Noven Receives FDA Approval For World's Smallest Transdermal Estrogen Delivery System

-- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) announced today that its second generation transdermal estrogen delivery system (transdermal 17ß-estradiol) has been approved by the U.S. Food and Drug Administration for the treatment of the symptoms of menopause. The new product, developed and manufactured by Noven, is the smallest transdermal estrogen patch ever approved. The patch is expected to be marketed and sold in the U.S. by Vivelle Ventures LLC, a women's health products company jointly owned by Noven and Novartis Pharmaceuticals Corporation, beginning in the first half of 1999.

Slightly larger than a nickel, the patch is less than half the size of any other estrogen patch on the U.S. market, and less than one-third the size of the current market leader. Available in four dosage strengths (.0375, .05, .075 and .10 mg/day), the patch provides prescribing physicians with greater dosing flexibility than competitive products.

The new patch, which is applied twice per week, utilizes Noven's proprietary adhesive matrix technology, and delivers 17ß-estradiol through the skin and into the bloodstream. 17ß-estradiol is identical to a woman's own estrogen, unlike those estrogen therapies derived from equine sources.

Robert C. Strauss, Noven's President and Chief Executive Officer, said: "Noven's product development philosophy is straightforward: first identify the consumer need, then develop the product that meets that need. In this case, consumer research indicated that patients would prefer a smaller, less conspicuous estrogen patch that is well-suited to an active lifestyle. In response, we engineered a new generation system - the smallest available - that is thin, comfortable, virtually translucent and extremely adherent, permitting patients to shower and swim without the need to change patches. Our new product also reduces skin irritation levels to below the already low levels of the original Vivelle product. The Vivelle Ventures sales force, comprised of over 100 sales representatives, is understandably eager to begin promoting this leading-edge transdermal system to physicians across the country."

Noven has retained exclusive marketing rights to the product in all territories other than North America and Japan, and is presently pursuing European regulatory approvals and evaluating strategies to commercialize the patch internationally. In 1997, sales of transdermal estrogen patches totaled approximately $160 million and $180 million in the U.S. and in Europe, respectively.

Noven Pharmaceuticals, Inc., headquartered in Miami Florida, is a leader in the development of advanced drug delivery technologies. Noven's existing products include advanced estrogen transdermal delivery systems (Vivelle®, licensed to Vivelle Ventures LLC, and Menorest, licensed to Rhône-Poulenc Rorer); combination estrogen/progestogen transdermal delivery systems (CombiPatch™ and Estalis®, licensed to Rhône-Poulenc Rorer); and the first transmucosal patch delivery system approved by the FDA (DentiPatch®, developed, marketed and sold by Noven). 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.

Forward-looking statements contained herein are qualified by and subject to the risks and uncertainties specified by Noven in its most recent filings with the Securities and Exchange Commission.