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Mr. Rosenman has nearly 15-years executive experience in the health and wellness sectors, including weight loss, cosmetics skincare and nutrition, both Rx and OTC. Expertise areas include strategic market and product planning and corporate development (evaluation, recommendation and execution of... More
  • Yet More New Developmetn Re; Amarin 75 comments
    Jul 29, 2013 1:11 PM | about stocks: AMRN, OMTH

    IP continues to go AMRN's way. Epanova patent argument rejected by USPTO. Not a typical non-final. It's a thumbs down, prior art response. Epanova has zero composition patents. AZN just wasted a few hundred million bucks.

    Stocks: AMRN, OMTH
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Comments (75)
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  • Did they get any tax losses to go along with that buy?
    29 Jul 2013, 03:17 PM Reply Like
  • not so much as the tax savings picking up an Irish domiciled Co ( see ELN / Perrigo PRs )
    29 Jul 2013, 05:08 PM Reply Like
  • Was Epanova patent rejected today or are we still talking about the AMRN patent?
    29 Jul 2013, 05:16 PM Reply Like
  • Author’s reply » There is next to no tax benefit for buying OMTH, whereas if they acquired AMRN today, they would gain approx. $900MM in NLFO, which would actually help pay for the transaction itself, unreal that AMRN is not $12-15 on no additional news right now...
    29 Jul 2013, 06:03 PM Reply Like
  • Yes shocking. Sometimes I think AZn bought OMTH just to save a billion on AMRN,,Its just makes no sense to me.
    29 Jul 2013, 06:20 PM Reply Like
  • Hey where are you getting the $900 mm from? I saw on the latest 10k "The Company has combined Irish, UK, and Israeli net operating loss carryforwards of $315.6 million, which began to expire in 2011. In addition, the Company has available U.S. Federal tax credit carryforwards of $0.4 million and state tax credit carryforwards of $2.3 million. These carryforwards which will expire between 2029 and 2031 may be used to offset future taxable income, if any. "
    22 Aug 2013, 05:59 PM Reply Like
  • Author’s reply » google finance stats on amarin as of 2 months ago.
    23 Aug 2013, 04:05 AM Reply Like
  • Author’s reply » Yes, OMTH does not have much to go on.
    29 Jul 2013, 06:03 PM Reply Like
  • Steve, when do you guess a sustained AMRN rally beginning? The chart shows a double bottom around 5.20. Also, in a weird-world, if AMRN fails the adcom, how much could it hit the stock ($4...) and new BO target price levels?
    1 Aug 2013, 08:24 AM Reply Like
  • Author’s reply » I am of the very firm opinion that with Anchor behind us, AMRN makes new highs, and goes for $28-32 on premium.

     

    Should we have no decision on anchor in december, $5 range is where we would be. To clarify: ANCHOR WILL BE APPROVED DUE TO ITS PHASE 3 DATA RESULTS... some people questioning when, but not me.
    1 Aug 2013, 04:21 PM Reply Like
  • Steve,

     

    Is there any precedent for early PDUFA approval - such as for Anchor before December 20 - following a confirming AdComm? All indications are that the sNDA was deemed extremely clean (more so even than Marine) and safety & efficacy are stellar. Thoughts? Thx.
    1 Aug 2013, 04:45 PM Reply Like
  • and Anchor safety data is already on the Vascepa label now! Adcom mostly about safety!
    1 Aug 2013, 04:56 PM Reply Like
  • Make the hoops Amarin has to jump through all the more bizarre!
    1 Aug 2013, 04:59 PM Reply Like
  • Author’s reply » It "can" happen, but not really likely. FDA busy...
    1 Aug 2013, 05:37 PM Reply Like
  • This conference with dr. Deepak Bhatt , do u think we might get some prelim reduce it results, and maybe a huge pps jump
    2 Aug 2013, 09:24 AM Reply Like
  • kokoszka,

     

    Probably not. The company is blinded to the data, and can't know how well the trial is going until it finishes.
    4 Aug 2013, 01:59 PM Reply Like
  • Author’s reply » A new article is coming and includes some dialog I ad with one of AMRN's largest fund managers. Bottom line I got out of the conversation is that anyone holding AMRN through the fall is going to be in a really good position.
    4 Aug 2013, 01:31 PM Reply Like
  • Steve-

     

    It's almost 3 weeks later and I have still not seen your new article about your "conversation" with AMRN's largest fund managers. Will you still be sharing this info with us, or was there ever a conversation to begin with?

