Re: Continued Roth coverage imo points to a Nasdaq listing....
in response to
by
posted on
May 02, 2019 10:45AM
"Its my understanding that CVOT trials, post Crestor/Lipitor....that there have been a long list of trial failures. Assuming that to be true, then imo it would explain AMRN trending down, the market conditioned to and anticipating failure."
Not true at all. There have been several successful CVOTs in the past few years.
For diabetics, there have been several successful CVOT trials for the SGLT2 inhibitors and GLP1-R agonists. However, these were first tested and approved for blood glucose control prior to the CVOTs completing. The subsequent CVOTs that tested for superiority and/or non-inferiority cemented these glucose lowering agents as having additional benefits of reducing MACE in diabetics. This is a very important accomplishments, since diabetics have high residual cardiovascular risk despite current standard of care. It seems that maintaining normal glucose control is only part of the story, since not all interventions to improve blood glucose have elicited this cardio benefit. These SGLT2 inhibitors and GLP1-R agonists likely have cardio benefits beyond glucose control. However, these are agents for diabetics, not for reducing MACE in non-diabetics.
Aggressive LDL-C lowering has also shown success in reducing MACE in both diabetics and non-diabetics. The FOURIER and ODYSSEY CVOTs for the PCSK9 antibodies validated that aggressive LDL-C lowering on top of statin and/or ezetimibe standard of care, and lowering LDL-C below prior LDL-C guidelines, elicited MACE reduction. Ongoing CLEAR OUTCOMES study for bempedoic acid ATP-citrate lysase inhibitor from Esperion and ongoing ORION trial for the inclisiran PCSK9 siRNA from The Medicines Company should lend even more support for the LDL-C hypothesis and options for doctors and patients (assuming these trials are successful).
The CANTOS trial for canakinimab anti-IL-1B antibody proved that targeting inflammation reduces MACE. However, due to various reasons, Novartis isn't pursuing marketing/NDA approval of canakinumab for cardio risk reduction. Still a successful trial.
Vascepa and REDUCE-IT is unique in that it is targeting triglycerides, not LDL-C. Seems to work for both primary and secondary prevention of MACE (both were included in REDUCE-IT). Seems top work in both diabetics and non-diabetics (both were included in REDUCE-IT). Also seems to elicit MACE reduction regardless of baseline triglyceride or change in triglyceride. They'll probably market to those with triglyceride above 150 mg/dL, consistent with the REDUCE-IT trial population. However, they may be seeking a label for treating patients with even lower triglycerides than 150 mg/dL. We won't know for a while since the sNDA application/approval process will take another several months. So this REDUCE-IT trial provided the first evidence of high-dose omega-3 supplementation reducing MACE and the first evidence of triglyceride lowering reducing MACE. It is a huge market. It is a novel non LDL-C target. It is an oral pill. However, there is some concern about competiors on the horizon in this omega-3 space.
BearDownAZ