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| |  Woman's Well-Being Improves When Natural Progesterone Is Added To Estrogen MIAMI, April 25, 1996 --Columbia Laboratories Inc. (AMEX: COB) today announced that the three pivotal studies for the U.S. NDA for its patented natural vaginal progesterone product, Crinone(R) have been completed and analyzed. The level of efficacy exceeded expectations. The incidence of depression, emotional liability, sleep disorders, headache and bloating, which normally rise significantly with synthetic progestins, decreased when Crinone(R) was added to estrogen. As a result, patient well-being improved during Crinone(R) therapy. This completed the studies needed for an NDA. Columbia plans to submit its NDA in the United States in the middle of this year. These studies examined the effects of two doses of Crinone(R) (progesterone) 45 mg. and 90 mg. in 110 women with secondary amenorrhea (loss of menstrual period). Ballet dancers, long distance runners, anorexic women, and patients with premature ovarian failure (POF), all with documented secondary amenorrhea, were included. All patients were first given estrogen only to prime the endometrium (lining of the uterus). Approximately 80% of patients had the expected menstruation after both doses of Crinone(R). In addition, biopsies confirmed that 94% of patients in the 45 mg. group and 100% of patients in the 90 mg. group had endometrial effects consistent with progestational activity. "The unpleasant side effects caused by synthetic progestins are the reason the majority of women stop hormone therapy. We believe that the improvement in patient well-being while on Crinone(R), natural progesterone, will lead to greater patient compliance in long-term hormonal therapy," said William J. Bologna, Columbia's Chairman of the Board. Crinone(R) is a natural progesterone delivered vaginally in Columbia's patented bioadhesive delivery system. Columbia has previously announced that the Wyeth-Ayerst division of American Home Products has licensed the product worldwide. The first launches are expected in Europe during the second half of 1996. Columbia Laboratories Inc. is a U.S.-based international pharmaceutical company, dedicated to the development of women's prescription and over-the-counter products, including those which help prevent sexually transmitted diseases. Columbia's products primarily utilize the company's patented bioadhesive delivery system.
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