     

    Thanks.
    21 Aug 2013, 04:12 PM Reply Like
  • Author’s reply » Yes there was a conversation. While I have been busy, they have also asked me not to share some of the info. There are some things I can share though and I will when time allows. I can tell you that they are aligned with what we are hearing from JZ about doing things to maximize shareholder value vs. just get press releases out. I will not be submitting editorial for now. Once FDA updates OB I will consider the piece. There seem to be many wheels in motion on several fronts right now. Thanks for hanging in.
    22 Aug 2013, 09:55 AM Reply Like
  • Ok, thanks for the update. Appreciate the insight, as always.
    22 Aug 2013, 10:16 AM Reply Like
  • Yes, thank you for the update Steve. Any tidbits helps holding these longs.
    22 Aug 2013, 12:08 PM Reply Like
  • If this asset was coveted by BP they would not wait till Anchor decision to make a deal. If multiple parties were interested, they would not sit around and wait for Amarin to fail for fear of losing out. The fact that a deal hasn't been made means that there is something that concerns BP enough to wait. Something likely very damaging to us longs.
    5 Aug 2013, 10:24 PM Reply Like
  • That is a very sweeping statement that very likely isn't true. The more valuable the asset, the more arduous the negotiations. Last year Amarin had 1 patent, hadn't even submitted an sNDA for the ANCHOR indication and had no regulatory exclusivity. Tough to make a deal encompassing the entire value of the Vascepa franchise under those circumstances. Presently we have 27 patents allowed or granted, The ANCHOR sNDA has been submitted and accepted and Vascepa is on the market and prescribed by over 7000 doctors with over 75,000 scripts written to date. REDUCE -IT is likely to be fully enrolled by the end of this year, early 2014.
    Things are firming up and tremendous progress is being made which changes the entire landscape. If we were talking about a 400 million dollar acquisition by BP, the deal would have already been done. However a $28 - $32/share price tag equates to a $5.6 to$ 6.4 billion dollar deal. These type of deals don't happen fast if at all in this case. Much more likely to see a partnership of sorts and if successful a much much larger price tag down the road.
    6 Aug 2013, 01:08 PM Reply Like
  • Further to my comment above, I wouldn't be surprised at all to see Amarin engage in a co promotion / revenue and expense sharing deal that excludes BP altogether with the intent of getting us to a REDUCE IT trial outcome. REDUCE it may be double blinded but if there is an observed statistical diversion noted early, we could see a request for interim results. Then all hell would break loose one way or the other. Management has nothing to lose here unless there is a snag with the ANCHOR approval.
    There is a large body of evidence and thought that REDUCE-IT will show results early because of the JELIS study results and the fact that REDUCE-IT trial participants are dosed higher (4 grams vs 1.8 grams) and the trial particpants are sicker( than JELIS participants) and so stat sig will show earlier.
    6 Aug 2013, 01:41 PM Reply Like
  • I've looked all over and can't find what JELIS. Would appreciate explanation. Thank you.
    6 Aug 2013, 04:50 PM Reply Like
  • Author’s reply » Well, may be true, but that fear would go away once Anchor is given the nod.
    6 Aug 2013, 06:38 PM Reply Like
  • Steve - When are you coming out with the new article? I always look forward to your articles. So when.......?
    6 Aug 2013, 06:47 PM Reply Like
  • Author’s reply » cant really say, due to my schedule
    7 Aug 2013, 02:47 PM Reply Like
  • I just noticed that AMRN hit yearly low on 26 July 2013, and was approved by FDA on 26 July 2012. This post is off-topic but I would like to know what exactly determines the pps? Is it the company fundamentals or the market or what? And what does it mean by "market"? I mean, what/who decides that ok, the pps needs to be $5.4? Isn't AMRN significantly worth more than that? And why only $5.4? why not $1.3? I mean if ALL know that AMRN should be trading higher, what is it that keeps it at $5 and how is it kept at $5? And then who decides, ok, it is time for AMRN to be at $12 now? Who/what is a MM and its role? If the stocks in general are all undervalued and typically always falling, why do more people not short a stock? Why is shorting not considered illegal? How does shorting helps a company that issues shares to raise money? How is stock trading different from betting in a casino? Why betting in casinos is usually frowned upon in societies worldwide, but stock investing is considered scholarly? A retail investor has no control on the stock price and is at the mercy of the so-called "market" (which i do not know what is it), so in a way stock investing is gambling, isn't it? In a roulette, if you see a series of even numbers, then there is a very high probability of getting odd numbers. So if I bet on an odd number and lose my money, friends and family are ready to beat me up. But if I invest in a very good company and lose money, friends and family say "hard luck, the stock was not supposed to go down." In short, I want to know who/what decides the pps.
    7 Aug 2013, 10:04 AM Reply Like
  • The wall street illuminati... nobody knows for sure

