Icosapent Ethyl Included in the Chinese Society of Cardiology (CSC) Updated Guidelines for Primary Prevention of Cardiovascular Diseases Today 4:30 PM ET (GlobeNewswire)Print Amarin Corporation plc (NASDAQ:AMRN) today announced that the Chinese Society of Cardiology (CSC) has included icosapent ethyl in its updated Guidelines for Primary Prevention of Cardiovascular Diseases for 2021 as published in the Chinese Journal of Cardiovascular Diseases. The guideline authors include "icosapent ethyl 2 grams twice a day (as studied in REDUCE-IT) as a treatment consideration to further lower atherosclerotic cardiovascular disease (ASCVD) in the appropriate patient population."
"Inclusion of icosapent ethyl in the CSC treatment guidelines further validates the increasing independent support and acceptance of this unique drug to reduce cardiovascular risk," stated Craig B. Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Amarin. "Importantly, these updated guidelines also support that the preventive effect of omega-3 fatty acids on ASCVD is not only related to the dose, but also to the type and formulation of omega-3 fatty acid and incorporates findings from the REDUCE-IT cardiovascular outcomes study of VASCEPA."
"With this new recommendation, icosapent ethyl is now included in the treatment guidelines or otherwise recommended for use by 13 medical associations internationally, solidifying its role as an important treatment option beyond cholesterol management for millions of patients worldwide at risk for a cardiovascular event," added Dr. Granowitz. Similar to Europe, where the European Society of Cardiology and the European Atherosclerosis Society added icosapent ethyl to their medical treatment guidelines prior to completion of the ongoing regulatory submission and review processes for VASCEPA (icosapent ethyl), CSC inclusion of icosapent ethyl in its updated treatment guidelines has been made separate from and in advance of completion of the analogous regulatory processes for VASCEPA in China.
In November 2020, Amarin shared positive, statistically significant top-line results from a Phase 3 clinical trial of VASCEPA conducted in China by Amarin's partner, Edding. The study, which investigated VASCEPA as a treatment for patients with very high triglycerides (greater-than or equal to500 mg/dL), met its primary efficacy endpoint and demonstrated a safety profile similar to placebo. This pivotal study mirrored Amarin's MARINE study in patients from the United States and other countries and showed consistency across the Chinese and non-Chinese study populations. These findings will provide support as Edding progresses towards and through the next steps of regulatory submission and review of VASCEPA for potential approval in Mainland China.
The CSC recommendation is classified as a Category IIa recommendation denoting that icosapent ethyl is useful and effective and should be considered for treatment of at-risk patients. The classification is an Evidence Level B recommendation which reflects that the evidence comes from a single randomized trial or multiple large non-randomized studies. CSC cited that its recommendations are supported by the results of the REDUCE-IT cardiovascular outcomes study. The CSC does not provide endorsements of any brand name commercial product. Accordingly, CSC Guidelines for Primary Prevention of Cardiovascular Diseases reference icosapent ethyl. The CSC guideline does not reference VASCEPA, the brand name of icosapent ethyl in the United States, and such guideline should not be construed as an endorsement or approval by the CSC of VASCEPA.
Amarin acknowledges the rigor with which the Guidelines for Primary Prevention of Cardiovascular Diseases are crafted and approved by the CSC, which is comprised of leading medical professionals in China who specialize in the care of patients with cardiovascular disease.
The complete 2021 updates to the Guidelines for Primary Prevention of Cardiovascular Diseases from the CSC can be accessed online here.
About Hypertriglyceridemia in China
There were approximately 180.4 million hypertriglyceridemia (HTG) patients in China in 2019, representing approximately 20.2% of the adult population. Among all HTG patients in China, there were approximately 9 million adults who had very high TG levels (greater-than or equal to500 mg/dL). In 2019, there were approximately 36.1 million statin-treated adult patients in China with elevated TG levels (greater-than or equal to150 mg/dL) and either established CVD or diabetes mellitus and two or more additional risk factors for CVD, the addressable patients of the U.S. FDA-approved indication for reducing CV events of VASCEPA in China.
T
Reiterating this issue:
Even a judge should be able to understand that unlike most other inventions, this one is swallowed. That is a big difference. Prior art and its proof of concept was limited by the size of the studies. Only after a large enough phase 3 was it obvious that this chemical is safe to consume by itself and its degree of effectiveness known with sufficient accuracy so it could be approved by the FDA and then prescribed.
Prior art was not sufficient evidence. It demonstrated a promising possibility, maybe a probability, but not an obvious, actual invention. Without phase 3, little or nothing in the way of health benefit claims could be made by a manufacturer. The vast majority of physicians will not prescribe until a drug's effects are evidence-based. Without Amarin's efforts, most patients would remain unaware of the benefits of EPA alone
A device versus a drug should be treated as two different patent situations. Du and Appeals regarded Vascepa as if it is some sort of implement or machine which someone else thought of first. The prior art were not big enough studies to qualify as an invention. Apparently Amarin's lawyers were too incoherent to make this clear, a substance to be ingested, not a hand-held object.
If investors pay for the definitive proof, or obviousness, of safety and efficacy in phase 3, the company in which they have invested should be entitled to a patent.
Only if prior art had performed a study equivalent to a phase 3, would there have been obviousness sufficient to justify Amarin not being deserving of a patent. Ingesting an invention carries big, unique risks, not applying to non-ingestibles.
Amarin deserves its patents and the case deserves review by the SCOTUS.
T
Some random observations - the ones that keep me buying on dips below 5: (1) after 8 months on Vascepa (and additional stay-at-home/not traveling exercise), my cardiologist opined that my 66 yr. old heart had 'gotten younger' since my year-ago exam - plaque actually measurably reduced on arterial walls; (2) my dear deceased internist father, someone who carefully weighed scientific data with observations from his own and partners' patients, would likely be a strong V supporter; (3) the patient benefits identified by numerous serious studies appear to be significant and various - and the study results trend line remains consistently positive; (4) US patent disputes and US addressable market aside, there is an immense ex-US need for this drug (esp. Europe and China) - in all likelihood, the question is "when", not "if"; and (5) with the US patent situation out of the way - one way or another - substantial risk will be removed from any possible 3rd party valuation and offer - and it is more likely that a serious offer could emerge.
Net net, on both subjective and objective bases, I see a game-changing drug with short (within 12 months) and long term VALUE.
R
i am a doctor, and I have a subscription to a New England Journal of Medicine service called Journal Watch, which looks for the most interesting new articles in medicine, briefly summarizes these articles, and offers an opinion about them. I just got an email in which they mention their top Cardiology stories for 2018: "More than half of the top stories selected by our editorial board focused on prevention strategies. Our top story was on the REDUCE-IT trial, which found that icosapent ethyl reduced cardiovascular risks beyond statins in patients with established cardiovascular disease (CVD) or diabetes. Despite some controversy about the unclear mechanism of action, our Editor said that she would consider using this medication."
