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Bayer files low dose contraceptive patch for EU approval

Will offer alternative to J&J’s Evra

Bayer has submitted its low dose contraceptive patch for marketing authorisation in the EU.

Containing ethinylestradiol and gestodene, the transparent patch would offer competition to Johnson & Johnson's once-weekly birth control patch Evra (known as Ortho Evra in the US).

Bayer's product may be a more attractive proposition, however, as Evra has been associated with a risk of blood clot, with US Food and Drug Adminsitration (FDA) advisers recommending the patch's label be updated to better explain concerns.

Like Evra, Bayer's contraceptive patch is to be applied once a week to either to the abdomen, buttocks or outer upper arm, where it then delivers a continuous does of hormones across the following seven days.

Each patch is replaced after seven days, and after three weeks women should go a week without wearing one.

According to Dr Flemming Ornskov, chief marketing officer – strategic marketing general medicine at Bayer HealthCare Pharmaceuticals, more women are becoming attracted to the idea of a patch compared to pills that need to be taken every day.

“Market research shows that more and more women prefer non-daily contraception,” he said, “and we as a market leader in female contraception are committed to meet the individual needs of women by providing a broad range of different types of contraceptives.”

The patch has been through phase III trials involving 4,200 women worldwide where it has demonstrated its effectiveness as a contraceptive.

If approved, it will be manufactured by Swiss company Acino following an agreement with Bayer in 2011 and Acino will make use of its new €20m factory in Germany that is due to begin operations by the end of 2012.

According to Acino, the facility is scaled to increase the currently produced volume of 37 million patches per year by two to threefold.

21st September 2012

From: Sales



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