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AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that its European partner, Guerbet S.A. of France, has withdrawn its European marketing authorization application (MAA) for Sinerem™ (trade name Combidex® in the U.S.).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.
Sinerem™/Combidex is AMAG Pharmaceutical's investigational functional molecular imaging agent consisting of superparamagnetic iron oxide nanoparticles for use in conjunction with magnetic resonance imaging (MRI) as an aid in the differentiation of cancerous from normal lymph nodes. AMAG Pharmaceuticals, Inc. has granted Guerbet an exclusive right to manufacture and sell Sinerem™ in certain countries in Europe and other parts of the world.
In March 2005, AMAG Pharmaceuticals, Inc. received an approvable letter from the U.S. Food and Drug Administration (FDA) with respect to Combidex subject to certain conditions. The company is working to determine whether additional data from a Phase III study sponsored by Guerbet in Europe in patients with pelvic cancers, including prostate, bladder, cervical and uterine cancer, together with other additional analyses and new information to be provided to the FDA will address the concerns raised in the March 2005 approvable letter. Based on a preliminary review of the data from the Guerbet trial, it remains highly uncertain whether the data from that trial will be sufficient to address the concerns raised by the FDA, and until the evaluation is complete and until the company meets with the FDA to discuss its intended response to the March 2005 approvable letter, the company cannot predict with certainty the timing or likelihood of its ability to satisfy the conditions specified by the FDA for approval of Combidex.
About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its proprietary nanoparticle technology for the development and commercialization of therapeutic iron compounds to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease.
Ferumoxytol, the company’s key product candidate, is being developed for use as an intravenous iron replacement therapeutic for the treatment of iron deficiency anemia in chronic kidney disease patients. The company has completed four Phase III clinical trials with fermuoxytol and has presented data on all four trials.
The company has two commercial products, Feridex I.V.® and GastroMARK®, both of which are imaging agents that are approved and marketed in the United States, Europe and other countries.
For more information about AMAG Pharmaceuticals, please visit our website at http://www.amagpharma.com, the content of which is not part of this press release.
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AMAG Pharmaceuticals, Inc.
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