Edited Press Release
FRANKFURT -(Dow Jones)- Bayer Schering Pharma AG is starting the European roll-out of its new oral contraceptive Qlaira (estradiol valerate/dienogest), the company said Thursday.
From May 15, 2009, Qlaira will be available in several European countries, including Germany. More European countries will follow from autumn 2009 onwards. Qlaira is the first in a new class of oral contraceptives to deliver estradiol, the estrogen identical to the one produced by the female body. Over the past 50 years, many new progestins have been developed for use in oral contraceptives, but the estrogen component remained the same - ethinylestradiol. The introduction of Qlaira thus offers women a new choice in oral contraception.
"We are highly delighted that we will now bring Qlaira - our latest innovation in the field of contraception - to women all over Europe," said Phil Smits, Head of Women's Healthcare at Bayer Schering Pharma. "As worldwide market leader in women's healthcare and a company leading in research, we are committed to developing new products and improving on the existing range in order to better serve women and their contraceptive needs."
Qlaira contains the combination of estradiol valerate - which is immediately metabolized to estradiol, the same estrogen as produced by a woman's ovaries - with the progestin dienogest in a unique dynamic dosing regimen. This dosing regimen has been designed to deliver hormones at the right levels at the right time during the cycle to provide reliable contraception and good cycle control.
Until now, efforts to use estradiol in oral contraception have failed to achieve a satisfactory level of bleeding control. Clinical studies with Qlaira however have shown that the new combination's cycle control is as good as that of oral contraceptives containing 20 µg of ethinylestradiol.
Bayer Schering Pharma is also developing Qlaira for the treatment of heavy and/or prolonged menstrual bleeding in women without organic pathology who desire oral contraception. An approval for this additional indication would represent another important milestone; no other contraceptive has yet been approved for treating this condition.
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Publié le 14 Mai 2009 Copyright © 2009 Dowjones