FDA Issues Approvable Letter For EPIX Pharmaceuticals Blood-Pool Contrast Agent Vasovist(TM); US Regulators Want Another Trial
BERLIN, Germany, November 23 /PRNewswire-FirstCall/ -- Schering AG, Germany (FSE: SCH, NYSE: SHR) announced today that its development partner, EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX - News), received an approvable letter from the U.S. Food and Drug Administration (FDA) for Vasovist(TM) (gadofosveset trisodium).
In the letter, the FDA indicated that at least one additional clinical trial, and a re-read of images obtained in previously completed Phase III trials, will be necessary before the agency could approve Vasovist. No safety or manufacturing issues were raised in the approvable letter.
In October 2005, Vasovist was approved in all EU member states, making it the first in a new class of blood-pool contrast agents for magnetic resonance angiography (MRA) to diagnose vascular disease. Under the European labeling, Vasovist is indicated for visualization of abdominal or limb vessels in patients with known or suspected vascular disease such as stenosis or aneurysms.
Vasovist was co-developed under a strategic partnership with EPIX Pharmaceuticals. Schering AG has the global marketing rights for the product and will continue to support EPIX in their efforts to address the requests of the FDA.
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: +49-30-468-12-431, 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
Your contacts in the U.S.:
Media Relations: Heather Levis, T: +1-973-305-5313, heather_levis@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 AG