Miami, FL, May 20, 2002
Noven Announces FDA Approval of Vivelle-Dot Additional Indication And New Low Dose Strength
Novogyne's Dime-Sized Patch will be Smallest Estrogen Patch Ever Marketed;
Vivelle-Dot Approved for Prevention of Postmenopausal Osteoporosis
-- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) announced today that the U.S. Food and Drug Administration has issued to Novartis Pharmaceuticals Corporation an approval letter for the expanded use of Vivelle-Dot® (estradiol transdermal system) and the addition of a new low dose strength.
The approval expands the indications for Vivelle-Dot to include the prevention of postmenopausal osteoporosis. Previously, Vivelle-Dot was approved only for the treatment of menopausal symptoms. According to the American Menopause Foundation, after menopause a woman can lose up to five percent of bone mass every year, making her more susceptible to osteoporosis. In the U.S., 10 million people have osteoporosis. Another 34 million people are diagnosed with low bone mass and are at risk of developing the disease. Women account for 80% of all cases of osteoporosis.
The approval also adds a new 0.025 mg/day strength for the prevention of postmenopausal osteoporosis. (This new strength 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). With the approval of this fifth strength, the Vivelle-Dot line will offer among the broadest dosing ranges available for transdermal estrogen replacement therapy. Like all strengths of Vivelle-Dot, the new low dose patch is thin, nearly translucent and easy to apply.
At 2.5 cm2, the thin and flexible low dose patch 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. DOT Matrix is the technology behind a new generation of 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 solutions for both the estrogen-only and combination hormone replacement therapy markets. Novogyne expects to launch the new low dose Vivelle-Dot in the third quarter of 2002.
"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 and President of Novogyne. "The new indication and new low dose will help Vivelle-Dot become an even more valuable and flexible therapy for physicians and patients to consider."
Vivelle-Dot is available by prescription and delivers estradiol, the primary estrogen produced by the ovaries, through a small, comfortable transdermal patch, which 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.
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, 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 drug delivery systems. For additional information on Noven, visit http://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. The Vivelle-Dot PI is available at http://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 "expects" and "will 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 launched in a timely manner because of manufacturing issues, marketing strategies or other matters, and that the new dosage strength may not be accepted by patients or physicians or may not compete effectively with products offering similar dosing ranges.
Investor & Media Contact:
Joseph C. Jones
Noven Pharmaceuticals, Inc.