2014

Vivelle(R) (Estradiol Transdermal System) Receives Indication for Osteoporosis Prevention Estrogen Replacement Patch Offers Dosing Flexibility

While Now Helping to Prevent Bone Loss



    MIAMI, Aug. 18 /PRNewswire/ -- Doctors now have a new, effective treatment
 option to help patients reduce their risk of developing postmenopausal
 osteoporosis.  The U.S. Food and Drug Administration (FDA) has approved an
 existing transdermal estrogen patch, marketed by Novogyne Pharmaceuticals, a
 joint venture between Noven Pharmaceuticals, Inc. and Novartis Pharmaceuticals
 Corporation, for the prevention of postmenopausal osteoporosis.  The patch,
 sold under the Vivelle brand name, has been available for the treatment of
 menopausal symptoms since March 1996.
     Vivelle is available by prescription and utilizes Noven's transdermal
 matrix technology.  The product delivers estradiol, the primary estrogen
 produced by the ovaries, through a patch that is applied twice weekly.
     Vivelle is now indicated for the prevention of osteoporosis and 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, is expected to be available in U.S.
 pharmacies in late 2000. The 0.025 mg/day dosage strength is about the size of
 a quarter.
     After menopause, a woman can lose up to 20% of her bone mass, making her
 more susceptible to osteoporosis. In the U.S., 80 percent of those suffering
 from osteoporosis are women.  "Use of hormone replacement therapies, such as
 Vivelle, can help reduce the risk of osteoporosis and, at the same time, help
 women experiencing menopause ease menopausal symptoms such as hot flashes,
 night sweats and vaginal dryness," said W. Neil Jones, Executive Director
 Marketing and Sales at Noven Pharmaceuticals, Inc.
     In clinical trials, systemic adverse events with Vivelle (estradiol
 transdermal system) 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.
     Vivelle is marketed by Novogyne Pharmaceuticals, a joint venture between
 Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, and Noven
 Pharmaceuticals, Inc. of Miami, Florida.
     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.
     Novartis Pharmaceuticals Corporation is an affiliate of Novartis, A.G.
 (NYSE:   NVS).  Novartis, A.G. is a world leader in healthcare with core
 businesses in pharmaceuticals, consumer health, generics, eye-care, and animal
 health.  In 1999, the Group (including Agribusiness) achieved sales of CHF
 32.5 billion and invested more than CHF 4.2 billion in R&D. Headquartered in
 Basel, Switzerland, Novartis employs about 82,000 people and operates in over
 140 countries around the world.  The Group recently announced plans to spin-
 off its Crop Protection and Seeds sectors and to merge them with the
 agrochemicals business of AstraZeneca in the second half of 2000.
     Vivelle Prescribing Information is available at www.novogyne.com, or by
 calling (888) NOW-NOVA.
 
 

SOURCE Noven Pharmaceuticals, Inc.

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