NOVEN ANNOUNCES VIVELLE® APPROVED FOR PREVENTION OF OSTEOPOROSIS

NOVEN ANNOUNCES VIVELLE® APPROVED FOR PREVENTION OF OSTEOPOROSIS

New Low Dose Vivelle® (0.025 mg/day) Also Approved


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MIAMI, FL, August 17, 2000 - Noven Pharmaceuticals, Inc. (Nasdaq: NOVN) announced today that the U.S. Food and Drug Administration (FDA) has approved Vivelle® (estradiol transdermal system) for the prevention of postmenopausal osteoporosis. Vivelle® has been available for the treatment of menopausal symptoms since March 1996, and is marketed by Novogyne Pharmaceuticals, a joint venture between Noven and Novartis Pharmaceuticals Corporation.

Vivelle® is available by prescription and utilizes Noven's transdermal adhesive matrix technology. The product delivers estradiol, the primary estrogen produced by the ovaries, through a transdermal patch that is applied twice weekly.

Vivelle® is now indicated for the prevention of osteoporosis and is currently available in four dosage strengths (0.0375, 0.05, 0.075 and 0.1 mg/day). A new low dose of Vivelle®, 0.025 mg/day, was also approved by the FDA for postmenopausal osteoporosis and is expected to be available in U.S. pharmacies in late 2000.

In clinical trials, systemic adverse events with 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%). Local application site reactions with Vivelle® were approximately 9% vs. 10% in patients treated with placebo; most cases were considered mild, none were considered severe.

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 presently 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 wide 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.

Forward looking statements contained in this release are qualified by and subject to the risks and uncertainties specified by Noven in its most recent filings with the Securities and Exchange Commission, including the risk that the new Vivelle dosage strength may not reach market in a timely fashion or at all.

 

 

Copyright ©  2000 Noven Pharmaceuticals, Inc. All rights reserved.