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Bayer files three-year contraceptive device in US, Europe

Intrauterine system potentially low-hormone alternative to company's Mirena

Bayer has filed for approval in Europe and the US for a new contraceptive device to go inside the uterus, aimed at young women, which provides protection from pregnancy for up to three years.

The intrauterine system (IUS) delivers a low dose of the progestin levonorgestrel and is targeted at younger women who want to minimise their exposure to hormones. It has a small, flexible T-shaped plastic body that allows the controlled release of levonorgestrel at a low rate (initially 10mcg/day) for up to three years.

Bayer also sells a higher-dose IUS - called Mirena - which releases around 20mcg/day of levonorgestrel and has been on the market since 2000. At present, Bayer has not identified a possible brand name for the low-dose variant.

It is estimated that around 2 million women in the US alone use Mirena, which has seen its sales grow from around $215m in 2006 - when Bayer bought original developer Schering -  to $700m last year, over a period when oral contraceptive use has been in decline.

The IUS has been submitted for approval in the US and Sweden, which will serve as the reference member state via the decentralised procedure for gaining marketing authorisation across the EU.

"Once approved our new low dose intrauterine system will be an excellent choice especially for young women who haven't had children so far and who are looking for a reliable, convenient contraceptive option with a very low hormonal dose," said Dr Flemming Ornskov, chief marketing officer for the general medicine unit at Bayer HealthCare.

Mirena was initially launched as a treatment for women who had already had children, as a result of lingering concern about the impact of intrauterine devices on fertility. This was largely because of experience with the early-generation products in the 1970s and 1980s. Since then its use has gradually expanded into younger age groups, and the latest IUS follows that trend.

"Compared to oral contraceptives, once approved the new IUS is a reliable contraceptive option for young women that does not require remembering to take a pill every day," said Bayer in a statement.

"It also offers rapid return to a woman's usual level of fertility after removal."

15th December 2011

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