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JohnCappello

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  • Amarin's Smart 1st Amendment Strategy [View article]
    I'd say your assessment is obviously shared as evidenced by the current trading range. NCE would solve a short term problem, as defending 40+patents will be costly, but I can't think of a competitor in the prescription Omega 3 space with (any) patents whatsoever. I would expect for most big pharma, its the kind of problem you want to have, a hot drug that everyone wants, yet the IP protected by patents galore. In less than 12 months the data from Reduce It will dictate the fate of Amarin. The run-up to R-I could be explosive, and might occur sooner than anyone anticipates. The CVD space is enormous, and if Vascepa proves to materially reduces CVD, it will be a very valuable franchise with, or without the FDA consent. Imagine the 1st amendment case being considered and news breaks that the trial was halted for overwhelming efficacy. That scenario might be keeping attorneys up at night. Risk? Yes of course, but one heck of an upside as well.
    May 11, 2015. 02:24 PM | Likes Like |Link to Comment
  • Amarin's Smart 1st Amendment Strategy [View article]
    Consider Amarin is exploiting a new target to grow scripts; illuminating the positive impact of EPA on lower health care costs which means improved insurance profits. Should this data be studied by insurers (as they should) and they discover that those on Vascepa consistently consume less less health benefits (as those of us that know the science suspect they will) we might see insurers evolve into proponents of Vascepa. That would be a very interesting turn of events. FYI, see this new cost study sponsored by Amarin intended to do just that.

    http://bit.ly/1FfRHHR
    May 11, 2015. 12:34 PM | 1 Like Like |Link to Comment
  • Prospective New Investors Have To Wake Up To See Amarin Now [View article]
    think of total available market as current statin users, which is roughly $35B / year globally. At flat 5% mkt penetration (defined as a statin patient adding Vascepa ) , Amarin drives $2B each year for 10 years . That suggest mkt cap of $6B -$10B

    Now IMO, 5% seems conservative especially if R-It yields north of 30% risk reduction , and its a drug with zero SE's

    we got a winner..... a very big one
    Mar 7, 2015. 09:02 AM | 1 Like Like |Link to Comment
  • Good News: Vascepa Kept Its Place On National Formularies [View article]
    The approval of the Lp-PLA2 test by the FDA last week should help Amarin with securing more coverage, and increase script growth. Vascepa lowers Lp-PLA2 by 19%. Additionally, the approval signals the FDA has finally moved away from being fixated on LDL-C as the only marker for CVD that matters. Vascepa's therapeutic effect is far more than simply lowering TGs. Vascepa Improves arterial stiffness & endothelial, lowers inflammation, reduction of small particles, improved plaque stability, better AA:EPA ratio, Improves insulin sensitivity and more. Studies continue to be published supporting the thesis of CVD risk reduction. An Interim look on Reduce can't come soon enough. Given the increasing scientific body of evidence on EPA, it's hard to conceive a scenario in which Vascepa does not clear the 20% risk reduction hurdle and could very possibly yield much more making it a blockbuster drug for CVD.
    Dec 18, 2014. 06:57 AM | 4 Likes Like |Link to Comment
  • The FDA Oil Tanker Will Not Be U-Turned And Amarin Corporation Faces Collateral Damage [View article]
    Vascepa will produce therapeutic benefit, not only because of lowering TGs
    but because of additional MOA

    such as EPA:AA ratio
    http://bit.ly/1nO2WcK

    or recent JAMA article on 18 HEPE
    http://bit.ly/1nO2WcM
    Sep 11, 2014. 11:22 AM | 2 Likes Like |Link to Comment
  • The FDA Oil Tanker Will Not Be U-Turned And Amarin Corporation Faces Collateral Damage [View article]
    To suggest the FDA will reverse is foolhardy, yet Amarin has made it clear they will exercise 1st Amendment rights to use Anchor Data. Bottom line? Anchor indication will be actively "sold" regardless of FDA decision. Furthermore it is most likely a lawsuit against the FDA would be filed for rescinding the SPA.

    I would not want to be the FDA attorney to defend the FDA position that lowering High TG does not lower CVD risk, as the basis of rescinding SPA, especially after recent APCO3 mutation study that showed a 40% reduction in CVD risk by lowering High TGs! And recent vocal positions on TGs by National Lipids Association.

    We live in a world in which Fats are now good and Carbs declared bad for CVD risk. Will LDL-C's also fall as the 'king" to other biomarkers such as LDL-P?

    Lastly, should your prediction come true, I would expect Amarin to stop enrollment of Reduce It and ask for an early peek at data. The hurdle is only 15% risk reduction, its likely to be far greater. Reduce it is considered vital among CVD research since it answers a long debated topic of TG lowering. If the FDA proves to be a bad business partner , why would Amarin spend $100M with someone they cant trust to abide by Reduce It SPA? ? Enough is enough.