M
Note from Wainwright
HCW - AMRN: Europe Can Present Second Wind for Vascepa, Despite Program’s Infancy (Buy PT 10)
European Vazkepa on verge of launch; approval expected April 2021. With domestic Vascepa’s European counterpart Vazkepa on the heels of a positive CHMP opinion, we note formal approval from the European Commission is expected in April 2021. Specifically informed by: (1) Amarin’s displayed domestic launch aptitude from Vascepa’s expanded label in cardiovascular (CV) risk reduction; (2) preliminary market access discussions in preparation for commercial launch and (3) the company’s actively growing European commercial team, we believe that pending approval, Vazkepa is well positioned to enter the European market comprised of upwards of millions of patients at high risk for CV events, despite potential statin therapy. While we believe education remains a top priority in terms of Vazkepa awareness and understanding of its CV risk reduction profile, we believe key strategic strengths of the prospective European launch are driven by: (1) Amarin conducting commercial launch without a strategic partner, with the potential to in turn reap the progressive country-by-country commercial benefits based on coverage market access negotiations; and (2) design of its intended label to focus on Vazkepa’s evidenced CV risk reduction benefit and not targeted to triglyceride (TG) reduction, which we note had presented the Achilles’ heel for the threat of generic entry within the U.S. market. A key point to appreciate about prospective European launch is that Vazkepa would be entering a CV market where there are no immediate competitors in the space and with established IP protection from generic entry. While we note Vascepa has continued to perform from a revenue standpoint domestically, reporting 43% year-over-year growth in net total revenue for 2020, we believe that the European presence of Vazkepa can directly drive both CV risk reduction awareness and top-line growth looking into the near-term horizon.
You thought that was it? China approval potentially near end of 2021. We emphasize opportunity for global expansion continues with strategic partner Edding (private) for the potential approval of Vascepa in China, further broadening the reach of its preventative CV risk benefits. We note approval is anticipated near the end of 2021, with: (1) the Chinese National Medical Products Administration (NMPA) reviewing icosapent ethyl for Mainland China approval; and (2) the Hong Kong Department of Health reviewing icosapent ethyl for approval in Hong Kong. Further informed from Edding’s positive topline from its pivotal Phase 3 trial, we believe that a potential approval in the region could be well received among high TG patients at risk for CV events. Lastly, as we turn our sights back to domestic positioning of Vascepa, we believe commercial progress continues to benefit specifically from: (1) Hikma Pharmaceuticals’ (HIK.L; not rated) launch of generic icosapent ethyl comprised of a skinny label targeted to treat severe hypertriglyceridemia (SHTG) patients, which Amarin notes is limited to approximately 7% of current Vascepa usage; (2) continued question of generic manufacturing capacity, product purity and stability; and (3) the prospect of Vascepa being able to potentially compete with regard to pricing informed from co-pays and rebates, as Amarin continues to determine the overall cadence of educational marketing.
4Q in numbers. The company recorded total revenues of $167.3M for 4Q20 compared to consensus of $164.4M, representing 17% YoY growth despite limitations posed by the ongoing pandemic. Total revenues of $614.1M were reported for full-year 2020, and represented 43% YoY growth. The company reported net income of $4.9M, or $0.01/share for 4Q20, and reported net loss of $18.0M, or $0.05/share for full-year 2020. Reported R&D expenses were $39.0M, and SG&A expenses were $463.3M for full-year 2020. As of December 31, 2020, the company reported $563.4M in cash and investments.
Valuation and risks. We reiterate our Buy rating and $10 price target. Our price target of $10 is based on equally weighted average of: (a) $9.23/ share, as a 30x multiple of taxed and diluted FY29 GAAP EPS of $0.95 discounted back to FY21 at 15%; and (b) an NPV of $10.16/share (discount rate 10%, growth rate 2%). Risks to our investment thesis include: (1) Vascepa commercial ramp-up and/or peak sales not meeting our projections; and (2) further competitive disruption of the omega-3 market by branded drugs or generics and/ or OTC supplements beyond our model.
J
About todays presentations (if already linked here no harm done).
[quote]AMARIN-SUPPORTED RESEARCH AND ANALYSES FROM ACADEMIC COLLABORATORS TO BE FEATURED IN TWO LATE BREAKER AND SIX E-POSTER PRESENTATIONS, INCLUDING ENCORE OF REDUCE-IT® EPA, PRIMARY RESULTS OF THE VASCEPA COVID-19 CARDIOLINK-9 TRIAL, AND MECHANISM OF ACTION INSIGHTS DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that scientific findings that add to the growing body of knowledge on VASCEPA® (icosapent ethyl) will be presented during the National Lipid Association (NLA) Scientific Sessions 2020, being held virtually from December 10 – 12, 2020. These findings will be featured in two Late Breaker and six e-Poster presentations from a variety of academic collaborators based on research or analyses supported by Amarin.
“We are pleased to support several Late Breaker and numerous e-Poster presentations at the upcoming NLA Scientific Sessions 2020,” said Steven Ketchum, Ph.D., senior vice president and president, research & development and chief scientific officer, Amarin. “We continue to showcase data from our REDUCE-IT® study demonstrating the unique and proven efficacy of VASCEPA in cardiovascular risk reduction while providing support to investigators to explore other ways in which VASCEPA can potentially impact public health.”
Amarin added that the Late Breaker presentation of the VASCEPA COVID-19 CardioLink-9 Randomized Trial is of primary results from a trial supported by Amarin and HLS Therapeutics, Inc. that was conducted by independent investigators.
Featured Amarin-supported Late Breakers to be presented:
[b]“EPA Levels and Cardiovascular Outcomes in the Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial” – presented on behalf of all authors by Michael Miller, M.D., University of Maryland Medical System, Baltimore, MD – December 12, 4:30-5:15 pm CST[/b]
There does not seem to be web/pod cast arranged from any of the events (that I have been able to find anyway)
The Investor Relations website contains information about Amarin Corporation plc's business for stockholders, potential investors, and financial analysts.
The Investor Relations website contains information about Amarin Corporation plc's business for stockholders, potential investors, and financial analysts.
investor.amarincorp.com
1
AMRN closed ABOVE the 50 day moving average today, on the WEEKLY chart, for the first time since 12/4, when it closed at $5.01. Once it closed above 50 day moving average AMRN proceeded to Double over the next 8 weeks , hitting $9.25 per share on 2/5.
With 20m shares short & average daily volume just a couple million, & a couple short months from Vascepa Launching in Europe.
Currently AMRN have generated over 600M in revenues, drug only being approved in late 2019. Cardiovascular Disease is the #1 cause of death. TEVA pharm recently discontinued their Generic version , and Additionally the CEO clarified today, generics do not pose a Viable threat to AMRN as 1) physicians Favor Writing the Brand name due to multiple reasons including a. Minimal savings if any at all when compared with Vascepa b. Due to lack of avail. With generics, as generic makers have not ramped up manufacturing/ production c. Education
Either shares less then $5, it may be a matter of a short period of time before AMRN valuation prices in Vascepa sales coming down Germany and larger Europe with sales set to accrue late summer. Remember Europe Provides 15 year exclusivity from March 2021.
J
Dear Colleague:
Late Friday evening on April 8, 2022, Kowa Research Institute, Inc. (Japan) issued a press release announcing the discontinuation of the PROMINENT study (Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes), an international, multi-center study of a potential fibrate drug in cardiovascular (CV) disease prevention, as it was determined to be unlikely to meet its primary endpoint (a composite of nonfatal myocardial infarction, nonfatal ischemic stroke, coronary revascularization and cardiovascular death). Click here to access the press release.
