Heard about Vascepa launch?

Discussion in 'Pfizer' started by Anonymous, Jun 13, 2012 at 12:40 AM.

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  1. Anonymous

    Anonymous Guest

    I give up on you. Keep carrying the bag and drinking the GSK Kool-Aid until they fire you to increase value and profits for shareholders. Companies are bought on other things besides absolute sales and EBITDA multipliers: projected drug sales and growth, value of product portfolio, patents, assets, R & D, key personnel, etc... To say that Amarin is worth zero proves your ignorance. Buh bye.
     

  2. Anonymous

    Anonymous Guest

    Amarin is collapsing AFTER approval, not surprising really as their only product have no commercial value. Anyone can make a pure EPA supplement (with even higher concentration than Vascepa) and sell it without prescription!!
     
  3. Anonymous

    Anonymous Guest

    Please read the following from Jason Napodano to help in your education about Amarin and Vascepa:

    http://www.twitlonger.com/show/ik9ou2

    Jason Napodano, CFA (@JNapodano)
    Posted Wednesday 1st August 2012 from Twitlonger

    "Spent the past hour or so reading up on $AMRN and the Vascepa label. I've come to the following conclusions:

    1- The current label for Vascepa includes key differentiators to $1B drug Lovaza, such as superior TG lowering, LCL-C neutrality, reduction in ApoB, and super clean safety. Even without ANCHOR, this is a superior drug to Lovaza and should take 70% of the NRx within 6-9 months post-launch. Depending on the marketing partner, I think the total Rx "fish oil" market will grow by 50% once Vascepa launches, so the company will benefit two-fold: dominating NRx and growing TRx.

    2- The ANCHOR sNDA should be filed late Q4-12, so with 6-month review that puts another fun PDUFA in June 2013! The label should be expanded at that time, raising peak US sales on the drug from $750M to around $2-3B. Can you say, AMRN-RunUp Part-Deux?

    3- NCE (decision expected 8/17) is important, as it protects from immediate paragraph-4 filings, but less important than the current "twittersphere" thinks because of the growing IP estate around the molecule. Worse-base scenario, no NCE and paragraph-4 filings come 1H-2013. Generic company-A claims non-infringment and plans to launch 2015 (after 3-years of NME). AMRN surely files an injunction. AMRN and Generic-Co-A settle on an authorized generic sometime around 2022.

    Under this scenario, the stock is worth $20 via DCF, which assume they secure a marketing partner with deep pockets. I have not re-worked my model to see what the company is worth if they "go alone" (basically because I'm too lazy), but if they do I would expect the hiring of 250-300 reps, a dilutive offering later this year to fund that, significantly higher upside in terms of revenues in the later years, but higher share count and much higher operating expenses so the risk around those FCF's would be greater. I'd have to jack-up my discount rate as a result, so just guessing, the DCF would probably come in between $16 and 22 per share (it all depends on when you model terminal growth).

    On a side note, I think AZN makes the most sense. A Vascepa-Crestor combo would be a crazy-effective product. Almost a nuclear bomb for dysplipidemia. They would need the 2g dose for this though, as it might be viewed as too powerful. I think PFE, ABT, SNY, BMY, and LLY make sense as well. I do not think GSK makes sense at all, and I think MRK is too conservative to be a bidder.

    4- Best-case scenario for the company is NCE and ANCHOR sNDA approval mid-2013, along with a marketing partner. NCE protects from paragraph-4's until 2017, so I would expect settlements in the 2025-2027 timeframe. I think the stock is easily worth $28 per share if this happens. But I would not expect to see this level until after ANCHOR approval, so keep that in mind.

    5- I do not think AMRN gets taken out until after the outcome study is completed. I think they can secure a nice partnership later this year - after NCE is known - but I simply do not see a buy-out until after the outcome study. Big pharma is not going to spend that kind of money unless they know the outcome claims can be marketed. But hey, that's just my take. I would never invest in a name hoping for a buy-out.

    6- A marketing partner is not contingent on NCE. Big pharma would like to see NCE, but it's not a deal-breaker if they don't get it. What is a deal-breaker is the unknown. Once NCE is approved or rejected big pharma can begin to value the asset. Once ANCHOR is approved, the value goes up. Big pharma hates uncertainty. Not getting NCE is a bummer, but it does not prohibit a deal.

    At $12 per share the stock is very attractive. There will be volatility around the NCE decision on August 17th, however, even without NCE I think the stock is 65% under-valued. You're not going to see generics on the market before 2020 regardless, so keep that in mind.

