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Short interest update
Settlement Date Short Interest Avg Daily Share Volume Days To Cover
6/29/2018 5,466,756 2,883,574 1.895826
6/15/2018 4,333,649 1,374,970 3.151813
5/31/2018 4,092,597 1,824,591 2.243022
5/15/2018 3,852,031 1,645,840 2.340465
4/30/2018 3,454,505 3,165,407 1.091330
4/13/2018 7,565,880 2,041,309 3.706386
3/29/2018 7,633,216 2,223,094 3.433600
3/15/2018 7,746,155 1,657,541 4.673281
2/28/2018 7,830,992 1,415,727 5.531428
Mochida patents are available for viewing and there are many. Let the speculation begin.
The majority of the options traded this afternoon have been out of the money calls. Not much volume.
Jun 7, 2018 8:00 AM EDT JEFFERIES 2018 GLOBAL HEALTHCARE CONFERENCE Listen to webcast
INVESTOR RELATIONS / AMARIN SPONSORS THREE SCIENTIFIC PRESENTATIONS SCHEDULED FOR AMERICAN DIABETES ASSOCIATION SCIENTIFIC SESSIONS
Back
Jun 7, 2018
BEDMINSTER, N.J. and DUBLIN, Ireland, June 07, 2018 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, is supporting the presentation of three accepted scientific presentations at the American Diabetes Association (ADA) Scientific Sessions in Orlando, FL, June 22-26, 2018.
“This research shows that more than a third of U.S. adults with diabetes, or approximately 10 million people, have high triglycerides and are at elevated risk for cardiovascular disease,” said Craig B. Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Amarin. “These studies reinforce that high triglycerides and diabetes are predictors of worse cardiovascular disease and health economic outcomes despite statin use and well-controlled low-density lipoprotein cholesterol.”
Data to be presented include:
Poster Presentations
Diabetes Mellitus and High Triglycerides Are Significant Predictors of Major Cardiovascular Events and Increased Health Care Costs and Resource Utilization: A Real-World Analysis of High-Risk Statin-Treated Patients
Peter P. Toth, MD, PhD, Craig Granowitz, MD, PhD, Michael Hull, MS, Sephy Philip, RPh, PharmD
Increased Cardiovascular Risk in Patients with Diabetes, Statin-Controlled LDL Cholesterol and Residual Hypertriglyceridemia
Gregory A. Nichols, Sephy Philip, Craig Granowitz, Kristi Reynolds, Sergio Fazio
Oral Presentation
Prevalence and Predictors of Residual Hypertriglyceridemia According to Statin Use in US Adults with Diabetes
Wenjun Fan, MD, MS, Sephy Philip, RPh, PharmD, Craig Granowitz, MD, PhD, Peter P. Toth, MD, PhD, and Nathan D. Wong, PhD
About Amarin
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Vascepa® (icosapent ethyl), Amarin's first FDA-approved product, is a highly-pure, omega-3 fatty acid product available by prescription. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.
About REDUCE-IT
Amarin's clinical development program for Vascepa includes a trial known as the REDUCE-IT cardiovascular outcomes study, an 8,175-patient study commenced in 2011. REDUCE-IT is the first multinational cardiovascular outcomes study evaluating the effect of prescription pure EPA therapy, or any triglyceride lowering therapy, as an add-on to statins in patients with high cardiovascular risk who, despite stable statin therapy, have elevated triglyceride levels (150-499 mg/dL). A large portion of the male and female patients enrolled in this outcomes study are anticipated to also be diagnosed with type 2 diabetes. As reported previously, Amarin expects to announce top-line results of this important study before the end of Q3 2018. The REDUCE-IT trial is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration.
Additional information on clinical studies of Vascepa can be found at www.clinicaltrials.gov.
About VASCEPA® (icosapent ethyl) Capsules
Vascepa® (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex FDA-regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient. Vascepa, known in scientific literature as AMR101, has been designated a new chemical entity by the FDA. Amarin has been issued multiple patents internationally based on the unique clinical profile of Vascepa, including the drug’s ability to lower triglyceride levels in relevant patient populations without raising LDL-cholesterol levels.
FDA-Approved Indication and Usage
Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information for Vascepa
Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components.
Use with caution in patients with known hypersensitivity to fish and/or shellfish.
The most common reported adverse reaction (incidence > 2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported adverse reaction > 3% and greater than placebo.
Patients receiving treatment with Vascepa and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
Patients should be advised to swallow Vascepa capsules whole; not to break open, crush, dissolve, or chew Vascepa.
Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the United States Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Nothing in this press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.
