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The Netherlands will serve as the Reference Member State for the Decentralized Procedure to gain European-wide Marketing Authorization
BERLIN, Germany | December 3, 2007 | Bayer Schering Pharma AG, Germany, has submitted for registration the first combined oral contraceptive product based on estradiol and the progestin dienogest to all Member States of the European Community. The Netherlands will serve as the Reference Member State for the Decentralized Procedure to gain European-wide Marketing Authorization.
This new oral contraceptive provides estradiol, the same estrogen produced by the female body. A comparative clinical study showed that this new combination results in a good cycle control, comparable to combined oral contraceptives with 20 µg ethinylestradiol. Clinical research also demonstrated that this new oral contraceptive has a less pronounced impact on liver and metabolic parameters compared to the investigated comparators.
“With this submission we demonstrate our commitment as the worldwide market leader in female contraception to develop innovative oral contraceptives with added health benefits for women,” said Phil Smits, M.D., Head of Women’s Healthcare at Bayer Schering Pharma AG. “Our new product is the first oral contraceptive that is based on a bio-identical estrogen. We are absolutely delighted to be the first to have achieved this important milestone in the development of oral contraceptives.”
Bayer Schering Pharma has developed the product as "DUB-OC (E2/DNG)" for oral contraception. It is also being studied for the treatment of prolonged, frequent and excessive bleeding (dysfunctional uterine bleeding), however is only seeking approval for the oral contraception indication at this time. The decision for a brand name is pending.
During the last 50 years several progestins have been developed for the use in oral contraceptives, but basically only one estrogen, namely ethinylestradiol, is currently being used worldwide. Numerous efforts have been made in the past to use estradiol. All these attempts have proven disappointing with regard to cycle control. Use of estradiol was made possible with this new product by the use of dienogest.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.
About Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.
SOURCE: Bayer Schering Pharma AG |
