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FOR IMMEDIATE RELEASE
Organon Receives FDA Approval to Market MIRCETTE(tm)
Oral Contraceptive Innovation Provides First Shortened Hormone-Free Interval
WEST ORANGE, NJ, April 22, 1998 -- Organon Inc. has received approval from the U.S. Food and Drug Administration to market MIRCETTE(tm) (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets, the first oral contraceptive to use a shortened hormone-free interval.
The MIRCETTE regimen reduces the daily estrogen dose from the commonly prescribed 30-35 mcg level to the 20 mcg level, while maintaining cycle control and a favorable tolerability profile.
The United States will be the first country in which this advanced technology will be available.
MIRCETTE's uniqueness is based on the patented shortened hormone-free interval. The dosing begins with 21 days of 20 mcg ethinyl estradiol and 150 mcg desogestrel. The last seven days in the MIRCETTE cycle start with two days of placebo pills, followed by five days of 10 mcg ethinyl estradiol pills. In contrast, all other combined oral contraceptives currently available in the U.S. have an initial three-week estrogen/progestin cycle, followed by the traditional one week of placebo pills.
Doctors have prescribed supplemental estrogen during an oral contraceptive's seven-day hormone-free interval to women experiencing menstrual migraines and other inter-menstrual side effects such as dysmenorrhea and pre-menstrual syndrome.
"This is good news for millions of women and their care givers who want new options for birth control," said Dr. Sarah Berga, Associate Professor of OB/GYN, Division of Reproductive Endocrinology, The University of Pittsburgh School of Medicine. "An oral contraceptive with a low daily dose of estrogen and a shortened hormone-free interval is a welcome addition to the oral contraceptives available. Clinical studies of this new drug regimen indicate effective and well tolerated contraception for new patients, patients who change therapy, perimenopausal and postpartum women," said Dr. Berga.
"The seven-day placebo regimen is no longer the only option," said Dr. Hans Vemer, President, Organon Inc., the developer of MIRCETTE. "With the new shortened hormone-free interval that MIRCETTE offers, Organon Inc. continues to provide innovations in women's health care," said Dr. Vemer, who is an obstetrician/gynecologist. Dr. Vemer indicated that MIRCETTE will be available later this year.
Organon Inc. of West Orange, NJ, is the U.S. affiliate of N.V. Organon, a renowned international ethical pharmaceutical company. Organon maintains an unprecedented commitment to women's health care, conducting research in three critical areas: contraception, fertility, and hormone replacement therapy. Besides its strong presence in reproductive medicine, the company markets a wide range of pharmaceuticals -- and leads groundbreaking research programs -- in the fields of anesthesiology, psychiatry, thrombosis and immunology. Organon is one of the business units of Akzo Nobel N.V. Akzo Nobel, headquartered in the Netherlands, is a market-driven and technology-based company, serving customers throughout the world with healthcare products, coatings, chemicals, and fibers. The company employs 70,000 people and has activities in more than 60 countries.
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NOTES TO REPORTERS: To receive a list of contraception experts in major markets who can speak about the impact of MIRCETTE, or to receive a full package insert for the product, please call SPECTRUM Science Public Relations, Inc. at 202-955-6222.
Photographs of MIRCETTE are available via NewsCom, http://www.newscom.com/cgi-bin/pub/pd/pdz?f=PRN/prnphotos&grid=2 or NewsCom, 305-448-8411; or AP PhotoExpress Network, PRN #4; or PressLink Online, 800-888-6195.
NOTE TO BROADCASTERS:
B-roll is available by calling Hart Billings at Orbis Broadcast Group, 312-942-1199 X175.
Hardcopy of the VNR script and the B-roll is available by calling Orbis Broadcast Group, 312-942-1199 X285.
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