The discontinuation of PROMINENT marks the latest in a series of randomized clinical trials, following ACCORD Lipid and FIELD, in which fenofibrates, a class of fibrate drugs, have failed to meet the primary CV endpoint and have not demonstrate a cardiovascular risk reduction benefit for patients with a high-risk of CV disease.[i],[ii] The failure to demonstrate CV benefit with fenofibrates as adjunct to statin therapy is further evidence that lowering triglyceride levels with these agents does not correlate directly with CV risk reduction. Furthermore, the U.S. Food and Drug Administration (FDA) previously revoked the approval of fenofibrates to manage CV risk in 2016, concluding that they should not be used in combination with statins because the risks outweigh the benefits.[iii]
As you may know, many physicians continue to prescribe fibrates extensively in the U.S., with an estimated 13 million prescriptions dispensed and over 2 million patients treated annually.[iv] Despite the fact the FDA withdrew the CV risk reduction indication for fibratesiii, 61% of those patients are concurrently taking fenofibrate and a statin.[v] Consequently, millions of patients at an increased risk of heart attack or stroke may be unknowingly still receiving medications that have not been shown to reduce their CV risk.
Amarin believes that, based on available evidence and current medical society guideline recommendations, healthcare practitioners with patients with elevated and high triglycerides taking fibrates as adjuncts to statins to reduce CV risk should consider the potential benefits of only FDA-approved therapies to further reduce CV risk for appropriate patients on statins with established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease as studied in REDUCE-IT.[vi],[vii],[viii],[ix],[x],[xi],[xii],[xiii],[xiv],[xv]
Although the mechanisms of action by which VASCEPA® (icosapent ethyl) reduces CV risk are not completely understood, they are likely multi-factorial.xiv Evidence from the landmark CV outcomes trial, REDUCE-IT, suggests pleiotropic effects of VASCEPA and the opportunity to treat the patient rather than merely affecting a laboratory score. xv
If you wish to review the Kowa press release, you are able to do so by clicking HERE.
This information is being shared with you for your background knowledge and information only.
Indications VASCEPA is indicated for the following patients:
As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease. As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
Limitations of Use The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information
VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components
VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter
It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur
Please see the complete Important Safety Information at the end of this communication.
Thank you for your continued commitment to patient care.
Sincerely,
Mark Carmon, PharmD, CDE
Executive Director, Medical Affairs
Amarin Pharma Inc.
Attachments: VASCEPA Prescribing Information
Important Safety Information
VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components. VASCEPA was associated with an in
a
5/25,,,salt&lime,,, Time to set the record straight, so I'm going to break the news about over-the-counter EPA's availability to the public. First, there is still "way to much concern" over Amarin's competion with script generics, no matter what outcome from SCOTUS's decision to rule or send back to lower court for review. AMARIN'S "ace in the hole" is that they can sell their name brand VASCEPA and market off brand icosapent ethyl just as Hikma and others may come on board to compete. Currently because Amarin has tied up large contracts for natural EPA amongst suppliers, the generic(s) have an issue of supply sources. Now for the meat and potatoes. The main known over the counter EPA products are Epadel from Japan which is also a synthetically powder form of EPA and the synthetic form is not approved for script usage at all in the USA but can be marketed for over the counter consumption. The main other two fish oil derived forms, (there are others) are from the supplement company GNC ( EPA in a mini or full size pill is available) and the brand name product, Pharmepa (Restore) which is produced in the United Kingdom. Based on a medicare co-pay of $95/month, extrapolating the dosage of 4grams/day and cost compared to Vascepa over the ones I have mentioned (and personally have used other than Epadel), Vascepa is slightly more expensive (even over Hikma's generic). The main issue over the ones I have mentioned is "purity and potential oxidation". Pharmepa actually claims oxidation reduction from air and light due to their specific encapsulation and "blister packaging" for each capsule, their answer to Vasacepa's patented encapsulation to prevent early oxidation of the EPA molecule. So, you may ask, "since you've used the over-the-counter products, what have been your results with your blood work?". I will not comment, that's up to you and your doctor. The generic's won't be allowed in all of Europe, but I'm not sure if the over-the-counter products will be. Most of us are down a bundle with AMRN, it's a long waiting game now to hopefully break even. BOL to all.
J
April 1, 2022 7:00 AM EDT Eicosapentaenoic Acid (EPA) Combined with Widely Used Statins Significantly Reduced Lipid Oxidation in Model Membranes ,, great news now just get out there and get the world using Vascepa !
"“The message that emerged for us from these in vitro study results was that, while statins and EPA can work independently to reduce lipid oxidation which can contribute to cardiovascular risk, they might work even better together,” said Dr. Mason. “This is an important finding with potential implications in particular for those facing persistent, elevated cardiovascular risk or who have had a prior event, as they may need more potent solutions than the standard of care can provide.”
“These findings are another compelling piece of evidence in line with our beliefs regarding the potential for increased benefit to appropriate high-risk patients from VASCEPA/VAZKEPA in combination with statins, consistent with the results from the REDUCE-IT® trial, and supports Amarin’s decision to focus on research and development efforts toward the possible development of a combination product,” said Karim Mikhail, Amarin’s president and chief executive officer.
S
An interesting post from ihub poster Keystone_Investments..post is below:
Keystone_Investments Tuesday, 01/21/20 04:13:03 PM Re: None 0 Post # 242665 of 242699 AMRN Valuation Discussion.
There have been several posters that have opined regarding AMRN valuation whether that be as a multiple of peak revenue or discounting EUR valuation based on royalties, etc. I'd like to add my view as a former investment banker involved in M&A transactions.
Valuation essentially boils down to discounting a stream of future free cash flows.
While the above sentence may make sense to many folks here, there's a lot of assumptions that go into this type of projection model. Patent protection assumptions across different geographies is one of them. How quickly and how big will revenues grow in each market and for how long. At what margin. What other income streams are reasonable in your valuation (DE, ALZ, cancer, NASH, etc.; you can bridge that last point with CVRs). What discount rate do you use to calculate your NPV (net present value). Note that the discount rate is different if you are AMRN or a BO contender. These are just some of the issues and there are many more (e.g., SG&A, tax rates, tax loss carryforwards, etc.)
When looking at a multiple of peak revenues, this is usually derived from your NPV divided by peak revenues and not by itself a primary deterministic valuation factor. Think about what peak revenues will be right before patent expiration. It's highly unlikely that you'll get 5x revenue at that stage of your drug product life cycle.
As for looking at EU as a royalty stream, that is important for AMRN, however, any BO contender will look at the NPV of DCF for the EUR market to determine the value to the acquirer.
The equity analysts covering AMRN all have DCF models that have determined their valuation on a GIA basis or in a BO scenario. As I run down the list of analyst estimates I see a GIA SP target of 22-51 (not including the Opp clown). The average is $31. I think all but one of the analysts are too low.
As for BO vs GIA, the numbers will tell the story. AMRN has developed a very valuable drug and BP knows this and certainly wants it. My guess is that the projection models have been tweaked by BP contenders and by AMRN internally and there is a current valuation gap. This gap can close via continued script growth, continued de-risking (e.g., patent, operational and supply) or possibly a CVR structure. These models are likely advanced at this stage by many interested parties, so any M&A offers can be swift.
Whether you are a "BO Boy" or in the "GIA Gang", I believe we will wake up one morning with news of a BO offer. I'm not saying it gets approved, but with a BB drug this attractive, it's very likely going to happen. Resolution of the patent issue will be a de-risking event and as one analyst has already indicated, "will open the M&A window". We are not yet at peak valuation for AMRN as the impact of continued de-risking (via the discount rate) is more than offsetting projected future FCF. That will reverse certainly within the next year and perhaps much sooner.
