Miami, FL, August 19, 2002
Noven Announces U.S. Launch of New Low Dose Vivelle-Dot® Patch
Novogyne's Dime-Sized Patch is Smallest Estrogen Patch Ever Marketed
-- Noven Pharmaceuticals, Inc. (Nasdaq: NOVN) today announced that Novogyne Pharmaceuticals, a women's health products company jointly owned by Noven and Novartis Pharmaceuticals Corporation, has launched a new low dose strength of Vivelle-Dot® (estradiol transdermal system) in the U.S. The product is now available at pharmacies across the U.S.
The new 0.025 mg/day dose is indicated for the prevention of postmenopausal osteoporosis. (It is not indicated for the treatment of menopausal symptoms.) Vivelle-Dot is now available in five dosage strengths - 0.025, 0.0375, 0.05, 0.075 and 0.1 mg/day. No U.S. estrogen patch product has a broader dosing range.
Like all strengths of Vivelle-Dot, the new low dose patch is thin, flexible, translucent and easy to apply. At 2.5 cm2, it has about the same surface area as a dime. The small size is made possible by Noven's patented DOT Matrix™ transdermal drug delivery technology, which delivers prescription drug therapies 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, and provide controlled, sustained release directly into the bloodstream.
Novogyne Pharmaceuticals also markets CombiPatch® (estradiol/norethindrone acetate transdermal system), making it the only company in the U.S. offering transdermal solutions for both the estrogen-only and combination hormone replacement therapy markets.
"Vivelle-Dot has led the Vivelle® family to become the most dispensed family of estrogen patches on the market," said Robert C. Strauss, President, CEO & Chairman of Noven. "The new low dose should help Vivelle-Dot become an even more valuable and flexible estrogen replacement therapy."
Vivelle-Dot is available by prescription and delivers estradiol, the primary estrogen produced by the ovaries, through a patch that is applied twice weekly. Vivelle-Dot is indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause; vulvar and vaginal atrophy; hypoestrogenism due to hypogonadism, castration or primary ovarian failure; and the prevention of postmenopausal osteoporosis. Vivelle-Dot 0.025 mg/day is indicated for the prevention of postmenopausal osteoporosis only.
In clinical trials, systemic adverse events with Vivelle® (estradiol transdermal system) and placebo, respectively, included headache (32.3% vs. 28%), breast tenderness (10% vs. 0%), fluid retention (2.4% vs. 1.9%) and back pain (9% vs. 6.4%). (Vivelle-Dot, the revised formulation with smaller system sizes, was shown to be bioequivalent to the original formulation, Vivelle, used in the clinical trials.)
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, or stroke. Estrogens have been reported to increase the risk of endometrial carcinoma in postmenopausal women.
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products. Noven has developed and manufactures a series of leading-edge products, including the world's smallest estrogen transdermal delivery system and the United States' only combination estrogen/progestin transdermal delivery system. With a wide range of additional products in development, Noven is committed to becoming the world's premier developer, manufacturer, and marketer of transdermal drug delivery systems. For additional information on Noven, visit www.noven.com.
Vivelle-Dot® and Vivelle® are registered trademarks of Novartis Pharmaceuticals Corporation; CombiPatch® is a registered trademark of Novogyne Pharmaceuticals; Dot Matrix™ is a trademark of Noven Pharmaceuticals, Inc. Vivelle-Dot prescribing information is available at www.vivelledot.com.
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 "should help". 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 the new dosage strength may not be accepted by patients or physicians or may not compete effectively with products offering similar dosing ranges, and that the market for HRT products, including Noven's products, may decline in light of public reaction to recent published studies examining the health effects of certain forms of HRT.
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.