Montville, NJ, December 6, 2000 Berlex Laboratories, Inc., the U.S. subsidiary of Schering AG, Germany (NYSE: SHR), announced today that the U.S. Food and Drug Administration (FDA) approved MIRENA(R) (levonorgestrel-releasing intrauterine system), a convenient, innovative contraceptive that is as effective in preventing pregnancy as tubal ligation (better than 99 percent) and lasts for five years, or until removed.
Available for 10 years in Europe, MIRENA has been used by approximately two million women worldwide and will be available for the first time in the U.S. in the first quarter of 2001. "Women in European and Asian countries have used MIRENA successfully and safely." says Felicia Stewart, MD, Incoming Chair of the Association of Reproductive Health Professionals. "For many women in the U.S. there has been a limited choice in convenient, reliable and reversible long-acting contraception. MIRENAs availability gives these women a choice they need and deserve."
In addition to preventing pregnancy, MIRENA use may result in a change in bleeding patterns. In the first three to six months following insertion, there may be an increase in intermenstrual bleeding. After this, a womans period may become shorter and lighter. Some women experience an absence of menstrual bleeding after one year.
MIRENA does not contain estrogen. It delivers a low dose of the progestin levonorgestrel directly to the lining of the uterus. Studies suggest several mechanisms that prevent pregnancy: thickening of cervical mucus, which prevents the passage of sperm, inhibition of sperm mobility and inhibition of endometrial growth. Berlex will market MIRENA under a license from The Population Council, which initially developed the contraceptive.
"MIRENA is the first in a series of major new products that Berlex will bring to market, and its introduction marks the beginning of an expansion in the Berlex position in women's health," said Reinhard Franzen, Vice
Contact: Julie Mandell