Palatin Technologies, Cranbury, NJ, Feb. 16 (DDMAC).

DDMAC took issue with four professional digital billboard exhibit panels, one multi-product exhibit panel and one product-specific exhibit panel regarding Palatin's NeutroSpec [Kit for the Preparation of Technetium (99m Tc) fanolesomab]--all of which were displayed at the American Pharmaceutical Assn's 2005 Meeting in Orlando, FL--because the promotional items minimized the risks of NeutroSpec, while overstating the benefits of the product.

The same letter was sent to Mallinckrodt, Inc., Hazelwood, MO, which markets NeutroSpec on behalf of Palatin, after DDMAC reviewed a product video for NeutroSpec found on a website administered by Mallinckrodt. The video has since been removed, but it was posted on the website until at least October 2005.

According to the Description section of the approved PI, NeutroSpec is an in vivo diagnostic radiopharmaceutical that can be visualized by nuclear medicine instrumentation. It is indicated for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older.

The PI also lists several important contraindications, warnings and precautions, including that NeutroSpec should not be administered to patients who are hypersensitive to any murine proteins or other component of the product because hypersensitivity reactions, including anaphylaxis, can occur.

Moreover, the PI cautions that NeutroSpec has not been studied in repeat administration to patients. Lastly, the PI recommends that patients be told that to minimize the radiation-absorbed dose to the bladder, adequate hydration should be encouraged to permit frequent voiding during the first few hours after injection.

According to DDMAC, the digital billboard panels, the exhibit panels and the product video are misleading because they failed to provide information about the most serious and frequently occurring risks of NeutroSpec, while emphasizing numerous claims about the effectiveness of the product, such as, "rapid, safe, and simple," and "[NeutroSpec is] an in vivo imaging agent that radiolabels white blood cells and myeloid precursors, and is indicated for equivocal appendicitis in patients 5 years or older."

The agency felt that the digital billboards and exhibit panels overstated the efficacy of NeutroSpec through numerous presentations of the claim "simple" and "It's easy to do," because the NeutroSpec is an involved process actually requiring a nine-step reconstitution procedure and a seven-step radiochemical purity test on the prepared radiolabeled agent.

The product video included claims, such as, "NeutroSpec is a white blood cell antibody directed specifically against the neutrophils, and the neutrophils are the white blood cells that come out of the bone marrow that specifically help fight acute infections" and "by the end of the study they [the participating surgeons] would not do a patient without a NeutroSpec study. It was that valuable to them."

FDA also objected to Palatin's web video [since removed], which contained an overstatement of efficacy of NeutroSpec to detect appendicitis. Specifically, the product video claimed:

"We ended up with a 98% sensitivity for Neutro-Spec to detect appendicitis, and the specificity was approximately 80%."

DDMAC said it is not aware of substantial evidence or substantial clinical experience demonstrating a 98% sensitivity for NeutroSpec or that NeutroSpec can definitively and independently detect appendicitis in patients. F-B, Lab, Web; Doc. 13735W