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4.502 / 15.480

Re: Farmas USA


los de fool tb


With that in mind, the FDA just released its briefing documents for the October 16 advisory committee review, and investors were not happy. It surprisingly raised questions about the mineral oil placebo potentially negatively impacting the control group data and consequentially overstating Vascepa's effectiveness. This review also comes at a time when a number of new studies have shown limited improvement of cardiovascular outcomes for patients taking fish oil.


Re: Farmas USA


los de Leerink Swann

"The FDA released briefing documents for next Wednesday's ad com which look fairly non-committal, and do not raise any new issues, in our view, but could lead to a fairly close vote for Vascepa label expansion,"

El documento liberado de la FDA para el adcom del proximo mirrcoles el cual no compromete a nada, y no eleva ninguna nueva preocupacion, desde nuestro punto de vista, pero que podria conducir a una votacion ajustada para la expansion de la indicaciom Vascepa"

creo que lo he traducido con la intencion que querian expresar


Re: Farmas USA



aunque sea un tochazo , interesan mucho los comentarios de BiotechWill

" I will just add a comment since the briefing docs are out and people are really focusing on the discussion portion versus the voting question - as stated in this article and in the briefing doc, the actual question is "Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT? Please provide the rationale underlying your recommendation."

Clearly the effects on the described lipid/lipoprotein parameters are sufficient. They were sufficient in MARINE, and the efficacy and safety is already proven. The discussion will not be enough to push the vote against Amarin. I'm obviously bullish, but reading the actual language of both, I still believe it all boils down to the efficacy and safety I discussed above. Good luck to all."

What would you expect the new information to be that would result in this? Because when I read the entire briefing doc, it appeared that at the time of the SPA the research discussed in the briefing docs was already known and considered, with the exception of the Italian Risk and Prevention study, again with low doses and different ingredients than Vascepa.

See, the particular reviewer brings up REDUCE-IT and CV outcomes, but mainly under the secondary endpoints, and not the first. The review then goes on to state that the primary goal of all of these therapies is ultimately the reduction of CV events, through various modalities.

However, if Vascepa is approved for the MARINE indication because it is effective at lowering trigs, how could it not also be approved for ANCHOR, with the efficacy in lowering trigs. It seems very strange to me to say that we will focus on efficacy and safety of triglycerides, which is what the voting question actually asks, and then say the panel is really all about REDUCE-IT.

The other thing about these studies in the documents, beyond having nothing to do with the efficacy and safety of Vascepa for lowering trigs, is the fact that they make no differentiation of dosing/composition - which the reviewer even makes a note of in terms of the amount of EPA in Vascepa.

Even with the worst case scenario of a delay, this all seems crazy to me in terms of price action, as most of the targets have focused on MARINE only.

Summary: After reading the entirety of all the documents, I expect approval, but a lot of discussion around REDUCE-IT, and perhaps a revisit of the indication after REDUCE-IT concludes. I didn't read a single thing in there that makes me think no, especially again after comparing COMBOS data and concerns.
Actually, it likely depends on how they read the document. Most people went to the question page first in terms of the vote, which looks favorable in Amarin. Then, as the reviewer comments were reviewed, opinions were formed as to what the documents say and what the panel will do. Some shorts tried to cover expecting the opposite reaction on the questions, and then the price went bonkers as people read through the document. Overreaction in my opinion, but it will take until Wednesday to see.

I just speaking about that $5.50 put play yesterday - I expect someone will be having a look into that. I really didn't see anything in the docs that surprised me, so I don't really understand the fuss. You hit the nail on the head on the studies, not to mention that the majority either contained DHA, or involved another substance like niacin all together.

The Panel is actually asked to vote on the efficacy and safety of Lovaza - I just reread the briefing documents for the third time, and then went back and looked at the question they are asked to vote on. It specifically says, "Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT?"

There is no actual reason so say no - it is safe and efficacious. Maybe Wednesday will come and I will look like an idiot, or perhaps a genius... time will tell.
The reason the stock dropped, however, is that the language in the discussion portion prior to the question for vote referenced CV events, and then the question itself read, "Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT?"

Most seem to be reading this and reviewer comments as requiring the completion of REDUCE-IT prior to approval, but to me that makes little sense. The potential benefits very much outweigh any issues given the safety profile, and the absolute worst case scenario in the event of approval would be no additional CVR effect. However, to this point, I would pose the question as to why we have triglyceride treatment given the lack of supporting CVR data.

Ultimately, I think it comes down to saying the equivalent of, "We don't know if it will rain, but should you have an umbrella with you if it does?" In this case, if it does rain, it's better to have had the so-called umbrella for over two years than to wait until 2016.
parrafo del documento
"The changes in lipid and lipoprotein parameters from baseline to week 12 in the mineral oil placebo group are rather atypical for a trial that included a stabilization period for diet and lipid-lowering therapy, raising the possibility that mineral oil may not be as inert as assumed. If true, the treatment effects observed with AMR101 may be overestimated."

Your quote comes from page 57 of the documents, and I think it unlikely to be a big deal for a few reasons. First of all, the FDA approved the MARINE indication, which means they believed in the safety and efficacy of Vascepa once. Even if we account for some type of "treatment effect" overestimation here, the numbers would still show Amarin effective.

Secondly, and pages 53-56 discuss this, there is an important contention by Amarin that is noted on page 54, notably that "if mineral oil reduced statin exposure, then LDL-C should have increased after 12 weeks of treatment, not decreased." As I actually referenced in this article, LDL-C was the main concern prior. Even if we were to assume mineral oil is not inert (despite being shown as such in other studies), Vascepa did not cause an increase.

I could see where this could raise some issues, and saw some Tweets about it, but I cannot really see how it changes the idea that Vascepa is effective and safe for lowering triglycerides.


I definitely could see how it could relate to a delay, but I think Amarin's briefing docs cover this, and the shift in patient population would only become a concern in my opinion, if there was a negative impact. Even accounting for the mineral oil in the worst light, we will end up with Amarin having at worst no impact on LDL-C in terms of raising it.

I'll use the analogy above regarding the umbrella - if there is no reason not to carry it beyond the fact that it might not rain, you might as well bring it along. Vascepa shows no harm and was efficacious enough for approval before, then it should be fine here.

I could see reviewing this later after the results of REDUCE-IT, but the main reason I do not see a delay is that it would only hurt patients who might benefit, versus approving which may show no benefit but would not hurt (worst case scenario).

We are talking about the 4g dose, as Amarin petitioned to have the 2mg dose removed from consideration. The basic concern on this is that the use of mineral oil as a placebo may lead to some overestimation (as opposed to the corn oil use in the Omacor/Lovaza trials, or the olive oil used in the Epanova trials) as to the effectiveness of Vascepa.

I think this worry is too broad, and was actually addressed by the company previously. Amarin's briefing docs actually address this for those who took the time to read both, and on page 51 state, "Corn oil, which had been sued as a placebo in other trials of omega 3 polyunsaturated fatty acids, contains triglycerides and has a distinctive yellow color different from icosapent ethyl (colorless). Therefore, Amarin proposed to use light mineral oil, NF, in the placebo capsules for the pivotal studies. The FDA agreed that light mineral oil was acceptable as a palcebo as long as the amount per capsule did not exceed the amounts in FDA-approved products given by the same route of administration."


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Re: Farmas USA


Se comenta lo del cambio de Bloomberg por stocktwits.....que cabrones!!


Framus....acuestate ya hombre...tu que puedes!!!

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