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david22hughes

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  • Analysis of Vascepa's FDA Briefing Documents [View article]
    And so it is. The FDA officially make it up as they go along. SPA my ass. Sales off label until REDUCE-IT outcome study results are available in 2016 is surely the only way to go now. Management would be barking mad to scrap REDUCE-IT and sell the company at this stage. But how do they fund it's completion without repeated dilution? Partnership with big pharma to fund its completion seems the only realistic option. Positive REDUCE-IT data would open the door for ANCHOR approval and Amarin finally have themselves a >$10 billion drug and a share price well north of $50. It's not all doom and gloom.
    Oct 16 09:37 PM | Likes Like |Link to Comment
  • Will Cardiovascular Concerns Jeopardize Amarin's Upcoming FDA Advisory Panel? [View article]
    Read the question being asked again:

    "Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT?"

    Here's a summary of Vascepa's main effects:

    "After 12 weeks of therapy, statistically significant differences were observed between placebo and AMR101 4g with respect to TG (-21.5%; p<0.0001) and with respect to secondary endpoints such as LDL-C (-6.2%; p=0.007) and non-HDL-C (-13.6%;p=0.0001)."

    A statistically significant reduction in TG's ALONE should be considered enough as that was the agreed upon primary endpoint of the ANCHOR trial. What incentive do pharmaceutical companies have to spend hundreds of millions of $'s conducting clinical trials if the FDA then moves the goalposts come ADCOM, PDUFA time? When combined with the secondary endpoint reductions in LDL-C and non-HDL-C along with all the other favourable lipid parameters, Vascepa clearly meets all the criteria necessary for it to be granted approval.

    From Page 8 of the ADCOM document (and repeated word for word again on page 63):

    "In considering the results of the ANCHOR trial, the presumption has been that improving various lipid parameters will translate into a reduction in cardiovascular risk. With rare exception, FDA has historically considered granting approval for lipid-altering drugs based on favorable changes in the lipid profile, with the assumption that these changes would translate into a benefit on clinical outcomes."

    REDUCE-IT, once complete, will finally back-up the assumptions, but at this time it is NOT required for ANCHOR approval.

    From page 87:

    "The applicant-sponsored cardiovascular outcomes trial, REDUCE-IT, which is studying patients at high-risk for cardiovascular disease at LDL-C goal on statin therapy with residually high triglycerides (TG ≥200 mg/dL to <500mg/dL), intends to confirm this implied benefit."

    Vascepa is safe, efficacious and has implied CHD benefit. It's as simple as that. Everything else is smoke and mirrors.
    Oct 15 05:18 AM | 15 Likes Like |Link to Comment
  • The 3 Most Likely FDA Outcomes For Amarin's Vascepa [View article]
    The FDA only required REDUCE-IT to be substantally underway before they accepted the sNDA for ANCHOR. They obviously had meetings with their management and Amarins management and the terms of the ANCHOR trial were agreed upon. To move the goalposts and to delay approval for ANCHOR at this stage makes zero sense. The FDA are about approving drugs that are safe and efficacious. Vascepa is exactly that.

    Read the question being asked again:

    "Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the
    completion of REDUCE-IT?"

    Here's a summary of Vascepa's main effects:

    "After 12 weeks of therapy, statistically significant differences were observed between placebo and AMR101 4g with respect to TG (-21.5%; p<0.0001) and with respect to secondary endpoints such as LDL-C (-6.2%; p=0.007) and non-HDL-C (-13.6%;
    p=0.0001)."

    A statistically significant reduction in TG's ALONE should be considered enough as that was the agreed upon primary endpoint of the ANCHOR trial. When combined with the secondary endpoint reductions in LDL-C and non-HDL-C along with all the other favourable lipid parameters, Vascepa clearly meets all the criteria necessary for it to be granted approval.

