The Amarin house leak was rainy again

Amarin suffered a series of blows this week when a federal appeals court refused to change a March decision that several patents on its only product, Vascepa, were invalid because of a lack of invention, ingesting little chance of turning the product around, and ARN shares fell 7 percent on Thursday.
results of a small trial called EVAPORATE were published at the European Heart Conference and the European Heart Impurities on Friday, but caused many to question them.
the trial recruited 80 patients with high TG and better LDL control, and the first endpoint was Vascepa's effect on a substitute called low attenuation plaque (LAP).
Vascepa fell 17 percent, the control group rose 109 percent, causing some experts to question its reliability, and the baseline was not equal.
5, AMRN fell another 5%.
vascepa is AMRN's only product, falling by as much as 10% after hitting hard because the stock had plunged 70% when its patent was ruled invalid in March, both of which were aftershocks.
Vascepa is an old-fashioned compound, the existing patents are not material patents, it is very troublesome to start a lawsuit.
general manufacturers will reach a certain agreement with generic drug companies in exchange for some patent time, drug king Xiumeile after the expiration of the substance patent with many challengers reached a ceasefire agreement.
but AMRN is not a general manufacturer, and that year with the FDA called the board to challenge its off-label promotion restrictions in violation of the First Amendment.
didn't flinch from Vascepa's narrow label and poor sales, but instead dumped a REDUCE-IT, which turned out to be the only fish oil preparation to show CV benefits in a multi-center trial to date.
AMRN has reached an agreement with Teva, but somehow has not been interested in Dr. Reddy and Hikma lost patience.
REDUCE-IT showed CV benefits, the rationale was unclear and the use of mineral oil as a placebo caused some to question.
today's trial is mainly aimed at increasing understanding of the effect, and of course, if explained, it will increase doctors' confidence.
the baseline was not completely uniform, with the drug group improving by 17 per cent, but the mid-nine-month analysis also showed that both groups had deteriorated.
the control group's 18-month LAP growth of 109% was significantly different from the normal growth curve.
Professor Francis, a professor at Imperial College who often tweets about why no one dies of heart disease, also found that one of the miscalculations in the experiment, the actual increase, was 150 percent instead of 109 percent.
Steve Nissen, a well-known master of upsets who pulled Avandia off the horse that year, was more scathing, saying he had never seen a control group grow so fast after all these years of vascular plaque growth/shrinking.
or the placebo is toxic, or the data are incorrect, so the product may not have been valuable, and some of the positive data are the result of the placebo deterioration.
but the experimenters say LAP is smaller and doubles.
AmRN did this test in a situation where REDUCE-IT earnings have been largely accepted by the industry, and it is generally surprising that such tests as EVAPORATE are done first to increase the confidence of gambling, such as the ENHANCE test of the Merca East fat-lowering drug Vytorin, where Nissen used the knife.
but what's the need to go back and prove how far-sighted your bet is now that you've won? Interestingly, Vytorin also did not show efficacy in ENHANCE but later large phase III clinical IMPROVE-IT showed CV gains, albeit very small ones.
two experimental names, REDUCE-IT and EVAPORATE, apparently refer to heart disease and TG, but these two days have unfortunately been teased as referring to AMRN's stock.
REDUCE-IT was a very important experiment that also consumed AMRN a lot of money and luck, and finally married others to show the importance of patents in the pharmaceutical industry.
is the most generous for products that do not have a patent, even though the FDA offers data protection periods of 3-10 years.
this event also shows that if there is only one product bet carefully, especially continuous gambling, if you want to bet on the best to have a substitute product.
Vascepa is still more well-known than generics, and its patents in Europe have not expired, so the value is not zero.
if AMRN had foreseen the verdict, it would not have risked REDUCE-IT.
's unexpected success is so, the more likely failure is even worse.
investment is not even a gamble.