Heres what WSJ Interactive had to say:
Dow Jones Newswires -- June 17, 1998
Seragen, Ligand Get FDA Complete
Review Letter For Ontak
Dow Jones Newswires
HOPKINTON, Mass. -- The Food and Drug Administration issued a
complete review letter for Seragen Inc.'s (SRGN) biologics license
application for its Ontak treatment of cutaneous T-cell lymphoma in adult
patients.
In a press release Wednesday, Seragen said the FDA 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 complete 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.
As reported May 11, Ligand Pharmaceuticals Inc. (LGND) definitively
agreed to acquire Seragen for $67 million in cash and stock, of which $37
million is contingent upon final regulatory approval of Ontak.
Seragen expects the merger close in the third or fourth quarter.
As reported June 2, an FDA expert advisory panel endorsed Ontak.
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