That's my 2 cents. I am not posting my valuation for AMRN, but I will say that I am a very large shareholder and have owned and increased since 2010.
t
Clearly these lawsuits(that will go nowhere) are a coordinated hit on the company to weaken its financial position through legal fees and or settlement. No coincidence these were all dropped during a period of high cash burn with EU rollout and current US litigation. The goal is to muddy the company up. Chess games are being played at the highest levels. Management is not blind to this. Don't expect them to speak much about pending litigation. Management needs to stay focused on executing the current game plan. It's the only way out. As an investor don't get distracted by the shiny objects. Life is not easy for a single pipeline biopharma even with a blockbuster drug.
t
Piper Sandler analyst Yasmeen Rahimi is confident of Vascepa's path forward in the global market following Amarin's "successful" earnings call, and sees approval in the EU and China later this year, the analyst tells investors in a research note. The analyst also remains bullish on Vascepa's U.S. sales as Amarin makes headway into persistent CV risk patients and expects Phase 3 PREPARE-IT COVID-19 data from Argentina and YE21 for Phase 4 MITIGATE-IT readout from the U.S. in 2021. Rahimi made no change to her Overweight rating or $19 price target.
t
Now that PFE has dipped its toes in the water in Canada with HLS and, based on HLS' results, it seems to be going well, I would think they are looking at AMRN and the underwhelming sales. AMRN has already cleared the decks by laying off a major part of the underperforming sales force. PFE could overlay its US cardio sales team and do wonders. AMRN has built staff and sales in Germany, but with dossiers filed in 9 other countries in the EU and starting the process in other EU countries and the ROW, wouldn't it make sense for PFE to move now before there is a large staff build up throughout. PFE has their own teams and could add Vascepa. I would not think they are overly concerned about current litigation. Their own legal teams have the experience to go after patent infringement.
The stock price is extremely low for the potential AMRN sales in EU, China, ROW (and the US with a dynamic sales team). PFE knows they would be the best one to realize those sales by buying out AMRN with its depressed market price. The head of PFE North America has to be thinking along those lines. I would think it would be under consideration by their global corporate development (M&A) team.
jmho
l
John posted the article from MD Edege 2 hours ago and the article uncovers a gem for AMRN about which I had not previously thought. I'm a physician and V user(off label). The point is that most physician offices no longer perform lipid panels fasting since it has been found that time from last food consumption has little effect on LDL cholesterol levels and the inconvenience of having patients return fasting for a lipid panel; however, TGs are uniformly higher when not fasting. Bottom line is that there will be many more patients with TGs>150 and hence a much larger target for V under the official guidelines then I had previously anticipated.
v
I visited my cardiologist yesterday and ended up talking about Vascepa. Full disclosure-I am a surgeon and I am long on AMRN. I noticed some reluctance on his part to accept the premise of the Reduce-it study. He finally told me about one of this partners going to a conference and being told by one of the "experts" about the increase risk of prostate cancer in patients taking fish oil. As soon as I got home i went to research the topic, and found 1- The origen of this topic was first brought out in 2011 by Bradsky. 2-There have been MULTIPLE studies since that have looked at this issue. In evaluating the evidence i am comfortable with the following facts The original Bradsky study clearly differentiated risks associated between DHA and EPA (Vascepa). It concluded that DHA did seem to increase risk of Protate Cancer.EPA DID NOT. This has held throughout, and furthermore, at this stage, looking at all the studies, the premise of increased prostate cancer risk is not justified. See .Fish-Derived Omega-3 Fatty Acids and Prostate Cancer: A Systematic ... https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5736071/ In addition,all the epidemiological data from the Japanese and Inuit populations contradicts the premise of higher risk in men with high intake of fish oil, all fish oil. The benefits of intake are many in cardiac arrhythmia, arteriosclerosis and anti-inflamatory effects. At the end, I am very happy to be long, and I can see such a wide use for this compound in the future that makes me wish I had more money to invest in AMRN.
K
Pushing FDA review to November is a temp setback in share price. Everyone is forgetting that Health Canada has given Priority Review Status to Vascepa. April + 215 days puts that decision in Nov or Dec.
BEDMINSTER, N.J., and DUBLIN, Ireland, March 29, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company focused on improving cardiovascular health, today announced that its licensee in Canada, HLS Therapeutics Inc. (TSX:HLS), has received formal confirmation from Health Canada that the Canadian regulatory authority has granted priority review status for the upcoming New Drug Submission (“NDS”) for Vascepa® (icosapent ethyl) capsules. HLS Therapeutics anticipates filing the NDS in April 2019 seeking approval to market and sell Vascepa in Canada to reduce the risk of ischemic cardiovascular events in statin-treated patients with elevated triglycerides and other risk factors. Priority review status may be granted to regulatory filings in Canada for new treatments that potentially address serious, life-threatening conditions for which no drug is currently marketed in Canada, and for which there is substantial evidence of clinical effectiveness of that new treatment. Under priority review the performance target for the screening and review of the original submission is 215 calendar days versus 355 days for a standard review. Therefore, receipt of priority review status could expedite the launch of Vascepa in the Canadian market, if the product is ultimately approved by Health Canada.
B
What are the odds of a buy out? Well Lots of folks comparing potential buy out of Amarin to Pfizer’s purchase of Warner Lambert in early 2000 for 90B. By the way I’m not saying Amarin will sell for 90B, I think much lower actually but the buy out will occur 1 to 1.5 year(s) max. I ask the reader to keep Amarin in mind while reading this novel. Let’s dive into some Facts of Warner Lambert(WL) and Pfizer.
Warner Lambert had been around since the mid 1800’s very established and grew through acquisitions and mergers. They owned consumer products such as Benadryl, Lubriderm, Rolaids, Listerine, halls cough drops, Schick razors, Certs and clorets mints, Trident gum, chicklets gum. By the mid 80’s Warner Lambert had 3 main businesses: prescription pharmaceuticals, consumer healthcare products and gums and mints. This shows how establish Warner Lambert was.
Going into FDA approval for Lipitor they were already up against a crowded market due to established statins by big pharma. Many believed Lipitor, despite its success in clinical trials, was a “Me too” statin. Not to mention Mevacor was going generic by 2001 which would be a less expensive option in the near future. In 1996 FDA expedited WL application for Lipitor. It was approved in 6 months, Dec of 1996 and hit the market in January of 1997. Biggest challenge for WL was marketing and sales force, most believe the first 6 months of a drugs launch is the most critical time in a products life cycle. (Take notes John Thero).
Income Pfizer a joint co marketing agreement with WL to squeeze all the potential out of Lipitor. Details of the co-marketing agreement state that Pfizer paid $205 million in up front money and milestone payments for the rights to sell Lipitor. Pfizer also committed to splitting all future product expenses including advertising, promotion, sampling and sales force. Furthermore, Pfizer agreed to pay for half of any ongoing and planned clinical trials, which were reported to number more than 100 and involve 100,000 patients. In return, Pfizer would receive variable payments based on sales targets established in the agreement. Given the annual sales that Lipitor had reached, the arrangement indicates that Pfizer received 48% of net sales.
Warner-Lambert and Pfizer outgunned the competition with the largest statin sales force. Between Warner-Lambert and Pfizer, more than 2,200 sales representatives were believed to be selling Lipitor during its launch in the U.S targeting 91 000 key prescribers.
