By Brady Huggett
Palatin Technologies Inc. received a complete review letter from the FDA for its product LeuTech that, while saying clinical efficacy and safety data are complete, requested additional manufacturing and process data.
"We have no other issues outstanding on the safety and efficacy," said Stephen Wills, chief financial officer of Palatin. "We are extremely pleased with that aspect - the product is safe. But before we can get final approval, we need to address the manufacturing issues brought up by the FDA."
In July, LeuTech - Palatin's appendicitis imaging agent - was unanimously recommended for FDA approval by the Medical Imaging Drugs Advisory Committee for patients whose symptoms neither rule out appendicitis nor clearly indicate it. (See BioWorld Today, July 11, 2000, p. 1.)
LeuTech is a monoclonal antibody labeled with technetium that is injected intravenously. The antibody moves to infection sites in the body, showing up brightly on gamma cameras, and has been proved effective in quickly diagnosing body infections, particularly appendicitis. Palatin filed a biologics license application in November 1999. Mallinckrodt Inc., of St. Louis, has signed on to handle the marketing of LeuTech. (See BioWorld Today, April 27, 1999; Nov. 24, 1999; and May 17, 1999.)
Wills said the product itself isn't in question and the company believes it will handle the request quickly.
"We are confident there is nothing in the letter that can't be resolved," he said. "We are done with the hard stuff. There are certain parameters that have to be addressed, and they will be addressed, very quickly."
The letter only potentially pushes back the launch, said Wills, and the amount it might do so leaves the launch date undetermined.
"We have only just received this letter and we are still going through the review process. I can't say what we need yet, but it is specifically related to manufacturing issues," he said.
Palatin has LeuTech in trials for other indications. Wills said the positive aspect of any delay would be the progression of those studies by the time LeuTech is launched.
Palatin's stock (AMEX:PTN) closed at $5.50 Thursday, down 62.5 cents, or 10 percent.