July 8, 2009 / 7:07 AM / 10 years ago

UPDATE 1-Bayer files for U.S. approval of Qlaira pill

* Aims for peak annual sales of 500 mln euros from pill

* Shares gain 0.4 percent in early trade

(Adds details and background)

FRANKFURT, July 8 (Reuters) - Bayer BAYG.DE, Germany’s largest drugmaker, has filed for approval in the United States for a new birth control pill it started to market in Europe in May to shore up its best-selling contraceptives business.

Bayer is seeking approval from the Food and Drug Administration for the pill, based on a new type of the female hormone oestrogen, for use as contraceptive and to treat excessive menstrual bleeding, the company said on Wednesday.

Bayer has previously said it aimed to generate sales of up to 500 million euros ($698.9 million) per year from the pill, marketed in Europe as Qlaira.

It aims to build on the market success of its established birth control pills, which it obtained as part of its takeover of German rival Schering.

The group of contraceptives 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 contraceptive pill with a type of oestrogen that is identical to the hormone produced by the female body.

Bayer has said that the combination of estradiol, or body-identical oestrogen, and the progestin dienogest used in Qlaira put less of a strain on the liver and the body’s metabolism than conventional pills. (Reporting by Ludwig Burger)

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