| NOVEN
ANNOUNCES FILING OF MARKETING APPLICATION FOR |
BackNovartis Sverige AB Seeks Swedish Marketing Authorization for New Estalis Strength
Miami, FL, January
16, 2003 -- 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 www.noven.com.
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.
Contact:
Investors & Media
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.
(305) 253-1916
Copyright © 2003 Noven Pharmaceuticals, Inc. All rights reserved.