Replies to post #151837 on Biotech Values

[DewDiligence]

REGN/SNY—John LaMattina (who should know about these things) estimates that the 18,000-patient phase-3 trial of REGN727, called ODYSSEY OUTCOMES, will cost $500M (!) to conduct:

http://www.forbes.com/sites/johnlamattina/2012/11/06/will-sanofi-regeneron-ride-odyssey-into-riches/

[mcbio]

PCSK9—Lots of articles this week on the various programs from several companies/partnerships (but, oddly, no one has posted them). Perhaps it’s time for an iHub survey on which of these compounds will turn out to be best in class.

Comments?

I think this was brought up before: isn't the fact that a biotech with their own PCSK9 candidate (believe it was ALNY) abandoned the drug due to concerns over the FDA and the likelihood of very long and very expensive trials to disprove any safety concerns still a bearish sign for this drug class?

[genisi]

I think it is already clear that PCSK9 inhibition is very effective in lowering LDL-C and safety looks ok so far but too early to know. As for use, beyond narrow indications like FH this class will need to show benefit in decreasing CV and stroke risk and death in huge outcomes studies like you've mentioned, plus the drawback of being injectables.

[biotech jim]

An iHUB survey on the (to be) best PCSK9 medicament IMO does not have sufficient data yet made public to opine. For all molecules we need 2 and 4 week dosing frequency (in dose response fashion) coupled with LDL-C levels.

Not that all such data is needed for people to provide opinions of course, happens all the time.