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Berlin, December 7, 2009 - Bayer Schering Pharma AG, Germany, has successfully
completed the decentralized part of drug approval procedure in Europe for a new
treatment of endometriosis called Visanne®. Visanne is a once-daily oral tablet
containing dienogest 2 mg that has been developed specifically for the
treatment of endometriosis. A dedicated clinical study programme has proven
that Visanne relieves endometriosis pain with high efficacy, reduces
endometriosis lesions and demonstrates a favourable safety and tolerability
profile. Market launch of the product is planned from the second quarter 2010
onwards.
"With Visanne, we will be able to offer women a new treatment option which can
reduce the substantial burden of endometriosis," said Phil Smits, MD, Head of
Bayer Schering Pharma's Business Unit Women's Healthcare. "Surgical treatment
of endometrosis is associated with high relapse rates and many currently
available medical therapy options have side effects which do not allow for
long-term use. Patients often need to use different combinations of the
available treatment options and even undergo repeat surgical procedures.There
is therefore a high medical need for new treatment options."
The current standard therapy (regarding efficacy), GnRH analogue, can only be
used for the short-term relief of symptoms associated with endometriosis, as
safety concerns such as decreased bone mineral density and side effects such as
hot flushes limit its long-term use. Visanne has been shown to be as effective
as GnRH analogue and to be superior to placebo in reducing pain related to
endometriosis. Pain relief is sustained over time (shown in a clinical study
lasting 15 months) and includes dysmenorrhea-like pain, pre-menstrual pain,
diffuse pelvic pain and dyspareunia.
About Endometriosis
Endometriosis is a chronic gynecological disease defined by presence of
endometrium-like tissue outside the uterus, which induces a chronic,
inflammatory reaction. The endometrium is a layer of mucous tissue, which lines
the uterus cavity and undergoes hormone-dependent changes during the menstrual
cycle. Endometriosis is a common disease among women of reproductive age. The
prevalence is estimated to be around 5-10% in women of childbearing age. Lower
abdominal and pelvic pain, cramping menstrual pains (dysmenorrhea), painful
sexual intercourse (dyspareunia) and infertility are well recognized symptoms
of endometriosis.
About Bayer
The Bayer Group is a global enterprise with core competencies in the fields of
health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary
of Bayer AG, 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,
Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business
operates under the name Bayer Schering Pharma AG. Bayer HealthCare's aim is to
discover and manufacture products that will improve human and animal health
worldwide. Find more information at www.bayerhealthcare.com.
About Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.
Its research and business activities are focused on the following areas:
Diagnostic Imaging, General Medicine, Specialty Medicine and Women's
Healthcare. With innovative products, Bayer Schering Pharma aims for leading
positions in specialized markets worldwide. Using new ideas, Bayer Schering
Pharma aims to make a contribution to medical progress and strives to improve
the quality of life. Find more information at www.bayerscheringpharma.de.