Sales: 1997 0.9B (WL was expecting 250 million pre launch) 1998 2.2 B 1999 3.4B (end of year hostile takeover attempt by Pfizer for a little over 80B) 3 months in court battling. Ended with Pfizer buying WL for 90B and all WL executives got tossed/not promoted. Which is what WL was fighting against in the first place. Not sure why they caved. 2000 4.6B 2001 5.6B 2002 6.7B 2003 7.7B and so on...
Conclusion IMO: Warner Lambert, an established company for over a century, needed help to get (arguably the best drug of all time) to sell. So I think Amarin has ZERO chance of making Vascepa hit it’s full potential if they go at it alone. I hope the board can put their Ego’s aside and realize that this will not fly like they want it to if they chose to undertake this without Big Pharma. I think a buy out is guaranteed at this point I just don’t know for how many billions. Yes a BO is in the shareholders best interest John Thero!
K
Quarterly Rpt and CC were about what I was expecting. Impact of generics on U.S. market has peaked, Amarin working diligently to remind payers that there are strict limits for generics. Leaves them open to being liable for economic damages if they push generic to any patient with cardio issues. Marketing campaign in U.S. using virtual office visits and electronic communication to contact Physicians. No need for 800 sales reps since there are limits on people visiting offices. Canada-Pfizer thing moving along & Amarin happy to have Pfizer in the game. Germany market just went on line for Rx Sales as of Oct 1 - revenue for quarter from Germany was $200K. That market will grow significantly. 20 other nations around the globe are being worked with to get cost issues worked out so Rx sales can begin. China FDA most likely to approve by end of year with sales beginning in 2022. The future is bright for AMRN.
K
Kiplinger rates AMRN as Strong Buy
TipRanks consensus rating: Strong Buy Amarin (AMRN, $16.74) has already earned approval for Vascepa, a purified fish oil derivative that treats elevated triglyceride levels. However, the biotech company now is trying to get the drug approved for use in reducing the risk of major adverse cardiovascular events, more than a year after releasing the results of the landmark REDUCE-IT trial that sent shares from around $3 into the $20s within weeks. Amarin was notified on Aug. 8 that the FDA planned on holding an advisory committee meeting (AdCom) on Nov. 14, likely pushing Vascepa's PDUFA date back into December. The FDA confirmed in September that the PDUFA date would be Dec. 28. The AdCom announcement knocked shares 22% lower in just two days. Advisory committee meetings are held to seek outside input, so that – in combination with the delayed PDUFA date – made Wall Street less certain about Vascepa's fate. The biotech stock has recovered since then, however, and the analyst community remains mostly upbeat, issuing seven Buys on AMRN versus just one Hold over the past three months. That includes Cantor Fitzgerald analyst Louise Chen, who cites an Institute for Clinical and Economic Review (ICER) report that evaluated the cost-effectiveness of the therapy. "Despite the stringent criteria of the analysis, the report concludes that Vascepa easily meets commonly cited thresholds for cost-effectiveness and therefore represents a high long-term value for money," writes Chen, who has an Overweight rating and $35 price target (109% upside potential). "This report underscores the findings of the landmark REDUCE-IT trial and strengthens our belief that the peak sales potential of Vascepa is underappreciated." Jeffries analyst Michael Yee reiterated his Buy rating and $30 price target (79% upside potential) in September, writing that he expects a positive AdCom outcome. "Of note, the final ICER guidance report for Vascepa was released this morning and largely appears in line with the draft guidance released in late July. (Prescriptions) continue to grow, and we think 2020 Street estimates remain low with a likely positive AdCom vote and approval later this year." Discover how other top analysts rate Amarin at TipRanks.
Icosapent Ethyl Included in the Chinese Society of Cardiology (CSC) Updated Guidelines for Primary Prevention of Cardiovascular Diseases
Today 4:30 PM ET (GlobeNewswire)Print
Amarin Corporation plc (NASDAQ:AMRN) today announced that the Chinese Society of Cardiology (CSC) has included icosapent ethyl in its updated Guidelines for Primary Prevention of Cardiovascular Diseases for 2021 as published in the Chinese Journal of Cardiovascular Diseases. The guideline authors include "icosapent ethyl 2 grams twice a day (as studied in REDUCE-IT) as a treatment consideration to further lower atherosclerotic cardiovascular disease (ASCVD) in the appropriate patient population."
"Inclusion of icosapent ethyl in the CSC treatment guidelines further validates the increasing independent support and acceptance of this unique drug to reduce cardiovascular risk," stated Craig B. Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Amarin. "Importantly, these updated guidelines also support that the preventive effect of omega-3 fatty acids on ASCVD is not only related to the dose, but also to the type and formulation of omega-3 fatty acid and incorporates findings from the REDUCE-IT cardiovascular outcomes study of VASCEPA."
"With this new recommendation, icosapent ethyl is now included in the treatment guidelines or otherwise recommended for use by 13 medical associations internationally, solidifying its role as an important treatment option beyond cholesterol management for millions of patients worldwide at risk for a cardiovascular event," added Dr. Granowitz. Similar to Europe, where the European Society of Cardiology and the European Atherosclerosis Society added icosapent ethyl to their medical treatment guidelines prior to completion of the ongoing regulatory submission and review processes for VASCEPA (icosapent ethyl), CSC inclusion of icosapent ethyl in its updated treatment guidelines has been made separate from and in advance of completion of the analogous regulatory processes for VASCEPA in China.
In November 2020, Amarin shared positive, statistically significant top-line results from a Phase 3 clinical trial of VASCEPA conducted in China by Amarin's partner, Edding. The study, which investigated VASCEPA as a treatment for patients with very high triglycerides (greater-than or equal to500 mg/dL), met its primary efficacy endpoint and demonstrated a safety profile similar to placebo. This pivotal study mirrored Amarin's MARINE study in patients from the United States and other countries and showed consistency across the Chinese and non-Chinese study populations. These findings will provide support as Edding progresses towards and through the next steps of regulatory submission and review of VASCEPA for potential approval in Mainland China.
The CSC recommendation is classified as a Category IIa recommendation denoting that icosapent ethyl is useful and effective and should be considered for treatment of at-risk patients. The classification is an Evidence Level B recommendation which reflects that the evidence comes from a single randomized trial or multiple large non-randomized studies. CSC cited that its recommendations are supported by the results of the REDUCE-IT cardiovascular outcomes study. The CSC does not provide endorsements of any brand name commercial product. Accordingly, CSC Guidelines for Primary Prevention of Cardiovascular Diseases reference icosapent ethyl. The CSC guideline does not reference VASCEPA, the brand name of icosapent ethyl in the United States, and such guideline should not be construed as an endorsement or approval by the CSC of VASCEPA.
Amarin acknowledges the rigor with which the Guidelines for Primary Prevention of Cardiovascular Diseases are crafted and approved by the CSC, which is comprised of leading medical professionals in China who specialize in the care of patients with cardiovascular disease.
The complete 2021 updates to the Guidelines for Primary Prevention of Cardiovascular Diseases from the CSC can be accessed online here.
About Hypertriglyceridemia in China
There were approximately 180.4 million hypertriglyceridemia (HTG) patients in China in 2019, representing approximately 20.2% of the adult population. Among all HTG patients in China, there were approximately 9 million adults who had very high TG levels (greater-than or equal to500 mg/dL). In 2019, there were approximately 36.1 million statin-treated adult patients in China with elevated TG levels (greater-than or equal to150 mg/dL) and either established CVD or diabetes mellitus and two or more additional risk factors for CVD, the addressable patients of the U.S. FDA-approved indication for reducing CV events of VASCEPA in China.
