November 20, 2015
Bayer's new five-year-contraceptive submitted for EU and US Marketing Authorization
Clinical studies demonstrated efficacy of new long-acting contraceptive with lowest available daily hormone dose for five years of contraceptionBerlin, November 20, 2015 - Bayer has submitted an application for marketing
authorization in both the European Union and in the United States for LCS-16, a
new low-dose levonorgestrel-releasing intrauterine system (LNG-IUS) which is
directly placed in the uterus for contraception for up to five years.
Long-acting contraception is one of the most effective methods of birth
control. An LNG-IUS can be removed at any time and offers rapid return to a
woman's usual level of fertility after removal.
"As a leader in Women's Healthcare we are committed to continuously advance our
portfolio of innovative contraceptive methods to meet the needs of a broad
range of women", said Dr. Joerg Moeller, Member of the Bayer HealthCare
Executive Committee and Head of Global Development. "An intrauterine system
does not only bring the advantage that women do not have to think about their
contraception every day, but also that it contains fewer hormones than other
hormonal contraceptive options like the pill or implant. With the application
for marketing authorization for LCS-16, we hope we will be able to offer women
an additional option of a reliable and convenient long-acting reversible
contraception that contains the lowest available dose of hormones for up to
Data from Phase III clinical trials, including 574 nulliparous and 878 parous
women from North America and several European countries have demonstrated that
LCS-16 is highly effective and well tolerated regardless of age and parity. The
primary endpoint of the Phase III clinical trial program was contraceptive
efficacy assessed by the Pearl index. The data showed that the new IUS is more
than 98.5 percent effective in preventing pregnancy. Moreover, LCS-16 was
generally well tolerated, with no unexpected adverse events reported. Low
incidences of ectopic pregnancy, pelvic inflammatory disease, expulsion of the
device from the uterus and uterine perforation were seen.
LCS-16 is a small, flexible plastic T-shaped device. Once placed in the uterus,
it releases a low dose of the progestogen levonorgestrel directly into the
uterus and provides effective birth control for up to five years. It also
offers rapid return to a woman's usual level of fertility after removal.
With a Pearl-Index of 0.31 after three years and 0.29 after five years based on
reported efficacy in clinical trials, LCS-16 provides highly effective,
long-acting contraception for women who desire a low-dose contraceptive option
for up to five years.
About Bayer in Women's Healthcare
Bayer is committed to delivering science for a better life by advancing a
portfolio of innovative treatments. With a long heritage in Women's Healthcare,
Bayer offers a wide range of effective short- and long-acting birth control
methods as well as therapies for menopause management and gynecological
diseases with several other compounds in various stages of clinical
development. Together, these products reflect the company's approach to
research, which prioritizes targets and pathways with the potential to impact
the way how women's health related conditions are treated.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of
health care and agriculture. Bayer HealthCare, a subgroup of Bayer AG with
annual sales of around EUR 20.0 billion (2014), is one of the world's leading,
innovative companies in the healthcare and medical products industry and is
based in Leverkusen, Germany. The company combines the global activities of the
Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer
HealthCare's aim is to discover, develop, manufacture and market products that
will improve human and animal health worldwide. Bayer HealthCare has a global
workforce of 60,700 employees (Dec 31, 2014) and is represented in more than
100 countries. More information is available at www.healthcare.bayer.com.
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