FDA Approves New Fill/Finish Facility For ONTAK

SanDiego, CA - Ligand Pharmaceuticals Incorporated announced recently that the company has received FDA approval for the fill/finish of Ligand's cancer drug ONTAK(R) (denileukin diftitox), at the Hollister-Stier Laboratories facility located in Spokane, Washington. ONTAK bulk drug substance for fill/finish and labeling continues to be manufactured at the Cambrex Bio Science facility located in Hopkinton, Massachusetts.

"We submitted the manufacturing supplement for this facility in December 2004 following technology transfer and worked closely with Hollister-Stier and the FDA to obtain this facility approval," said Taylor Crouch, senior vice president, operations and president, international. "We are pleased with the rapid approval and the beginning of this new relationship with a seasoned manufacturing partner for ONTAK, which is our largest-selling oncology product. We expect demand for ONTAK to continue growing, and look forward to working closely with Hollister-Stier on fill/finish of the current formulation of ONTAK and on our second-generation formulation."

The fill/finish work will be done under a contract which was announced in 2004 following completion of our work with our previous fill/finish supplier in 2003. The initial term of the agreement is five years, with a provision for automatic renewal extension in additional two-year increments. Financial terms of the contract were not disclosed.

SOURCE: Ligand Pharmaceuticals Incorporated