Re: New ATB blog posting:
in response to
by
posted on
Aug 16, 2016 03:35AM
Led,
Nice blog. A couple comments. First, apabetalone does indeed target cardiovascular disease. In fact, patients in BETonMACE are required to have had an acute coronary syndrome event within 90 days to be eligible for enrollment. They also must have low HDL. Furthermore, the primary outcome of BETonMACE is MACE (major adverse cardiac events). Although apabetalone may have some beneficial effects on lowering blood glucose, and BETonMACE is targeting diabetic, low HDL patients at high risk for cardiovascular disease, this is not a diabetes trial.
As for the ESPR comparison, yes that wild ride up to the 2.2 billion MC was crazy, fueled by investor expectations that ETC-1002 had a clear path to FDA approval. ETC-1002 is for LDL lowering and is especially promising for statin intolerant patients. The first big hit to that 2.2 billion MC came with the approval of the PCSK9 antibody therapies to lower LDL. Despite the prohibitively exoensive cost of these antibody therapies, which will prevent them from ever having widespread use in my opinion, the market viewed this competitor as taking out a significant portion of ESPRs market. However, the more recent and significant hit came from the FDA decision (or lack thereof) to provide a clear path to approval based on LDL lowering alone, as it had done for the PCSK9 antibody therapies. Instead, the FDA may require a longer cardiovascular outcomes trial prior to approval. The European EMA is a different story and is on board with an approval path for LDL lowering, without needing cardiovascular outcomes trial for approval, after the Phase 3 long term safety trial concludes around early 2018. I suggest folks cruise over to Esperion website and view the most recent company presentation/transcript for the full story.
I'm long RVX and long ESPR, and I continue to have confidence in both as they each proceed with Phase 3 despite the FDA, but not EMA, dragging their feet with both companies. None of what I comment on here should be taken as investment advice. Do your own due diligence. Best of luck to all.
BearDownAZ