     

    Most will tell you that its just a matter of supply and demand, but we are not that stupid. The market is manipulated by the large holders and market makers. They are the ones to call the price... cramer has admitted that as a fund manager he had the power to control a stock price and that they do it a lot. Amarin currently not so popular among those players I guess.

     

    Bottom line market is pretty much rigged, and you can only hope its rigged in your favor and that those who call the shots like the stock.
    In case of a buyout however, the game is over and the price is set.. lets hope that happens..
    7 Aug 2013, 10:26 AM Reply Like
  • Author’s reply » FDA holding up Amarin's NCE for a reason, a good reason. Q4 going to be a lot of surprises, to the upside....way upside.
    7 Aug 2013, 09:09 PM Reply Like
  • most people just don't get it... but thanks for the accurate insight.. I get it.. as joe said I think all the POSSIBILITIES are all the same.. thanks for your insight.. you have called it right every step of the process... it looks to me that your background has you in the right place at the right time... thanks again
    8 Aug 2013, 10:40 PM Reply Like
  • GSK is going to be the first to make an offer.

     

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

     

    Can you share your "reason for delay"?

     

    Williams
    8 Aug 2013, 09:19 AM Reply Like
  • Author’s reply » Waiting to resolve Lovaza characterization.
    8 Aug 2013, 11:36 PM Reply Like
  • Steve, are you tying the Lovaza characterization to some specific activity on part of FDA? If so, what is it?

     

    Thanks.
    9 Aug 2013, 06:30 AM Reply Like
  • Well.....one can find a few bright spots in the CC but nothing too impressive. Hopefully we will see margins improve dramatically going forward and Tier 2 pull through make a difference in scripts. It is clear that the whole ball of wax rests on getting ANCHOR approved. I don't see a partnership or buyout unless ANCHOR is delayed. Without a dramatic downward shift in COGs and a dramatic shift upwards in scripts, Amarin's hand will be forced if ANCHOR doesn't make it through the Adcom.

     

    If ANCHOR is approved I think Amarin will attempt a GIA strategy dependent on revenues until REDUCE-IT is finished. Those looking for $28 - $35/share anytime soon are more than likely overly hopeful.
    8 Aug 2013, 06:48 PM Reply Like
  • Well one point made during the conference call was directed at substantially lowering cost on materials due to BASF and Chemport being approved. I also heard Joe say that " on a conservative estimate that gross profts would be somewhere between 78 to 85 percent". Did everyone miss this?
    8 Aug 2013, 10:45 PM Reply Like
  • Didn't miss it. I'll believe it when I see it. Cost reductions won't just be a function of bringing additional suppliers into the fold but will depend on volume. So tier 2 conversion will become very important and ANCHOR approval will be mandatory if we are to see margins the likes of which Joe spoke about. BASF isn't simply going to produce small amounts of Vascepa and sell it cheaply on a promise. There likely will be a sliding scale according to volume.
    9 Aug 2013, 12:54 AM Reply Like
  • Author’s reply » Getting lots of messages asking about NCE and hearing lots of rumblings regarding NCE granted to Amarin. I have no confirmation of this at all. I believe much of the action is tied to various documents FDA is releasing regarding Lovaza citizen petition and unrelated recent legal documents related to FDA's position on NCE that seem favorable to Amarin's situation.
    22 Aug 2013, 02:37 PM Reply Like
  • Steve - Obviously there must have been some developments subsequent to your post indicating an imminent article on your part and discussions with one of Amarin's institutional investors. Are you maintaining your bullish position and price targets?
    22 Aug 2013, 03:13 PM Reply Like
  • Could all of these new legal FDA documents be why OB is late this month?
    22 Aug 2013, 05:01 PM Reply Like
  • Author’s reply » I am a buyer here and maintain $28-32 is where we end up.
    22 Aug 2013, 05:38 PM Reply Like
  • So it is around $6B BO.
    22 Aug 2013, 06:04 PM Reply Like
  • Author’s reply » correct.
    23 Aug 2013, 04:05 AM Reply Like
  • Do u think $6 billion buyout and that's it or a $6 billion buyout with future payments if certain achievements are meet? I for one think that as crazy as it sounds that even $6 billion could be a steal after anchor, reduce it, combos, etc come into full play, your thoughts please
    23 Aug 2013, 07:10 AM Reply Like
  • golfstud this is too early to be asking\guessing something like that
    23 Aug 2013, 07:46 AM Reply Like
  • Probably right but when anchor gets approved by year end a buyout could be in the works so that means less then 4 months from today. If your joe z do u sell for $6 billion and walk away or do u want more? Fast forward 5 yrs from today, could be a drug that sells that amount in 1 yr ....
    23 Aug 2013, 08:10 AM Reply Like
  • Anyone care to comment on this ihub post?