    From Page 8 of the ADCOM document (and repeated word for word again on page 63):

    "In considering the results of the ANCHOR trial, the presumption has been that improving various lipid parameters will translate into a reduction in cardiovascular risk. With rare exception, FDA has historically considered granting approval for lipid-altering drugs based on favorable changes in the lipid profile, with the assumption that these changes would translate into a benefit on clinical outcomes."

    REDUCE-IT, once complete, will finally back-up the assumptions but AT THIS TIME IS NOT REQUIRED FOR ANCHOR APPROVAL.

    From page 87:

    "The applicant-sponsored cardiovascular outcomes trial, REDUCE-IT, which is studying patients at high-risk for cardiovascular disease at LDL-C goal on statin therapy with residually high triglycerides (TG ≥200 mg/dL to <500mg/dL), intends to confirm this implied benefit."

    Wake up people. Arent you tired of swallowing bear shit?
    Oct 15 12:28 AM | 1 Like Like |Link to Comment
  • Analysis of Vascepa's FDA Briefing Documents [View article]
    From page 87:

    "The applicant-sponsored cardiovascular outcomes trial, REDUCE-IT, which is studying patients at high-risk for cardiovascular disease
    at LDL-C goal on statin therapy with residually high triglycerides (TG ≥200 mg/dL to <500mg/dL), intends to confirm this implied benefit."
    Oct 15 12:24 AM | 1 Like Like |Link to Comment
  • Analysis of Vascepa's FDA Briefing Documents [View article]
    The FDA only required REDUCE-IT to be substantally underway before they accepted the sNDA for ANCHOR. They obviously had meetings with their management and Amarins management and the terms of the ANCHOR trial were agreed upon. To move the goalposts and to delay approval for ANCHOR at this stage makes zero sense. The FDA are about approving drugs that are safe and efficacious. Vascepa is exactly that.

    Read the question being asked again:

    "Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the
    completion of REDUCE-IT?"

    Here's a summary of Vascepa's main effects:

    "After 12 weeks of therapy, statistically significant differences were observed between placebo and AMR101 4g with respect to TG (-21.5%; p<0.0001) and with respect to secondary endpoints such as LDL-C (-6.2%; p=0.007) and non-HDL-C (-13.6%;
    p=0.0001)."

    A statistically significant reduction in TG's ALONE should be considered enough as that was the agreed upon primary endpoint of the ANCHOR trial. When combined with the secondary endpoint reductions in LDL-C and non-HDL-C along with all the other favourable lipid parameters, Vascepa clearly meets all the criteria necessary for it to be granted approval.

    From Page 8 of the ADCOM document (and repeated word for word again on page 63):

    "In considering the results of the ANCHOR trial, the presumption has been that improving various lipid parameters will translate into a reduction in cardiovascular risk. With rare exception, FDA has historically considered granting approval for lipid-altering drugs based on favorable changes in the lipid profile, with the assumption that these changes would translate into a benefit on clinical outcomes."

    REDUCE-IT, once complete, will finally back-up the assumptions but AT THIS TIME IS NOT REQUIRED FOR ANCHOR APPROVAL.

    Wake up people. Arent you tired of swallowing bear shit?
    Oct 14 11:59 PM | 2 Likes Like |Link to Comment
  • Analysis of Vascepa's FDA Briefing Documents [View article]
    So the ADCOM is apparently not just about the shoe in that is the ANCHOR indication (10X the size of the currently approved MARINE indication) -such a ridiculously easy decision to approve it that it barely merits discussing at all- it is also about whether or not to include labeling language for the REDUCE-IT patient population before results are known:

    "Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the
    completion of REDUCE-IT?"

    Well now, "taking into account the described efficacy and safety data for Vascepa" based on all the available evidence, you would have to conclude that yes, "its effects on the described lipid/lipoprotein parameters ARE sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT".

    A reminder to all that the REDUCE-IT patient population is about twice the size of MARINE and ANCHOR combined ie >$10 billion/year.
    Oct 14 06:39 AM | 6 Likes Like |Link to Comment
  • A Stock That May Rally $20 In 3-Months [View instapost]
    "Your comparing AMRN to ARNA."

