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

    Why would they be at Amarin's HQ? To get a good laugh at a worthless companys expense?

    Look moron, you are not fooling anyone (but yourself), you are as desperate as Amarin who has been trying to out-license it's decades old product for years. Enjoy your coming bankruptcy:)
  2. Anonymous

    Anonymous Guest

    I use it with your wife, too! Lovaza has MANY uses! The ONLY and best drug in the world, biatches!
  3. Anonymous

    Anonymous Guest

  4. Anonymous

    Anonymous Guest


    "Will GlaxoSmithKline Purchase Amarin? by BioTech Will

    After the PHASE III results for AMR-101, Amarin shares (AMRN) traded at almost twenty dollars a share amidst the speculation that a major pharmaceutical company would acquire Amarin. When that event failed to occur, the shares dropped in price, briefly touching the high six dollar range.

    Now, Amarin has received FDA approval for the drug, now known as Vascepa, and many investors are once again pondering the potential suitors for this small pharmaceutical company. Many names have been tossed into the hat, but one that has not received as much talk as I might have suspected is GlaxoSmithKline (GSK).

    On December 19, 2007, GSK closed a deal to purchase Reliant pharmaceuticals in an all-cash transaction valued at approximately $1.65 billion. One of the driving forces behind this deal was the drug Lovaza, the first FDA approved "fish oil" product for the treatment of very high triglycerides. The transaction has proven beneficial for GSK, as sales of Lovaza have topped $1 billion in the United States.

    Why then, after purchasing Reliant and Lovaza, would GSK now want to purchase Amarin and Vascepa? There are many reasons, and they all point towards GSK being a major player in any acquisition discussion.

    First, Vascepa as approved relegates GSK to second-in-class status for the treatment of very high triglycerides, also known as severe hypertriglyceridemia. Vascepa has a better side effect profile, is more efficacious, does not raise LDL-cholesterol (due likely to being EPA only), and a host of other benefits that do not exist with Lovaza. In essence, assuming equal tier coverage and a decent marketing campaign, Vascepa makes Lovaza obsolete, as doctors will for the aforementioned reasons prescribe Vascepa instead. The GSK sales force already has the background to sell a triglyceride lowering drug, and they would also have the credibility to sell the new best-in-class therapy, making Vascepa easy to bring to market for GSK.

    Beyond Vascepa's superiority, GSK has another problem with Lovaza - a looming patent expiration in September of 2012, and likely generics on the market no later than 2015 via a deal with Apotex (although when it comes to patent litigation, it is hard to predict exactly). The problem for GSK with Lovaza overall is that with its limited number of patents (high-trigs with no LDL-elevation population) combined with the generic competition effectively means the revenue from Lovaza cannot be counted on much longer, a fact which GSK is most certainly very aware of. Combine this expected loss of revenue and Vascepa's superiority with the fact that GSK's last quarter showed earnings per share down by 11% and you realize that GSK needs a blockbuster drug to both offset the loss of Lovaza sales and to help the company in general - and this is where Vascepa and Amarin come into play.

    Amarin's current market cap is approximately $1.57 billion, and with the current label indications Vascepa can be expected to at least equal Lovaza sales. However, to play it safe for the doubters, I'll discount Vascepa as indicated down by 20% to reflect second-in-class Lovaza and generic competition, and say that Vascepa will sell $800 million annually.

    Based on those numbers, the granting of NCE status for five year exclusivity plus the robust patent portfolio would make Amarin worth acquiring for anything under a heavily discounted $4 billion in expected sales over those five years - over twice the current market cap.

    However, as this article is intended to deal with naysayers, let's assume Vascepa does not get NCE status, and instead only gets three years of exclusivity and all the patents are held invalid - 3 times the heavily discounted $800 million still surpasses the current market cap, albeit it only slightly and not enough to provide a nice shareholder premium. So the question is then, if we consider this discounted scenario with no NCE status, would GSK still want to buy Amarin? The answer is "Absolutely."

    Despite those who decided to cry wolf about the Vascepa label, the fact of the matter is that the ANCHOR trial population was never supposed to be on the original Vascepa label - instead, the plan was to file the SNDA for this population after the FDA approval of the MARINE trial population indication for very high triglycerides. Assuming that Vascepa is able to add to its market the roughly ten times larger patient population with high triglycerides upon FDA approval of the SNDA, continuing our calculations using our same discount model, an interesting revelation comes to light. Suddenly Vascepa's sales even without NCE status are up to $24 billion (assuming proper marketing, correct inventories, etc).

