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. MIRENA’s 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 woman’s 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 President and General Manager, Female Healthcare, Berlex Laboratories, Inc. "As a global leader in female health care, we are proud to be able to offer MIRENA to women in this country."
According to the 2000 Gallup Survey of Women’s Health and Contraception Methods, a syndicated research service conducted by Multi-sponsor Surveys, Inc. under a license agreement with the Gallup Organization, Inc., nearly 26 million -- or 40 percent -- of women in the U.S. between the ages of 18 and 49 currently use a method of long-acting contraception. Long-acting methods of contraception include sterilization (female and male), injectables, implants and intrauterine devices. Of these women, nearly 80 percent (approximately 21 million) use sterilization, a method that is typically not reversible.
The insertion and removal of MIRENA take only a few minutes and are easily done by a trained health care professional in a doctor’s office on an outpatient basis. Health care professionals should be thoroughly familiar with insertion procedures before inserting MIRENA. Once MIRENA is removed, fertility returns rapidly. Approximately eight out of every 10 women who want to become pregnant will become pregnant in the first year after MIRENA is removed.
"My patients are very excited about the prospect of MIRENA," says Mitchell Creinin, MD, Associate Professor and Director of Family Planning and Family Planning Research at the University of Pittsburgh. "Because the progestin in MIRENA is released just within the uterus, it provides very effective contraception with very few effects throughout a woman’s body. The insertion of MIRENA is a simple office procedure that really only takes a couple of minutes – a very simple procedure for very effective birth control that can last for up to five years."
"I’m a mom and a wife. I have a full-time job. I sing with a band on the weekends. I just don’t have time to think about taking a pill every day," says Michelle Fleissner, one of the first women in the U.S. to use MIRENA. "I know MIRENA works, which means that when my husband and I have intimate time together, we don’t have to stop and worry about birth control. Right now, we’re not interested in having children. But in two or three years we’ll want to, and we like knowing that when we do decide to have children, I can quickly and easily have MIRENA removed."
Appropriate MIRENA candidates are women in stable mutually monogamous relationships with at least one child and no history of pelvic inflammatory disease (PID), and have no history of ectopic pregnancy or a condition that would predispose to ectopic pregnancy.
In clinical studies, side effects of MIRENA were most common during the first months after insertion and subsided during prolonged use. Side effects include, acne, back pain, breast tenderness, headaches, mood changes and nausea.
Like many contraceptives, MIRENA does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Use of IUDs has been associated with an increase risk of PID. A decision to use MIRENA must include consideration of the risks of PID. The highest risk of PID occurs shortly after insertion (usually within the first 20 days thereafter).
Please see the Prescribing Information for further information including Contraindications, Warnings and Precautions.
For more information about MIRENA, please visit www.MIRENA-us.com or call 1-800-BERLEX-2.
Berlex Laboratories, Inc.
Berlex Laboratories is a major presence in the area of Female Healthcare. Currently, marketed products serve the patient in the areas of estrogen replacement therapy (ERT) and contraception. Berlex is committed to conducting research in these and other healthcare areas that are central to a woman’s quality of life.
Committed to developing novel therapeutics that address unmet medical needs, Berlex Laboratories, Inc., the U.S. subsidiary of Schering AG, Germany (NYSE: SHR), researches, manufactures and markets ethical pharmaceuticals in five strategic areas: Diagnostic Imaging, Female Healthcare, Dermatology, Oncology and Therapeutics for life-threatening and disabling diseases. Berlex business divisions are located in Montville and Wayne, New Jersey, and in Richmond, California. For more information on currently marketed products, please visit www.berlex.com.
CONTACTS:
Berlex Laboratories, Inc.
Julie Mandell
Manager, Public Relations
973/487-2592
julie_mandell@berlex.com
Joanne Marion
Investor Relations
973/276-2164
joanne_marion@berlex.com
Amanda Moulson
Porter Novelli
212/601-8492
amoulson@porternovelli.com