October 5, 2009 / 4:04 PM / 11 years ago

Bayer contraceptive Qlaira shown to quell bleeding

* Blood loss reduced by 458 millilitres over 90-day period

* Results to underpin EU filing next year

* Bayer sees up to 500 mln eur in annual sales from pill

FRANKFURT, Oct 5 (Reuters) - Bayer’s (BAYGn.DE) new birth control pill Qlaira was shown to reduce excessive menstrual bleeding in a late-stage drug trial, the company said, underpinning its plan to widen the use of the pill in Europe.

The Phase III study showed that Qlaira helped reduced blood loss by 458 millilitres on average over a 90-day period, while the blood loss in a control group of women on placebo was lowered by only 93 millilitres, the German drugmaker said on Monday.

Participants on Qlaira — from which Bayer expects up to 500 million euros ($730 million) in annual sales — also had better haemoglobin and blood iron parameters.

In May, Bayer brought Qlaira to European markets, initially pureley as a contraceptive.

It plans to file for EU approval to extend the pill’s use to alleviate heavy or prolonged menstrual bleeding next year, a company spokeswoman said.

Bayer filed for regulatory approval of the pill in the United States both as a contraceptive and to treat excessive bleeding in July.

Bayer is trying to build on the market success of its existing birth control pills, which it obtained as part of its acquisition of rival Schering.

The group of pills comprising the Yasmin, YAZ and Yasminelle brands are Bayer’s best-selling pharmaceutical product, generating 1.2 billion euros in revenues last year.

Qlaira is the first birth control pill with a type of oestrogen that is identical to the hormone produced by the female body. It was shown to put less of a strain on the liver and the body’s metabolism than conventional pills.

The drugs trial was carried out in Europe and Australia. Results of a similar Phase III in the United States and Canada will be released at a congress of the American Society for Reproductive Medicine from Oct 17-21.

In the global market for hormonal birth-control pills Bayer competes with Johnson & Johnson (JNJ.N) of the United States, Barr Pharmaceuticals, now part of Israel’s Teva TEVA.O, and Ireland-based Warner Chilcott WCRX.O.

Reporting by Ludwig Burger

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