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

To: John O'Neill who wrote (19337)	4/20/1998 5:41:00 AM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

JO, The time in the clinic can vary quite a bit, depending on the endpoint. In an effort to speed up trials for some life threatening diseases like cancer, the FDA has agreed to use endpoints such as tumor shrinkage instead of extension of lifetime as an end point. The shrinkage usually occurs relatively early (weeks or months), while extension of life can take years or decades. After an IND is filed, a safety (Phase I) test is used on a smaller population. In LGND's case most of the patients have advanced cancer, so this phase can be relatively short (6-12 months). Phase II is also on a relatively small population and it is used to identify the optimal concentration of the compound. This can take 1-2 years. The pivotal Phase III trial uses a larger number of patients treated at the optimal dose and it can take another 1-3 years. Thus the trial portion could be as little as 2 1/2 years or as long as 6 years. It really depends on how many patients are required to show efficacy as well as how long it takes to recruit patients and see the primary end point. For Targretin, LGND essentially owns the compound for cancer and dermatology (with a small royalty to AGN) and that is where the drug would initially be sold (in a Ligand package by Ligand's sales force). When approved for metabolic diseases such as type II diabetes, it will probably be at a lower concentration and could be sold under a different name. Sale for that indication will be controlled by LLY (through their sales force or a licensee) and Ligand will get a double digit royalty (which could increase by 1 1/2% if LGND doesn't take the LLY drug and chooses Targretin as the compound to apply the increased royalty rate to). I think that LGND expects Targretin sales for diabetes to begin around 2001 or 2002.