Even a judge should be able to understand that unlike most other inventions, this one is swallowed. That is a big difference. Prior art and its proof of concept was limited by the size of the studies. Only after a large enough phase 3 was it obvious that this chemical is safe to consume by itself and its degree of effectiveness known with sufficient accuracy so it could be approved by the FDA and then prescribed.
Prior art was not sufficient evidence. It demonstrated a promising possibility, maybe a probability, but not an obvious, actual invention. Without phase 3, little or nothing in the way of health benefit claims could be made by a manufacturer. The vast majority of physicians will not prescribe until a drug's effects are evidence-based. Without Amarin's efforts, most patients would remain unaware of the benefits of EPA alone
A device versus a drug should be treated as two different patent situations. Du and Appeals regarded Vascepa as if it is some sort of implement or machine which someone else thought of first. The prior art were not big enough studies to qualify as an invention. Apparently Amarin's lawyers were too incoherent to make this clear, a substance to be ingested, not a hand-held object.
If investors pay for the definitive proof, or obviousness, of safety and efficacy in phase 3, the company in which they have invested should be entitled to a patent.
Only if prior art had performed a study equivalent to a phase 3, would there have been obviousness sufficient to justify Amarin not being deserving of a patent. Ingesting an invention carries big, unique risks, not applying to non-ingestibles.
Amarin deserves its patents and the case deserves review by the SCOTUS.
Net net, on both subjective and objective bases, I see a game-changing drug with short (within 12 months) and long term VALUE.
HCW - AMRN: Europe Can Present Second Wind for Vascepa, Despite Program’s Infancy (Buy PT 10)
European Vazkepa on verge of launch; approval expected April 2021. With domestic Vascepa’s European counterpart Vazkepa on the heels of a positive CHMP opinion, we note formal approval from the European Commission is expected in April 2021. Specifically informed by: (1) Amarin’s displayed domestic launch aptitude from Vascepa’s expanded label in cardiovascular (CV) risk reduction; (2) preliminary market access discussions in preparation for commercial launch and (3) the company’s actively growing European commercial team, we believe that pending approval, Vazkepa is well positioned to enter the European market comprised of upwards of millions of patients at high risk for CV events, despite potential statin therapy. While we believe education remains a top priority in terms of Vazkepa awareness and understanding of its CV risk reduction profile, we believe key strategic strengths of the prospective European launch are driven by: (1) Amarin conducting commercial launch without a strategic partner, with the potential to in turn reap the progressive country-by-country commercial benefits based on coverage market access negotiations; and (2) design of its intended label to focus on Vazkepa’s evidenced CV risk reduction benefit and not targeted to triglyceride (TG) reduction, which we note had presented the Achilles’ heel for the threat of generic entry within the U.S. market. A key point to appreciate about prospective European launch is that Vazkepa would be entering a CV market where there are no immediate competitors in the space and with established IP protection from generic entry. While we note Vascepa has continued to perform from a revenue standpoint domestically, reporting 43% year-over-year growth in net total revenue for 2020, we believe that the European presence of Vazkepa can directly drive both CV risk reduction awareness and top-line growth looking into the near-term horizon.
You thought that was it? China approval potentially near end of 2021. We emphasize opportunity for global expansion continues with strategic partner Edding (private) for the potential approval of Vascepa in China, further broadening the reach of its preventative CV risk benefits. We note approval is anticipated near the end of 2021, with: (1) the Chinese National Medical Products Administration (NMPA) reviewing icosapent ethyl for Mainland China approval; and (2) the Hong Kong Department of Health reviewing icosapent ethyl for approval in Hong Kong. Further informed from Edding’s positive topline from its pivotal Phase 3 trial, we believe that a potential approval in the region could be well received among high TG patients at risk for CV events. Lastly, as we turn our sights back to domestic positioning of Vascepa, we believe commercial progress continues to benefit specifically from: (1) Hikma Pharmaceuticals’ (HIK.L; not rated) launch of generic icosapent ethyl comprised of a skinny label targeted to treat severe hypertriglyceridemia (SHTG) patients, which Amarin notes is limited to approximately 7% of current Vascepa usage; (2) continued question of generic manufacturing capacity, product purity and stability; and (3) the prospect of Vascepa being able to potentially compete with regard to pricing informed from co-pays and rebates, as Amarin continues to determine the overall cadence of educational marketing.
4Q in numbers. The company recorded total revenues of $167.3M for 4Q20 compared to consensus of $164.4M, representing 17% YoY growth despite limitations posed by the ongoing pandemic. Total revenues of $614.1M were reported for full-year 2020, and represented 43% YoY growth. The company reported net income of $4.9M, or $0.01/share for 4Q20, and reported net loss of $18.0M, or $0.05/share for full-year 2020. Reported R&D expenses were $39.0M, and SG&A expenses were $463.3M for full-year 2020. As of December 31, 2020, the company reported $563.4M in cash and investments.
Valuation and risks. We reiterate our Buy rating and $10 price target. Our price target of $10 is based on equally weighted average of: (a) $9.23/ share, as a 30x multiple of taxed and diluted FY29 GAAP EPS of $0.95 discounted back to FY21 at 15%; and (b) an NPV of $10.16/share (discount rate 10%, growth rate 2%). Risks to our investment thesis include: (1) Vascepa commercial ramp-up and/or peak sales not meeting our projections; and (2) further competitive disruption of the omega-3 market by branded drugs or generics and/ or OTC supplements beyond our model.
[quote]AMARIN-SUPPORTED RESEARCH AND ANALYSES FROM ACADEMIC COLLABORATORS TO BE FEATURED IN TWO LATE BREAKER AND SIX E-POSTER PRESENTATIONS, INCLUDING ENCORE OF REDUCE-IT® EPA, PRIMARY RESULTS OF THE VASCEPA COVID-19 CARDIOLINK-9 TRIAL, AND MECHANISM OF ACTION INSIGHTS
DUBLIN, Ireland and BRIDGEWATER, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that scientific findings that add to the growing body of knowledge on VASCEPA® (icosapent ethyl) will be presented during the National Lipid Association (NLA) Scientific Sessions 2020, being held virtually from December 10 – 12, 2020. These findings will be featured in two Late Breaker and six e-Poster presentations from a variety of academic collaborators based on research or analyses supported by Amarin.
“We are pleased to support several Late Breaker and numerous e-Poster presentations at the upcoming NLA Scientific Sessions 2020,” said Steven Ketchum, Ph.D., senior vice president and president, research & development and chief scientific officer, Amarin. “We continue to showcase data from our REDUCE-IT® study demonstrating the unique and proven efficacy of VASCEPA in cardiovascular risk reduction while providing support to investigators to explore other ways in which VASCEPA can potentially impact public health.”
Amarin added that the Late Breaker presentation of the VASCEPA COVID-19 CardioLink-9 Randomized Trial is of primary results from a trial supported by Amarin and HLS Therapeutics, Inc. that was conducted by independent investigators.
