From everything I have read, it appears both thelin (ency) and amb... (gild/myog) are superior to tracleer. And amb... is superior to thelin. Amb... appears to have best efficacy (hard to really tell since you CANNOT compare across trials) but no head to head data against anyone. It also would appear to have best side effect profile with limited effect on liver function (but they seem to have used a methodology which is much more aggressive than the other two but apparently this did not stop FDA from accepting the application). They also have fast track, which does not necessarily increase odds of approval - simply means FDA thinks more treatments are needed for this indication.
Thelin appears equivalent on efficacy and slightly better on safety to tracleer. On safety, it would appear much safer on liver function (1/4 or so events of raised levels vs. tracleer and close to placebo - amb... claims 0% vs. thelin 3% but again methodologies are different with amb.. needing 2 raised measurements in a row. On other side effects, thelin has drug-drug interaction issues with warfarin (common drug in patient group) while tracleer does not. Tracleer appears to have issues with drug-drug on revatio (Viagra). Thelin was run in head to head trials vs. tracleer and was as above.
Based on the above, I would think you were correct in your assessment except I would not expext no post-marketing studies. Problem is that there appears to be an issue with FDA and NO ONE knows why. Buzz of medical community by the way seems to be that both will be approved even given these facts. Thelin is basically approved globally except US and Asia at this point (Canada, Europe, Australia, ...). Database of users up over 1000 vs. 500 or so for amb...
Buzz of analyst community seems to be GILD approved no problem and thelin may or may not be approved. For the analysts (except Punk), it does not really matter. They expect GILD to dominate new patients with share trends on order of 40/40/20 for tracleer (entrenched share, why change if not having side effects and having efficacy), amb..., and then thelin. I have seen numbers as skewed as 20-30/50-60/10-20. Even Punk is something like 20/45/35 if memory is right. Remember Viagra vs. Cialis - usage comes down to several factors including label, trial results, real world results, marketing, entrenched bases. Viagra still outsells Cialis 2-1 despite efficacy differences (shorter acting) and perhaps more safety issues. Analysts BELIEVE in amb.. superiority and GILD marketing might along with tracleer entrenched base and its owner's (Actelion) marketing might in this space. They view Given and company as much weaker.
Additionally, remember that ENCY has $100+ MM of debt if royalty backed debt included. Nothing is near the marketing stage except Thelin and the approved drug on which they get royalties. Thelin in ROW is probably worth $100-150 of peak revenues. I believe $3-5 is supportable by the royalties and the ROW but expect failure to lead to $2.50 or so. Upside is probably to $6-7 if approved this week and then to $8-10 if GILD not approved (anything except approved/approvable for label). If GILD gets the nod too, back down to $5-6.
Jon
AI
