Bayer wins European approval for Qlaira pill16 Oct 2008 • by Natalie Aster
Bayer AG said it has won European approval for Qlaira, a contraceptive pill which it expects to generate sales of up to 500 million euros ($683.1 million) per year.
Bayer is also developing Qlaira for the treatment of an excessive menstrual bleeding condition known as dysfunctional uterine bleeding, or DUB, the German drugmaker said in a statement on Thursday.
It said there were currently no approved treatments for DUB.
Bayer is trying to build on the market success of its existing birth control pills, which it obtained as part of its takeover of rival Schering.
The group of contraceptives comprising the Yasmin, YAZ and Yasminelle brands, became Bayer's best-selling pharmaceutical product last year, generating more than 1 billion euros in revenues.
Qlaira is the first birth control pill with a type of oestrogen that is identical to the hormone produced by the female body.
The drug would likely come to European markets next year, Bayer said. It also said it planned to file for approval in the United States next year.
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.
For Qlaira, Bayer went through a so-called decentralised approval process. As part of the procedure, the clearance given by Dutch regulators would be recognized and converted into national law by the other EU member states in coming weeks. (Reporting by Ludwig Burger; Editing by Hans Peters)