Source: Immunology  |  Posted 10 years ago

Smallest Estrogen Replacement Patch in the World to Offer Protection Against Bone Disease

MIAMI, FL -- May 21, 2002 -- Don't blink or you might miss it! About the size of a dime, Vivelle-Dot's newest dosage strength of 0.025 mg/day is not only the smallest estrogen replacement patch in the world, but also the newest weapon in the fight against postmenopausal osteoporosis. Vivelle-Dot is now approved in the 0.025 mg/day dosage strength, providing among the lowest effective ERT dosage strengths available in the U.S. for the prevention of postmenopausal osteoporosis. This new, low dose patch is small, thin, nearly translucent and easy to apply. Vivelle-Dot's original four dosage strengths (0.0375, 0.05, 0.075 and 0.1 mg/day) available for the treatment of menopausal symptoms since May 1999, are now also indicated for prevention of postmenopausal osteoporosis.

Vivelle-Dot 0.025 mg/day utilizes state-of-the-art proprietary DOT Matrix? technology. The new product delivers estradiol, the primary estrogen produced by the ovaries, through a patch that is applied twice weekly. Although all original four doses of Vivelle-Dot (0.0375, 0.05, 0.075 and 0.1 mg/day) are currently available, its newest and lowest dose 0.025 mg/day is expected to first become available in August 2002.

"Many women of postmenopausal age are at risk for osteoporosis. With estrogen replacement therapy and simple lifestyle changes, including regular weight-bearing exercise and adequate intake of calcium and vitamin D, osteoporosis is a preventable problem," said Karen Cashmere, Director of Women's Health Marketing at Noven Pharmaceuticals, Inc. "We are pleased to provide women with a new option in the fight against bone disease. Our new patch is an innovative solution -- it's not only tiny, but offers sustained estrogen delivery."

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 US, 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.

Women with the highest risk factors for osteoporosis are usually white or Asian, and are small and thin. Other risk factors include family history of osteoporosis, early or surgically induced menopause, physical inactivity, cigarette smoking, excessive alcohol use, a low calcium intake and high doses of cortisone-like drugs or thyroid medication.

Vivelle-Dot is approved in five dosage strengths (0.025, 0.0375, 0.05, 0.075 and 0.1 mg/day). Applied two times a week to the lower abdomen, its small size means it can be worn comfortably even while exercising, swimming, or bathing. In clinical trials, systemic adverse events with Vivelle?* (estradiol transdermal system) and placebo, respectively, include headache (32.3% vs. 28%), breast tenderness (10% vs. 0%), fluid retention (2.4% vs. 1.9%) and back pain (9% vs. 6.4%).

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.

Vivelle-Dot, Vivelle and CombiPatch? (estradiol/norethindrone acetate transdermal system) are marketed by Novogyne Pharmaceuticals, a joint venture between Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, and Noven Pharmaceuticals, Inc. of Miami, Florida. Since May 1998, Novogyne has been offering pharmaceutical products that enable physicians to better serve the medical needs of mature 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/progestins 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.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS), a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2001, the Novartis Group's businesses achieved sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 71,000 people and operate in over 140 countries around the world. For further information please consult http://www.pharma.novartis.com or http://www.novartis.com.

* Vivelle-Dot, the revised formulation with smaller system sizes, was shown to be bioequivalent to the original formulation, Vivelle, used in the clinical trials.

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 http://www.novogyne.com, or by calling (888) NOW-NOVA.

SOURCE: Novogyne Pharmaceuticals