Featured Amarin-supported Late Breakers to be presented:
[b]“EPA Levels and Cardiovascular Outcomes in the Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial” – presented on behalf of all authors by Michael Miller, M.D., University of Maryland Medical System, Baltimore, MD – December 12, 4:30-5:15 pm CST[/b]
[b]“First Human Trial of a Loading Dose of Icosapent Ethyl in Patients with COVID-19: Primary Results of the VASCEPA COVID-19 CardioLink-9 Randomized Trial” – presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women’s Hospital, Harvard Medical School, Boston, MA – December 12, 4:30-5:15 pm CST[/quote][/b]
https://investor.amarincorp.com/news-releases/news-release-details/vascepar-icosapent-ethyl-related-scientific-findings-be
There does not seem to be web/pod cast arranged from any of the events (that I have been able to find anyway)
With 20m shares short & average daily volume just a couple million, & a couple short months from Vascepa Launching in Europe.
Currently AMRN have generated over 600M in revenues, drug only being approved in late 2019. Cardiovascular Disease is the #1 cause of death. TEVA pharm recently discontinued their Generic version , and
Additionally the CEO clarified today, generics do not pose a Viable threat to AMRN as 1) physicians Favor Writing the Brand name due to multiple reasons including a. Minimal savings if any at all when compared with Vascepa b. Due to lack of avail. With generics, as generic makers have not ramped up manufacturing/ production c. Education
Either shares less then $5, it may be a matter of a short period of time before AMRN valuation prices in Vascepa sales coming down Germany and larger Europe with sales set to accrue late summer. Remember Europe Provides 15 year exclusivity from March 2021.
Late Friday evening on April 8, 2022, Kowa Research Institute, Inc. (Japan) issued a press release announcing the discontinuation of the PROMINENT study (Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes), an international, multi-center study of a potential fibrate drug in cardiovascular (CV) disease prevention, as it was determined to be unlikely to meet its primary endpoint (a composite of nonfatal myocardial infarction, nonfatal ischemic stroke, coronary revascularization and cardiovascular death). Click here to access the press release.
The discontinuation of PROMINENT marks the latest in a series of randomized clinical trials, following ACCORD Lipid and FIELD, in which fenofibrates, a class of fibrate drugs, have failed to meet the primary CV endpoint and have not demonstrate a cardiovascular risk reduction benefit for patients with a high-risk of CV disease.[i],[ii] The failure to demonstrate CV benefit with fenofibrates as adjunct to statin therapy is further evidence that lowering triglyceride levels with these agents does not correlate directly with CV risk reduction. Furthermore, the U.S. Food and Drug Administration (FDA) previously revoked the approval of fenofibrates to manage CV risk in 2016, concluding that they should not be used in combination with statins because the risks outweigh the benefits.[iii]
As you may know, many physicians continue to prescribe fibrates extensively in the U.S., with an estimated 13 million prescriptions dispensed and over 2 million patients treated annually.[iv] Despite the fact the FDA withdrew the CV risk reduction indication for fibratesiii, 61% of those patients are concurrently taking fenofibrate and a statin.[v] Consequently, millions of patients at an increased risk of heart attack or stroke may be unknowingly still receiving medications that have not been shown to reduce their CV risk.
Amarin believes that, based on available evidence and current medical society guideline recommendations, healthcare practitioners with patients with elevated and high triglycerides taking fibrates as adjuncts to statins to reduce CV risk should consider the potential benefits of only FDA-approved therapies to further reduce CV risk for appropriate patients on statins with established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease as studied in REDUCE-IT.[vi],[vii],[viii],[ix],[x],[xi],[xii],[xiii],[xiv],[xv]
Although the mechanisms of action by which VASCEPA® (icosapent ethyl) reduces CV risk are not completely understood, they are likely multi-factorial.xiv Evidence from the landmark CV outcomes trial, REDUCE-IT, suggests pleiotropic effects of VASCEPA and the opportunity to treat the patient rather than merely affecting a laboratory score. xv
If you wish to review the Kowa press release, you are able to do so by clicking HERE.
This information is being shared with you for your background knowledge and information only.
Indications
VASCEPA is indicated for the following patients:
As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
established cardiovascular disease or
diabetes mellitus and 2 or more additional risk factors for cardiovascular disease.
As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
Limitations of Use
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information
VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components
VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter
It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur
Please see the complete Important Safety Information at the end of this communication.
Thank you for your continued commitment to patient care.
Sincerely,
Mark Carmon, PharmD, CDE
Executive Director, Medical Affairs
Amarin Pharma Inc.
Attachments: VASCEPA Prescribing Information
Important Safety Information
VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
VASCEPA was associated with an in
Eicosapentaenoic Acid (EPA) Combined with Widely Used Statins Significantly Reduced Lipid Oxidation in Model Membranes ,, great news now just get out there and get the world using Vascepa !
"“The message that emerged for us from these in vitro study results was that, while statins and EPA can work independently to reduce lipid oxidation which can contribute to cardiovascular risk, they might work even better together,” said Dr. Mason. “This is an important finding with potential implications in particular for those facing persistent, elevated cardiovascular risk or who have had a prior event, as they may need more potent solutions than the standard of care can provide.”
“These findings are another compelling piece of evidence in line with our beliefs regarding the potential for increased benefit to appropriate high-risk patients from VASCEPA/VAZKEPA in combination with statins, consistent with the results from the REDUCE-IT® trial, and supports Amarin’s decision to focus on research and development efforts toward the possible development of a combination product,” said Karim Mikhail, Amarin’s president and chief executive officer.
Keystone_Investments Tuesday, 01/21/20 04:13:03 PM
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AMRN Valuation Discussion.
There have been several posters that have opined regarding AMRN valuation whether that be as a multiple of peak revenue or discounting EUR valuation based on royalties, etc. I'd like to add my view as a former investment banker involved in M&A transactions.
Valuation essentially boils down to discounting a stream of future free cash flows.
While the above sentence may make sense to many folks here, there's a lot of assumptions that go into this type of projection model. Patent protection assumptions across different geographies is one of them. How quickly and how big will revenues grow in each market and for how long. At what margin. What other income streams are reasonable in your valuation (DE, ALZ, cancer, NASH, etc.; you can bridge that last point with CVRs). What discount rate do you use to calculate your NPV (net present value). Note that the discount rate is different if you are AMRN or a BO contender. These are just some of the issues and there are many more (e.g., SG&A, tax rates, tax loss carryforwards, etc.)
When looking at a multiple of peak revenues, this is usually derived from your NPV divided by peak revenues and not by itself a primary deterministic valuation factor. Think about what peak revenues will be right before patent expiration. It's highly unlikely that you'll get 5x revenue at that stage of your drug product life cycle.
As for looking at EU as a royalty stream, that is important for AMRN, however, any BO contender will look at the NPV of DCF for the EUR market to determine the value to the acquirer.
The equity analysts covering AMRN all have DCF models that have determined their valuation on a GIA basis or in a BO scenario. As I run down the list of analyst estimates I see a GIA SP target of 22-51 (not including the Opp clown). The average is $31. I think all but one of the analysts are too low.
As for BO vs GIA, the numbers will tell the story. AMRN has developed a very valuable drug and BP knows this and certainly wants it. My guess is that the projection models have been tweaked by BP contenders and by AMRN internally and there is a current valuation gap. This gap can close via continued script growth, continued de-risking (e.g., patent, operational and supply) or possibly a CVR structure. These models are likely advanced at this stage by many interested parties, so any M&A offers can be swift.
Whether you are a "BO Boy" or in the "GIA Gang", I believe we will wake up one morning with news of a BO offer. I'm not saying it gets approved, but with a BB drug this attractive, it's very likely going to happen. Resolution of the patent issue will be a de-risking event and as one analyst has already indicated, "will open the M&A window". We are not yet at peak valuation for AMRN as the impact of continued de-risking (via the discount rate) is more than offsetting projected future FCF. That will reverse certainly within the next year and perhaps much sooner.
