CYBERKEN, Hope this doesn't scare you away, but LGND did have some additional good news. New trials with ONTAK for non-Hodgkin's Lymphoma, and Targretin for Breast Cancer (probably Tamoxifen resistant) should be announced this quarter or the beginning of Oct. Clinicals on Panretin and Targretin for psoriasis should also be announced fairly soon (about the same time frame).
Targretin is effective for psoriasis and diabetes, but LGND is currently scaling the dose back to keep the efficiency without elevated triclycerides. Although triglycerides had been associated with retinoids, it seems that there is some conversion of rexinoids to retinoids in vivo, so there are problems associated with high doses (the side effects are acceptable for treating cancer patients, but not acceptable for chronic diseases like psoriasis and diabetes).
LGND is running the European trials and LLY is using the data to determine when and how to start US trials, and they are not saying anything (and don't want LGND to say anything either).
LGND could get significant milestone payments from AHP, PFE, and LLY this year and possibly ABT and GLX. AHP should be introducing their SERM for breast cancer soon. LGND may not get the LGD1331 IND filed until the beginning of next year.
Phase II trails for Prostate, Ovarian, and Lung are taking longer than expected (I think that all three are farmed out) and some data may be out by the end of the year.
NDAs for oral and topical Targretin for CTCL should be filed around the end of this year or beginning of next. ONTAK approval should not prevent Targretin from getting an expedited review because the drugs target different patient populations and may have benefit when used in combination.
Panretin NDA (next year sometime) will probably be for KS before APL. APL trials are primarily in Europe now.
LGND's upcoming road show will include Bear Stearns, BARS, and Oppenheimer.
Overall there were not too many surprises. Some of the clinicals are sliding a bit, but there are quite a few that are wrapping up. I couldn't tell if drift will hit earnings. I would call the 2Q financials iffy, with improvement after that.
For profitability to be achieve next year, all revenue generators to not have to hit. Assuming ONTAK and topical Panretin approvals, LGND can achieve profitability with additional income from other products (oral and topical Targretin) or additional milestones (from just about everyone). |