About Cardiovascular Disease
Worldwide, cardiovascular disease (CVD) remains the #1 killer of men and women. In the United States CVD leads to one in every three deaths – one death approximately every 38 seconds – with annual treatment cost in excess of $500 billion.1, 2
Beyond the cardiovascular risk associated with LDL-C, genetic, epidemiologic, clinical and real-world data suggest that patients with elevated triglycerides (TG) (fats in the blood), and TG-rich lipoproteins, are at increased risk for cardiovascular disease.3, 4, 5, 6
Leading clinical investigations seeking to address cardiovascular risk reduction beyond lowering LDL-C focus on interrupting the atherosclerotic process (e.g., plaque formation and instability) by beneficially affecting other lipid, lipoprotein and inflammation biomarkers and cellular functions thought to be related to atherosclerosis and cardiovascular events.
Forward-Looking Statements
This press release contains forward-looking statements, including statements about the potential relevance of persistent high triglyceride levels to clinical outcomes and on the healthcare system as well as statements concerning the REDUCE-IT cardiovascular outcomes study such as the anticipated inclusion of certain patient populations, related timing and announcements with respect to final outcomes and the anticipated successful completion of the REDUCE-IT study. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated with research on biomarkers thought to be relevant in the treatment of cardiovascular disease, healthcare costs and clinical trial risk, that studied parameters may not have clinically meaningful effect and the risk that patents may not adequately protect Vascepa against competition. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent quarterly report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Availability of Other Information About Amarin
Investors and others should note that Amarin communicates with its investors and the public using the company website (http://www.amarincorp.com/), the investor relations website (http://investor.amarincorp.com/), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
References
1American Heart Association. 2018. Disease and Stroke Statistics-2018 Update.
2American Heart Association. 2017. Cardiovascular disease: A costly burden for America projections through 2035.
3 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
4 Toth PP, Granowitz C, Hull M, et al. High triglycerides increase cardiovascular events, medical costs, and resource utilization in a real-world analysis of statin-treated patients with high cardiovascular risk and well-controlled low-density lipoprotein cholesterol [abstract]. Circulation. 2017;136(suppl 1):A15187.
5 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
6 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular disease. Lancet. 2014; 384: 626–635.
Amarin Contact Information
Investor Relations:
Elisabeth Schwartz
Investor Relations and Corporate Communications
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Lee M. Stern
Trout Group
In U.S.: +1 (646) 378-2992
lstern@troutgroup.com
Media Inquiries:
Kristie Kuhl
Finn Partners
In U.S.: +1 (212) 583-2791
Kristie.kuhl@finnpartners.com
Primary Logo
Source: Amarin Corporation plc
I have seen general counsel in particular for other companies regularly sells their shares after exercising options. ARNA is one of them where GC has continued to sell despite the large increase in share price.
Some legal counsel just do it so that it lessens their conflict of interests. I think it is sometimes a curse for lawyers, compliance people and sometimes even the accountants.
Actually it looks to me like he still has plenty.
Shares Beneficially
Owned
Name and Address of Beneficial Owner
Number(1) Percent of
Class(2)
Greater than 5% Holders:
Consonance Capital Management LP (3)
1370 Avenue of the Americas
Floor 33
New York, NY 10019
24,476,520 8.34
Current directors and named executive officers:
John F. Thero(4)
5,215,305 1.75
Lars G. Ekman, M.D., Ph.D.(5)
360,138 0.12
Kristine Peterson(6)
282,495 0.10
Jan van Heek(7)
292,698 0.10
Patrick J. O’Sullivan(8)
207,495 0.07
David Stack(9)
177,495 0.06
Joseph S. Zakrzewski(10)
2,449,209 0.83
Joseph T. Kennedy(11)
1,760,042 0.60
Steven B. Ketchum, Ph.D.(12)
1,298,498 0.44
Michael W. Kalb(13)
363,353 0.12
Mark W. Salyer
— 0.00
All current directors and executive officers as a group (11 persons)
12,406,728 4.08
(1) Represents Ordinary Shares, or Shares, held as of March 31, 2018, plus Shares that may be acquired upon exercise of options exercisable within 60 days of March 31, 2018.
(2) Based on 293,584,140 Ordinary Shares outstanding as of March 31, 2018. The percentage ownership and voting power for each person (or all directors and executive officers as a group) is calculated by assuming the exercise or conversion of all options exercisable within 60 days of March 31, 2018 held by such person and the non-exercise and non-conversion of all outstanding options held by all other persons.
Will anyone posting here be at the oral arguments?
Fatty acids modulate the efficacy of lutein in cataract prevention: Assessment of oxidative and inflammatory parameters in rats.
Padmanabha S1, Vallikannan B2.
Author information
1
Department of Biochemistry, CSIR-Central Food Technological Research Institute, Mysore 570020, Karnataka, India.
2
Department of Biochemistry, CSIR-Central Food Technological Research Institute, Mysore 570020, Karnataka, India. Electronic address: baskaranv@cftri.res.in.
