BiotechBillionair

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  • Can Amarin Make Me A Believer This Thursday?  [View article]
    Bird Brain,
    You consistently miss the point and have your "catalysts" WRONG and out of order.
    So, we have a few catalysts coming up for Amarin:
    1)earnings on Thursday
    2)ANCHOR approval (?)
    3)subsequent NME status if approved
    4)continued Vascepa script data
    5)possible introduction of generics for MARINE use
    Let me help you:
    1)Combo patent application NOA due anytime for 13417899
    2)Release of AMR102 dosing study (probably after the above)
    3)Addition of Anchor data to Marine label when REDUCE-IT 50% enrolled
    4)Earnings & CC Thursday
    5)Every Sunday with IMS/Symphony weekly updates
    6)Monthly scripts growing at 100% Month over Month over Month
    7)NCE, (FDA considers Icosapent Ethyl an EPA prodrug in the Marine review documents) not NME...it's one or the other for Marine. Not neither. BASF and Chemport approvals dropped API costs by 50%. Generic entry will be easy after: Waiting for NME/ NCE to expire, they defeat all now 13 OB patents, they find API cheaper than Amarin. None of which will happen in the next 3 yrs.
    8)Anchor approval
    9)Patent 13540319 combo patent with rx of 200-500
    10)Patent app. 12888994, combo Vascepa and prodrug of lipitor (NCE combo)
    11)sNDA for combo
    12) The REDUCE-IT risk...Using JELIS as a giude and adding the unhealthy Western diet, risk is mitigated by using history.

    Your average for a reason.

    CC:What I want:
    1) earnings
    2) COGs
    3) Relationship with BASF defined ie. Pronova
    4) expanded sales force
    5) FDA update
    6) Growth forecast 2014

    You'll soon be on the wrong side of the trade if you maintain short.

    Far from average,
    Williams
    May 6, 2013. 02:20 PM | 10 Likes Like |Link to Comment
  • Amarin: The Bull Argument (Or How I Learned To Stop Worrying And Love Vascepa)  [View article]
    Bond's
    I liked the article, very well written with accurate NCE/NME analysis in my opinion. A couple things to add, first the FDA has stated in the formal review: "The drug product from Amarin contains a purified icosapent ethyl. Icosapent ethyl (ethyl eicosapentaenoic acid or ethyl-EPA) is the ethyl ester of EPA. Icosapent ethyl acts as a prodrug for EPA, as it is hydrolyzed enzymatically by esterases, particularly pancreatic lipase, to liberate the free acid EPA".
    Pg.19
    http://1.usa.gov/ZREP5j

    "Acts as a prodrug", I assume if it quacks like a duck, it's a duck. If the FDA is calling Vascepa a prodrug of EPA, they plan on granting 5 yrs of NCE exclusivity, in my opinion. I can find no examples that a prodrug has been rejected NCE status, PERIOD. When the FDA makes their decision public is anyone's guess, but it should be before December Anchor PDUFA.

    Next I would like to add to the combo discussion. It appears that Amarin is leaning toward the Atorvastatin/Vascepa combination. The metabolite from Atorvastatin, also a prodrug, combined with Vascepa produced the most efficacious results. Let the speculation start on whether Amarin's combo pill will contain the prodrug of Atorvastatin and Icosapent. AMR 102 can apply for 5 yrs of exclusivity with the lipitor prodrug under a 505 (b)(2) application using previous studies, and there are several. Remember JZ stated we would see the AMR 102 dosing study before the end of the second quarter.

    Finally, why has the BO not happened? Amarin has a price in mind and so does BP, so far the two numbers are too far apart. With the recent developments overhangs will be removed, and BP will see the value.

    Williams
    May 1, 2013. 11:56 AM | 3 Likes Like |Link to Comment
  • Amarin Will Be Granted NCE  [View instapost]

    Steve
    The FDA claims Icosapent Ethyl is a Prodrug of EPA. The FDA has consistantly ruled in favor with prodrugs and I again change my mind this could very well happen with the next OB update. The prodrug angle has nothing to do with the increased label for Anchor and I believe it has nothing to due with the NCE delay. The delay has been due to new MAPP's and guidance related to NCE and API labeling, none of which has been remotely negative to Vascepa's position.
    Pg. 20 for the Prodrug in the Medical Review for Vascepa
    http://1.usa.gov/ZREP5j

    On another note, the medical review also states Amarin can add the Anchor data to the label after REDUCE-IT is 50% enrolled.

    pg 10
    http://1.usa.gov/ZREP5j

    50% enrollment?Now?
    http://bit.ly/ZRERds

    A little insight into how impressed the statistician was with the Statin/Vascepa data.
    http://1.usa.gov/12RfS8K
    AMR 102 has preliminary stats:) Should see the Lipitor (prodrug) and Vascepa combo data soon after the patent NOA. It's looking like the Liptitor prodrug is a NCE as well:)

    Time will tell, but I see a bidding war with all this information.

    Williams
    Apr 30, 2013. 04:55 PM | 4 Likes Like |Link to Comment
  • Amarin Will Be Granted NCE  [View instapost]
    Only if they approve the Anchor indication at the same time. Update in May, it would be for the Marine. I'm leaning toward the FDA granting NCE with an Anchor approval, but time could be the December 21 PDUFA.

    Anything that's in the FDA's hands is unpredictable.
    Apr 28, 2013. 09:56 PM | 1 Like Like |Link to Comment
  • Amarin Will Be Granted NCE  [View instapost]
    Steve

    I should have included this for my vetted comment.

