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  • Amarin's Case Vs. FDA Will Garner Positive Attention [View article]
    Ralphey,
    It's far worse than just bureaucratic malpractice...the FDA calculated a scheme to defraud Amarin and use bureaucratic means to perpetrate not just NCE "mistake" but rescindment of Anchor SPA.

    The 2-6-2014 CDER "Exclusivity" Board meeting minutes, suggest the FDA's motivation was to give Amarin's patented molecule to generic filers as soon as possible. By doing so CDER collects $500,000 in GDUFA fees...which apparently was enough for CDER to use their regulatory powers to execute Amarin.

    After Amarin didn't bleed to death from delaying exclusivity, CDER rescinded Anchor SPA, with Anchor Amarin would unstoppable. NME assigned 18 months post approval, was meant to be the fatal blow to the back of Amarin's head. Amarin did not die of the wound and now are pointing the finger directly at the gun man.

    BB
    Mar 21, 2015. 10:02 AM | 10 Likes Like |Link to Comment
  • Amarin Argues In Court For Vascepa Exclusivity [View article]
    Case "Held in Abeyance" yesterday after arguments.

    Minute Entry; for proceedings held before Judge Randolph D. Moss: Motion Hearing held on 3/17/2015. [11] MOTION for Summary Judgment filed by AMARIN PHARMACEUTICALS IRELAND LIMITED, [13] Cross MOTION for Summary Judgment filed by MARGARET A. HAMBURG, FOOD AND DRUG ADMINISTRATION, KATHLEEN SEBELIUS Held in Abeyance. (Court Reporter Chantal Geneus) (hs)
    Mar 19, 2015. 10:10 AM | 1 Like Like |Link to Comment
  • Amarin: Will The Lamb Of Ireland Bleat Or The Lion Of The People Roar? [View article]
    The FDA is set out to destroy a publicly traded company...The history:

    1) 28 USC § 1346 (b)
    7-26-2012 FDA/CDER failed to exercise due care with the omission of New Drug Exclusivity in Marine NDA 202057. CDER did not COMPLETE the requested RPM form, assigning exclusivity. This was not a discretionary function; in addition, not providing a reasonable explanation or timeline is also a required function of the review team. Adequate communication is a reasonably expectation as evidenced by MAPPs 6010.5 PURPOSE BACKGROUND REFERENCES POLICY RESPONSIBILITIES EFFECTIVE DATE and MAPP 6010.8 PURPOSE BACKGROUND REFERENCES DEFINITIONS POLICY RESPONSIBILITIES PROCEDURES EFFECTIVE DATE.

    It's unclear what Office made the decision to hold Vascepa's exclusivity, 6-22-2012 Amarin met with Elizabeth H. Dickinson, Esq., FDA Chief Counsel, Mustafa Unlu, Kim Dettlebach, Rachael Vieder, Jay Sitlani, Denise Esposito, Keith Webber David Read, Eric Coleman, Kurt Rosebraugh, and Kati Johnson. I would argue exclusivity delay, leading to damages, was made at or above Chief Counsel. This is very disturbing considering the substantial conflicts of interests Mr. Taylor brings to the table advising the Commissioner.

    A reasonable response in this particular situation would have clearly laid out the issues and given a reasonable time frame for an Exclusivity action date. Instead the uncertainty of exclusivity led to the erosion of Amarin common stock providing a barrier for Amarin and Stakeholders to value Amarin's Vascepa life time value. With the inability to value Amarin's drug asset it created a material barrier to: obtaining financing, enter into a Co-market Partnerships or Value and sell the Company which was the well stated business plan. Amarin has failed to successfully market Vascepa and will financially be destroyed due to Negligent Supervision, Negligent Hiring/Rehiring (18 US CODE 207), Negligent Retention and Negligent training.

    2) 28 USC § 1346 (b)
    September 21, 2012 Filed a request for patent term extension 35 U.S.C. 156. No action by the USPTO could be taken due to the omission of the RPM FILING REVIEW and exclusivity determination. June 11, 2013 the FDA Office of Regulatory Policy, Beverly Friedman, was requested to confirm "If the approval of Vascepa constitutes the first permitted commercial marketing or use of Icosapent ethyl for the purposes of compliance with 35 U.S.C. 156(a)(5)(NYSE:A)". Office of Regulatory Policy failed to submit the required documents within the prescribed Regulatory time frame of 60 days and further failed to follow Regulation 35 U.S.C. 35 CODE 156 to advance the decision to the Secretary of Health and Human Services.

