You are probably right that we should wait and see how things turn out with the current FDA/Amarin discussions, but it may be a play after that. I see that the new Amarin marketing and sales VP was deeply involved with the development of Niaspan, the drug studied in the failed AIM-HIGH. I wonder what this signals?
The FDA must be pushed to do what is the obvious action based on its public pronouncement at the Vascepa Adocom that failed outcome studies of these 2 drugs show that Vascepa will not work. These drugs were approved for trigs under 500 based on a clinical trial such as Anchor. Now that a long term study has shown that they do not reduce CVD (according to the FDA), these drugs should not be available for on- label sale for this indication. This petition would have 2 possible outcomes-both positive to Amarin. If it is successful and makes these drugs only available off-label, it would remove their competitive advantage over Vascepa. If it is unsuccessful, the FDA would be admitting that it erred in its "new scientific evidence." My guess is that if big pharma is faced with the loss of this indication for niacin and fenofibrates that they would suddenly be supporting Amarin's position that no new scientific evidence has been found.
Someone needs to do this ASAP. Maybe another citizen's petition is in order. Right now there is no big pharma in Amarin's corner about the FDA's new "scientific evidence." If the companies behind niacin and fenofibrates are threatened with a loss of this market, they will suddenly back Amarin in its battle with the FDA.
Since the FDA said at the Amarin ADCOM that "new scientific evidence" was found in the three studies they cited, they should immediately act on this evidence and pull its approval of niacin and fenofibrates for treating trigs under 500. These drugs have been found to have no positive CVD outcomes and also carry the risk for serious side effects such as liver damage. How can they justify keeping these on the market while denying Vascepa approval for this indication? Vascepa has a much better safety profile and is the only one of the three that actually had a positive outcomes trial-the Jelis Study.
IMO the most important part of this article is the fact that the FDA approved niacin and fenofibrates based on clinical trials (like the Anchor clinical trial) and they are now denying Anchor approval based on the failed outcome studies of those two approved drugs. If these outcome studies are so important to the FDA, why are they not rescinding the approval of niacin and fenofibrates (both of which have serious side effects).
AMRN is not in a similar position. ARNA's only avenue to higher PPS is increased sales. AMRN has this plus some kind of label expansion (although not full Anchor), European expansion and possible partnership outside the US (ARNA shares popped when they announced a similar partnership), plus interim results from REDUCE-IT.
I think that some at the FDA need to take Vascepa so that their brains don't shrink any more than they already have!
Amarin management also said that they are going to put a much greater effort into bringing Vascepa to market in Europe and elsewhere that it holds the rights. A partnership outside the US could provide the necessary funds for RI completion.
This was one of the three studies that the FDA cited in rescinding the Amarin SPA. As others have pointed out, the post hoc analyses of the other two studies showed that the subgroup relevant to Anchor did indeed show a large decrease in CV events. The sub group analysis of this third study is pending a finished peer review and will probably be completed and published in early Spring. Maybe the FDA is waiting for the final results before deciding.
I looked at this article and the conclusion reached by the study:
EPA plays a pivotal role as demethylating agent, by directly acting on
C/EBPd and H-Ras, an upstream C/EBPb activator. A new role
emerges for EPA and, possibly, other PUFA, which may represent
a new class of DNA demethylating agents, whose action should be
investigated in cancer cells, as well as in other diseases, when
aberrant DNA hypermethylation is involved.
I commented and said that at the very least they should delay their decision until January when the subgroup analysis from the HPS2-THRIVE study will be published.
I think that they are pretty similar in this one area. However, with L you get possible Afib and liver damage which you do not get with V. L also raises LDL significantly when used with a statin, whereas V does not.
Biwatch did reply as follows: The SPA has been amended in May 2013 to modify qualifying TG to 200 to
I also emailed my question to Biwatch. If I receive a reply, I will post it here. I completely agree about applying for approval outside the US. There should be enough money there to get us through REDUCE-IT. I also previously suggested that they combine the Amarin sales force with Vivus- they have a similarly sized sales force (after their reductions) and would hit the same doctors while not being direct competitors. What do you think?
There is a new Seeking Alpha article just out today that addresses the REDUCE-IT trial. It discusses the 15% endpoints, Jelis, etc. and suggests that the interim analysis which will be done in early 2016 has a good chance of being positive enough for approval at that time. He also thinks that the company will have enough cash to reach this point without a partner or further dilution.
Joe Z came out fighting after the FDA screwed Amarin threatening lawsuits and so on. The BOD realized that this approach was getting nowhere so now they can approach the Type A meeting and further negotiations with a clean slate and blame all the negativity on that "hot head" Joe.
They definitely should file in the EU and elsewhere. Amarin has patents in Europe and should have done this months ago. Arena recently announced a partnership for Belviq in Europe and elsewhere and their stock shot up. Amarin needs to also do this ASAP and maybe use the proceeds to fund REDUCE-IT. Maybe the new CEO will get the message.