clinical studies, regulatory matters and product commercialization efforts are the responsibility of Novartis Pharma AG and are outside the control of Noven.

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