    3) 28 USC § 1346 (b)
    FDA/CDER failed to exercise reasonable communication related to Exclusivity. The FDA/CDER did not adhere to appropriate MAPPS 6010.5 & 6010.8 as would be a reasonable expectation. Failure to communicate led to massive a Market Share value and limited business opportunities.

    4) Antitrust laws Sherman Act 1890, the Clayton Act 1914 and the Federal Trade Commission Act 1914

    "Free and open markets are the foundation of a vibrant economy. Aggressive competition among sellers in an open marketplace gives consumers — both individuals and businesses — the benefits of lower prices, higher quality products and services, more choices, and greater innovation. The FTC's competition mission is to enforce the rules of the competitive marketplace — the antitrust laws. These laws promote vigorous competition and protect consumers from anticompetitive mergers and business practices. The FTC's Bureau of Competition, working in tandem with the Bureau of Economics, enforces the antitrust laws for the benefit of consumers."---FTC ( http://1.usa.gov/1zZb5Dw )
    Negligent Supervision, Negligent Hiring/Rehiring (18 US CODE 207), Negligent Retention and Negligent conflicts of interests, and omissions all within of scope of FDA/CDER Offices employment but were not limited to completing Regulatory paperwork, following guidance documents relating to SPA rescindment, following guidelines when excepting Citizen Petitions and violating confidential posting rules, but most notably the failure to assign ANY exclusivity.

    The omission of exclusivity has been noted by Amarin as a barrier to raise funds, transact a co-marketing arrangement or engage in M&A transactions. This has been anticompetitive while Amarin's competition has received expanded labels, and new patent use codes despite DRUG SPECIFIC CLINICAL BENEFIT FAILURES.

    This is in violation of the Sherman Act 1890, the Clayton Act 1914 and the Federal Trade Commission Act 1914. "These Acts, first, restrict the formation of cartels and prohibit other collusive practices regarded as being in restraint of trade. Second, they restrict the mergers and acquisitions of organizations which could substantially lessen competition." This was indeed the case!

    5) Tucker Act 28 USC 1491

    The SPA agreement was considered "binding", Amarin met all obligations, No public safety concerns where expressed to the company, No change significant change in science was communicated...until concerns where expressed at Ad Com, the FDA breach terms of SPA related to communication and unjustified rescindment, the FDA's breach has materially damaged Amarin. Damages include but are not limited to lay off of 50% Amarin's sales force, a huge drop in market capital, loss of institutional investor support limiting the ability of Amarin to fund Market, Sales and continuation of the cardiovascular reduction trial REDUCE-IT.

    CDER/DMEP unjustly rescinded Anchor SPA agreement, in addition to the writen SPA, terms where recapitulated during October 16th Advisor Committee meeting as follows:

    DR. HIATT: I can see the challenge you're
    facing because you've sort of set yourself up for it in some ways because historically, you've approved lipid drugs because they improve lipid parameters and diabetes drugs because they drop blood sugar and A1c. And it's only later that we really learn whether those decisions were the right thing or the wrong thing.
    So it would seem to me unfair to the sponsor if you've historically approved lipid drugs because in a population they do something that looks good; why would you suddenly change the bar at this moment in time? Which is why I was asking that earlier question about, well, what's up? Are you going to change the way new add-on therapies should be judged? But on the other hand, if you do approve it and the REDUCE-IT trial is negative, what will you do then? Will you withdraw the drug from the market?

    DR. COLMAN: Well, that's a big hypothetical, so I'll tread carefully. But if we were truly convinced that the trial was negative, showed no benefit, I suspect the first thing we would do is we'd contact the company and say, look, we think that this trial clearly failed, and we think you should remove the indication from the labeling.
    Now, if they say, "Okay, we agree with you," fine. Everything's fine. If they disagree, then we go down a whole different path that involves lawyers and that involves potentially misbranding, imminent hazard, and I suspect it could be very prolonged before anything would happen.

