Appendicitis-Diagnosing Agent Is Withdrawn From the Market
FDA Presses Tyco Unit And Palatin to Take Action On NeutroSpec After Deaths
By WILLIAM M. BULKELEY
Staff Reporter of THE WALL STREET JOURNAL
December 20, 2005; Page D6
The Food and Drug Administration pushed Palatin Technologies Inc. and a unit of Tyco International Ltd. to withdraw from the market an imaging agent used in diagnosing appendicitis, after the product was linked to two deaths and 20 other severe reactions.
The FDA said some patients given the agent, NeutroSpec, appeared to have allergic reactions to it. An agent is a chemical used to enhance the images produced by scanning equipment -- in this case a gamma camera.
The FDA said the harmful events occurred within minutes after the administration of NeutroSpec, which was used to detect clumps of white blood cells that signal infections such as appendicitis.
"These reactions led to the death of two patients, and to cardiopulmonary failure, central nervous-system reactions and infusion reactions in other patients," the FDA said in a statement.
Palatin said the deaths and other problems had occurred in patients with severe heart disease when NeutroSpec was administered for "off label" uses such as diagnosing bone disease. Off-label usage, which is legal, refers to the practice of using an FDA-approved product for conditions other than those they were approved to treat.
Palatin said the two companies had alternatively proposed to the FDA a more restrictive label for the chemical, including warnings, but the agency requested they suspend the sales. Palatin said its decision was "voluntary."
Carl Spana, president of Palatin, which is based in Cranbury, N.J., said in a Web call with investors that in the past, it would have been typical for the FDA to take less-drastic action. He said the "external environment," with litigation over heart attacks and a product withdrawal of Merck & Co.'s Vioxx, may have been a factor in the FDA decision. "Since it's a diagnostic rather than a therapeutic, their level of risk tolerance is very low," he added.
NeutroSpec is one of the few products on the market from Palatin, a biotech company developing drugs designed to treat male and female sexual dysfunction. Since NeutroSpec went on sale in September 2004, it has been administered to about 11,000 patients and generated $9.8 million in sales and $2.5 million in royalty payments. In the fiscal year ended June 30, Palatin reported a net loss of $14.4 million on revenue of $18 million.
Tyco's Healthcare Mallinckrodt unit markets and distributes the product under an agreement with Palatin. Last summer, Tyco estimated the total appendicitis-imaging market at $70 million to $100 million. NeutroSpec had been approved by the FDA for use in imaging in cases of "equivocal appendicitis," or when initial diagnosis wasn't clear.
At 4 p.m., Palatin stock was down 60 cents, or 17%, to $2.85 in American Stock Exchange composite trading, and Tyco stock was up eight cents to $28.46 in New York Stock Exchange composite trading.
Mr. Spana said in the conference call that early next year Palatin and Tyco plan to present again the original clinical-trial data to the FDA. At that time they will also propose more-restrictive labeling. He said the companies hope the product will be approved for sales at that time. "There's a good possibility of us being able to reintroduce the product to the marketplace," he said.
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