Draxis Health (DRAX)

Description - DRAXIMAGEÒ I-131 MIBG is used to treat neuroendocrine (cardinoid) tumours, adrenal tumors (neuroblastoma in children and phaechromocytoma) and on rare occasions it can be used to treat thyroid cancer.  Iobenguage is m-iodo-benzylguanidine (MIBG), a guanethidine derivative structurally resembling norepinephrine. There exists extensive literature reports that indicate that I-131 MIBG has been used over the last two decades as a therapeutic agent for the treatment of pheochromocytoma, paraganglioma, neuroblastoma, carcinoid, and medullar thyroid carcinoma.  The diagnostic use of I-131 MIBG is approved in Europe, the U.S. and Canada.  The therapeutic use of I-131 MIBG is approved in Europe but is investigational in the United States and Canada.  DRAXIMAGE manufactures the I-131 MIBG at its facility.

Regulatory Status - DRAXIMAGE will provide I-131 MIBG for two clinical trials approved by the FDA under a recently submitted Investigational New Drug (“IND”) application.  One trial is a Phase II study in which I-131 MIBG will be administered with intensive chemotherapy and autologous stem cell rescue for high-risk neuroblastoma patients.  The second trial is a Phase I study in which irinotecan and vincristine, two common chemotherapy agents, will be administered in combination with I-131 MIBG to determine safety and tolerability in patients with resistant/relapsed high-risk neuroblastoma.

Both clinical trials will be coordinated by a group of eleven children’s hospitals and two universities in the United States known as the New Advances in Neuroblastoma Therapy (NANT) consortium.  These two trials are continuations of earlier NANT studies.  They are expected to start in early 2007.  NANT member institutions are:

·                                          C.S. Mott Children’s Hospital, University of Michigan — Ann Arbor, MI

·                                          Children’s Healthcare of Atlanta — Atlanta, Georgia

·                                          Children’s Hospital and Regional Medical Center — Seattle, WA

·                                          Children’s Hospital Boston, Dana-Farber Cancer Institute — Boston, MA

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·                                          Children’s Hospital Los Angeles — Los Angeles, CA

·                                          Children’s Hospital Medical Center — Cincinnati, OH

·                                          Children’s Hospital of Philadelphia — Philadelphia, PA

·                                          Children’s Memorial Hospital — Chicago, IL

·                                          Lucile Packard Children’s Hospital — Palo Alto, CA

·                                          Riley Hospital for Children, Indiana University — Indianapolis, IN

·                                          Texas Children’s Cancer Center, Baylor College of Medicine — Houston, TX

·                                          University of California, San Francisco — San Francisco, CA

·                                          University of Wisconsin Comprehensive Cancer Center — Madison, WI

Competing Therapeutic Products - We also believe that AZEDRAÔ, being developed by Molecular Insight Pharmaceuticals, Inc. (“MIPI”) may compete with our DRAXIMAGEÒ I-131 MIBG product under clinical development.  AZEDRAÔ has received Orphan Drug status and a Fast Track designation by the FDA.  According to information set forth in its website, MIPI is conducting a Phase I clinical trial with AZEDRAÔ in adults at Duke University.  The initial target market for AZEDRAÔ is the treatment of metastatic neuroendocrine tumours such as pheochromocytoma, carcinoid and neuroblastoma that are not amenable to treatment with surgery or conventional chemotherapy.  Metastatic tumours are turmours that spread to other organs or parts of the body.