Ligand Pharmaceuticals Inc. (LGND) Release: FDA Approves New Fill/Finish Facility For ONTAK(R); Includes Capability For Second-Generation Product Formulation
10/19/2005 5:09:25 PM
SAN DIEGO--(BUSINESS WIRE)--July 5, 2005--Ligand Pharmaceuticals Incorporated (Nasdaq:LGNDE) announced today 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."
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