Re: Buyout?......
in response to
by
posted on
Jun 02, 2019 10:07PM
"it is prescribed for decreasing the amount of triglycerides made by the body and lowers MACE."
Right now the only approved indication for Vascepa is for lowering triglycerides in those with values above 500 mg/dL. The supplemental NDA application to the FDA, which is expected to have decision by end of September, will likely seek expanded indication for those with triglycerides around 150 mg/dL and above, as well as the reduced MACE indication. Although approval is very likely, there is still some baggage associated with the REDUCE-IT trial that doesn't make it a guaranteed slam dunk. As Tada indicated, there is much more competition on the horizon for Amarin too with other high dose Omega-3 products already approved or in late stage trials. If triglyceride lowering has cardio benefit, as Amarin argues, then the other triglyceride lowering omega-3 products are competitors. However, if in addition to triglyceride lowering there is a benefit of EPA only over DHA/EPA mix, then Amarin has a unique niche. The STRENGTH trial for Epanova that reads out next year will provide first comparable cardiovascular outcome data to determine if there is EPA only magic or if DHA/EPA mix also has cardio benefit. If the latter, this invites even more competition for Amarin. So for various reasons above, the market cap for Amarin is somewhat restrained right now until further clarity, in my opinion.
BearDownAZ