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( PTN ) FDA Approves NeutroSpec(TM) Imaging Agent to Help Detect Difficult-to-Diagnose Cases of Appendicitis
Tuesday July 6, 8:25 am ET
Provides Rapid, Safe, And Simple Diagnosis Of Appendicitis


ST. LOUIS, July 6 /PRNewswire/ -- Mallinckrodt, a business unit of Tyco Healthcare, announced today that the company and its strategic collaboration partner, Palatin Technologies, Inc., Cranbury, N.J., received approval from the U.S. Food & Drug Administration (FDA) to market and distribute NeutroSpec, a new imaging agent to help diagnose cases of appendicitis in patients 5 years and older with atypical symptoms. NeutroSpec was formerly referred to as LeuTech® in clinical trials and articles.
NeutroSpec enables physicians to rapidly diagnose appendicitis in cases without straightforward symptoms, eliminating delays and risks often associated with other imaging agents and modalities. Ninety percent of the positive appendicitis cases in the NeutroSpec Phase 3 clinical trial were diagnosed within one hour. (1)

Frederick Weiland, M.D., FACNP, co-director of Nuclear Medicine at Sutter Roseville Medical Center, Sacramento, Calif, noted that about half of the 700,000 patients in the United States with suspected appendicitis each year lack typical symptoms, such as pain and tenderness in the right lower abdomen, fever, nausea, and elevated white blood cell count.

"There are many causes of abdominal pain, and it can be difficult to differentiate appendicitis from other causes," Dr. Weiland stated. "In addition, other non-invasive tests to diagnose appendicitis, such as spiral CT with contrast, are not available everywhere and can be difficult to perform and interpret. If a diagnosis of appendicitis is missed, there can be significant medical consequences such as perforation of the appendix and peritonitis (acute inflammation of the membrane lining of the abdominal cavity)."

Dr. Weiland added that 10 to 20 percent of all appendix surgeries, or appendectomies, are unnecessary because the appendix turns out to be normal. By helping physicians rapidly and accurately diagnose appendicitis, NeutroSpec has the potential to lower healthcare costs and shorten patient recovery by reducing unnecessary surgery.

He also indicates that, "NeutroSpec is easy to read. The vast experience of physicians familiar with reading other Tc 99m based infection imaging agents will find the learning curve to be minimal. A NeutroSpec procedure can be successfully executed on any gamma camera and does not require high tech imaging equipment or computer support."

Benefits of NeutroSpec include:
-- Rapid diagnosis. Ninety-eight percent of the positive appendicitis
cases in the NeutroSpec Phase 3 clinical trial were diagnosed within
one hour after injection. Other radiopharmaceuticals can take hours
longer.
-- Safety. No serious adverse reactions occurred with NeutroSpec during
the Phase 3 trial. The most frequently reported adverse reactions were
flushing (3.6 percent of patients) and shortness of breath (1.4
percent of patients). Unlike other imaging agents, NeutroSpec requires
no blood handling, which greatly reduces potential cross-contamination
issues.
-- Ease of use. NeutroSpec is provided in a quick and easy prep kit. No
additional equipment is needed and, in most cases, NeutroSpec will be
available as a unit dose injection.


NeutroSpec is a radiolabeled monoclonal antibody -- Technetium (99m Tc) fanolesomab -- that binds to white blood cells, which localize at infection sites. When injected into a patient's bloodstream, NeutroSpec radiolabels white blood cells and myeloid precursors with a radioactive tracer. This enables a physician to quickly locate the site of infection with images generated by a gamma camera in a hospital's Nuclear Medicine department.

NeutroSpec is different because it is an in vivo product -- it radiolabels white blood cells inside the body -- while other white blood cell imaging agents are ex vivo products. With ex vivo white blood cell radiolabeling, a patient's blood is withdrawn, transported to a radiopharmacy, labeled with a radioactive tracer, returned to the hospital and re-injected in the patient. This takes far longer and poses potential blood-handling safety risks.

While NeutroSpec is currently approved for use only in detecting difficult-to-diagnose appendicitis, Phase 2 studies using NeutroSpec to diagnose osteomyelitis, or bone infection, have been conducted. The results have been published in The Journal of Foot & Ankle Surgery in January 2003 and in Radiology in June 2002. Additional Phase 2 studies are underway for the imaging and detection of other infections, such as fever of unknown origin, post-surgical abscesses, and inflammatory bowel disease.

"We are excited about improving the current standard of care for difficult-to-diagnose cases of appendicitis. Using NeutroSpec will assist in providing more accurate diagnoses, decreasing unnecessary surgeries and reducing the risk of perforation," said Steve Hanley, president, Mallinckrodt Imaging. "This is consistent with our mission to provide state-of-the-art healthcare products that improve the diagnosis and treatment of disease."

Carl Spana, president and CEO, Palatin Technologies, said, "Palatin is very pleased that FDA has approved NeutroSpec for the indication of equivocal appendicitis in patients 5 years of age and older. This approval is not only a significant milestone for both Mallincrockdt and Palatin Technologies but also a significant development for the nuclear medicine community. Palatin Technologies looks forward to working with Mallincrockdt to effectively launch NeutroSpec."

Mallinckrodt and Palatin entered into an agreement in 1999 for Mallinckrodt to exclusively market and distribute NeutroSpec throughout the world, except in Europe, through its distribution center in Maryland Heights, MO and network of U.S. radiopharmacies.

About Mallinckrodt

Mallinckrodt, a business unit of Tyco Healthcare, is a leading global provider of specialty healthcare products in the areas of diagnostic imaging, respiratory care, and pain relief. Mallinckrodt products contribute to patient care in every type of healthcare setting. Learn more about Mallinckrodt by visiting the company's web site at www.mallinckrodt.com or www.tycohealthcare.com.

About Palatin Technologies, Inc.

Palatin Technologies, Inc. (Amex: PTN - News) is a biopharmaceutical company focused on discovering and developing melanocortin (MC)-based therapeutics. NeutroSpec(TM), the Company's proprietary radiolabeled monoclonal antibody product for imaging and diagnosing infections, has been approved by the FDA as an imaging agent for the diagnosis of equivocal appendicitis. NeutroSpec is marketed and distributed by Palatin's strategic partner, Mallinckrodt, a business unit of Tyco Healthcare. The company is currently conducting clinical trials with its lead drug PT-141, an MC receptor agonist, for the treatment of male and female sexual dysfunction. Palatin's patented drug discovery platform, MIDAS(TM), streamlines the drug design process with an efficient approach to identify lead compounds from protein targets for drugs. For further information, visit the Palatin web site at http://www.palatin.com.

(1) Rypins E., Kipper S. Scintigraphic Determination of Equivocal
Appendicitis. The American Surgeon, September 2000, Vol 66, No. 9:
891-895




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Source: Tyco Healthcare