For a company whose pipeline is based on antisense technology, the mention of adverse effects, particularly cancer, is troublesome for them as a whole.
Is this sour grapes? Are there studies showing these concerns, (animals)? Wouldn't there be some other support for this claim?
That concern is independent of the drug type whether it’s molecule antibody protein, antisense small molecules or what.And they have quite a number of concerns. I think many of them are, it’s hard to justify some of them, but they have also indicated that they are going to require, certainly requested in a strangerous way, a very substantial addition of studies. Some of these studies are going to be very difficult to do because they want them done in combination with statin.
They have also indicated that they want (Inaudible) studies done very early because they are very worried about potential malignancies and our read of it is that even for FH it’s not going to be possible to get approval even for FH without outcome studies. There is plenty of room for interpretation there, but that’s our interpretation.
Seems to be bearish for everyone targeting PCSK9 (REGN, ALNY, etc.) and not just ISIS.
This may be a good call as it relates to ALNY's ALN-PCS which targets PCSK9. Last Wednesday ALNY touted the drugs early Phase 1 results and during the C.C. management was asked whether they would move forward without a partner. They failed to answer the question but on Sunday ALN-PCS was clearly moved to the "drugs to be partnered list" upon stating their "Key goals for 2012"
This move doesn't instill confidence in their second generation MC3 RNAi delivery considering they ended the year with 260 million in cash to invest along with all the built-up excitement over this drug. Is it the target? The expense of running trials in severe hypercholesterolemia? What bothers me is they chose to license another form of RNAi delivery from ARWR for their 5TH drug in the 5x15 initiative.
I can rationalize that this is being done to hedge their pipeline from legal claims by TKMR but shelving ALN-PCS, and partnering with ARWR for delivery, should raise doubts over second generation MC3.
Isis Pharmaceuticals chief executive Stanley Crooke thinks that Wall Street is wildly undervaluing the cholesterol drug he is developing with drug giant Sanofi’s Genzyme unit – and that there may be substantial delays for another type of medicine that could be a competitor down the road.