Replies to post #85636 on Biotech Values

[biomaven0]

At the end of the day CRME's drug is for something of a niche indication compared with the wide usage that amiodarone has despite its absolutely miserable side effect profile. Amiodarone is basically the drug of choice in heart failure patients with atrial fib (which is between 15-30% of all heart failure patients) because unlike other atrial fib drugs it has no negative inotropic effects. Amiodarone has to be a candidate for the trickiest-to-use and most toxic widely-used non-oncology drug.

So the comparison isn't really a good one. If Budiodarone is an easier-to-use amiodarone that works in a good percentage of HF patients with atrial fib, it would find wide use as a first-line agent, with amiodarone reserved for patients that don't respond. So it clearly has at least potential as a significant blockbuster, although it's still too early to project its ultimate efficacy and S/E profile and hence how it will actually play out.

[turtlepower]

ARYX - The two hurdles you've mentioned may be spot on and may be part of the reason for the delay in finding a suitable partner.

However I'm not too sure about the toxicity being a deterrent. If I remember correctly only 1 of 60 patients treated with 2042 had microdeposits after 3 months of treatment whereas 80-90% of amiodarone patients had microdeposits after 3 months of treatment.

I agree about the PE. Though assuming that 2042 was indeed designed to have similar efficacy to amiodarone, i guess the assumption is it will be as efficacious if not more than dronedarone though that can't be relied on.

I haven't looked at oral V results that thoroughly. Only one dose was effective and the same for D. Two doses met the PE for 2042. Assuming both doses are effective for whatever PE, that may an advantage in itself. Start patients off with a smaller dose and then increase it depending on efficacy and safety. Also it looks like IV V has either safety or efficacy concerns. What are the odds that those concerns are carried over to oral V? D also has safety concerns for patients with HF.

Also the 2042 trial had patients with pacemakers so I'm assuming data from those can be used to analyze the results more thoroughly to alleviate any concerns about efficacy or safety.

All in all, you may be right about ARYX getting a lesser deal than CRME. I wish they had gotten a quarters worth of money when the share price was at 4 to be in a better bargaining position. I think though that not financing then also shows the confidence they have in the data though at the same time I wonder if the data were that good then a partner would have signed up by now to catch up with oral v.

[drbio45]

It still shows hints of many of the toxicities seen for Amiodarone - more in fact than Dronedarone (another Amiodarone redo - but with lesser efficacy than Amiodarone). (Note the word 'hints' because from the data released so far it is hard to tell anything other than that it probably still has some kind of tox for thyroid and liver - both of which are significant for Amiodarone, although I can't, for instance, find median blood data for such Amiodarone SAEs) In contrast Vernakalant(sp?) appears to have fewer side effects.

Not a comment, just a question. You are saying there is probably tox in the liver and thyroid based on the data presented. What data that was presented gives you that idea?