Combidex®

Combidex® (generic name: ferumoxtran-10) is an investigational functional molecular imaging agent consisting of iron oxide nanoparticles for use in conjunction with magnetic resonance imaging (MRI) to aid in the differentiation of cancerous from normal lymph nodes.

In March 2005, we received an approvable letter from the U.S. Food and Drug Administration (FDA), with respect to Combidex®, subject to certain conditions. In December 2006, Guerbet S.A, or Guerbet, our partner, submitted a marketing authorization application, the European equivalent of an NDA, to the European Agency for the Evaluation of Medicinal Products, or the EMEA, seeking approval for Combidex under the tradename Sinerem® as an aid in the differentiation of lymph nodes in patients with pelvic cancers, including prostate, bladder, cervical and uterine cancer. In December 2007 Guerbet withdrew its EMEA application for Sinerem after the Committee for Medicinal Products for Human Use indicated that the data submitted by Guerbet did not provide sufficient statistical demonstration of the efficacy of Sinerem. Based on our review of the data from the Guerbet trial, it appears unlikely that the data from that trial will be sufficient to address the concerns raised by the FDA, which means we may have to sponsor one or more additional clinical trials to obtain approval for Combidex. We cannot at this time predict with certainty the timing or likelihood of our ability to satisfy the conditions specified by the FDA for approval of Combidex, if at all. We do not currently have plans to sponsor additional clinical studies of Combidex.