GUERBET SUBMITS APPLICATION FOR COMBIDEX TO EMEA

Advanced Magnetics announced that its European partner, Guerbet, has submitted a marketing authorization application for Combidex to the European Medicines Agency (EMEA). Combidex is Advanced Magnetics' investigational functional molecular imaging agent for use in conjunction with magnetic resonance imaging (MRI) to aid the differentiation of normal from metastatic lymph nodes.

Guerbet is seeking approval for Combidex under the trade name Sinerem. The company plans to launch the product in Germany and the UK during the second quarter of 2008. Guerbet also said it will file an application for Sinerem in Switzerland before the end of 2006.

In March 2005 an FDA's Oncologic Drugs Advisory Committee voted 15-4 against approving the imaging agent, citing insufficient clinical data. The panel agreed there is not enough data to support a board indication for use of Combidex to differentiate metastatic from non-metastatic lymph nodes across all cancer types. The FDA then issued an approvable letter for the Combidex new drug application.