All's Fair in Love, War, and FDA Decisions

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Talk about throwing a Hail Mary.

Amarin (NASDAQ: AMRN  ) has appealed the Food and Drug Administration's decision to rescind the Special Protocol Assessment, or SPA, it had with the biotech over an expanded indication for its lipid-lowering drug Vascepa.

Who does Amarin get to appeal to? A judge? A committee of outside experts? The President?

No, Amarin has to appeal to the FDA. With a decision as big as this, you don't think those making the decision talked to their bosses? It's not like SPAs are rescinded every day.

And then what?
Considering Amarin is fighting against the establishment that put it in this position, I'd say the likelihood of Amarin getting the SPA put back is somewhere between slim and none. But even if it is re-established, the SPA doesn't bind the agency into approving the drug.

The FDA clearly believes that there's no evidence that lowering triglyceride levels in patients with moderately high triglycerides has a clinical benefit. Of course, that was true when Amarin and the FDA established the SPA. The difference is that the hypothesis seemed reasonable a few years ago. Now, after multiple triglyceride-lowering drugs have failed to show an improvement in cardiovascular outcomes, the hypothesis appears less likely to be correct.

Amarin claims that the FDA shouldn't have focused the advisory committee -- which voted overwhelmingly against the expanded indication -- on the potential to reduce cardiovascular events because Amarin isn't asking for an expanded indication that includes reducing risk of cardiovascular disease. While it's true that Amarin only wants to claim that Vascepa reduces triglyceride levels, the FDA doesn't approve drugs for indications with surrogate endpoints unless it feels the surrogate endpoint is a reasonable proxy for a clinical endpoint. Otherwise, what's the point in taking the drug?

For instance, the FDA isn't convinced that raising good HDL cholesterol means anything clinically, which is why it made Merck (NYSE: MRK  ) run an outcomes trial before approving Cordaptive. Ironically, Merck's failed HPS2-THRIVE study was one of the clinical trial results the FDA cited as part of its argument to the committee since Cordaptive also lowers triglyceride levels.

Oh yeah, we sold some Vascepa
While much of Amarin's conference call was focused on how it's planning on fighting back against the FDA, Vascepa is still on the market for patients with very high triglyceride levels. Unfortunately, it's a small indication, and Vascepa hasn't picked up the off-label sales that GlaxoSmithKline's (NYSE: GSK  ) Lovaza has been able to capture. Despite being approved for essentially the same indication, Vascepa sales were just $8.4 million in the third quarter, compared to the $208 million in Lovaza sales that GlaxoSmithKline recorded.

The FDA's decision isn't fair, but Amarin needs to get over it and move on. It seems to me that focusing on improving sales of Vascepa would be a much better use of Amarin's time and energy than a fruitless appeal of the FDA's decisions.

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Read/Post Comments (11) | Recommend This Article (3)

Comments from our Foolish Readers

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  • Report this Comment On November 08, 2013, at 4:57 PM, yazzbro wrote:

    Here is the thing with the FDA, they made an AGREEMENT with AMRN and now they don't want to live up to their end of the bargain. First, why did FDA make the Anchor (which was simply asking to expand the label to people with 200 trigs+) into whether or not Vascepa will reduce CV events? The FDA knew that according to their AGREEMENT that AMRN only needed to be 50% enrolled for Reduce-It for them to consider expanding the label for AMRN. Why did this all the sudden become the ADCOM for Reduce-It and not for Anchor? Second, why would FDA rescind Anchor SPA? They basically told all the pharmacautical world that the FDA's SPA agreements aren't worth a hill of crap. So if I am a small biotech with a new drug going through trials I would be a little leary of ANY SPA AGREEMENT the FDA makes. I would want something a little bit more binding than that. So not sure what kind of message the FDA sent to drug companies. Lastly, and the most embarrassing thing for the FDA is the FDA wants to impliment a ban on trans fat. So they want to ban trans fats but they don't want give Anchor Approval to AMRN's Vascepa which helps control Trans fats. SAY WHAT?? I am sorry but this whole ordeal just reeks of FDA corruption. There literally is no other way to explain it. If I were AMRN I would sue sue and sue some more. I don't know but Government corruption seems to be the norm for this administration. IRS, SEC, FDA, USDA all have many many examples of recent Goverment corruption and the FDA is part of that. AMRN went into the Adcom thinking it was going to be for simply expanding the label from 500+Trigs to 200+Trigs. Instead the Adcom becomes about Reduce-It with the FDA full knowing that the Adcom was SUPPOSED TO BE ABOUT ANCHOR!! Then they rescind the SPA. Why don't they just RESCIND Marine while they are at it? Sorry this is nothing but corruption. No if's and's or but's about that. The FDA, the Adcom panelist where obviously paid off by someone to deliberately tank AMRN. It's a shame and it's a sham.

