Germany’s Schering AG was celebrating this morning after winning a green light in Europe for its new low-dose oral contraceptive, Yasminelle (ethinyl estradiol and drospirenone). The product, which is already available in Switzerland, will be rolled out across the continent over the remainder of 2006.
First approved in the Netherlands last August, Schering used the nod to seek pan-European clearance through the mutual recognition procedure.
Schering is banking on Yasminelle to bolster its successful OC franchise, headed by Yasmin. Yasminelle contains 20mcg of ethinyl estradiol and 3mg drospirenone – a synthetic hormone that the company says bears close resemblance to progesterone and offers benefits in terms of alleviating water retention and improving the skin; it is taken over a 21-day period.
Yasmin is available in 100 countries and is the biggest selling oral contraceptive in the world. It pulled in 180 million euros during the first three months of this year, up 30% on the like, year-earlier quarter.
As well as this new 21-day Yasminelle regimen, Schering also has a 24-day regimen of another drospirenone-containing oral contraceptive called YAZ in the portfolio. YAZ was finally launched in the USA in April after a rocky road to market, having first been issued an approvable letter by the US Food and Drug Administration in 2004 - requesting additional clinical data - and subsequently being hit by a further three-month delay in the regulatory review.
YAZ is another low-dose form of Yasmin, but is taken for 24 days followed by 4 days of placebo pills, rather than the 21-day regimen of Yasminelle; it was deemed approvable by the drug regulator for a severe form of pre-menstrual syndrome, premenstrual dysphoric disorder, in January, and Schering has forecast peak sales of 200 million euros.