Here's what Dow Jones had to say:
HOPKINTON, Mass. -(Dow Jones)- The Food and Drug Administration
Wednesday rejected Seragen Inc.'s biologics license application for its Ontak treatment of non-Hodgkin's lymphoma.
Seragen (SRGN) said the FDA complete review letter identified certain deficiencies in the application related to safety, efficacy, manufacturing and product characterization.
Under FDA procedures, the review clock is suspended upon issuance of the review letter and is not reactivated until Seragen addresses all deficiencies.
Seragen said it plans to work closely with the FDA to address the
issues outlined in the letter.
The review letter received by Seragen fulfills the FDA's commitment
under the Prescription Drug User Fee Act to a six-month review of Seragen's biologics license application for Ontak, which was designated for priority review.
The application was submitted Dec. 9, 1997, and the complete review
letter is dated June 9.
Last month, Ligand Pharmaceuticals Inc. (LGND) agreed to acquire
Seragen for $67 million in cash and stock, of which $37 million is contingent upon final regulatory approval of Ontak.
Earlier this month, an FDA expert advisory panel endorsed Ontak,
finding that in clinical tests Ontak was effective in treating cutaneous T-cell lymphoma, a disease that affects between 5,000 and 10,000 people in the U.S.
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