     

    Re: BioChica Post# 13009
    What I'm worried about is that the ANCHOR adcom is about statin + V, not just V for TGs 200-500, which is why I'm taking it. Prior to that language being put out, I believe ANCHOR was "with or WITHOUT a statin". If the revised label says V + statin for ANCHOR, insurance may not cover it unless you're also taking a statin. THAT'S what I'm worried about! Over the last 3-4 months my health costs have gone up dramatically, close to $200/mo out of pocket, because of no insurance coverage for V and another issue - for someone on a fixed income with no COL adjustments, that HURTS.
    25 Aug 2013, 07:33 AM Reply Like
  • The sNDA is for triglycerides 200 mg/dl - 500 mg/dl. The ANCHOR trial was done with optimized background statin therapy to show that Vascepa has a positive effect on trigs and several inflammation biomarkers despite statin usage. I have yet to see where the sNDA specified Vascepa usage as an adjunct to statin therapy only. That wouldn't make sense to me. A patient may have a normal lipid profile except for trigs. Dictating that Vascepa only be approved with statins would be pre-empting a doctors discretion unnecessarily.
    Clearly if a patient has an abnormal lipid profile, statins would be the first line of defense and the standard of care. Use of Vascepa would be for residual risk due to trigs remaining out of range. However, if trigs are the only issue, Vascepa would/could be prescribed only.
    25 Aug 2013, 08:31 AM Reply Like
  • I enjoy Steve's articles... The make me believe (if only for a few moments) that I made a good investment. Still here we are at the end of August, and hardly any bullish authors write articles on this dog. There were more positive articles last year when we were in the teens. Now a few additional patents and some sales data and we are close to $5. I am getting more than concerned. Wall Street knows something we don't. GIA is basically a failure in my opinion. Still I wait for Dec 20th. I am selling this dog first chance I get to break even. My fear is management gets anchor and continues the GIA strategy that Wall Streets obviously hates.. I would expect we would continue to get punished if this is the case. Hopefully there is a run-up and I can get out with minimal losses or perhaps a small gain at or around Dec 20th.
    25 Aug 2013, 09:25 AM Reply Like
  • I wonder what this stock would trade for in case of Anchor+GIA.
    25 Aug 2013, 10:33 AM Reply Like
  • Samuel - That is my greatest fear. My guess - around $5.00. At least until they can show some scripts. Than maybe a double to around $10.00. Our only hope is a BO. Somewhere between $12-$20 after anchor... I just don't see anything above $18 as some people are overly optimistic on a stock thats been trading in the $5s..... PS, I would love to be wrong!!!
    25 Aug 2013, 11:56 AM Reply Like
  • I've been asking the same thing not long ago.. no response.
    Could it be that price levels won't change much even after the long awaited approval... Wall street not being excited over potential value until reached\buyout, if and when...
    25 Aug 2013, 01:36 PM Reply Like
  • The greatest fear here is not adcom or fda date, It's ANCHOR+GIA.

     

