LeuTech partners amend marketing agreement

The $10 million Mallinckrodt agreed in 1999 to pay Palatin Technologies on receipt of FDA approval for its infection-imaging agent LeuTech and attainment of certain sales goals is off the table. A revised agreement between the two companies, announced May 15, ties the $10 million to a new milestone schedule that has adjusted payments based on LeuTech's anticipated marketing approval and future sales. Mallinckrodt has committed to paying an additional $3.2 million to defray Palatin's expenses, roughly half the expected cost of completing the FDA review process. The money depends on the company meeting certain milestones, although LeuTech was scheduled to receive the first installment of $800,000 before the end of May.

The FDA has raised questions about the initial Biologics License Application for the agent. Palatin executives expect to file an amended application in the second half of this year and hope to gain marketing approval from the FDA in the first half of 2003.

The radiolabeled monoclonal antibody, which binds to white blood cells at the site of an infection, may be especially useful in the diagnosis of equivocal appendicitis. Approximately 320,000 appendectomies are performed annually, according to Palatin. Of these, an estimated 250,000 are equivocal. Of the performed surgeries, a normal appendix is found in about 20% of procedures.