    Sep 11, 2014. 10:10 AM | 7 Likes Like |Link to Comment
  • The FDA Gives Itself Room To Move On Amarin's Appeal [View article]
    I have no knowledge of any FT application, I must have missed the reference in Adcom
    Sep 4, 2014. 08:08 AM | Likes Like |Link to Comment
  • The FDA Gives Itself Room To Move On Amarin's Appeal [View article]
    Once we're past the SPA decision, (one way or the other) what will be left is "Reduce It" outcomes. I cant find a study of any kind, in which 2-4 grams of pure EPA daily didn't result in significant therapeutic benefit and not just for CVD, but for other disease including cancer, cognitive function, skeletal, diabetes , periodontal, and more . There are many studies that indicate EPA is biologically active in mediating inflammation, improve insulin sensitivity, arterial stiffness, plaque reduction, improved Fibrous Cap Thickness in Patients with Coronary Atherosclerotic Plaque. The list of therapeutic value goes far beyond TG lowering. When considering the totality of the information including the JELIS study and all these additional EPA studies , and the recent APCO3 mutation study- I can't help but be confident Reduce It will not only meet the endpoints, but blow past them. Reduce it is a very important study and needed to (once and for all) settle the debate of EPA for CVD risk reduction and give us key info on effect of lowering high TGs . Reduce It enrollment was stipulated as condition for Anchor approval. Not only did Amarin meet its Reduce It enrollment obligation on Anchor , it exceeded the clinical endpoints. Rescinding the Anchor SPA using misleading and non EPA data was egregious and capricious. For Amarin to take a body blow from the Anchor SPA being rescinded was a travesty. The FDA ignored SPA legislation, caused hundreds of people to lose their jobs, destroyed billions in shareholder value and in doing so confirmed the doubt and disgust in the FDA.
    Amarin should think hard and long about Reduce IT. The FDA has already proven its capable of cooking the books and reneging on agreement. How can Amarin be expected to invest $100M going forward while in partnership with a corrupted business "partner" as the FDA? As a shareholder I demand Amarin not simply trust the FDA to do the right thing, in fact the opposite was proven. Its hard to predict what the FDA will do with the Anchor SPA exactly, but what they should do is obvious to anyone who studies the circumstances of the Anchor SPA. Will they step up and do the right thing? It is questionable and reflected in the paltry run-up thus far. This fed agency is out of control and needs to be revamped. Heads need to roll while a top to bottom make over be instituted by congress.
    Aug 30, 2014. 10:50 AM | 2 Likes Like |Link to Comment
  • The FDA Gives Itself Room To Move On Amarin's Appeal [View article]
    this is being presented at ESC this month

    Low EPA /AA ratio associated with Coronary Plaque even if Hypercholesterolemia not present

    http://stks.co/h0vzg

    ( uh-oh..... )
    Aug 12, 2014. 08:23 AM | Likes Like |Link to Comment
  • The FDA Gives Itself Room To Move On Amarin's Appeal [View article]
    also, Cardiologists across the pond at ESC Aug will be getting an earful of science about what EPA does to CVD

    Pre-treatment with pure eicosapentaenoic acid in addition to statins can reduce the index of microcirculatory resistance after percutaneous coronary intervention Akiyoshi KURITA (Nagakute, JP)

    Effect of pitavastatin and eicosapentaenoic acid on coronary artery calcification detected by multi detector-row computed tomography. Kazufumi NAKAMURA (Okayama, JP)

    Eicosapentaenoic acid treatment reduces acute inflammatory response and ventricular arrhythmias in patients with reperfused acute myocardial infarction Saori TSUKUDA (Takamatsu City, JP)

    Clinical outcomes of early initiation of pure eicosapentaenoic acid supplement after percutaneous coronary intervention in patients with acute coronary syndrome. Fumi YOKOHAMA (Takamatsu, JP)

    Association between plaque vulnerability and eicosapentaenoic acid to arachidonic acid in non-hypercholesterolemia patients Maoto HABARA (Toyohashi, JP)

    Combined administration of eicosapentaenoic acid and docosahexaenoic acid reduces atherosclerotic lesion in apolipoprotein E-deficient mice Akira TAKASHIMA (Tokushima, JP)

    Eicosapentaenoic acid to arachidonic acid ratio is associated with the presence of thin-cap fibroatheroma determined by optical coherence tomography Yasushi WAKABAYASHI (Saitama, JP)

    Inhibitory effects of eicosapentaenoic acid on arterial calcification in klotho mutant mice, an animal model of typical aging Kazufumi NAKAMURA (Okayama, JP)

    http://bit.ly/1oXRvm1
    Aug 11, 2014. 01:38 PM | 3 Likes Like |Link to Comment
  • The FDA Gives Itself Room To Move On Amarin's Appeal [View article]
    this now seems more relevant : http://on.mktw.net/1mD...

    and this showing 18 HEPE (metabolite of EPA active in CVD:
    http://bit.ly/1mD0CEo

    from concerned citizens:
    http://bit.ly/1mD0CEp

    and this

    http://1.usa.gov/1mD0CEr;rpp=50;po=0;D=FDA-201...