    "Don't cross a bridge until you come to it"
    25 Aug 2013, 02:03 PM Reply Like
  • No. ANCHOR+GIA is not a fear. It is exactly what the true longs want, contrary to what most analysts continue to sell to their audience. Premature BO will kill any shareholder value. AMRN never needed nor will need BP's charity to be successful. AMRN pps should be worth $80 in 2 years time. Only flippers who want to make a quick 200-400% are misguiding the general public as to what AMRN should do. And don't worry, AMRN has what it takes for a successful launch after ANCHOR approval. Investors should do their independent DD rather than rely on anybody else's personal opinions.
    1 Sep 2013, 08:18 AM Reply Like
  • I didn't expect Novasep sNDA for some time yet. Great to know the worlds largest chromatography separation plant is coming along ahead of schedule.
    26 Aug 2013, 03:33 PM Reply Like
  • Even if ANCHOR gets approval in Dec, AMRN pps will continue to be in the $5-7 range. It is highly unlikely (almost impossible) that any BP will shell out what JZ is demanding. GIA is the only option left. Buyout will not happen before 2016.
    28 Aug 2013, 12:49 PM Reply Like
  • great opinion.. and could you give us retail investors some insight please. what is your opinion based upon.. please?
    28 Aug 2013, 09:19 PM Reply Like
  • Author’s reply » hahaha, that one is so funny I think i'll leave it up for the rest of the board to laugh at.
    29 Aug 2013, 10:07 AM Reply Like
  • Coldcoffee, so you are saying that any BP will pay what JZ wants for ANCHOR but a BO can be possible after 2016 ( REDUCE-IT) when AMRN value reach over 10 Billion $.
    Very smart, better pay 10 in a few years than 4-5 right now ... hilarious!!!
    28 Aug 2013, 10:13 PM Reply Like
  • I'm not sure JZ would sell for 5-7 billion now. With all the work Amarin has put into getting the Vascepa franchise off the ground, JZ may very well attempt to take this all the way. If in fact Vascepa can develop enough revenue in 2014 and Amarin can leverage that type of volume to secure high margins......why sell at all until REDUCE-IT outcomes are known? And...if REDUCE-IT were to show stat sig reductions in cardiac events.........10 billion might be too low, lol.

     

    If BP really wants this, they had better put their best foot forward now or forever hold their piece.

     

    Either JZ has turned into a tremendous poker player with a stone face or we have passed the window of opportunity as respects sale of the company.
    29 Aug 2013, 12:58 AM Reply Like
  • You got that right. AMRN would be stupid to sell now. Plus, they do not need to. I challenge anyone to give me one good reason why AMRN should sell. They did not sell when they were offered $22 in 2011, then why should they now? I do not see why AMRN should sell itself out because some analysts think they should sell. That to me is hilarious. AMRN is well suited to GIA all the way to REDUCE-IT. I am long AMRN for next 3 years. Investors who know the game, are actually of the opinion that AMRN must not sell. SR has his own opinion, nothing wrong with that. The only problem is it is not the only opinion, and certainly not JZ's.
    29 Aug 2013, 09:52 AM Reply Like
  • thanks for your insight..and could you extrapolate on the " investors who know the game, are actually of the opinion that AMRN must not sell",, and how also,, could you give us retail investors some insight concerning.. OPINIONS... "certainly not jz's" thanks my good man
    30 Aug 2013, 09:33 PM Reply Like
  • Author’s reply » We'll see. One thing I know is that come approx. 2 months from now, a nuclear weapon is going to be dropped on shorts and non-believers.
    29 Aug 2013, 10:01 AM Reply Like
  • The lack of institutional support and meaningful price movement we are currently seeing is part and parcel of the outstanding issues that will come to a head at the end of the year. Whether we agree or not, an exclusivity decision by the FDA will remove a huge overhang. Despite an impressive and growing patent portfolio, I think everyone is waiting for a decision and subsequent fallout ( if we don't receive NCE) before taking a pencil to this. First though, we have to get through the panel and PDUFA.
    Yesterday the mainstream press and news wire carried a very important story connecting systemic inflammation to disease progression.
    http://bit.ly/187jxRd

     

    Since Vascepa lowers important inflammatory markers and changes the EPA/arachidonic acid ratio, we should start to see a very important tie in soon. Hopefully the panel discussion will shed light on this. I think we are on the cusp of a very important paradigm shift in treating heart disease and many other diseases as a matter of fact.
    29 Aug 2013, 11:20 AM Reply Like
  • Well that is obviously after the ad-com date. Can you give a hint??
    13 Sep 2013, 06:22 PM Reply Like
  • although JZ disagrees with me, NCE determination will be cataylst for everything. It will rocket us 100% immediately, and potential suitors will pull trigger, or wait for adcom, then pull trigger, all depends on when decision gets issued.
    29 Aug 2013, 12:01 PM Reply Like
  • I tend to think a decision on exclusivity will come after PDUFA, in Jan 2014.
    29 Aug 2013, 12:34 PM Reply Like
  • respectfully disagree, it will come before, optimistically before ADCOM, conservative before pduda
    then after pfuda in Jan 2014, Anchor will recieve NME with 3 years, no matter though, 5 years with Marine will do
    I don't think (just my opinion) fda wants NCE topic discussed during ADCOM, put it to bed before panel
    29 Aug 2013, 12:46 PM Reply Like
  • Exclusivity won't be discussed during the adcom. An adcom may be mandated because a drug compound is considered an NCE but the proceedings under an adcom are to determine a benefit/risk profile and won't include discussions on exclusivity issues.

