Berlex Laboratories announces FDA approval of YASMIN (R), new oral contraceptive with unique progestin

May 13, 2001

National survey demonstrates need for new birth control pill options

Montville, NJ, May 14, 2001 -- Berlex Laboratories, Inc., a U.S. affiliate of Schering AG, Germany (NYSE:SHR), announced today that the U.S. Food and Drug Administration (FDA) approved YASMIN (R) (drospirenone and ethinyl estradiol). YASMIN is a new, low-dose, monophasic oral contraceptive and the first and only birth control pill to contain the unique progestin, drospirenone.

"YASMIN is the second major innovation that we've introduced to the U.S. market this year. Its market entry, along with the introduction of the levonorgestrel-releasing intrauterine system MIRENA early this year, represents further expansion of the Berlex leadership in contraception," said Reinhard Franzen, Vice President and General Manager, Female Healthcare, Berlex Laboratories, Inc. "Because of the unique clinical pharmacology of YASMIN, we believe this product will provide women with an important new option in contraception."

Drospirenone is different from the progestins currently available in other oral contraceptives. As an analogue of spironolactone, widely used by Ob/Gyns for many women, drospirenone exhibits antimineralocorticoid activity that influences the regulation of water and electrolyte balance in the body. This activity may increase potassium levels in some patients. Therefore, it is recommended that women with kidney, liver or adrenal disease should not take YASMIN, because this activity could cause serious heart and health problems. Patients taking drugs that could increase potassium should consult their health care professional before taking YASMIN.

The launch of YASMIN continues in the tradition of Berlex's parent company, Schering AG, which introduced oral contraceptives in the European market 40 years ago. Over 500,000 women in Europe are currently using YASMIN, where the product has been available in several countries, including Germany, since November of 2000.

Survey Finds Women Are Dissatisfied

While more than 18 million women in this country use one of the more than 40 oral contraceptives available today, a new national survey of U.S. women aged 18-45 commissioned by the National Women's Health Resource Center (NWHRC) shows that nearly half (47 percent) of women who have used birth control pills in the past five years were dissatisfied enough to discontinue use or switch brands.

"Nearly 700,000 unintended pregnancies occur each year in this country because women stop taking their birth control pills," said Amy R. Niles, Executive Director of the NWHRC. "The results of our survey show that women are dissatisfied with the choices currently available to them. That being the case, an oral contraceptive that makes birth control more acceptable for more women in this country is not only important, but necessary progress."

Data Demonstrate Safety, Efficacy and Tolerability

Large-scale clinical trials involving 2,629 women with over 33,160 cycles established the contraceptive effectiveness, safety and menstrual cycle control of YASMIN. Trials found that YASMIN offers excellent cycle control with a low rate of spotting and breakthrough bleeding.

YASMIN proved more than 99 percent effective in preventing pregnancy, with only one pregnancy occurring in 3,201 cycles of 326 YASMIN users.

Women who participated in clinical studies tolerated YASMIN very well, with only six percent discontinuing use due to side effects.

Important Information about YASMIN and All Oral Contraceptives

Drugs that may increase serum potassium when used on a daily long-term basis to treat chronic conditions or diseases include ACE inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, heparin, aldosterone antagonists and NSAIDs (i.e., daily use for arthritis).

Oral contraceptives (OCs) are not appropriate for all patients, and serious as well as minor side effects have been reported with the use of all OCs. OCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases. Women who use oral contraceptives are strongly advised not to smoke.
Information for Consumers

Women who would like to learn more about YASMIN should visit or call the toll-free number 866-YASMIN1 (927-6461) to receive a complimentary, informational product brochure by mail.

The National Women's Health Resource Center

The National Women's Health Resource Center is the nation's leading independent, nonprofit organization dedicated to educating women of all ages about health and wellness issues. Its programs include the award-winning newsletter, the National Women's Health Report, public education campaigns, and its Web site,, a one-stop-shop for women's health on the Web.

Berlex Laboratories, Inc.

Berlex Laboratories, Inc., is a major presence in the area of Female Healthcare. Currently marketed products serve the patient in the areas of hormone replacement therapy (HRT) 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 diagnostics and therapeutics that address unmet medical needs, Berlex Laboratories, Inc., a U.S. affiliate of Schering AG, Germany (NYSE:SHR), researches, manufactures and markets ethical pharmaceuticals in five strategic areas: Female Healthcare, Diagnostic Imaging, Dermatology, Oncology and Therapeutics for life-threatening and disabling diseases. Berlex Laboratories, Inc., has business operations in Montville and Wayne, New Jersey, and in Richmond, California. For more information about Berlex and its products, you may visit our Web site at

Certain statements in this press release that are neither reported financial results nor other historical information are forward-looking statements, including but not limited to, statements that are predictions of, or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties, and can be affected by other factors that could cause actual results, as well as the plans and objectives of Schering AG, or its US subsidiary, Berlex Laboratories Inc., to differ materially from those expressed or implied in the forward-looking statements. Certain factors that may cause such differences are discussed in our Form 20-F registration statement. Schering AG and Berlex Laboratories undertake no obligation to update publicly or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.

Additional Contacts:

Joanne Marion, Investor Relations

Amanda Moulson
Porter Novelli

Porter Novelli

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