    DR. HIATT: So a simple approach to all that is to say, well, you already said that the reason that we would give a drug like this in this population is only one reason. It's to reduce cardiovascular risk. If there's uncertainty about that, it's simple enough to say, wait till the trial's over. Don't do anything. Don't paint yourself in a corner or evoke more problems because you approved something and then you had to change the label later. Just wait for the event trial to conclude to judge whether the primary endpoint is positive or negative, and then it's a simple decision at that moment in time. But historically, you haven't done that, and this sponsor's done everything you've asked them to do. They've started the trial, they're in the middle of it, and they've got a drug that does what it's supposed to do. Why would you --

    DR. COLMAN: Well, let me remind people what I said this morning. The special protocol assessment is a binding agreement unless it's determined that a substantial scientific issue is essential to determining the safety or efficacy of the drug has been identified after the testing has begun. Now, we believe that ACCORD Lipid, AIM-HIGH, HPS2-THRIVE, and perhaps some of the Omega-3 fatty acid outcomes trials that have been published in the last two or three years, that does change the landscape.

    DR. HIATT: Remind us what was agreed upon because usually special protocol assessments are around the trial design.

    DR. COLMAN: Right. So in other words, this would -- well, I don't want to get too far into this. But let's just say that they are binding agreements about the design, the analysis, and the size of the trials. But if some external information comes up after the testing began that you think influences the size or the analyses, then the agreement doesn't necessarily hold.

    DR. HIATT: I know you stated this at the beginning. But just so I understand it, what did you actually agree to?

    DR. SEELY: Could you put the slide back up. That would be helpful.

    DR. HIATT: Yes. The ANCHOR trial was under
    a special protocol assessment and REDUCE-IT was under a special protocol assessment. But the fact that we are here 50 percent of the way through enrolling REDUCE-IT, was that part of your agreement? Yes, that is.

    DR. COLMAN: Right.

    DR. HIATT: So you hit that number, and that's part of the SPA agreement.

    DR. COLMAN: Right.

    DR. HIATT: So that's why we're here.

    DR. COLMAN: What we said was, you would
    have to have a 12-week study, ANCHOR --

    DR. HIATT: Done.

    DR. COLMAN: -- have the outcomes trial
    50 percent enrolled before we would accept a submission for consideration of approval. So we agreed again. We agreed to the design, to the size, to the analyses of those two studies. But as I've mentioned, if there are new data that appear that could influence the design or the size or the analyses, that can be factored in.

    DR. HIATT: Certainly, and that's clear.
    But absent that new data, do the agreements that you've made essentially commit you to say, you have a positive ANCHOR trial, you've 50 percent enrolled in a cardiovascular outcomes trial, and we agreed that if you did the lipid things that you said you'd do in ANCHOR and the outcomes trial was
    50 percent recruited, that we would grant you a change in your label? Was that the agreement?

    DR. COLMAN: Yes. For example, if ACCORD Lipid and AIM-HIGH and THRIVE were all positive, I think we'd have a very different discussion going on.

    DR. HIATT: Sure. And the only thing that could change that agreement is an interpretation of new evidence that came after the agreement.

    DR. COLMAN: Or, obviously, the data that are generated in the studies themselves. If you don't know the TG-lowering that they showed is sufficient, that's obviously --

    DR. HIATT: But it's statistically significant.

    DR. COLMAN: No. I'm just saying if someone
    argued that that wasn't as large as they'd like to see.

    DR. SMITH: Dr. Parks?

    DR. PARKS: Yes. I think that we're getting into the slippery slope, Dr. Hiatt, of the hypotheticals.
    ------

    The debate was abruptly ended by Dr. Parks
    Jul 21, 2014. 09:04 PM | 11 Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    What you fail to understand is science and spelling. I'm a terrible speller so I forgive this part, but you claim to know the science. You are ignorant. Statins perceived success is built on lower LDL, this is a false assumption. LDL is a poor surrogate marker, perhaps as bad as Triglycerides. JUPITER, Crestor success is based on inflammation, not LDL. Vascepa happen's to be the body's physiological back bone to inflammation via the Eicosanoids system.

    You are clueless and should move on.

    Williams
    Nov 19, 2013. 07:00 PM | 6 Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    Adam
    How did you guess the FDA was going to tank Amarin?
    Have you ever spoken to John Fuson?
    Have you ever been in contact with GSK?
    If yes, was Amarin a topic?
    Who do you know at the FDA?
    Who have you been in contact with at the FDA? (either E-Mail, Phone call, or person to person meeting)
    Have you ever accepted money, from anyone other than the Street dot com, to publish articles in the past two years? If yes, where you paid in cash and did you pay taxes on this "income"?

