New Low Dose Oral Contraceptive YAZ® Launched In Europe

Main Category: Sexual Health / STDs
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 09 Sep 2008 - 1:00 PDT

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Bayer Schering Pharma´s YAZ® will be available across Europe as of September 2008. YAZ® is the first oral contraceptive containing 3 mg of the unique progestin drospirenone combined with 0.02 mg of ethinyl estradiol in a new dosing regimen of 24 days of active hormone tablets followed by 4 days of hormone-free tablets. With this new regimen, a new pill pack is started immediately on the day after the last hormone-free tablet was taken. In the U.S., where YAZ® has been available since 2006, women´s overall satisfaction with this new pill is very high and YAZ® is the fastest growing branded oral contraceptive in the U.S.

"Taking active pills for three additional days can result in a reduction of hormonal fluctuations which often occur with conventional 21/7 pills," said Phil Smits, M.D., Head of Women's Healthcare at Bayer Schering Pharma AG. "Women who usually experience hormone withdrawal symptoms such as headaches or cramps during the pill-free week should benefit from the unique features of drospirenone delivered in the innovative YAZ® regimen."

YAZ will be available in Germany, Netherlands, Czech Republic, Slovakia, the Alpine countries and Scandinavia as from beginning of September 2008 closely followed by Portugal, Finland, Ukraine, Baltics and others. More European countries will launch YAZ® by the end of the year or first and second quarters of 2009.

Bayer Schering Pharma submitted the Premenstrual Dysphoric Disorder (PMDD) indication for YAZ® in Europe in July 2008 and will also submit the acne indication to the European Health Authorities later this year.

In several major countries and regions throughout the world, including the U.S., Latin America, and Asia-Pacific, YAZ® is already registered in three different indications: oral contraception, treatment of the emotional and physical symptoms of Premenstrual Dysphoric Disorder (PMDD) and treatment of moderate acne in women seeking contraception.

About YAZ®

Drospirenone, the unique progestin contained in YAZ®, has both anti-mineralocorticoid and anti-androgenic properties. It counteracts the water retention often seen when taking estrogens, thereby reducing the "bloated" feeling that many women experience especially when starting on the pill. Clinical studies have also shown that because of the anti-androgenic properties, pills containing drospirenone can help to improve women's skin condition. Extending the treatment period of active pills from 21 to 24 days per cycle means that the period of the therapeutic effects of drospirenone is prolonged by 3 days, leading to a more pronounced effect of drospirenone. In addition, with a half-life of 30 hours, the beneficial effects of drospirenone extend into the pill-free period.

About Bayer

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 http://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, General Medicine, Specialty Medicine 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 http://www.bayerscheringpharma.de.

Forward-looking statements

This 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.