CAMBRIDGE, Mass.--(BUSINESS WIRE)--AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that its European partner, Guerbet S.A. of France, has withdrawn its European marketing authorization application (MAA) for Sinerem™ (trade name Combidex® in the U.S.). Guerbet submitted an MAA to the European Medicines Agency (EMEA) in November 2006 seeking marketing approval for Sinerem™ for the detection and characterization of metastatic lymph nodes in patients with pelvic cancer. According to Guerbet, the Committee for Medicinal Products for Human Use (CHMP) indicated that the Phase III data submitted by Guerbet does not provide sufficient statistical demonstration of the efficacy of Sinerem™. Guerbet stated that it plans to evaluate all possible options that would satisfy the EMEA’s requirements for the proposed indication.
