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| |  Wyeth-Ayerst Introduces First Progesterone For Use With Infertility Treatment PHILADELPHIA, May 15, 1997 -- Wyeth-Ayerst Laboratories announced clearance from the U.S. Food and Drug Administration (FDA) to market Crinone(TM), natural progesterone in a bioadhesive gel. Crinone is a whole new approach to progesterone therapy used in conjunction with infertility treatment, and will be available this summer. Crinone is indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency. Eight to 9 percent of reproductive age women suffer from infertility. Wyeth-Ayerst Laboratories will market Crinone worldwide through a licensing agreement with Columbia Laboratories, Inc., a U.S.-based international pharmaceutical company that developed the product. Crinone 8% (progesterone gel) is packaged in an easy-to-use, pre-filled vaginal applicator which avoids the pain of intramuscular (IM) injection, and the untidiness and inconsistency associated with vaginal suppositories. This applicator and the technological breakthrough of a bioadhesive gel, allow Crinone to deliver progesterone, via the vagina to the uterus. Progesterone is required to prepare the lining of the uterus, or endometrium, to receive and nourish an embryo. "Crinone offers an advantage over intramuscular progesterone therapy for infertility -- a direct effect on the endometrium despite substantially lower blood levels of progesterone without the pain associated with an injection. In addition, it provides increased convenience and ease of use," said William Gibbons, M.D., Chairman of Obstetrics and Gynecology, Jones Institute for Women's Health, Eastern Virginia Medical School. "The clinical research shows that Crinone is both effective and well-tolerated for progesterone replacement or supplementation in women with progesterone deficiency," Gibbons added. "Our study was conducted in women whose bodies do not produce progesterone, so there was never a doubt where the endometrial support was coming from." Clinical Research Results The effectiveness of Crinone in preparing the endometrium to receive an embryo and maintaining pregnancy was evaluated in two separate studies -- one employing an embryo transfer, the other employing in-vitro fertilization (IVF), a common method of Assisted Reproductive Technology (ART) treatment. Progesterone Replacement In the key clinical study, conducted at the Jones Institute, women requiring progesterone replacement were administered Crinone 8% (progesterone gel) at a dose of one applicator (90 mg) twice daily. Of the 54 women who underwent an embryo transfer and were treated with Crinone, 48 percent achieved a clinical pregnancy and 31 percent delivered. Progesterone Supplementation In the second study, women requiring progesterone supplementation were evaluated following an in-vitro fertilization (IVF) procedure. In this study, patients received one applicator (90 mg) of Crinone 8% once daily. Of the 139 Crinone patients who received an embryo, 26 percent achieved a clinical pregnancy and 23 percent delivered. Side Effects and Other Important Information In women requiring progesterone replacement, the most frequently reported side effects were cramps, breast pain and headache. In women requiring progesterone supplementation, the most frequently reported side effects were breast enlargement, constipation, somnolence, nausea and headache. Some women should not use progesterone therapy, including those with the following conditions: a known sensitivity to progesterone or any other ingredient in Crinone, undiagnosed vaginal bleeding, liver dysfunction or disease, known or suspected malignancy of the breast or genital organs, if the patient has a miscarriage and her physician suspects some tissue remains in the uterus, or a history of blood clots in the legs, lungs, eyes or elsewhere. Wyeth-Ayerst, a division of American Home Products Corporation, is a major research-oriented pharmaceutical company with leading products in the areas of women's health care, cardiovascular and metabolic disease therapies, central nervous system drugs, anti-inflammatory agents, vaccines and generic pharmaceuticals.
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