Schering AG has been given the go ahead by US regulators to launch its new contraceptive pill Yaz onto the world’s most lucrative drug market, with the product now due to roll out in April.
Yaz (drospirenone/ethinyl estradiol), a member of the group’s Yasmin franchise of low-dose contraceptives, is the first pill which combines the innovative progestin drospirenone and a low dose of ethinyl estradiol in a new dosing regimen of 24 days of active hormone pills and four days of placebo.
According to Schering, Yaz offers an important benefit as it reduces typical monthly hormonal fluctuations compared to traditional oral contraceptives with regimens of 21 days of active pills and seven days of placebo.
Dr Hubertus Erlen, Chairman of the Executive Board of Schering, commented that Yaz’ approval is an important milestone for Schering, which “significantly adds to the blockbuster potential of our Yasmin product family…and will certainly contribute to our near and long-term success.”
The company, which is currently staving off a $17.7 billion hostile takeover from fellow German drugmaker Merck KGaA, originally planned to introduce the medicine in the US last year but was knocked back by an approvable letter from the FDA. Whether the approval of Yaz will have any impact on further bids for the firm remains to be seen, but it could lend weight to Schering’s stance that Merck’s offer undervalues the firm.
Schering also said that it plans a similar filing with European regulators “very soon,” and that it will continue to pursue clearance for the emotional and physical symptoms of premenstrual dysphoric disorder, a severe form of premenstrual syndrome, in the USA. If it obtains a green light for PDD, Yaz would be competing with Eli Lilly’s Prozac (fluoxetine), GlaxoSmithKline’s Paxil (paroxetine) and Pfizer’s Zoloft (sertraline).
Schering has previously forecast peak annual sales for YAZ of around 200 million euros, providing it wins approval for PDD as well as contraception. The company also got an approvable letter for the latter indication in 2004.