BERLIN, October 20 /PRNewswire-FirstCall/ -- On the occasion of the United European Gastroenterology Week (UEGW) in Copenhagen, Denmark, Schering AG, Germany announced plans to initiate an additional phase 3 trial to evaluate sargramostim as a potential new treatment option for Crohn’s disease.
The trial is being initiated as a result of a patient recruitment delay faced by NOVEL 3, one of two ongoing Phase 3 studies of sargramostim in Crohn’s disease, and aims to achieve finalization of the phase 3 program as soon as possible.
Patient enrollment for NOVEL 4, the other pivotal phase 3 clinical trial of sargramostim in Crohn’s disease, recently completed enrollment of more than 240 patients ahead of schedule. Data from NOVEL 4 are expected to be available in 2006.
These trials are part of N.O.V.E.L.(TM) (New Opportunities to Verify Evolving Logic in Crohn’s disease), a comprehensive, worldwide clinical trials program supported by Schering AG for the ongoing development of sargramostim as a potential new treatment for Crohn’s disease.
“Sargramostim provides a unique mechanism of action in Crohn’s disease. We are strongly committed to continuing the phase 3 program with this compound,” said Marc Rubin, MD, member of the Executive Board of Schering AG, responsible for Development. “We look forward to initiating this additional phase 3 trial, which will broaden the patient population and generate additional safety and efficacy data in support of making sargramostim available to Crohn’s patients worldwide.”
Schering currently anticipates to submit sargramostim in the indication of Crohn’s disease by the end of 2007, beginning of 2008.
About Schering
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 Schering AG 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: Dr. Claudia Schmitt, T: +49-30-468-158-05, claudia.schmitt@schering.de
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.
Schering AG
CONTACT: Your contacts at Schering AG Corporate Communication: MediaRelations: 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: Dr. Claudia Schmitt, T:+49-30-468-158-05, claudia.schmitt@schering.de