    No, i'm not. You're missing the point entirely. I am analysing the share price action of ARNA around 2 crucial binary events that are just around the corner for AMRN. ARNA had a hell of a lot riding on last years PDUFA and ADCOM just as AMRN do. With ANCHOR and its massive potential AMRN's share price possibly stands to increase even more than ARNA's did. I've done my homework on other biotech companies and the share price action around their PDUFA and ADCOM dates and noticed a trend. You can do that yourself if you feel so inclined.

    ANCHOR is about 10x the size of the MARINE population by the way - not 4x. Your math is sloppy and your grammar is poor. Thanks ever so much for the comment though.
    Oct 1 10:14 PM | 2 Likes Like |Link to Comment
  • A Stock That May Rally $20 In 3-Months [View instapost]
    Correct - Goldman Sachs set the pre ADCOM price target at $6.80....i highly doubt the run-up between now and the ADCOM sees the share price go over that....here's some data from Arena based on their share price around last years ADCOM and PDUFA....

    Arena ADCOM scheduled Thursday, May 10th, 2012.

    One month before this date on April 10th, shares closed at $2.87.

    Monday, May 7th: $2.72
    Tuesday, May 8th: $3.42 (up 26% on 50 million volume)
    Wednesday, May 9th: $3.66 (up 7% on 42 million volume)

    Thursday, May 10th: Shares halted due to ADCOM. Press release issued announcing positive ADCOM vote

    Friday, May 11th: $6.36 (up 74% on 76 million volume)
    Monday, May 14th: $6.61 (up 4% on 25 million volume)
    $3.66-$6.61 = 81% gain
    Tuesday, May 15th: $6.06 (down 8%)

    Shares ran down from there 9% to a low of $5.52 on Friday, May 18th.

    FDA PDUFA date scheduled for June 27th, 2012.

    Thursday, June 21st: shares reached pre-PDUFA date high of $11.68 (up 219% from $3.66)
    Friday, June 22nd: $9.88 (down on 90 million volume)
    Monday, June 25th: $9.20
    Tuesday, June 26th: $8.85 (down 25% from $11.68 high)
    Wednesday, June 27th: FDA approval granted. Shares up 29% to $11.39 on 90 million volume.
    Thursday, June 28th: $10.23 (down 10%)
    Friday, June 29th: $9.98

    Read into all that what you will........do some more digging yourselves with other biotech companies and adcom/pdufa event related price action and you may notice something of a trend
    Oct 1 03:51 AM | 1 Like Like |Link to Comment
  • AF Backtracking, AMRN Will Be Approved On Time [View instapost]
    In August 2011, Amarin announced that it had reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) agreement for the design of the previously described cardiovascular outcomes study of Vascepa formally titled REDUCE-IT (Reduction of Cardiovascular Events with EPA - Intervention Trial). In REDUCE-IT, Amarin will evaluate the effectiveness of Vascepa in reducing the first major cardiovascular events in an at-risk patient population. The control arm of the study will be patients on optimized statin therapy. The active arm of the study will be patients on optimized statin therapy plus Vascepa. All subjects enrolled in the study will have elevated triglyceride levels. Amarin will be responsible for the study which will be conducted internationally. Amarin estimates that the study will require approximately 8,000 patients and take around 6 years for completion. They just announced that 6,000 patients have been enrolled so far.

    Once REDUCE-IT was substantially underway, Amarin believed that it would have met all of the requirements to request approval of Vascepa for treating the mixed dyslipidemia patient population studied in the ANCHOR trial. In April, the FDA accepted their sNDA submission for the ANCHOR indication and they have 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.

    On June 19th Amarin was informed by FDA of an October 16th Advisory Committee Date in connection with the sNDA for Vascepa in the ANCHOR indication. This is standard procedure.