    I sold 1/2 my shares pre-PDUFA at $15.70. I plan to hold the other 1/2 at this level, and will consider buying back if it gets uglier.

    GLTA,

    Jason"
     
  4. Anonymous

    Anonymous Guest

    Jason Napodano is clearly a fraud and liar.

    "Vascepa includes key differentiators to $1B drug Lovaza, such as superior TG lowering,"

    -Lovaza is vastly superior in lowering trigs, the main indication, so he is a straight out liar.

    "The ANCHOR sNDA should be filed late Q4-12, so with 6-month review that puts another fun PDUFA in June 2013!"

    -Yeah, really fun with a 25% drop in under a week WITH approval, but maybe he is just making fun of AMRN shareholders?

    "NCE (decision expected 8/17) is important, as it protects from immediate paragraph-4 filings"

    -NCE does not matter as Vascepa never will have margins of any value from 2015 with generic Lovaza.

    "I have not re-worked my model to see what the company is worth if they "go alone""

    -Then you don't have anything, all assumptions must be based on the company going it alone, a REAL DCF/NPV analysis including ALL costs shows that Amarin will have negative value on a stand alone basis!

    "A Vascepa-Crestor combo would be a crazy-effective product"

    -Yeah, like you know anything about that, that will take ten years of trials in a best case scenario and why would anyone pay a premium for that when they can get generic statins and Lovaza or high quality OTC omega-3? Clueless moron.

    "Best-case scenario for the company is NCE and ANCHOR sNDA approval mid-2013, along with a marketing partner"

    -No partner is interested in this low margin product and Amarin will not make anything in a partnership.

    "I do not think AMRN gets taken out until after the outcome study is completed."

    -No one will but Amarin, they will have no partner and as such will lose money for years before inevitable bankruptcy.

    "A marketing partner is not contingent on NCE. Big pharma would like to see NCE, but it's not a deal-breaker if they don't get it.

    -A partner is not interested in a low margin product that will just be a competitor to their own higher margin products under any circumstance! And it will provide nothing to AMRN and anyone can license pure EPA from Japan or sell it without prescription even, no one needs AMRN for ANYTHING.

    "At $12 per share the stock is very attractive. There will be volatility around the NCE decision on August 17th, however, even without NCE I think the stock is 65% under-valued

    -At $12 AMRN is INCREDIBLY overpriced and even with NCE the stock must drop over 95% to get to anywhere near fair value!

    What a clueless amateur clown, I haven't laughed this hard in months!
     
  5. Anonymous

    Anonymous Guest

    Some clown keeps bashing Amarin's AMR101 as nothing but fish oil. Here's a list of some other well known drugs derived from natural sources:

    -Taxol from the Pacific Yew
    -Aspirin from the Willow Tree
    -Byetta from Gila saliva
    -Alkaloids, morphine, cocaine, digitalis, quinine, tubocurarine, nicotine, and muscarine from
    plants
    -Lovastatin, cyclosporin, cephalosporins, tetracyclines, aminoglycosides, rifamycins, and
    chloramphenicol from Fungal metabolites
    -curacin A is obtained from a marine cyanobacterium and shows potent antitumor activity.
    Other antitumor agents derived from marine sources include eleutherobin, discodermolide,
    bryostatins, dolostatins, and cephalostatins.
    -antibiotic peptides and Epitadine were extracted from the skin of the African clawed frog
    and skin extracts of the Ecuadorian poison frog.
    -teprotide (from the venom of the Brazilian viper) was the lead compound for the
    development of the antihypertensive agents cilazapril and captopril.
    -Butolism toxin to help prevent muscle spasms
    -Ziconatide from marine cone snail venom

    and the list goes on and on. AMR101 (VASCEPA) is an ethyl ester of eicosapentaenoic acid (EPA) indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia, and not just "fish oil". You wouldn't tell patients prescribed Taxol to just chew on the bark of the Pacific Yew to get the same effect, either, would you?
     
  6. Anonymous

    Anonymous Guest

    From some European analysts that have some of the best knowledge of the omega-3 space:

    On Amarin/Vascepa:

    "Trials show a rather similar efficacy in lowering triglycerides for Omacor 4g and AMR101 4g. The pivotal trial for AMR101 showed a small reduction of LDL (bad) cholesterol, while Omacor has showed a small increase in its US trial.

    However, the Japanese head to head trial between Omacor and Epadel (same substance as AMR101) showed no difference in LDL.

    For this indication (very high-level of triglycerides) we do not believe the somewhat better LDL profile should be enough for AMR101 to take significant market share from Omacor which is already established on the market."