    and very small sampling of the science of EPA and it's MOA...

    http://bit.ly/1mD0AfY

    http://bit.ly/1mD0Ag2

    http://bit.ly/1mD0Awi

    http://bit.ly/1mD0CEw

    and you gotta love this "breaking news" on JELIS from 2005:

    http://cbsn.ws/1mD0CEz
    Aug 11, 2014. 12:48 PM | 4 Likes Like |Link to Comment
  • Small Cap BioPharmas With Near-Term Catalysts [View article]
    The grounds for rescinding the SPA are indefensible. At best, the FDA might get a court to agree that proof of lowering CVD risk by lowering High TGs does not yet exist, and thus the conclusion used by the FDA to rescind the SPA would be deemed premature and unwarranted. The SPA then gets reinstated and Anchor approved. FDA counsel is well aware if this.

    There has only been one other SPA ever rescinded other than this one and it is my understanding it happened because the company could not meet its SPA obligations as a result of financial difficulties. Rescinding a SPA using speculative extrapolation would seriously impair Biotech funding and innovation. Not only does this matter concern Amarin stakeholders, its a major concern for any biotech firm who intends to secure a SPA. If the FDA prevails, the value of any SPA is seriously "downgraded". And thus the reconsideration by the FDA is not because of any one letter, or one coalition, it is because of the outcry from the private sector, legislators , physicians, and patients. Witness the unprecedented 200+ comments on the formal Citizens Petition - reading them is advisable if you're a serious investor. I did and I find many to be very compelling. The FDA is not immune to public outcry and political pressure and I predict this situation will be remedied.
    Jan 4, 2014. 09:25 AM | 2 Likes Like |Link to Comment
  • Small Cap BioPharmas With Near-Term Catalysts [View article]
    I learned a lot about the AMRN saga here; http://bit.ly/17GJ1ts perhaps you can too
    Jan 3, 2014. 12:41 PM | 1 Like Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    Thank you for the comprehensive and thought provoking article . It is certainly among the highest quality to be published on Seeking Alpha.

    Your assertions got me thinking and I went back last night to watch the video taped adcom (again) last night to better understand the impact of your assertions and most importantly what effect if any it might have on Amarin chances of ever achieving an expanded label.

    What I came away with is the conclusion that the FDA was patently wrong. That despite the claims by the FDA that the science had changed, and thus the original thesis that supported the Anchor SPA as no longer valid, nothing has actually changed since 2011. The very same uncertainly that existed in 2011 as described the FDA official remains uncertain today .

    Specifically, during the Adcom, an FDA official describes to the panel that basis for the new thinking (and subsequently the basis for rescinding the SPA ) was that the original "uncertainty" back in 2011 of the thesis had been since proven otherwise ( paraphrased) , that the uncertainty of lowering CV risk from lowering high TG was no longer an uncertain thesis.

    Think about that . The FDA stance is that it's no longer uncertain that TG lowering affects CV risk!

    Another words, they claimed that proof now existed showing any therapy that lowered high TG did not result in lower CV risk. And yet we have your piece that refutes their argument and shows the fallacy in their argument, and very convincingly.

    I am left with only one conclusion; that the same uncertainty that existed in 2011 still exists today. Therefore, the argument used by the FDA as basis for rescinding the SPA is unfounded and the SPA should be reinstated immediately .

    The FDA has the right to question the thesis, as does anyone. But it should not have the right to rescind an SPA based on extrapolation,or mere interpretation . Something as important as rescinding an SPA needs to meet a higher burden of proof, not merely speculation.

    I think the FDA is in hot water and overstepped their bounds . I support an immediate investigation for improperly rescinding the SPA, overtly controlling the adcom voting, using questionable methods scientific methods to arrive at a unfounded conclusion. And perhaps in rescinding the SPA in the manner it did, violated the Sherman act.
    This unprecedented move by the FDA is baseless and anyone who relies on the integrity of the FDA should have cause for alarm.

    SPA's can be broken, but not on the basis of poorly interpreted studies and leaps of faith by the FDA . That's something I'd expect to find in a 3rd world country , not here. We need the FDA to hold itself to a higher standard , and thus regardless of your financial position long or short AMRN , much more than Anchor is at stake and everyone should be very concerned.
    Nov 20, 2013. 09:46 AM | 2 Likes Like |Link to Comment
  • FDA Reviewing Panel Comments In 9-2 Vote [View instapost]
    Type A" meeting with FDA officials is venue & next step to resolve disputes with SPAs


    "Type A meetings should be scheduled to occur within 30 days of FDAs receipt of a written
    request for a meeting from a sponsor or applicant for a PDUFA product. If the sponsor or
    applicant requests a date for the meeting that is beyond 30 days from the date the Agency receives the request, the meeting should be scheduled to occur no later than 14 days after the date requested."

    ----------------------...
    see page2

    http://1.usa.gov/1a4Y36A
    Oct 25, 2013. 09:56 AM | 1 Like Like |Link to Comment
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