"Because YASMIN is the first oral contraceptive in over 40 years to contain a new class of progestin, we believe there is significant market potential for this product," said Reinhard Franzen, Vice President and General Manager, Female Healthcare, Berlex Laboratories, Inc. "More than 18 million women in the U.S. currently use oral contraceptives, but nearly half of them discontinue use or switch brands. The major reason for such a high dissatisfaction rate is side effects. Yasmin offers these women a needed, new option in oral contraceptives."
The uptake of YASMIN by wholesale and retail pharmacy customers has been tremendous. "Many of our trade customers are utilizing specialized programs to get Yasmin to the pharmacy as fast as possible. These programs are typically reserved for products with $100 million market potentials. We are very optimistic that this response is indicative of potential sales growth for the product this year," added Franzen.
"Many of my patients have been dissatisfied with currently available birth control pills and a majority discontinue use due to side effects," said Michael Thomas, MD, Director of the Center for Reproductive Health, University of Cincinnati College of Medicine. "The unique mechanism of action in YASMIN places it in a class of its own, and I am pleased to offer my patients this new and exciting contraceptive option." Dr. Thomas added that YASMIN is ideal for patients who desire an oral contraceptive that is well tolerated. In clinical studies, only six percent of women discontinued use due to side effects.
The launch of YASMIN continues in the tradition of Schering AG, Germany, the Berlex parent company, which introduced oral contraceptives in the European market 40 years ago. YASMIN has been available in several European countries, including Germany, since November of 2000. Over 500,000 women in Europe are currently using YASMIN.
Large-scale clinical trials in the U.S. and Europe involving 2,629 women and over 33,160 cycles of use 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.
YASMIN contains 3 mg of the progestin drospirenone that influences the regulation of water levels and electrolyte balance in the body. This activity may increase potassium levels in some patients. Therefore, 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.
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).
Important Information About All Oral Contraceptives
OCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases. The use of OCs is associated with increased risk of several serious side effects. Cigarette smoking increases the risk of serious cardiovascular side effects; women who take OCs are strongly advised not to smoke.
Information for Consumers
Women who would like to learn more about YASMIN should visit www.YASMIN.com or call the toll-free number 866-YASMIN1 (927-6461) to receive a complimentary, informational product brochure by mail.
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 http://www.
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, Germany, 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, Germany, 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.