    The fact that AMR101 only consists of the EPA fatty acid and that the DHA therefore needs to be removed from the raw material fish oil means the production yield for AMR101 is worse and production costs much higher so it will be interesting to see how AMR101 will be priced.

    Amarin plan to launch Vascepa in Q1(13) and is considering different strategic alternatives including an acquisition of Amarin, a stratetic collaboration or to launch the product themselves.

    Amarin has already been trying to outlicense Vascepa for a long time."

    JFYI.
     
  7. Anonymous

    Anonymous Guest

    Speaking of the Europeans:

    7/27/2012 Pharmabiz
    Amarin Corporation plc, a late-stage biopharmaceutical company focused on the development of therapeutics to improve cardiovascular health, has received notice of intention to grant letter for European Patent Application Number EP2395991, titled "Use of Eicosapentaenoic Acid Ethyl Ester for Treating Hypertriglyceridemia" from European Patent Office. This patent application is intended to protect the exclusivity of Amarin's drug candidate, AMR101, for use in an indication that Amarin may seek through the European Medicines Agency (EMA).

    "This European intention to grant letter further substantiates that the findings from Amarin's MARINE clinical trial were unexpected and follows the recent issuance of a pharmaceutical composition patent in the United States (US Patent No. 8,188,146) covering EPA with no DHA in a capsule and Notice of Allowance for US Patent Application Serial Number 12/769,885 titled "Highly Stable EPA in a Capsule," stated Joseph Zakrzewski, chairman and CEO of Amarin. "This patent application is part of Amarin's expanding patent portfolio intended to cover AMR101. Amarin is currently prosecuting greater than 25 pending US patent applications and multiple other patent applications outside the United States with the goal of protecting the commercial potential of AMR101 to 2030 and beyond."

    http://pharmabiz.com/ArticleDetails.aspx?aid=70297&sid=2
     
  8. Anonymous

    Anonymous Guest

    Selling pure EPA in Europe? That was a good one.

    Omacor has total market domination in Southern-Europe (sold by several big pharma's incl. Pfizer in Italy) and at much lower margins than GSK have in the US.

    And Teva has just gotten approval for generic Omacor in the EU and Pronova will also launch a generic version there with their partners!
     
  9. Anonymous

    Anonymous Guest

    And in Germany and the rest of Northern-Europe doctors just don't generally like omega-3 as medicine for some reason.
     
  10. Anonymous

    Anonymous Guest

    Far be it from me to weigh in here but...
    It does appear that Lovaza does a better job on Trigs, VLDL, HDL and TC.
    However, the baseline is MUCH higher than the Vascepa baseline.
    Not really apples to apples there.
    An old "Actos" trick was to claim a huge drop in A1C (best in class, etc). But that was so because the baseline was so high....
    Vascepa does better on LDL - quite considerably - nearly a 50% swing (5% drop with V, 45% increase with Lovaza). That's a selling message. Hammer away at it.
    BUT...
    The drop in stock has been killer. Absolutely killer. "Sell the news" etc. doesn't quite account for everything that's gone on. Trading of blocks by the officers didn't help. The patent uncertainty doesn't help. And the NCE uncertainty doesn't help.
    Sure....there is other good information pending....good studies (JELIS)...and potentially good outcome studies on the horizon.
    So we'll see...
     
  11. Anonymous

    Anonymous Guest

    The overwhelming scientific consensus after thousands of clinical trials with n-3 fatty acids is that a combination of EPA/DHA is superior from a medical perspective and from an
    an economic perspective,

    (Even the Japanese have basically acknowledged this with Takeda's support of Lovaza in Japan (where pure EPA have been sold Rx for about 20 years).

    Just the fact that Amarin is positioning this decades old Japanese product as "next generation lipid management" or whatever, basically tells me all I need to know about that company.

    This is a giant fraud against naive uniformed investors, something you can see at the nonexistent level of knowledge from the "Amarin-pumpers" here..

    Everyone in pharma with any knowledge of these matters knows that EPA can never compete with generic Lovaza on the market.

    You must be pretty slow not to understand that there are strong reasons Lovaza has big pharma support worldwide and EPA has none, not even in Japan..

    You should also know that for people with hypertriglyceridemia the LDL are not relevant at all.

    Pure EPA has no commercial value as a drug (and even very little as supplements) because of the extremely high production costs and since it has no additional benefits or even negatives (DHA is extremely important, both for the brain and your body).

    And as is pointed out over here, pure EPA can be sold at pharmacies (at a higher concentration than Vascepa) tomorrow by anyone without a need for prescription and to a much lower price than Amarin can possibly match.