    This quote is from the recent press release announcing the ADCOM;

    "For key first-in-class indications, an FDA advisory committee meeting is expected, and this public forum will be an important opportunity to discuss the ANCHOR data, which demonstrated Vascepa's unique potential as an adjunct to diet in the treatment of adult patients with high triglycerides (TG 200-499 mg/dL) and mixed dyslipidemia," said Eliot A. Brinton, MD, FAHA, FNLA, Director of Atherometabolic Research, Utah Foundation for Biomedical Research, and President, American Board of Clinical Lipidology. "Currently, many of these patients are receiving another prescription omega-3 which is not indicated for this disorder. Having instead an omega-3 product which lowers LDL-cholesterol in addition to triglycerides, has tolerability comparable to placebo, and is FDA-approved for use on top of statin therapy would be a welcome addition to the physician's armamentarium for comprehensive lipid management."

    The other drug referred to is the inferior Lovaza which you will recall has been selling around $1 Billion annually.
    Sep 27 12:04 AM | 4 Likes Like |Link to Comment
  • This Amarin Bear Is Throwing In The Towel [View article]
    Dear oh dear. You're not a scientist are you? Guys like Declan Doogan (head of R&D at Pfizer before joining Amarin) have carefully studied the JELIS and ANCHOR data and designed the REDUCE-IT study in such a manner that will optimize its chance of success. With the 4g dose of EPA demonstrating the safety and efficacy it did in the ANCHOR trial, and the 1.8g dose of EPA in the JELIS study proving a reduction in preventing major coronary events, one can STRONGLY INFER that 4g in the REDUCE-IT outcomes study will do the same. It's only logical based on the previous evidence.
    Sep 24 09:29 PM | 2 Likes Like |Link to Comment
  • This Amarin Bear Is Throwing In The Towel [View article]
    "There are many other studies in the last 10 years showing no reduction in CVE using EPA."

    Oh yeah? Find me one where 4 grams of EPA (no DHA) is used. There is none. Find me just one where 2 grams is used? There is none. You dont understand the relationship between EPA, DHA, efficacy and dose. Fortunately for Amarin investors the guys who designed the REDUCE-IT trial do. 4 grams a day will be used. The JELIS study only used 1.8 grams

    http://1.usa.gov/19AVqtL

    The Japan eicosapentaenoic acid (EPA) Lipid Intervention Study (JELIS) tested the effects of long-term use of EPA 1800 mg/day in addition to a statin in Japanese patients with hypercholesterolemia. The study was substantial. A total of 18,645 subjects were recruited. The EPA formulation used in the trial, Epadel, contains highly purified (>98%) fish-derived ethyl EPA (just as Amarin's Vascepa does).

    After mean follow-up of 4.6 years, the primary endpoint of major coronary events, defined as sudden cardiac death, fatal or nonfatal myocardial infarction, unstable angina pectoris, and coronary artery bypass graft/percutaneous coronary intervention, was significantly reduced by 19% in the EPA group compared with the statin-only group.

    JELIS, the first large-scale, prospective, randomized trial of combined treatment with a statin and an omega-3 fatty acid originally derived from fish, eicosapentaenoic acid (EPA), showed that the addition of EPA to statin therapy provides additional benefit in preventing major coronary events, apparently through lipid-independent mechanisms. The results add support to previous evidence of the beneficial effect of omega-3 fatty acids in patients with known coronary heart disease, and show that that effect can extend the benefit of statins, the JELIS investigators believe.
    Sep 24 12:06 PM | 1 Like Like |Link to Comment
  • This Amarin Bear Is Throwing In The Towel [View article]
    Throw in a bunch of statistically significant positive data from the ongoing REDUCE-IT outcomes study and you have yourself a $10 billion a year drug on your hands. Which lucky big pharma company is going to take ownership? Bidding war in January post ANCHOR approval......NCE is tied to ANCHOR approval and should be done and dusted by mid-January. Selling this company for under $40/ share is giving it away.
    Sep 24 04:24 AM | Likes Like |Link to Comment
  • Note From Aegis On AMRN Situation [View instapost]
    From the most recent Q2 Conference Call.....

