FDA APPROVES NEW INDICATION FOR MIRENA® TO TREAT HEAVY MENSTRUAL BLEEDING IN IUD USERS

MIRENA is the First and Only Contraceptive FDA-Approved for Treatment of Heavy Periods

Wayne, NJ, October 1, 2009 - Bayer HealthCare Pharmaceuticals, Inc., announced today that the U.S. Food and Drug Administration (FDA) approved a new indication for Mirena® (levonorgestrel-releasing intrauterine system) for the treatment of heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception. Mirena provides an effective, non-surgical option for the treatment of heavy menstrual bleeding and is the first and only contraceptive approved in the U.S. for this indication.

Heavy menstrual bleeding is a problem that affects between nine and 14 percent of otherwise healthy women1 and is a common reason a woman sees her doctor. Heavy menstrual bleeding is defined as menstrual cycles with 5 tablespoons or more of blood loss (> 80 mL). Signs of heavy menstrual bleeding include:

  • the need to use double sanitary protection to control the heavy flow
  • menstrual flow that soaks through one or more sanitary pads or tampons every hour
  • the need to change sanitary protection during the night2

“Many women with heavy periods often suffer privately with their symptoms. And because approved effective non-surgical treatment options are limited, women who do seek treatment for heavy periods often face the choice of having surgical procedures, such as hysterectomies” said Dr. Andrew Kaunitz, M.D., FACOG, Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine-Jacksonville. ”In a clinical trial, nearly nine out of 10 women were treated successfully for heavy menstrual bleeding with Mirena – meaning it reduced monthly blood loss by more than 50 percent from baseline and to below 80 milliliters. This makes it an effective, nonsurgical first-line option.”

"Mirena has a proven track-record as an effective contraceptive that lasts for up to five years. We are pleased to now also offer Mirena as a treatment option for women with heavy menstrual bleeding who choose to use an IUD for contraception," said Stefan Oelrich, Vice President and General Manager, Women's Health Care, Bayer HealthCare Pharmaceuticals. "Today’s announcement demonstrates our continuing efforts to improve women’s health."

Only a woman and her healthcare provider can decide if Mirena is right for her. Mirena is recommended for women who have had a child. Mirena should not be used by a woman who has a pelvic infection, gets infections easily or has certain cancers. Less than 1% of users get a serious infection called pelvic inflammatory disease. A woman should talk to her healthcare provider about problems related to this condition. Mirena may attach to or go through the wall of the uterus and cause other problems. If Mirena comes out, a woman should use back-up birth control and call her healthcare provider. In the uncommon event a woman gets pregnant while using Mirena, she should seek emergency care because pregnancy with an intrauterine device may result in loss of pregnancy or loss of fertility. Pelvic and/or abdominal pain may occur. If persistent, women should talk to their healthcare provider. Ovarian cysts may occur and usually disappear. Bleeding and spotting may increase in the first few months and continue to be irregular. Periods may become shorter, lighter or even stop. Mirena does not protect against HIV or STDs.

About the Heavy Menstrual Bleeding Study
FDA approval is based on data from a randomized, open-label, active-control, parallel-group clinical trial of 160 healthy women of reproductive age who had confirmed heavy menstrual bleeding and did not have any medical conditions known to cause HMB, with the exception of small uterine fibroids in some patients. Heavy menstrual bleeding, defined as menstrual blood loss (MBL) of ≥ 80 mL, was determined using the alkaline hematin method. In the study, Mirena (n=79) was compared to an approved first-line hormonal therapy, medroxyprogesterone acetate (n=81), over six menstrual cycles. Successful treatment was defined when two outcomes were met: 1) a proportion of subjects with end-of-study MBL < 80 mL and 2) a ≥ 50% decrease in MBL from baseline to end-of-study. Mirena demonstrated a significantly superior reduction in MBL. Additionally, a greater number of women in the Mirena arm achieved successful treatment vs. those in the medroxyprogesterone acetate arm (85% vs. 22%: respectively, p=<0.001). The study excluded women with organic or systemic conditions that may cause heavy uterine bleeding (except fibroids, with total volume not > 5 mL). The most common reported adverse events for Mirena in the study were uterine bleeding/spotting at irregular intervals, headache, ovarian cysts, vaginitis, pain during menstruation (dysmenorrhea), pelvic pain, and breast tenderness.

About Mirena
Mirena (levonorgestrel-releasing intrauterine system) is a removable intrauterine contraceptive that delivers small amounts of hormone directly to the uterus. It is among the most efficacious forms of birth control and works for up to five years. Mirena received FDA approval for the prevention of pregnancy in December 2000. It is currently used by approximately two million women in the U.S. and has been used by more than 15 million women worldwide.3

About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals operation of Bayer HealthCare LLC, a division of Bayer AG. One of the world’s leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the United States, Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, Hematology/Neurology, and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

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Contacts:
Media:
Marcy Funk, Bayer HealthCare, marcy.funk@bayer.com, (973) 305-5385

This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

BAYER, the Bayer Cross, and Mirena are registered trademarks of Bayer HealthCare Pharmaceuticals.


1 van Eijkeren MA, Christiaens GC, Sixma JJ, Haspels AA. Menorrhagia: A review. Obstet Gynecol Surv 1989; 44:421.
2 Mayo Clinic: http://www.mayoclinic.com/health/menorrhagia/DS00394/
DSECTION=symptoms
3 Bayer: data on file.

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