FDA Issues Approvable Letter For Expanded Use of Vivelle-Dot™ And Addition Of New Low Dose Strength

Novogyne's Dime-Sized Patch Will Be Smallest Estrogen Patch Ever Marketed

-- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN), a leader in the development of transdermal and transmucosal drug delivery systems, announced today that the U.S. Food and Drug Administration (FDA) has issued to Novartis Pharmaceuticals Corporation an approvable letter relating to the expanded use of Vivelle-Dot™ (estradiol transdermal system) and the addition of a new low dose strength.

Currently, Vivelle-Dot is approved for the treatment of menopausal symptoms. The expanded use addressed in the approvable letter includes the prevention of postmenopausal osteoporosis, which impacts about 40 million women in the U.S. -- one in two women will suffer an osteoporosis-related fracture during her lifetime.

Vivelle-Dot is currently available in four dosage strengths (0.0375, 0.05, 0.075 and 0.1 mg/day). The approvable letter relates to the addition of a new 0.025 mg/day strength for the prevention of postmenopausal osteoporosis. Upon approval of this fifth strength, the Vivelle-Dot line will offer among the broadest dosing ranges available for transdermal estrogen replacement therapy. The new low dose strength will not be indicated for the treatment of menopausal symptoms.

At 2.5 cm2, the thin and flexible low dose patch has the same surface area as a dime. The small size is made possible by Noven's patented DOT Matrix™ technology. DOT Matrix is the technology behind a new class of diffusion-based drug-in-adhesive patches that deliver drug therapy through less patch surface area without using irritating enhancers and without compromising adhesion. DOT Matrix patches use precise ratios of silicone, acrylic and drug to regulate the rate of delivery through the skin, providing controlled, sustained release directly into the bloodstream.

Vivelle-Dot is marketed by Novogyne Pharmaceuticals, a women's health products company jointly owned by Noven and Novartis Pharmaceuticals Corporation. Novogyne also markets CombiPatch® (estradiol/norethindrone acetate transdermal system), making it the only company in the U.S. offering transdermal therapies for both the estrogen-only and combination hormone replacement therapy markets.

"Vivelle-Dot is already among the fastest growing estrogen replacement products in the country," said Neil Jones, Noven's Vice President -- Marketing & Sales. "The new indication and new low dose should help make Vivelle-Dot an even more valuable and flexible therapy for physicians and patients to consider."

An approvable letter usually represents a final step before a product receives FDA clearance for marketing in the U.S. In the Vivelle-Dot letter, the FDA states that it has reviewed the application and that it is approvable, subject to the completion of labeling matters and the submission and review of requested information. The approvable letter was received from the FDA on November 19, 2001.

Vivelle-Dot is available by prescription and delivers estradiol, the primary estrogen produced by the ovaries, through a small, comfortable transdermal patch that is applied twice weekly. Vivelle-Dot is indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause; vulval and vaginal atrophy; and hypoestrogenism due to hypogonadism, castration or primary ovarian failure.

In clinical trials, the most commonly reported systemic adverse event with Vivelle-Dot was mild headache. No erythema was observed at the application site after removal of the systems for a majority of patients, and no occurrence of erythema was greater than mild in severity. Systemic adverse events with original Vivelle® and placebo, respectively, include headache (36% vs. 30%), breast tenderness (4.9% vs. 1.1%), fluid retention (3.8% vs. 2.2%) and back pain (13% vs. 4.5%). (Clinical note: the original formulation (Vivelle®) that was tested in clinical trials has been revised to reduce the patch sizes and the revised formulation (Vivelle-Dot) was shown to be bioequivalent to the original formulation.)

Estrogens should not be used in individuals with known or suspected pregnancy, undiagnosed abnormal genital bleeding, breast cancer, estrogen-dependent neoplasia, active thrombophlebitis or thromboembolic disorders, or a documented history of these conditions. Estrogens have been reported to increase the risk of endometrial carcinoma in postmenopausal women.

Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leader in the development of transdermal and transmucosal drug delivery systems and technologies. Noven has developed and manufactures a series of leading-edge products, including the world's smallest estrogen transdermal delivery system, the United States' only combination estrogen/progestin transdermal delivery system, and the first transmucosal patch approved for marketing by the U.S. Food and Drug Administration. With a 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 additional information on Noven, visit www.noven.com. Vivelle-Dot™, Vivelle® and CombiPatch® are trademarks of Novartis Pharmaceuticals Corporation; DOT Matrix™ is a trademark of Noven Pharmaceuticals, Inc.

This release contains forward-looking statements relating to the business of Noven that can be identified by the use of forward-looking terminology such as: "will offer", "upon approval", "approvable", "should help" and "usually represents a final step". Such statements are qualified by and subject to the risks and uncertainties specified by Noven in its most recent filings with the Securities and Exchange Commission and those specified herein, including the risk that FDA will not issue final marketing clearance for the new Vivelle-Dot indication and the new low dose because, among other reasons, the conditions to approval identified by FDA may not be met and that FDA's review of requested information may result in non-approval. In addition, even if approved, the new dosage strength may not ultimately reach market or may not be accepted by patients or physicians.

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