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Biotech / Medical : Ligand (LGND) Breakout!
LGND 197.37-0.3%Dec 23 3:59 PM EST

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To: Andrew H who wrote (3785)6/27/1997 7:13:00 AM
From: Henry Niman   of 32384
 
Some have expressed concern that LGND will become the next LIPO insteads of the next AMGN. I have briefly addressed that concern elsewhere:
LGND has many initial trials, but only a few Phase III trials. The most advanced pivotol Phase III trial is Panretin topical for KS. The phase II data is not quite as good as phase II for Targretin for CTCL, but it was statistically significant, even when patients began treating their control (untreated) lesions with the drug.
The LIPO phase II trial was a joke (and a rather cruel one to shareholders). They had 25 patients divided into 3 groups so they based the decision to move to phase III on 8 patients. When numbers get that small, especially for a heterogeneous indication, pure chance can generate differences (although they are NOT statistically significant), which appears to be the case for LIPO (although there may be a benefit to a select population but small
numbers will not reliably identify such a population).
LGND's phase II trial involved over 100 patients (and each received the drug) and the final data was very similar to the interim data. The interim data for the Phase III trial indicates that the response to the carrier gel (placebo) is at or below 10% (as expected). The FDA has agreed that a delta of 15% is all that is required for approval.
The phase II data for Targretin is even more impressive. The longer the patient population is on the drug, the higher the response rate (up to 43% for the phase II trial). LGND again uses larger numbers and the phase II results ARE statistically significant.
LGND has a seasoned management team and a huge pipeline. I expect the phase III trials to be on the most promising drugs, and these are the trials that will be discussed in press releases.
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