    Even if we discount that number further down, giving Vascepa half of the Lovaza sales for the very high triglyceride patient population and then multiplying by a factor of 10 to account for the high triglyceride patient population, the numbers are still a staggering $5 billion annually. GSK is sure to realize that the worst case scenario for Vascepa with no NCE, but with the addition of the ANCHOR indication, makes Amarin worth paying $3.8 billion for, or approximately $27 per share - at the very least.

    Now that I've dealt with the naysayers, let's talk about the best case scenario for Vascepa. Let's assume that the five year NCE exclusivity is granted, that Amarin continues to obtain patents (which looks extremely likely based on the USPTO website) that add to the strong portfolio in place, the ANCHOR indication is granted for the label, and that Vascepa sales pre-ANCHOR equal Lovaza at $1 billion per year.

    The value of owning Vascepa is then likely $50-70 billion in the unlikely circumstance that the patent litigation went poorly, up to anywhere as high as $200 billion if the patents held up for 20 years. The GSK board of directors and shareholders must be salivating at the thought of this potential revenue stream.

    These positive numbers also ignore two potentially huge possibilities - the REDUCE-IT outcomes study and a combination statin-Vascepa drug. If Vascepa is shown to reduce cardiovascular events, or is effectively combined with a Lipitor or Crestor, these numbers would go even higher. The Jelis Study leads me to believe that the REDUCE-IT study will show this reduction in events, and the possibility of a combination drug just makes sense in terms of both patient treatment and revenues, so these are both likely in my opinion. The revenues would be enormous if either were to take place.

    In the end, I do not know who will purchase Amarin, but I do believe that even in the worst case scenario a purchase makes sense for big pharma. In the best case scenario, the acquirer can laugh all the way to the bank for many years to come. Shareholders should expect no less than $27 per share, and perhaps even more as the patents continue to be granted, the label indications expand, and the full value of Vascepa is realized.

    Obviously these numbers are the result of some objectivity mixed with a good dose of subjectivity, and thus all readers should do their own due diligence and consider the potential markets for Vascepa - those currently on the label, and all of the other opportunities that appear to be on the horizon."
  5. Anonymous

    Anonymous Guest

    Sounds like talks are starting to get serious.

    Amarin Buyout Rumors Gaining Traction?
    August 11, 2012 | 7 commentsby: Red Acre Investments | about: AMRN, includes: GSK, MRK It is well known that Amarin Corporation PLC (AMRN) management prefers a buyout as the path to commercialization of its anti-triglyceride drug Vascepa. Management has re-iterated this in conference calls and press releases for a while, and biotech speculators love to handicap which big pharma company would be a likely suitor. Recent events have some traders counting on a buyout announcement soon, while other explanations suggest no change in the status quo as we outline herein.

    Merck - the Latest Rumor

    Based on comments during AMRN's Q2 conference call and a story by Peter Loftus that appeared in the online edition of the Wall Street Journal, the latest speculation is that Merck (MRK) might have a deal in the works with AMRN.

    Loftus reports that Merck has placed development of a combination cholesterol drug on hold.

    Merck & Co. said it has placed on hold its development of a combination cholesterol drug, citing "business reasons." ...

    [Merck] no longer plans to file for U.S. regulatory approval of the drug, code-named MK-0524B, in 2014 as it had previously planned. The combination drug was meant to help raise levels of good cholesterol while also lowering levels of bad cholesterol and a related substance implicated in heart disease.

    MK-0524B was a combination of a generic cholesterol lowering statin with niacin, which is known to lower triglycerides, and a third compound, laropiprant, which helps alleviate some of the side effects of niacin.

    Add to this the following question and response during Amarin's conference call:

    Ritu Baral - Canaccord Genuity, Inc.

    Great. And last question, and then I'll jump back in the queue. Your combination products, have you picked a final formulation for the combination product? And can you confirm that it's only one statin at a time that you're going to be moving forward with?

    Joseph S. Zakrzewski - Chairman and Chief Executive Officer

    Well, I can't confirm that we have a final formulation. We have a statin or statins picked out. We have the ability to do many things and we still expect to start that study by the end of the year.

    From the above quotes it appears that Amarin has narrowed down its choice of a cholesterol lowering drug (statin) to run combination clinical trials and at the same time, Merck has put its combination drug trials on hold for business reasons. Putting the pieces together suggests that Merck may be in the running to acquire or partner with Amarin.

