[ off topic? ]
Palatin's Chairman, Dr. John Prendergast, was Blume's coauthor on an article (Bridging Genomics and Drug Discovery: DGI's Surrogates in Phenotypic Analysis of Genomic Data Can Speed Drug Discovery Process) in the June 1 issue of Genetic Engineering News. I believe that the DGI patent claims would be quite valuable in Palatin's hands, thus the question mark above........
Monday July 10, 3:47 pm Eastern Time
Company Press Release
SOURCE: Palatin Technologies, Inc.
FDA Advisory Committee Finds Palatin Technologies'
LeuTech(R) Infection Imaging Agent Safe and
Effective in Unanimous Votes
BETHESDA, Md., July 10 /PRNewswire/ -- In two unanimous (9-0) votes, the U.S. Food and Drug Administration Medical
Imaging Drugs Advisory Committee (MIDAC) today determined that LeuTech is safe and effective for use in the diagnosis of
appendicitis in patients with equivocal signs and symptoms and that the data presented support the clinical utility of LeuTech in
managing these patients. LeuTech is a new radiopharmaceutical for imaging infection sites developed by Palatin Technologies
(Amex: PTN - news) of Princeton N.J.
The FDA will make its final decision on the Biologics License Application of LeuTech based on a full review of the application
and a review of the MIDAC recommendation. Palatin and FDA agreed that any remaining issues in the BLA can be resolved in
the next two to three months.
``We are extremely pleased with the outcome of the advisory committee's review of the LeuTech clinical data,'' said Charles L.
Putnam, Palatin's COO and executive vice president. ``We have collaborated closely with the FDA throughout the LeuTech
development and testing process and will continue to do so as we address any remaining issues.''
Nearly 500,000 patients in the United States present to emergency departments and physician offices each year with symptoms
of appendicitis. Approximately 250,000 of those cases are considered to be equivocal. Appendicitis is the most common cause
of acute abdominal pain requiring surgical intervention.
Phase III clinical trial results were presented by Samuel Kipper, M.D., Medical Director of Nuclear Medicine, Tri-City
Medical Center in Oceanside, Calif., and Assistant Clinical Professor of Radiology at the University of California, San Diego.
The Phase III trials included 203 patients in ten sites across the United States.
All patients in the Phase III trial presented to emergency departments with signs and symptoms of equivocal appendicitis. A
patient management plan (surgery, admit for observation, or discharge to home) was developed by the attending surgeon
before and after the intravenous administration of LeuTech in order to determine the impact of LeuTech on patient
management. According to the researchers, the probability of correctly diagnosing appendicitis was 6 to 13 times greater with
the addition of LeuTech to the diagnostic process.
LeuTech demonstrated a 91 percent sensitivity, which is the ability to detect disease when present, and 86 percent specificity,
as determined by site investigators. Also important, LeuTech demonstrated a negative predictive value of 96 percent --
meaning surgeons could confidently discharge patients with a negative scan rather than admit them into the hospital for
observation and additional tests.
The diagnostic efficacy of LeuTech was unchanged in a subgroup of 48 pediatric patients, and no serious or severe adverse
affects were reported. Finally, diagnostic images with LeuTech were achieved within eight minutes post-injection for 50 percent
of patients and within 47 minutes for 90 percent of patients.
In 1999, Palatin and Mallinckrodt (NYSE: MKG - news), one of the world's leading providers of nuclear medicine products,
entered into an agreement under which Mallinckrodt will market and distribute LeuTech exclusively throughout the world,
except in Europe for which negotiations are underway. While there can be no assurance of when and if the FDA will approve
LeuTech for the diagnosis of equivocal appendicitis, the companies believe that LeuTech could be approved by the end of this
year and be on the market in early 2001.
``LeuTech is one of the most exciting new radiopharmaceutical products to emerge in quite some time,'' said Bradley J. Fercho,
president of Mallinckrodt's Imaging Group. ``The clinical research has been well-received by the imaging community and
today's vote by the advisory panel is an important milestone. We are actively preparing for the launch of LeuTech in the United
States, once full FDA approval is received.''
Other LeuTech Clinical Trials
Palatin is also currently conducting multiple Phase II clinical trials with LeuTech to demonstrate that the agent is safe and
effective in diagnosing various other types of infections, such as osteomyelitis and ulcerative colitis . The Company believes that
these trials will lead to additional utility and indications for its LeuTech infection imaging agent
About Palatin
Palatin Technologies, Inc. is a development-stage medical technology company developing and commercializing pharmaceutical
products for diagnostic imaging and therapy based on its proprietary monoclonal antibody radiolabeling and enabling peptide
platform technologies. Palatin's product pipeline includes PT-141 a therapeutic for treating erectile dysfunction. For further
information visit the Palatin website at www.palatin.com.
For Palatin investor information, visit the Allen & Caron Inc website at www.allencaron.com.
About Mallinckrodt
Mallinckrodt Inc. is a global manufacturer and marketer of specialty medical products designed to sustain breathing, diagnose
disease and relieve pain. Named one of America's most admired medical products and equipment companies by Fortune
magazine, Mallinckrodt does business in more than 100 countries. In fiscal 1999, combined net sales were $2.6 billion for
Mallinckrodt's respiratory, imaging and pharmaceutical product lines. Based in St. Louis, Mo., Mallinckrodt's website address
is www.mallinckrodt.com.
Statements about the Companies' future expectations, including development and regulatory plans, and all other statements in
this document other than historical facts are ``forward-looking statements'' within the meaning of Section 27A of the Securities
Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation
Reform Act of 1995. The Companies intend that such forward-looking statements be subject to the safe harbors created
thereby. Since these statements involve risks and uncertainties and are subject to change at any time, the Companies' actual
results could differ materially from expected results.
SOURCE: Palatin Technologies, Inc. |