     

    Whether or not the ANCHOR indication is approved or not, Vascepa is either a NCE or it isn't. The indication has no bearing on that decision.
    29 Aug 2013, 01:29 PM Reply Like
  • Any timeframe on when your article will be out?

     

    Also, I recently went to my primary care physician and mentioned Vascepa to him. His response "I won't try anything new until everyone tries it" and unfortunately next made this statement..."Fish oils can cause prostate cancer." He's been practicing medicine for 30+ years!!!

     

    We need to change this mentality! AMRN needs to spearhead a campaign to change this way of thinking! Blockbuster or not, proven trials are showing us that this is too important of a drug to let fall through the cracks!
    29 Aug 2013, 02:32 PM Reply Like
  • Author’s reply » I don't disclose specific time when it may hit, for obvious market reasons.
    29 Aug 2013, 03:11 PM Reply Like
  • what gives here? amarin submits for (TG =200 mg/dL and < 500 mg/dL)(ANCHOR) and FDA is discussing concomitant use with an inhibitor of HMG-CoA reductase (statin)?

     

    February 26, 2013
    Amarin Announces Submission of Supplemental New Drug Application (sNDA) for Vascepa(R) for the Treatment of Patients With High Triglycerides With Mixed Dyslipidemia
    BEDMINSTER, N.J. and DUBLIN, Ireland, Feb. 26, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that it has submitted a Supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Vascepa(R) (icosapent ethyl) capsules for use as an adjunct to diet in the treatment of adult patients with high triglycerides (TG =200 mg/dL and < 500 mg/dL) with mixed dyslipidemia. Amarin expects to hear within 74 days from the FDA whether the sNDA submission has been accepted for review (inclusive of the standard 60-day review and the standard 14-day communication periods).

     

    April 23, 2013
    Amarin Announces FDA Acceptance of Supplemental New Drug Application (sNDA) for Vascepa(R) for the Treatment of Patients With High Triglycerides (>200 mg/dL and <500 mg/dL) With Mixed Dyslipidemia
    BEDMINSTER, N.J. and DUBLIN, Ireland, April 23, 2013 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the Food and Drug Administration (FDA) has accepted its Supplemental New Drug Application (sNDA) seeking approval for the marketing and sale of Vascepa(R) (icosapent ethyl) capsules for use as an adjunct to diet in the treatment of adult patients with high triglycerides (TG =200 mg/dL and < 500 mg/dL) with mixed dyslipidemia. The acceptance of the sNDA indicates that the application is sufficiently complete to permit a substantive review. The application will be subject to a standard review and has been assigned a Prescription Drug User Fee Act (PDUFA) date of December 20, 2013. The PDUFA date is the target date for the FDA to complete its review of the sNDA.

     

    Agenda
    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.
    1 Sep 2013, 03:41 PM Reply Like
  • The ANCHOR trial: A multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal Phase 3 study in patients with high triglycerides (≥200 mg/dL and <500 mg/dL) who were also on statin therapy. http://bit.ly/14vf2U2

     

    The ANCHOR trial met its primary and secondary endpoints.

     

    Wed, 11/16/2011 -
    Amarin Corporation plc, a late-stage biopharmaceutical company with a focus on cardiovascular disease, announced the first presentation in a scientific session of data from Amarin's Phase 3 clinical trial, the ANCHOR study, in which patients with high triglycerides who were also on statin therapy experienced a significant reduction in triglyceride levels and other lipid parameters,
    as well as important inflammatory biomarkers.

     

    So what else is new ?
    2 Sep 2013, 12:51 AM Reply Like
  • yes, I realize amarin has presented additional scientific evidence of reductions in "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."

     

    but has amarin reported an sNDA for anything other than "the marketing and sale of Vascepa(R) (icosapent ethyl) capsules for use as an adjunct to diet in the treatment of adult patients with high triglycerides (TG =200 mg/dL and < 500 mg/dL) with mixed dyslipidemia."?
    2 Sep 2013, 11:11 AM Reply Like
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