NeutroSpec® [Technetium (99m Tc) fanolesomab] is a radiodiagnostic agent consisting of a murine (mouse) IgM monoclonal monoclonal antibody and technetium, the radioactive component. NeutroSpec was approved in 2004 for use in the scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older.

NeutroSpec, upon intravenous injection into a patient, radiolabels white blood cells and myeloid precursors. NeutroSpec is directed against the carbohydrate moiety 3-fucosyl-N-acetyllactosamine that defines the cluster of differentiation 15 (CD15) antigen. The CD15 antigen is expressed on the surface of polymorphonuclear neutrophils (PMNs), eosinophils and monocytes.

On December 19, 2005, Palatin and the Mallinckrodt division of Covidien (sales and marketing partner) voluntarily suspended the sales, marketing and distribution of NeutroSpec and recalled all existing customer inventories. Palatin and Mallinckrodt acted at the request of the U.S. Food and Drug Administration (FDA). The decision to voluntarily suspend the sales, marketing and distribution of NeutroSpec followed the occurrence of several serious adverse events in patients with severe underlying cardiopulmonary compromise who received NeutroSpec for off-label uses. Palatin and the Mallinckrodt division of Covidien have notified physicians of these serious adverse events and informed them that use of NeutroSpec should be discontinued until further notice.

Below are some frequently-asked questions:

I am a healthcare provider who would like to report an adverse event that occurred in a patient following administration of NeutroSpec. How would I do that?

Any potential adverse events that have occurred in a patient receiving NeutroSpec should be reported to Palatin, or to the FDA’s MedWatch reporting system by telephone (1-800-FDA-1088), facsimile (1-800-FDA-0178), the MedWatch Web site at www.fda.gov/medwatch , or mailed to MedWatch (HF-2, 5600 Fishers Lane, Rockville, MD 20853-9787). The FDA will maintain close contact with Palatin Technologies during this process and issue further information as it becomes available.

How do I obtain recall and credit information for NeutroSpec kits that I am now not going to use?

Customers should call the Mallinckrodt division of Covidien at 1-888-744-1414 regarding these issues.

Will NeutroSpec ever be commercially available in the future and, if so, when?

The FDA has stated that they would convene an Advisory Panel in early 2006 to discuss NeutroSpec’s safety profile, potential risk management measures and additional clinical evidence that may be required for the market re-introduction of NeutroSpec. Palatin feels it is not prudent to issue any commercial projections for NeutroSpec until after these advisory committee proceedings are complete.