Abstract
BACKGROUND:
Effects of lutein (L) and fatty acids [linoleic acid (LA), eicosapentaenoic acid (EPA)+docosahexaenoic acid (DHA) and oleic acid (OA)] on oxidative stress and inflammation in cataract were assessed.
METHODS:
Cataract was induced in male Wistar rat pups (11 days old) by giving a single dose of sodium selenite (25 µM/kg body weight) by IP. Lutein (1.3 µmol/kg body weight) was given one day before and five days after selenite injection as a micelle with 7.5 mM LA, or 7.5 mM EPA + DHA or 7.5 mM OA. Serum and lens oxidative stress and inflammatory parameters having a bearing cataract were assessed.
RESULTS:
Serum and lens nitric oxide, MDA and protein carbonyls were significantly (p?<?0.05) increased in cataract compared to control and experimental groups. Catalase, SOD, glutathione peroxidase and glutathione transferase activity and glutathione level in serum and lens of cataract group were significantly (p?<?0.05) decreased. Serum eicosanoids (PGE2, LTB4, and LTC4) and cytokines (CRP, TNF-a, IL1-ß, and MCP-1) were significantly (p < 0.05) increased in cataract. The activity of cPLA2 and Cox-2 in cataract lens was higher (p < 0.05) compared to other groups. EP-1, NOS-2 and NF-kB expression were higher (p < 0.05) in cataract. The ratio of water insoluble to water soluble protein was increased in cataract lens. Group administered with L + EPA + DHA exhibited highest cataract prevention compared to L + LA and L + OA. Pups given lutein with EPA + DHA had the highest amount of lutein in the lens.
CONCLUSIONS:
The anti-cataract activity of lutein was influenced by fatty acids and found to be highest with EPA + DHA compared to LA or OA.
Copyright © 2018 Elsevier Inc. All rights reserved.
BEDMINSTER, N.J. and DUBLIN, Ireland , May 24, 2018 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today a settlement agreement with Teva Pharmaceuticals USA, Inc. (Teva) that resolves Amarin’s previously reported Vascepa® (icosapent ethyl) patent litigation as it relates to Teva’s abbreviated new drug application seeking U.S. Food and Drug Administration ( FDA ) approval of generic forms of Vascepa (icosapent ethyl) capsules. This patent litigation continues in the United States District Court for the District of Nevada with parties West-Ward Pharmaceuticals Corp. and Dr. Reddy’s Laboratories, Inc. and their affiliated entities.
“We are delighted to announce this settlement with Teva as it reinforces our confidence in Amarin’s patent portfolio and allows us to avoid the incremental litigation expense and distraction associated with Teva’s participation,” said John F. Thero , president and chief executive officer of Amarin .
In the lawsuit, Amarin alleges that the generic forms of Vascepa adverse parties seek to market in the United States infringe upon multiple issued patents owned by Amarin . As part of the settlement agreement, Teva may first begin selling its generic version of Vascepa in the United States on August 9, 2029 , or earlier under certain customary circumstances. The agreement is subject to a required review by the U.S. Federal Trade Commission and the U.S. Department of Justice .
About Amarin
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Vascepa® (icosapent ethyl), Amarin's first FDA -approved product, is a highly-pure, omega-3 fatty acid product available by prescription. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.
About VASCEPA® (icosapent ethyl) Capsules
Vascepa® (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex FDA -regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient. Vascepa, known in scientific literature as
"How many recent studies showed that raising HDL didn't decrease CVD? " Give me a name of the CVOT trial that failed that was done on a safe drug that significantly reduced TG, non-HDL-C, Apo B, VLDL-C, TC, and HDL-C levels. That is what I was asking.
STS, This was from yesterday and I am not sure where I was going with it. There are other drugs that might be seen as safe until you get into a CVOT. Because of side effects over the long term what may be seen as a positive on the cardiology side can end up being negative because of the overall risk of the drug. Niacin would be one I would point out. I was just trying to say that Vascepa is safe and is effective for cardiovascular biomarkers. From what has been reported no deaths have been attributed to Vascepa from the FDA with Vascepa being the primary cause of death. As you have said, some thing get attributed to drugs that should not. What I was trying to get at from what I have seen is that the CVOTs that failed, failed because the drug was either unsafe to begin with or the drug did not have a positive impact on cardiovascular biomarkers.
"Excuse me" Your link is not a good one. It does not work.
Here is a website for you with facts. This study could fail but sponsor could still want patients to remain on the drug until trial is locked down and reported.
www.fdable.com
put in methotrexate click on Role Code - primary suspect and Outcome code - Death.
The search will come back with this -
Searched for Adverse Event Cases with drug names containing the term: methotrexate AND with the drug's role code reported as: Primary Suspect and found more than 10,000 results.
Nasty stuff. You can play around with this, check out Vascepa and see how it compares.
