Solvay Pharmaceuticals, Inc. Receives U.S. FDA Approval for EstroGel; First Transdermal Gel for Estrogen Therapy in the U.S.

Business Editors/Health/Medical Writers

MARIETTA, Ga.--(BUSINESS WIRE)--Feb. 10, 2004

Solvay Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved EstroGel(R) (estradiol gel), the first-ever estrogen therapy transdermal gel in the country for the treatment of moderate to severe vasomotor symptoms, as well as vulvar and vaginal atrophy associated with the menopause.

EstroGel(R) is a clear, odorless, hydro-alcoholic gel that provides for delivery of estradiol for estrogen replacement in a non-patch transdermal form.

"With the approval of EstroGel(R), women and healthcare professionals now have an additional hormone therapy option. EstroGel(R) will offer healthcare providers the opportunity to individualize a woman's therapy to help manage vasomotor symptom relief," said Harold H. Shlevin, Ph.D., president and CEO of Solvay Pharmaceuticals, Inc. "The FDA's approval of EstroGel(R) provides Solvay Pharmaceuticals with a complete line of women's health products, offering women and their healthcare professionals a range of first and second-line menopausal therapeutic options, as well as adjunctive therapy for women requiring endometrial protection."

The only FDA approved estrogen therapy available in gel form, EstroGel(R) provides women with a safe and easy-to-use treatment option. EstroGel(R) has been a prescribed therapy for more than 25 years in Europe. It will be available with a prescription in pharmacies throughout the United States by mid-year.

Transdermal delivery of EstroGel(R) will ensure the body receives a consistent and continuous supply of estrogen. Applied once daily on one arm from wrist to shoulder, EstroGel(R) avoids first pass metabolism in the liver and minimizes application site skin irritation. The gel dries in as little as two to five minutes.

EstroGel(R) will be prescribed at a 1.25g (0.75 mg estradiol) daily dose. EstroGel(R) is packaged in a non-aerosol, metered-dose pump that is designed to deliver 1.25g (0.75 mg estradiol) of gel per compression.

Data supporting the efficacy and tolerability of EstroGel(R) in reducing the frequency and severity of moderate-to-severe vasomotor symptoms was demonstrated in a 12-week, double-blind, randomized, placebo-controlled, multicenter study. The study analyzed the effects of EstroGel(R) on 145 healthy, postmenopausal women suffering from moderate-to-severe hot flashes.

"(EstroGel)(R) represents a promising new alternative delivery system for ET in menopausal women," said Dr. David Archer, lead investigator of the study.

The use of unopposed estrogens in non-hysterectomized women increases the risk of endometrial cancer. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease. The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. Other doses of conjugated estrogens with medroxyprogesterone and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials, and in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Estrogens are contraindicated for patients with known or suspected pregnancy, breast cancer, active thrombophlebitis, or thromboembolic disorders. Please see the package insert for complete safety and prescribing information.

Solvay Pharmaceuticals, Inc. (www.solvaypharmaceuticals-us.com) of Marietta, Georgia (USA), is a research-based pharmaceutical company, active in the therapeutic areas of cardiology, gastroenterology, mental health and women's health. It is a member of the worldwide Solvay Group of chemical and pharmaceutical companies, headquartered in Brussels, Belgium.