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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: celeryroot.com who wrote (22471)	6/18/1998 11:50:00 AM
From: tonyt	Respond to of 32384

Headline: (UPDATE) FDA Rejects Seragen Product For Lymphoma, Cites Deficiencies ======================================================= 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. Copyright (c) 1998 Dow Jones & Company, Inc. All Rights Reserved.

To: celeryroot.com who wrote (22471)	6/18/1998 12:12:00 PM
From: Harold Engstrom	Read Replies (1) \| Respond to of 32384

Yes. I have seen requests for clarification, but anything unclear enough to require declared inaction is very unusual.

To: celeryroot.com who wrote (22471)	6/18/1998 3:02:00 PM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

I did get through to LGND IR today and they still consider ONTAK "on track" with a 3Q approval and a 4Q launch anticipated. The "deficiencies" are well known to SRGN and they have been in talks with the FDA for some time. The announcement last night was due to the six month expiration date and a similar situation happened with IDPH (and their drug was approved after the deficiencies were removed). The new 6 month rule went into effect "about 9 months ago" according to LGND IR.