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Swedish approval for Bayer's long-term contraceptive Jaydess

Country is reference member state for approval under the decentralised EU procedure

Bayer has added to its stable of contraceptive products following approval in Sweden of Jaydess, a drug-eluting intrauterine system (IUS) that provides up to three year's pregnancy protection.

Sweden is operating as the reference member state for approval under the decentralised EU procedure, and other national authorities are expected to clear the product in the coming weeks and months.

The Jaydess device is placed in the uterus and gradually releases a very low dose of levonorgestrel, so that very little of the hormone is released into the blood stream.

The new product is targeted at "women who are looking for a reliable, convenient long-term contraceptive option with a very low hormonal dose", according to Kemal Malik, Bayer's head of global development.

Compared to oral contraceptives, the new IUS is a contraceptive option for women that do not want to take a pill every day, and also offers rapid return to a woman's usual level of fertility after removal, said the company in a statement.

Bayer's contraceptive franchise is led at the moment by its Yaz/Yasmin/Yasminelle portfolio of oral products, which pulled in €775m in sales for Bayer in the first nine months of 2012.

Health concerns with combined oestrogen/progestin hormonal contraceptives have started to affect sales, however, and Bayer has been hit by litigation charges that cost the company almost €500m in the first six months of the year.

Warnings were added to the products' labelling in April in the US indicating that they may increase the risk of blood clots, while the franchise is also starting to feel the effects of generic competition.

Bayer has responded by developing a series of products, including Jaydess, that reduce women's exposure to hormonal drugs.

In October, for example, the company was awarded EU approval for Flexyess/Yvidually, a low-dose combined oral contraceptive designed to help women control the timing and number of periods by selecting a tablet free interval at any time from day 25 to 120 of the treatment cycle.

Initial launches of the new Jaydess device in the EU are expected in the second quarter of 2013, said Bayer. It has also been submitted for approval in the US.

5th December 2012

From: Sales

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