BERLIN, Germany, September 29 /PRNewswire-FirstCall/ -- Schering AG, Germany (FSE: SCH , NYSE: SHR) announced today that the U.S. Food and Drug Administration (FDA) has approved Angeliq® to treat moderate to severe menopausal symptoms.
Angeliq® will be available in the U.S. by prescription in a preparation containing 0.5 mg drospirenone and 1 mg estradiol. Angeliq® is different from other available HRT in that it contains the anti-aldosterone progestin drospirenone. Anti-aldosterone activity has been shown to counter the excess water and sodium retention sometimes caused by estrogen. In addition, Angeliq® contains estradiol, the same estrogen produced by a woman's body prior to menopause.
"We have seen great success with our oral contraceptive Yasmin®, which also contains drospirenone. We look forward to offering Angeliq® to women in the U.S. as a new and unique option for treating menopause symptoms," said Philip Smits, M.D., Head of Gynecology&Andrology at Schering AG. "Angeliq® is already well accepted by women in Europe and we plan to launch it in the U.S. by mid-2006."
Additional information
Angeliq® quickly relieves the occurrence of vasomotor symptoms such as hot flashes and other symptoms of menopausal estrogen withdrawal, generally within four weeks of therapy initiation.
Angeliq® was studied in large-scale clinical trials involving 1,759 women that established the safety and efficacy in providing endometrial protection and an acceptable bleeding profile among post-menopausal women.
Schering AG is a research-based pharmaceutical company. Its activities are focused on four business areas: Gynecology&Andrology, Oncology, Diagnostic Imaging as well as Specialized Therapeutics for disabling diseases. As a global player with innovative products Schering AG aims for leading positions in specialized markets worldwide. With in-house R&D and supported by an excellent global network of external partners, Schering AG is securing a promising product pipeline. Using new ideas, Schering AG aims to make a recognized contribution to medical progress and strives to improve the quality of life: making medicine work This press release has been published by Corporate Communication of Schering AG, Berlin, Germany.
Your contacts at Corporate Communication: Media Relations: Oliver Renner , T: +49-30-468-124-31, oliver.renner@schering.de Investor Relations: Peter Vogt, T: +49-30-468-128-38, peter.vogt@schering.de Pharma Communication: Astrid Kranz, T: +49-30-468-120-57, astrid.kranz@schering.de Your contacts in the US: Media Relations: Kim Schillace, T:+1-973-487-2461, kimberly_schillace@berlex.com Investor Relations: Joanne Marion, T: +1-973-487-2164, joanne_marion@berlex.com Find additional information at: www.schering.de/eng Certain statements in this press release that are neither reported financial results nor other historical information are forward-looking statements, including but not limited to, statements that are predictions of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause actual results and Schering AG's plans and objectives to differ materially from those expressed or implied in the forward-looking statements. Certain factors that may cause such differences are discussed in our Form 20-F and Form 6-K reports filed with the U.S. Securities and Exchange Commission. Schering AG undertakes no obligation to update publicly or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise. Source: Schering Aktiengesellschaft
