Full Press Release Details
FOR RELEASE DECEMBER 19, 2005 AT 7:30 a.m. EST
| Contacts: | |
| For Palatin Technologies: | For Institutional Investors and Media: |
| Stephen T. Wills, CPA, MST | Carney Duntsch |
| EVP-Operations / Chief Financial Officer | Burns McClellan |
| (609) 495-2200 | (212) 213-0006 |
| info@palatin.com | cduntsch@burnsmc.com |
Technologies, Inc. Announces Voluntary Suspension of Sales, Marketing and Distribution of
CRANBURY, NJ December 19, 2005 Palatin Technologies,
Inc. (AMEX: PTN) announced today that, as a result of safety concerns recently raised in
connection with the use of NeutroSpec diagnostic imaging agent kits for the
preparation of Technetium (99m Tc) fanolesomab, identified during routine
pharmacovigilance, Palatin and Tyco Healthcare Mallinckrodt have decided to voluntarily
suspend the sales, marketing and distribution of NeutroSpec and recall all existing
customer inventories of this product. Palatin and Mallinckrodt acted at the request of the
U.S. Food and Drug Administration (FDA). NeutroSpec, the only diagnostic agent approved
for imaging equivocal appendicitis, was approved for marketing by the FDA on July 6, 2004.
The companies previously reported to
the FDA the occurrence of several serious adverse events, including two deaths, involving
patients with severe underlying cardiopulmonary compromise who received NeutroSpec for
off-label uses. As a result of these events, Palatin and Mallinckrodt proposed revised
labeling for NeutroSpec to the FDA. The companies also distributed a Dear Healthcare
Provider letter on November 30, 2005 to provide the medical community with information
about the safe use of NeutroSpec.
At a meeting with the FDA on December
15, the FDA informed the companies that it had reconsidered the risk/benefit assessment of
NeutroSpec and determined that the product should not be administered to patients,
until a further understanding and review of the relationship between NeutroSpec and
reported serious adverse events is complete. Although the companies believe that these
safety concerns could potentially be addressed in other ways, they have agreed to
voluntarily take the actions requested by the FDA. Palatin and Mallinckrodt will
immediately take steps to inform the medical community of this decision.
The FDA also stated that they would
convene an Advisory Panel early next year to discuss the use of NeutroSpec with additional
safeguards, and evidence needed to continue use of the product for equivocal appendicitis,
as well as plans for other indications, most notably being osteomyelitis.
Palatin and Mallinckrodt are
reviewing data and assessing approaches for understanding the relationship between
NeutroSpec use and the observed serious adverse events. No final decisions concerning
future activities involving NeutroSpec have been made by Palatin or Mallinckrodt.
Since it was introduced to the
marketplace in September 2004, NeutroSpec net sales to customers, through September 30,
2005, totaled $9.8 million, of which Palatin received royalty payments of $2.5 million and
product transfer sales of $2.5 million from its marketing partner, Tyco Healthcare
Mallinckrodt. For the quarter ended September 30, 2005, NeutroSpec net sales to customers
totaled $3.7 million, of which Palatin received royalty payments of $0.9 million and no
product transfer sales.
Palatin will hold a conference call
and webcast on December 19, 2005 at 9:00 a.m. EST to discuss this matter:
Schedule for the Press
Release & Conference Call/Webcast
| NeutroSpec Voluntary Recall Press Release | 12/19/05 at 7:30 a.m. EST | |
| Conference Call - Live | 12/19/05 at 9:00 a.m. EST | |
| Domestic Dial-In Number | 1-800-817-4887 | |
| International Dial-In Number | 1-913-981-5540 | |
| Confirmation Code | 5491527 | |
| Webcast Live | www.palatin.com |
NeutroSpec is Palatin s
proprietary radiolabeled monoclonal antibody imaging agent for the diagnosis of equivocal
appendicitis. NeutroSpec is marketed and distributed by Palatin s strategic
collaboration partner, Tyco Healthcare Mallinckrodt, a business unit of Tyco Healthcare.
NeutroSpec includes a technetium-labeled anti-CD 15 monoclonal antibody which selectively
binds to a type of white blood cell, neutrophils, involved in the immune response. When
injected into the blood stream, the antibody binds to neutrophils present at the infection
site, labeling these cells with a radioactive tracer. As a result, physicians can rapidly
image and detect infection using a gamma camera, a common piece of hospital equipment that
records radioactivity.
Palatin Technologies, Inc. is a
biopharmaceutical company developing melanocortin-based therapeutics. The Company has a
pipeline of product candidates in development. The Company s internal research and
development capabilities, anchored by its proprietary MIDAS technology, are fueling
product development. Palatin s strategy is to develop products and then form
marketing collaborations with industry leaders in order to maximize their commercial
potential. To date, the Company has formed partnerships with Tyco Healthcare Mallinckrodt
and King Pharmaceuticals. For additional information regarding Palatin, please visit
Palatin Technologies website at http://www.palatin.com.
Statements about the
Company s 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 Company intends that such forward-looking
statements be subject to the safe harbors created thereby. Palatin s actual results
may differ materially from its historical results of operations and those discussed in the
forward-looking statements for various reasons, including, but not limited to the
Company s ability to carry out its business plan, successful development and
commercial acceptance of its products, ability to fund development of its technology, the
risk that products may not result from development activities, protection of its
intellectual property, ability to establish and successfully complete clinical trials for
product approval, need for regulatory approvals, dependence on its partners for
development of certain projects, and other factors discussed in the Company s
periodic filings with the Securities and Exchange Commission. The Company is not
responsible for updating for events that occur after the date on this press release.