    So for Amarin, Peter Drucker summed up the situation for companies like that decades ago, "The costs will be higher than any possible return".
     
  12. Anonymous

    Anonymous Guest

  13. Anonymous

    Anonymous Guest

    Ask the FDA.
     
  14. Anonymous

    Anonymous Guest

  15. Anonymous

    Anonymous Guest

    I saw that! Nice going for mgmt I guess. Amarin stock is up 400% over two years vs the NEGATIVE return Lovaza (Pron.ol) has provided. I guess you get stock incentives when you perform. Any sales rep can relate to that. Just give us something we can sell like Vascepa.

    Here's a chart comparing the two. OUCH!
    http://finance.yahoo.com/q/bc?s=AMRN&t=2y&l=on&z=l&q=l&c=pron.ol
     
  16. Anonymous

    Anonymous Guest

    Hey guys. It looks like a lot of those "insider sales" are the Venture Capital funds like Soffinova and Abingworth cashing in the warrants they received in exchange for large tranches of cash provided to Amarin. That's kinda the way it works in the biotech financing world.
     
  17. Anonymous

    Anonymous Guest

    "One of the big differences between AMR101 and Lovaza is the ability of AMR101 to lower TG levels without increasing LDL in patients, this becomes especially important in patients with “mixed dyslipidemia” (not to be confused with “Dyslipidemia,” mixed dyslipidemia + high triglyceride levels= dyslipidemia). http://www.gekkowire.com/?p=7205&page=2

    When Omacor (Lovaza) was granted FDA approval in 2004 as an adjunct to diet in patients with very high triglyceride (TG) levels (>500 mg/dL) the FDA also issued an approvable letter (equivalent to a CRL) for the use of Omacor as an adjunct to diet and statin therapy to reduce high triglyceride levels (200-499 mg/dL) in adult patients. Since LDL-C is the primary target for treating dyslipidemia (hence the need AMR101’s advantage since it did not effect LDL-c levels in the MARINE study), the FDA has stated that it is likely that these patients (with TG within this range) will also be receiving statins. As a result, the FDA has requested additional information on the effect of Omacor in combination with statins. In the original Lovaza studies, LDL was increased in four of the eight studies ranging from approximately 16.7 to 31%. In the high triglyceride study, LDL levels were raised on the Lovaza arm by a placebo adjusted basis by about 49%. The increase in LDL’s seen in Lovaza can be problematic in patients with already high LDL levels so simultaneous use of a statin was studied in the COMBOS trial." Read the entire FDA’s review of the resubmission of the Lovaza COMBOS trials: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021853_021654s016_omacor_toc.cfm

    AMR101 (Vascepa) has been shown to significantly reduce TG levels and improve other lipid parameters without significantly increasing the LDL cholesterol levels in patients with very high TG levels (≥500 mg/dl) (MARINE trial). http://www.ncbi.nlm.nih.gov/pubmed/21683321, and in the ANCHOR trial (http://www.ncbi.nlm.nih.gov/pubmed/22819432AMR101), AMR101 4 g/day significantly decreased median placebo-adjusted TG, non-HDL cholesterol, LDL cholesterol, apolipoprotein B, total cholesterol, very-low-density lipoprotein cholesterol, lipoprotein-associated phospholipase A(2), and high-sensitivity C-reactive protein in statin-treated patients with residual TG elevations (≥200 and <500 mg/dl).

    Bottom line, if I were a physician left with the choice of prescribing Vascepa vs. Lovaza to a patient in these populations, I'd choose Vascepa hands down, based on this information.
     
  18. Anonymous

    Anonymous Guest

    "Hey guys. It looks like a lot of those "insider sales" are the Venture Capital funds like Soffinova and Abingworth cashing in the warrants they received in exchange for large tranches of cash provided to Amarin. That's kinda the way it works in the biotech financing world."

    Obviously a case of "Stockholm syndrome" that are typical in "ponzi frauds" etc..

    The victims in severe self-deception often engage in "escalation of commitment" and actually defends the people that are defrauding them until they themselves have lost everything.

    Victims will actually do that and lose everything rather than admit that they have been scammed and that is also one of the reasons why such schemes often can continue for a very long time..

    Really sad, but also interesting to observe.
     
  19. Anonymous

    Anonymous Guest

    Several high level GSK exec's are in Ireland. They're either at a pub or at Amarin HQ.
     
  20. Anonymous

    Anonymous Guest

    My wife loves using fish oil as an anal lube. Just cut the capsules open and away you go!!