    These are the questions that you'll be asked if you continue your involvement in the soon to be criminal investigation. Today, you've made the list of those that colluded to damage Amarin...
    Nov 19, 2013. 05:47 PM | 7 Likes Like |Link to Comment
  • Why The FDA Got It Wrong And Why It Will Approve Vascepa For ANCHOR SNDA Submission [View article]
    In 2014 the FDA will have to explain to the DOJ and OIG why it violated numerous policy's and colluded with BP to illegally destroy Amarin's Market value.
    Nov 19, 2013. 07:35 AM | 15 Likes Like |Link to Comment
  • AF Backtracking, AMRN Will Be Approved On Time [View instapost]
    Adam,
    Niacin is not fish oil. Fish oil is not Vascepa. Why do you ignore JELIS? JELIS sub group and 50% reduction in cardiovascular outcomes is undeniable. If the FDA wants to see the results of REDUCEIT, they'll approve Anchor to support the study costs. Otherwise, Amarin cuts study to penatrate Very High Trigs to Lovaza levels, business before science...the FDA should understand this concept.

    Fish oil does crap for CV outcomes, why? EPA blood levels
    Vascepa's EPA levels are 30 times higher than Lovaza, and 50+ higher than OTC ?toxic? fish oils. EPA is "essential" to the science of eicosanoids and inflamation. Over a year ago I though Amarin was total BS, until I studied the science. I could now teach a college level course on the subject, Vascepa will be the number one seller in the next 5 yrs, sell over $10 Billion in one year and take the top spot form Lipitor in life time sales. Perhapse you should research Dr. Sears.

    Jokes on me if I'm wrong...a risk I'm taking.

    Williams
    Sep 25, 2013. 09:26 PM | 7 Likes Like |Link to Comment
  • AF Backtracking, AMRN Will Be Approved On Time [View instapost]
    Adam, I think you and Steve should live blog the Ad Com together...

    There's no data to support waiting for an outcome study, yet numerous scientific evidence supporting significant reduction in TG, non-HDL-C, Apo B, LDL-C, TC, and VLDL-C. No Afib or increase in LDL...with a risk safety profile literally better than Tylenol. The committee will look like total bafoons if Vascepa receives a neg Ad Com vote for a SPA drug meeting all primary and secondary endpoints with zero safety signals.

    The committee will discuss the supplemental new drug application, NDA 202057/S-005, Vascepa (icosapent ethyl) Capsules, submitted by Amarin Pharmaceuticals Ireland Ltd. Vascepa is currently approved as monotherapy for the treatment of severe hypertriglyceridemia. This supplemental application proposes concomitant use with an inhibitor of HMG-CoA reductase (statin) to reduce triglycerides (TG), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (Apo B), low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and very-low-density lipoprotein cholesterol (VLDL-C) in adults with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent.

    Not sure how anyone could really see this ending with a negative vote. Steve get's a paragraph in your Oct 17 th article if Amarin get's an all thumbs up...what do you say?

    Williams
    Sep 25, 2013. 06:02 PM | 7 Likes Like |Link to Comment
  • This Amarin Bear Is Throwing In The Towel [View article]
    To add to "the generic issue"...getting generic API or Epanova cheaper than Amarin is not an easy feat, and likely down right impossible after Anchor. (Larger Vascepa batches will be less expensive with volume discounts)

    Epanova API will be significantly more expensive than both Vascepa and Generic, FFA form more expensive to produce also "Patent Capusule" is more expensive. But as you state both generics and Epanova are like ASA competing with Vicodin...
    Sep 23, 2013. 11:39 AM | 3 Likes Like |Link to Comment
  • Explosive Bidding Situation Setting Up For Amarin [View instapost]
    Steve
    It gets even hotter! Direct link to Pfizer on Patent PAIRs, patent ap # 13/266,085. It lists Pfizer Manager John Mulhern on Electronic Patent App Transmittal 9-13-2013. Guessing this was an oversight by new Chicago law firm handling this patent. K&L Gates, David Fournier changed firms 3-2013, from K&L Gates to Perkins Cole. New Attorney at Perkins Cole, Randy Micheletti, seems to be leading the charge. His speciality is Omega 3's and statin derivatives.

    I'd be surprised if Amarin doesn't field a low ball offer before the real deal.

    Williams/Biobillion
    Sep 16, 2013. 03:11 PM | 5 Likes Like |Link to Comment
  • Amarin's Stock Price Movement [View instapost]
    The FDA has no restrictions on the OB, they can skip the whole month if they desire.