  • Report this Comment On November 08, 2013, at 6:03 PM, bottomfisherman wrote:

    @yazzbro can you come up with something better than the standard there must be some kind of conspiracy against Amarin because it just does not hold water.

  • Report this Comment On November 08, 2013, at 6:29 PM, conceicaod wrote:

    If there nothing fishy going on then why take 14 months on NCE. This case is not unique. 9 to 2 vote on a drug that has no major side effect ? Seem odd to me.

  • Report this Comment On November 08, 2013, at 7:30 PM, bohdan wrote:

    Really must question your logic....."The FDA's decision isn't fair, but Amarin needs to get over it and move on."

    Aside of that an unfavorable decision severely restricts a safe, superior medication, that medical community is openly wanting, the potential loss of revenue to Amarin is huge.

    A final FDA decision against Amarin may decide the ultimate survival of the company.

    If the FDA want to continue the REDUCE-IT study, the FDA should abide by it's own agreement.

    Changing the rules in the last inning is blatantly unfathomable by any standard of fairplay.

    If you can't trust the FDA who should you trust?

    Backing out of the SPA agreement has stink all over it.

    Unfair? ... how about a stupidly, arrogant FDA.

  • Report this Comment On November 08, 2013, at 8:41 PM, BiotechStocker wrote:

    "The FDA clearly believes that there's no evidence that lowering triglyceride levels in patients with moderately high triglycerides has a clinical benefit." That is one way of thinking. Other way, which is the right one I believe, is to expand the label, which is already approved for >500 TGs, provided the safety is proven, Or just recede approval for everything, which aims to reduce TGs.

  • Report this Comment On November 09, 2013, at 1:15 AM, blueeyes338 wrote:

    Then why not pull all drugs without CV outcomes off the market??? Start with Tricor which failed outcomes. Then why not lovaza? Why give ok to one TG level and not the other. FDA should ok it and let the physician decide on whats best for the patient. Im not a conspiracy theorist by any means but i do believe there is definitely some shenanigans going on. Nothing surprises me today and money influences decisions everyday until we read or hear about it on 60 minutes a few years from now. Such a shame

  • Report this Comment On November 09, 2013, at 1:18 AM, blueeyes338 wrote:

    Also why didnt this have to go to a panel if it was to answer the question wait for Reduce it or not wait? FDA should implicitly state no approval without CV outcomes making it easy for the medical, Amrn and investment community make an informed decision on what to do. Absolutely nonsense and typical government agency nonsense to rescind an SPA. The FDA needs push back as they function like the medical untouchable IRS

  • Report this Comment On November 09, 2013, at 12:55 PM, jellybean213 wrote:

    It only a fool who compares sales of a drug that's on the market 5 years to one that on 9 months. Try turning you hat to the front and grow up. Compare Lovazas sales on its initial launch for 9 months. That just might be the right way to compare apples to apples. What are you a Doctor of anyway????

  • Report this Comment On November 09, 2013, at 1:13 PM, jellybean213 wrote:

    If you don't think the fix was in. zplain Lucy why Ms Parks from the FDA said much thought went into the leading question she asked the panel. They were so confused they asked her to rephrase the question. She said NO. Gee I wonder how she went over and over this question with the FDA to get a no vote from the panel so they could rescind the SPA?? Who was behind pushing the FDA? Could it be a large pharma that stands to lose a lot of $ if little AMRN get the nod?

  • Report this Comment On November 10, 2013, at 9:00 AM, RHMASS wrote:

    When the author says the FDA decision isn't fair, but AMRN must get over it, it has really indicated the mindset of the general population in our society. We are so conditioned to accept everything and every decision made by our government and are expected to simply accept it, because it is supposedly good for us. This is why there is no accountability for government officials from top to the bottom. This rescinding of the SPA is but a small example to show how out of control our government is.

  • Report this Comment On November 10, 2013, at 9:50 AM, pointsurfer wrote:

    I guess the FDA has become a sort of US drug Gestapo. And just like the innocent Europeans of the 30's &40's sufferd at the hands of the Gestapo the FDA, US judicial system, and government are going to sit idle while this scientific fraud and by the FDA needlessly endangers 40 million innocent Americans in the mixed D. population? By stalling the approval of Vascepa for this indication. What a sad day for us all then. Even a layman can see in the study results of AIm HIGH and the others that this is scientific fraud, as the subgroups in the 200 to 499 targeted in the spa benefited from lowering triglycerides.

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