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| |  Estring for Postmenopausal Urogenital Symptoms Cleared for Marketing KALAMAZOO, Mich., May 1, 1996 -- Pharmacia & Upjohn, Inc. (NYSE: PNU) announced today that it has received clearance to market Estring (estradiol vaginal ring) in the United States. Estring is used to treat local symptoms of urogenital atrophy, which affect 20 to 40 percent of postmenopausal women. Urogenital atrophy (UGA) is a condition caused by estrogen deficiency, with symptoms which include dryness and soreness of the vagina, painful intercourse, urinary urgency and frequency and painful urination. Estring is the only product that treats both vaginal and urogenital symptoms of UGA. A prescription product, Estring is an elastomer ring containing 2 mg of 17 beta-estradiol, the major naturally occurring estrogen produced in the ovaries of fertile women. The Estring ring is inserted into the upper portion of the vagina, where it releases 50 to 60 percent of the estradiol, providing a consistent low-dose of estrogen for three months. Estring was first approved in Sweden in 1993. It is currently available in a number of other countries, including the United Kingdom, Canada, New Zealand, South Africa and Switzerland. "We're pleased that we will now be able to make Estring available to postmenopausal women in this country and to their health care professionals," said William E. Walker, director of women's health care products at Pharmacia & Upjohn. "Because Estring exerts its effects locally on the lower urogenital tract, it allows those women who have only local, urogenital symptoms of the menopause to target their treatment." Unlike vasomotor symptoms associated with the menopause, such as hot flashes, sweating and tiredness, which are best treated with systemic estrogen therapy, symptoms of UGA can be treated with hormone preparations that act locally on the tissues of the lower urogenital tract. Because these tissues are very sensitive to estrogen, considerably lower doses of the hormone can be used in preparations for vaginal application than in systemic products, thus reducing the risk of systemic side effects. In a clinical trial conducted in the U.S., after 12 weeks of treatment, 95% of women rated product comfort for Estring as excellent or very good, compared with 65% of patients receiving conjugated estrogens vaginal cream. In addition, 95% of Estring-treated patients judged the product to be very easy or easy to use, compared with 88% of patients using the cream, and 82% gave Estring an overall rating of excellent or very good, compared with 58% of those using the cream. "Women in clinical trials felt very comfortable using a ring for treatment of urgogenital atrophy," said Gloria Bachmann, M.D., professor, Department of Obstetrics, Gynecology and Reproductive Sciences, UMDNJ -- Robert Wood Johnson Medical School, and chief of service at Robert Wood Johnson Hospital. "The estrogen vaginal ring is very effective in treating local symptoms that result from a lack of estrogen. UGA is a challenging and important health care concern, and this is an important option for postmenopausal women." In clinical trials conducted in the U.S. and Australia, Estring was compared with conjugated estrogens vaginal cream. No difference in efficacy was noted between the two products, as assessed by both physicians and patients. Very little estradiol from Estring reaches the systemic circulation from Estring, so systemic effects are minimal. From available clinical data, Estring is unlikely to have adverse effects on the endometrium. Endometrial overstimulation, seen in 11% of patients treated with conjugated estrogens vaginal cream in the U.S. study, was not seen in any of the Estring-treated patients. Patients who use Estring and also take a progestin are not expected to experience withdrawal bleeding. Estring was well tolerated by patients in clinical trials. It did not appear to cause more frequent or more severe local adverse events than other, existing treatments. Adverse events that occurred in clinical trials with Estring were generally mild, transient and local, such as vaginal discomfort or irritation and abdominal pain. The average age of onset of menopause in women is 52 years. At that time, vasomotor symptoms, such as hot flashes, peak, but then subside in a few years. UGA begins at this time and can continue to worsen as time goes on. Since the average woman now spends one-third of her life after the menopause, UGA is becoming a major problem. "Many women don't realize that the symptoms associated with UGA can be caused by a lack of estrogen following menopause," said Walker. "Estring can effectively treat these local symptoms for many patients, so they no longer have to live with the symptoms of urogenital aging."
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