    Furthermore, the CEO made the following comment at the end of the conference call:

    Joseph S. Zakrzewski - Chairman and Chief Executive Officer

    Thank you everyone and really appreciate all the support and I think as we continue to go forward here, we've got a lot of exciting times ahead over the next 60 to 90 days.

    Amarin currently has the near-term catalyst of new chemical entity (NCE) status designation coming up, possibly on August 17th when the FDA orange book comes out. Certainly, the NCE status decision, as well as further details of its go-forward commercialization plan, will come out in the next 60 to 90 days. But given the other pieces in the puzzle, some traders are speculating that this mention of a two-to-three-month time-frame is related to a buyout announcement.

    The Rumor Gains Traction

    This past week, investors had a great buying opportunity when Amarin's share price briefly dipped below $11 on August 7. The Wall Street Journal article mentioned above was published at 3:57pm on Wednesday August 8, and the AMRN stock rallied more than $1.50 on Thursday, indicating that traders might be giving some credence to this rumor.

    An Alternate Explanation

    While the timing of the article in the Wall Street Journal right around the time of Amarin's Q2 conference call, and the comments by ARMN during that call seem to imply a strong correlation between these events, in reality, the article from Mr. Loftus relies upon disclosures Merck made in its own Q2 SEC filings that became public on July 27. Furthermore, as the article explains:

    Investor expectations for Merck's niacin-based drugs were tempered by last year's halt to a government-funded study which found that adding niacin to cholesterol-lowering drugs known as statins didn't significantly improve cardiovascular outcomes versus statins alone.

    This suggests an alternate, and more mundane reason for Merck's decision to terminate the program. If combination therapy with niacin and a statin has not demonstrated clinical benefit, why should it continue spending on clinical trials?

    What's Next

    If NCE status is granted to Amarin, the buyout rumors will likely strengthen as will expectations of the takeout price. On the other hand, if NCE status is not granted, traders will likely take profits in the absence of further confirmation of a buyout. It is also possible that the AMRN management would sell shares on August 18 as part of its 10B5-1 pre-arranged stock trading plan. If they sold upon approval, they are likely to sell upon NCE status news. We view a sale by management upon NCE status, if it happens, as neutral to the long-term outlook for Amarin as long as the amount of stock sold is less than about 5% of management's total holdings. If management sells 10% or more of its holdings in aggregate, traders would do well to follow the lead.

    Buyout Timing is a Rule-Breaker

    One note of caution is in order here regarding buyout speculation. It is not the norm for a biotech company to be acquired right after approval. Large pharmaceutical companies historically have either partnered or acquired early-on well before approval in cases where they have a footprint in the therapeutic space, or they have waited for a few quarters of sales numbers to confirm an approved drug's value. In Vascepa's case, the success of Lovaza from GlaxoSmithKline (GSK) is a proxy indicating that the drug has blockbuster potential. As such, traders seem to be speculating that Amarin will be a rule breaker regarding the timing of a buyout.


    We generally do not place much emphasis on buyout rumors because they are easy to start and difficult to confirm. As the present case shows, there usually is an equally likely mundane explanation for a series of events that are the stuff of buyout rumor. On the other hand, since it is well known that Amarin's management is open to a buyout, and since anti-triglyceride drugs have achieved blockbuster status in the past, the possibility of a buyout cannot be ignored.

    Prior to Vascepa's approval, we recommended that those who were not already in AMRN should wait for a buying opportunity after approval. Investors who missed the buying opportunity when Amarin dipped below $11 on August 7 should consider scaling in to a position and be ready to buy on a future dip if they are looking to speculate on a potential buyout or partnership as the go-forward plan for Vascepa.

    More conservative investors may wish to wait until further confirmation of the exact go-forward plan. Amarin has indicated that it will provide more clarity on its commercialization strategy for Vascepa by October. If it ends up announcing a go-it-alone strategy for Vascepa's launch, the stock price could take a large haircut. In the long term, we see Vascepa having excellent prospects in the marketplace and Amarin's progress in expanding its IP estate builds long-term value under all three of its proposed commercialization scenarios.

    Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in AMRN over the next 72 hours.
  6. Anonymous

    Anonymous Guest

    Kolemup, you idiot, what are you doing here?!
  7. Anonymous

    Anonymous Guest

    Vascepa better efficacy than Lovaza? Really? No head to head studies but you be the judge.

    Lovaza studies: 45% reduction in very high TG from an 816 mg/dl baseline. 29.5% reduction in high TG from a 268 mg/dl baseline.

    Vascepa studies: 27% reduction in very high TG from a 680 mg\dl baseline.