    I'm thinking the Ad Com, & NCE got bumped up the chain of command.
    Aug 19, 2013. 05:22 PM | 2 Likes Like |Link to Comment
  • GlaxoSmithKline Clearing The Clouds Over NCE Prospects Of Amarin's Vascepa [View article]
    "If NCE is still undecided for MARINE when ANCHOR is approved, V is eligible for 3 yrs. for ANCHOR but not 5 yrs" How did you come to this conclusion?

    Icosapent Ethyl is by no question a NCE regardless of indication.

    As GSK has recently stated in the response to Crowell & Moring LLP- CP (FDA-2013-P-0148-0001), "the active ingredient (In Lovaza) is not simply the seven omega-3-acid ethyl esters, but the entire mixture", the Icosapent Ethyl should be considered a single agent separate from the mixture. Clearly CDER came to this conclusion with Biogen's Dimethyl Fumarate.
    http://1.usa.gov/Ydx1oN;D=FDA-2013-P-0148-0003

    The Biogen decision is backed by CDER director in a response to a TEVA CP here: http://1.usa.gov/Ydx1oN;D=FDA-2013-P-0025-0003

    To use the http://www.reg link 1) go to http://1.usa.gov/134gFCB 2) cut and paste the document number FDA-2013-P-0025-0003
    Aug 16, 2013. 06:55 AM | Likes Like |Link to Comment
  • GlaxoSmithKline Clearing The Clouds Over NCE Prospects Of Amarin's Vascepa [View article]
    "Complicated decisions" ---- what? It depends on what company files the NDA? If your Biogen it's clear cut, Amarin...well the FDA NCE question started March 2011. Pathetic...that's what it is.
    Aug 15, 2013. 07:13 PM | 1 Like Like |Link to Comment
  • GlaxoSmithKline Clearing The Clouds Over NCE Prospects Of Amarin's Vascepa [View article]
    Who was Crowell & Moring client?

    Why did CDER rule so quickly on Biogen's Dimethyl Fumarate, it was approved in Novartis's Aliskiren Hemifumarte mix?
    Dimethyl Fumarate was approved with no Ad Com and given NCE status..Immediately. CDER director Janet Woodcocks set's TEVA straight on the FDA's flexibility to approve a NCE with no Ad Com here: (pg 5-7) http://1.usa.gov/Ydx1oN;D=FDA-2013-P-0025-0003
    Too bad Vascepa's NDA didn't get the same consideration.


    Biogen Idec's Dimethyl Fumarate:
    Biogen Idec received NCE for Dimethyl Fumarate, after it's 505B1 application was approved. Like Icosapent Ethyl, Dimethyl Fumarate was previously approved as a "mix" in Novartis's Aliskiren Hemifumarte. The following links lead to the approvals and Pubchem sites clearly showing the compounds. I can find no FDA delays or confusion regarding the approval of and designation of NCE for Dimethyl Fumarate.

    Dimethyl Fumarate's OB Exclusivity:
    http://1.usa.gov/1dbmS6d

    Dimethyl Fumarate's chemical structure can be viewed here:
    http://1.usa.gov/1dbmS6h
    Aliskiren Hemifumarate's OB Exclusivity:
    http://1.usa.gov/1dbmUuR

    The mix containing Biogen's Dimethyl Fumarate can be viewed here at PubChem under Novartis's Aliskiren Hemifumarate:
    http://1.usa.gov/1dbmS6i


    Vascepa and Dimethyl Fumarate share the same mix/NCE parodox:
    As GSK has recently stated in the response to Crowell & Moring LLP- CP (FDA-2013-P-0148-0001), "the active ingredient (In Lovaza) is not simply the seven omega-3-acid ethyl esters, but the entire mixture", the Icosapent Ethyl should be considered a single agent separate from the mixture. Clearly CDER came to this conclusion with Biogen's Dimethyl Fumarate.
    http://1.usa.gov/Ydx1oN;D=FDA-2013-P-0148-0003

    Who's to say GSK isn't Crowell & Moring's client to delay Vascepa's NCE with the petition? Happens to be their MO:
    http://bit.ly/1dbmUuX
    If this is the case or another competitor filed through Crowell & Moring's to delay NCE, hopefully they'll have the brains to pull the trigger on a BO before the lawyers get this info:)
    Aug 15, 2013. 06:01 PM | 2 Likes Like |Link to Comment
  • Yet More New Developmetn Re; Amarin [View instapost]
    GSK is going to be the first to make an offer.


    http://1.usa.gov/132SsB4

    Can you share your "reason for delay"?

    Williams
    Aug 8, 2013. 09:19 AM | 4 Likes Like |Link to Comment
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