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


To: Brian Moore who wrote (15367)2/19/1998 4:00:00 PM
From: Hippieslayer  Respond to of 32384
 
Yes, Panretin gel and capsules for KS which are en route for FDA submission for approval, if I'm not mistaken. Are there other drugs that are approved that have shown the efficiency and ease of use of Panretin with out significant side affects?



To: Brian Moore who wrote (15367)2/19/1998 4:12:00 PM
From: Henry Niman  Read Replies (1) | Respond to of 32384
 
Brian, Panretin topical is slated for NDA filing this quarter for KS. There are no FDA approved topical treatments for KS. Panretin has generated statistically significant results in all 3 trials (1 Phase I/II and 2 Phase III). The International Phase III trial was halted after looking at the interim data because it would have been unethical to continue giving 1/2 of the patients a placebo.

LGND is also conducting Phase III trials on Targretin. There is no topical treatment for CTCL. One poster was so excited about the results of Targretin treatment of his mother's CTCL, that he called it a miracle drug. The Phase I/II data was strong for oral and topical. Phase III should be finished in a few months with 2 NDA filings around the end of the year. Most analysts (all on paper?) indicate that the likelihood of all three NDA's resulting in FDA approval is high (80-90% range).

The oral formulations (oral Panretin for KS is slated for NDA filing next year) could generate significant off-label sales, especially for cancer.