    So Lovaza lowered TG by about the same percentage from a much lower baseline TG value, 268 v. 680. Interesting. I call bullshit on any superior efficacy claim. This data is from both PI's.

    LDL? 25% of patients were taking statins in the Vascepa trials. So not a mono therapy study. The Tricor PI shows a 45% increase in LDL for very high TG patients. Lovaza does as well. These were mono therapy studies with no statin background use. You cannot lower very high TG's, VLDL, and not see an increase in LDL without the aid of a statin. This is lipid metabolism 101.
  8. Anonymous

    Anonymous Guest

    There are reasons why Vascepa/EPA-E/Epadel are left for dead by all large pharma's, even in Japan where it was invented 30 years ago!

    Amarin is basically considered a scam by people with real knowledge..

    If you read their SEC filings (99% of "investors" don't) you can see that management basically admits that they never will be profitable!

    But in their laughable presentations they hype some ridiculous "blue-sky" possible market share figures and that is what sell-side analysts are using to justify their insane "price targets" for this worthless company.
  9. Anonymous

    Anonymous Guest

    You mean that AMRN is considered a scam by you, an idiot. You don't have any sources to back up anything that you say, so why don't you quit posting your bs.


    PropThink: New Patents Further Vascepa's Intellectual Property Protection
    Press Release: PropThink – 42 minutes ago

    By Jake King
    Amarin Corp. (AMRN) got a bump in the pre-market Tuesday after announcing that two more patents have been added to Vascepa`s Intellectual Property, protecting the franchise out to 2030. Patents 8,793,727 and 8,293,728 speak to methods of use for icosapent ethyl, Vascepa`s chemical name, and relate to the former patent applications 12/702,889 and 13/349,153. Independent patent attorneys analyzing the applications deemed the `889 application among the strongest pieces of intellectual property surrounding Vascepa. The news should give investors, analysts, and more importantly, Amarin`s potential suitors, confidence that New Chemical Entity status is less important than the market may be assuming. The patent issuance lends exclusivity to icosapent ethyl for the treatment of hypertriglyceridemia, or high triglycerides, and leaves no pathway for generic companies to get around these patents without challenging the patents` validity or enforceability directly, which we see as a very low-probability prospect.
    Amarin is listing the patents in the FDA`s Orange Book, adding to Vascepa`s overall patent estate and making them part of the broader portfolio that generic drug makers would be required to challenge under Hatch-Waxman statues (common generic laws). Investors interested in the Amarin story may be better served with an options strategy, allowing for a hedge against major swings that could accompany a New Chemical Entity decision, a buy-out, or the company moving to launch Vascepa on its own. Expect AMRN to trade higher Tuesday on the new patent issuance.
  10. Anonymous

    Anonymous Guest

    New AstraZeneca boss 'planning to launch cash bid' for US biopharmaceutical group Amarin

    Read more: http://www.dailymail.co.uk/money/mar...#ixzz2ADZVDs2h

    "AstraZeneca's new boss Pascal Soriot didn’t mess about when on his first day in the job he announced the suspension of the drugs group’s £2.8bn share buy-back programme.
    Shareholders were obviously miffed, but analysts took it as a definite sign that he wanted to save the cash for earnings enhancing acquisitions.
    Soriot recently spent up to £169m on the rights to an experimental kidney drug, but rumours now suggest he has something much bigger up his sleeve.

    AZ’s shares shed 38p to 2900p ahead of tomorrow’s third-quarter trading statement.
    The fall was accompanied by speculation Soriot is planning to launch a cash bid for US biopharmaceutical group Amarin, whose shares moved against the trend on Wall Street yesterday with an early gain to $11.61.
    AstraZeneca, along with other larger pharmaceutical companies such as Merck, Pfizer, Abbott and Eli Lilly, would apparently love to get their hands on Amarin for Vascepa, a prescription medicine which helps with the treatment for cardiovascular disease. It is the group’s first FDA approval product.

    US analysts are of the opinion that Amarin’s days of independence are numbered.
    They reckon that Amarin now stands at the crossroads and appears to be waiting for a large pharmaceutical company, with a substantial cardiovascular or diabetes sales force, to come and swallow it whole.
    William Tanner, analyst at Lazard Capital Markets, currently has a target price of $26 on Amarin as has Canaccord Genuity’s Ritu Baral. What does that tell you?"
  11. Anonymous

    Anonymous Guest

    it is in italy, where pfizer is partner, small county 100 million sales
  12. Anonymous

    Anonymous Guest

    Any more news on this?