Bayer submits marketing application for new transparent low dose contraceptive patch in the EU
Berlin, September 20, 2012 – Bayer HealthCare has submitted an application for marketing authorization in the European Union for a new transparent low dose contraceptive patch (ethinylestradiol/ gestodene). France will serve as the reference member state in the decentralized procedure for gaining marketing authorization in countries in the European Union.
"Once approved and launched, our contraceptive patch will provide an additional choice among contraceptive methods especially for women who are looking for an aesthetic, convenient weekly transdermal application with a low hormonal dose," said Dr. Flemming Ornskov, Chief Marketing Officer - Strategic Marketing General Medicine at Bayer HealthCare Pharmaceuticals." Market research shows that more and more women prefer non-daily contraception and we as a market leader in female contraception are committed to meet the individual needs of women by providing a broad range of different types of contraceptives."
The data from clinical studies, including 4,200 women worldwide, show that the new low dose contraceptive patch is an efficacious contraceptive with a good safety profile. First data will be presented in October 2012 at the FIGO World Congress of Gynecology and Obstetrics in Rome.
The contraceptive patch is small, round and transparent and contains 0.55 mg ethinylestradiol and 2.1 mg gestodene. It is applied once a week either to the abdomen, buttocks or outer upper arm where it delivers a steady, continuous dose of hormones over the 7- day application period. The systemic exposure is the same as observed after daily administration of a combined oral contraceptive containing 0.02 mg ethinylestradiol and 0.06 mg gestodene. Each patch is replaced after seven days, and after three weeks, there is a hormone-free week.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 17.2 billion (2011), 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, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2011) and is represented in more than 100 countries. More information at www.healthcare.bayer.com.
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