That's my 2 cents. I am not posting my valuation for AMRN, but I will say that I am a very large shareholder and have owned and increased since 2010.
The stock price is extremely low for the potential AMRN sales in EU, China, ROW (and the US with a dynamic sales team). PFE knows they would be the best one to realize those sales by buying out AMRN with its depressed market price. The head of PFE North America has to be thinking along those lines. I would think it would be under consideration by their global corporate development (M&A) team.
jmho
I noticed some reluctance on his part to accept the premise of the Reduce-it study. He finally told me about one of this partners going to a conference and being told by one of the "experts" about the increase risk of prostate cancer in patients taking fish oil.
As soon as I got home i went to research the topic, and found
1- The origen of this topic was first brought out in 2011 by Bradsky.
2-There have been MULTIPLE studies since that have looked at this issue.
In evaluating the evidence i am comfortable with the following facts
The original Bradsky study clearly differentiated risks associated between DHA and EPA (Vascepa). It concluded that DHA did seem to increase risk of Protate Cancer.EPA DID NOT.
This has held throughout, and furthermore, at this stage, looking at all the studies, the premise of increased prostate cancer risk is not justified. See .Fish-Derived Omega-3 Fatty Acids and Prostate Cancer: A Systematic ...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5736071/
In addition,all the epidemiological data from the Japanese and Inuit populations contradicts the premise of higher risk in men with high intake of fish oil, all fish oil.
The benefits of intake are many in cardiac arrhythmia, arteriosclerosis and anti-inflamatory effects.
At the end, I am very happy to be long, and I can see such a wide use for this compound in the future that makes me wish I had more money to invest in AMRN.
BEDMINSTER, N.J., and DUBLIN, Ireland, March 29, 2019 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company focused on improving cardiovascular health, today announced that its licensee in Canada, HLS Therapeutics Inc. (TSX:HLS), has received formal confirmation from Health Canada that the Canadian regulatory authority has granted priority review status for the upcoming New Drug Submission (“NDS”) for Vascepa® (icosapent ethyl) capsules. HLS Therapeutics anticipates filing the NDS in April 2019 seeking approval to market and sell Vascepa in Canada to reduce the risk of ischemic cardiovascular events in statin-treated patients with elevated triglycerides and other risk factors.
Priority review status may be granted to regulatory filings in Canada for new treatments that potentially address serious, life-threatening conditions for which no drug is currently marketed in Canada, and for which there is substantial evidence of clinical effectiveness of that new treatment. Under priority review the performance target for the screening and review of the original submission is 215 calendar days versus 355 days for a standard review. Therefore, receipt of priority review status could expedite the launch of Vascepa in the Canadian market, if the product is ultimately approved by Health Canada.
Warner Lambert had been around since the mid 1800’s very established and grew through acquisitions and mergers. They owned consumer products such as Benadryl, Lubriderm, Rolaids, Listerine, halls cough drops, Schick razors, Certs and clorets mints, Trident gum, chicklets gum. By the mid 80’s Warner Lambert had 3 main businesses: prescription pharmaceuticals, consumer healthcare products and gums and mints. This shows how establish Warner Lambert was.
Going into FDA approval for Lipitor they were already up against a crowded market due to established statins by big pharma. Many believed Lipitor, despite its success in clinical trials, was a “Me too” statin. Not to mention Mevacor was going generic by 2001 which would be a less expensive option in the near future. In 1996 FDA expedited WL application for Lipitor. It was approved in 6 months, Dec of 1996 and hit the market in January of 1997. Biggest challenge for WL was marketing and sales force, most believe the first 6 months of a drugs launch is the most critical time in a products life cycle. (Take notes John Thero).
Income Pfizer a joint co marketing agreement with WL to squeeze all the potential out of Lipitor. Details of the co-marketing agreement state that Pfizer paid $205 million in up front money and milestone payments for the rights to sell Lipitor. Pfizer also committed to splitting all future product expenses including advertising, promotion, sampling and sales force. Furthermore, Pfizer agreed to pay for half of any ongoing and planned clinical trials, which were reported to number more than 100 and involve 100,000 patients. In return, Pfizer would receive variable payments based on sales targets established in the agreement. Given the annual sales that Lipitor had reached, the arrangement indicates that Pfizer received 48% of net sales.
Warner-Lambert and Pfizer outgunned the competition with the largest statin sales force. Between Warner-Lambert and Pfizer, more than 2,200 sales representatives were believed to be selling Lipitor during its launch in the U.S targeting 91 000 key prescribers.
Sales:
1997 0.9B (WL was expecting 250 million pre launch)
1998 2.2 B
1999 3.4B (end of year hostile takeover attempt by Pfizer for a little over 80B) 3 months in court battling. Ended with Pfizer buying WL for 90B and all WL executives got tossed/not promoted. Which is what WL was fighting against in the first place. Not sure why they caved.
2000 4.6B
2001 5.6B
2002 6.7B
2003 7.7B and so on...
Conclusion IMO:
Warner Lambert, an established company for over a century, needed help to get (arguably the best drug of all time) to sell. So I think Amarin has ZERO chance of making Vascepa hit it’s full potential if they go at it alone. I hope the board can put their Ego’s aside and realize that this will not fly like they want it to if they chose to undertake this without Big Pharma. I think a buy out is guaranteed at this point I just don’t know for how many billions. Yes a BO is in the shareholders best interest John Thero!
TipRanks consensus rating: Strong Buy
Amarin (AMRN, $16.74) has already earned approval for Vascepa, a purified fish oil derivative that treats elevated triglyceride levels. However, the biotech company now is trying to get the drug approved for use in reducing the risk of major adverse cardiovascular events, more than a year after releasing the results of the landmark REDUCE-IT trial that sent shares from around $3 into the $20s within weeks.
Amarin was notified on Aug. 8 that the FDA planned on holding an advisory committee meeting (AdCom) on Nov. 14, likely pushing Vascepa's PDUFA date back into December. The FDA confirmed in September that the PDUFA date would be Dec. 28. The AdCom announcement knocked shares 22% lower in just two days. Advisory committee meetings are held to seek outside input, so that – in combination with the delayed PDUFA date – made Wall Street less certain about Vascepa's fate.
The biotech stock has recovered since then, however, and the analyst community remains mostly upbeat, issuing seven Buys on AMRN versus just one Hold over the past three months. That includes Cantor Fitzgerald analyst Louise Chen, who cites an Institute for Clinical and Economic Review (ICER) report that evaluated the cost-effectiveness of the therapy.
"Despite the stringent criteria of the analysis, the report concludes that Vascepa easily meets commonly cited thresholds for cost-effectiveness and therefore represents a high long-term value for money," writes Chen, who has an Overweight rating and $35 price target (109% upside potential). "This report underscores the findings of the landmark REDUCE-IT trial and strengthens our belief that the peak sales potential of Vascepa is underappreciated."
Jeffries analyst Michael Yee reiterated his Buy rating and $30 price target (79% upside potential) in September, writing that he expects a positive AdCom outcome. "Of note, the final ICER guidance report for Vascepa was released this morning and largely appears in line with the draft guidance released in late July. (Prescriptions) continue to grow, and we think 2020 Street estimates remain low with a likely positive AdCom vote and approval later this year." Discover how other top analysts rate Amarin at TipRanks.