    #6 on page 3 http://1.usa.gov/14zrSjo

    "The applicant conducted one pivotal phase 3 clinical trial – MARINE – to support the efficacy of Vascepa in reducing triglyceride levels in patients with severe hypertriglyceridemia. Supportive data were provided from a second phase 3 clinical trial – ANCHOR – of patients on statins with TG levels between 200 mg/dl and 500 mg/dl. This memorandum will limit discussion to the MARINE trial"

    The FDA has little to review for the Anchor indication, except fill and file paperwork.

    When your next article coming?

    Have you every spoken to KJ from the FDA?

    Williams
    Apr 28, 2013. 09:32 AM | 1 Like Like |Link to Comment
  • Amarin Will Be Granted NCE  [View instapost]

    Steve
    More "review docs" released from the FDA at some point after March 6th.

    http://1.usa.gov/ZGNrvm

    Enjoy

    The FDA may be leaning on making the NCE decision public at Anchor approval. I'd be surprised if they waited for the December PDUFA date, efficasy and safety have been vetted already with the SPA's.

    Williams
    Apr 28, 2013. 09:17 AM | 1 Like Like |Link to Comment
  • Amarin Will Be Granted NCE  [View instapost]
    Testing
    Apr 28, 2013. 08:50 AM | Likes Like |Link to Comment
  • New FDA Document Could Mean NCE For Amarin  [View instapost]
    I Agee 100% Steve. The wording between Icosapent Ethyl and Omega 3 Ethyl Esters has many key differences both in API and inactive ingrediates. A generic Icosapent Ethyl is required by the FDA to have both the same API and Inactive ingrediates...infringing on the 24 NOA or issued patents currently.

    New MAPP documents are being posted still by the FDA so timing the FDA is impossible. (4-10-13 http://1.usa.gov/12HuV88)
    Apr 10, 2013. 08:18 AM | 3 Likes Like |Link to Comment
  • Substantial Shift Upward In Amarin Stock Likely After Hearing From FDA  [View instapost]
    The ride starts this week.
    -first Anchor patent tomorrow '520!!!
    -Wed. Rumored JPMorgan Amarin Meeting (flyonthewall)
    -AZN has met with JPMorgan twice in the last three weeks (flyonthewall)
    -Feb IMS monthly NOT leaked (SR 3 to 4 times?)
    -End of the second week of April?
    -sNDA acceptance with no outcomes for Anchor first week of May
    -Adumb Fearstain is oddly quiet...
    Apr 1, 2013. 08:32 PM | 2 Likes Like |Link to Comment
  • A Top Biotech Stock To Own In 2013  [View article]
    Adumb
    If I listen to you on ARNA my BMW would be a Toyota.
    Duh
    Mar 8, 2013. 09:12 PM | 2 Likes Like |Link to Comment
  • A Top Biotech Stock To Own In 2013  [View article]
    World wide statin treatment is a $30 billion dollar industry. Statins are primarily used to lower LDL's into a "target" range depending on your risk for CV dz. Vascepa and a statin lowers LDL significantly more than just a statin alone, safely. Combining prescription Omega 3's and a statin has been the goal for Pronova (Omacor/Lovaza) since inception.
    http://bit.ly/XuZryi
    http://reut.rs/15BO5tZ
    http://bit.ly/XuZoCw

    Unfortunately for Omacor/Lovaza the combo is not marketed because it RAISES the primary target for statin treatment, LDL.

    Vascepa LOWERs LDL with statins, your wrong Anchor won't sell Adam.
    Mar 8, 2013. 07:26 AM | 3 Likes Like |Link to Comment
  • The Price May Be Increasing For An Amarin Buyout  [View article]
    Steve

    It's been discussed with the overlap of Marine and Anchor 3 year exclusivity's Vascepa has secured 4 years. It's commonly agreed that Marine, Anchor and REDUCE-IT qualify for 3 yrs of exclusivity under current FDA guidance. Where do you see AMR 102 with the timing of it's sNDA? It would also appear to be eligible for 3 years.

    Marine 3 yr July 2012 - July 2015
    Anchor 3 yr Dec 2013 - Dec 2016
    AMR 102 3 yr ?2016?-2019
    REDUCE-IT complete 2016, sNDA & approval 2017-2020
    Feb 21, 2013. 05:01 PM | Likes Like |Link to Comment
  • The Price May Be Increasing For An Amarin Buyout  [View article]
    Adam
    Currently I'm down about a 2013 Lamborghini Aventador and sleeping well.
    Jan 5, 2013. 04:29 PM | 1 Like Like |Link to Comment
  • The Price May Be Increasing For An Amarin Buyout  [View article]
    Hey Adam

    Thanks for bashing ARNA so hard, I was able to load cheap and hold through the Ad Com.

    Let's repeat that with AMRN....K?

    Greatly appreciate if you could do the same with Amarin until will start to see the sales numbers.

    Thanks
    Jan 4, 2013. 06:11 PM | Likes Like |Link to Comment
  • The Price May Be Increasing For An Amarin Buyout  [View article]
    And this is where they're wrong. Active ingredient in Lovaza per FDA OB is Ethyl Esters, a class of drugs. Lovaza and the FDA can't claim a drug class is the active ingredient and not bow to phase 1-3 to specifically label that specific active compound Icosapent Ethyl.

    Say omega 6 cures cancer, company does clinical trials 1-3...results knock it out of the park. Omega 6 is a NCE.

    You have to 100% define your active ingredient or another company can do the research and Vitrase your mix. Lovaza could not define the active ingredient to have it listed in the OB.
    Jan 1, 2013. 07:42 AM | Likes Like |Link to Comment
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