    CEO Joe Zakrzewski:

    ".......we believe that we are well-positioned for approval of the ANCHOR indication. While we appreciate that investors took the risk associated with approval of this indication, we believe that our likelihood of success is much, much higher than we appear to be given credit for by the Street. (Funny he should refer to the Street. Isnt that the same crowd Adam Fartstain works for?) We are proud of successes we have had during first half of, and we believe that sticking to the five-point of light, if you will, that we have been talking about everything else will take care of itself.

    Number one, get the launch right. Number two, get managed care which we have done quite well on. Number three, get the ANCHOR sNDA accepted and get the indication approved. Number four, drive IP, particularly ANCHOR. Number five, supply chain. We are also eager for the tremendous opportunity that exists in the ANCHOR indication.

    I look forward to the positive catalyst that we believe will be the advisory committee and the PDUFA date. We look forward to the launch of Vascepa for the ANCHOR indication. When we do so, compared to the MARINE launch, we will be doing so with the advantage of significant managed care coverage and significant brand recognition amongst the highest prescribing physicians of other lipid lowering therapies. We will also have a first-in-class label with a very strong safety and efficacy profile."

    From the Q&A:

    Thomas Wei - Jefferies
    And maybe just a second question. I am sorry I think I have been hoping back and forth between calls here. I missed a little bit of what you said in terms of partnership for ANCHOR. Have you more shifted now towards thinking that you have got that you could do it yourself? How should we think about the different possibilities and where things stand?

    Joe Zakrzewski - Chairman of the Board, Chief Executive Officer
    I think the possibilities are all the same. So, Thomas, I think if we continue to get to know this market pretty darn well. We are seeing that we have got the right reach and penetration as well as the decile 7 to 10 we are [reaching frequently.] I think we have not made any decisions. We continue to have dialog and we are spending a lot of time both, as a management team and as Board thinking about these. We have got time, we are trying to do the right thing. What we don't want to do is, get into something that doesn't provides the right value if we do that.

    For example, there are companies out there that are getting a small fraction of what the economics are. This is got to be the right thing for us and any potential partner. I think other than that, I will go back to, we are still working those five things. And if we do those right, everything else will take care of itself, including whether we end up with a partner or not, but we are still sort of thinking about that and working through it."


    As far as shareholders are concerned, the company couldn't be in better hands. JZ has been here before and knows the score.

    Fear and negativity towards Amarin and its management team stems from a basic lack of knowledge about what is going on. If you havent done your homework you have every right to fear and shittalk. If you have studied ALL the available information and have even half a brain capable of processing it, you will KNOW that there is nothing to fear.
    Sep 16 07:29 AM | Likes Like |Link to Comment
  • Amarin's Counterpunch: What Q2 Earnings Could Mean For The Future [View article]
    The way I see it playing out for what its worth.

    I see a bottom at the current stock price. From here it should climb up towards $9 with Q2 earnings in August and anticipation of the ADCOM hearing in October. A successful hearing sees it jump up over $10 with the approaching December ANCHOR PDUFA then a mere formality.

    Expect NCE decision and an early approval of ANCHOR well before the scheduled December date and the share price to be over $20 by then. Buyout speculation will send it towards $30 and by the end of the year Amarin may be at the center of a bidding war. JZ isnt entertaining offers below $40 with ANCHOR in the bag and the enormous potential of the REDUCE-IT trial (twice the combined market potential of the MARINE and ANCHOR indications).
    Jul 18 10:21 AM | 5 Likes Like |Link to Comment
  • Bloomberg Article Inaccurate And Completely Fact-Less. [View instapost]
    Article on "Vascepa and Fish Oil"..........

    Feel free to comment.

    http://bit.ly/13qGO2a
    Jul 3 01:52 AM | 1 Like Like |Link to Comment
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