Your link is not a good one.
This may be too much for you. The drug sponsor is Paul M. Ridker, MD Director of the Center for Cardiovascular Disease Prevention Eugene Braunwald Professor of Medicine He is not a rheumatologist. He is not going to tell another group of specialists how to practice. He will publish the results and leave it to the rheumatologists to adjust their practice if necessary.
You might consider trying and looking for information on the internet that is not posted on this message board.
Just because the drug sponsor does not want patients to come off of Methotrexate for RA does not mean it is 100% safe.
You probably need to calm down about this. Methotrexate can be toxic and people have trouble staying on it. The mechanism of action is totally different than Vascepa so the results of one trial will not be predictive of the results of the other trial. The side effect list is long for Methotrexate. You might be able to save a few from heart disease but you will kill them in other ways. It is very unlikely that the results of this trial will impact Vascepa.
Are Dr. Nissan's comments you are referring to old or new? Do they relate to the previous trials or the current Reduce-it trial?
There is/was a second ancillary study. Towards Evidence-Based Monitoring of Low Dose Methotrexate: CIRT Ancillary Study Solomon, Daniel Hal Brigham and Women's Hospital, Boston, MA, United States
The Cardiovascular Inflammation Reduction Trial (CIRT) is an NHLBI funded trial (U01 HL 101422) that will examine the effects of low dose methotrexate (LDM) on secondary prevention of cardiovascular (CV) events in a high-risk post-MI population without systemic rheumatic disease. The hypothesis underlying this trial relates to the inflammatory underpinnings of CV disease and whether suppression of inflammation with LDM can reduce recurrent CV events. LDM has been in widespread use for several decades for rheumatic diseases, but most of the toxicity warnings and monitoring guidelines are based on data from relatively small trials and observational datasets not designed to study drug safety. We propose to study adverse events (AE) including hepatic injury, pneumonitis, hematologic deficiencies, infection, nausea, stomatitis and rash among 7,000 post- MI subjects randomized to LDM or placebo in CIRT. Our team has substantial expertise pharmacoepidemiology, genetics and predictive modeling.
Specific Aims are 1) To estimate the incidence rate and relative risk of LDM AEs, including hepatic, pulmonary, hematologic, infectious, and mucocutaneous; 2) To study sociodemographic, lifestyle, anthropometric, co-morbidities, co-medications, genetic, and methotrexate metabolites as predictors of LDM AEs; and 3) To develop and test various risk prediction rules for LDM AEs. We will use our epidemiologic expertise to build comprehensive models that include clinical variables, drug metabolites, genetic predictors and drug exposure that can be used to personalized targeted therapy. The discovery and clinical use of markers associated with a greater likelihood of AE from LDM would provide an important public health benefit to rheumatic disease patients and potentially to a large population from the general population if the CIRT trial shows reduction on cardiovascular events with LDM.
Public Health Relevance
Low dose methotrexate (LDM) is widely used and is expected to grow in prescriptions. The discovery and clinical use of markers associated with a greater likelihood of AE from LDM would provide an important public health benefit to many patients. Genotypic and methotrexate metabolite data will provide unique information for this application and others associated with CIRT.
It is an NIH funded trial for a generic drug. He will do some analysis, publish some papers and move on to the next trial.
"Pretty sure it's successful because of
“If all goes well we will present the results at the AHA in November,” "
So a clinical trial sponsor with no skin in the game says that if all goes well they will present results and based on that you decide that you are pretty sure it will be successful. Interesting.
It seems simple doesn't it. Have you seen one fail with those parameters?
Vascepa sigificantly reduces TG, non-HDL-C, Apo B, VLDL-C, TC, and HDL-C levels from baseline relative to placebo. Just think about that. Safety issues have not occurred during real world use for 5+ years. Do you really think that a drug that safely lowers inflammatory markers doesn't reduce cardiovascular events? If that is the case then all of cardiovascular drug discovery is flawed. Fenefibrates and niacin cause other issues in the body, hence the side effects. Advisory committee grouped Vascepa in with these flawed drugs and refused to believe that Vascepa is as good as it is. Or at least that was their "concern".
I wasn't referring to all studies. I was referring to long term CVOT trials. There are a few diabetes CVOT studies that failed but the drugs had side effects and did not have positive known impacts on CV biomarkers. A few niacin trials also failed but niacin has known side effects. Pumping that much niacin into your body can't be healthy. Safe and effective drugs that underwent CVOT trials that have positive impact on biomarkers have not failed.
A poorly run study would have been stopped by the data monitoring committee by now. This could be done so the company could either feed off of any shred of positive data or stopped for futility for lack of evidence of any clinical benefit. AMRN would not have continued with this study and cost without a sense that they would succeed. Check out VVUS results if you want to see a poorly run CVOT.
right on track.
AMRN down 5.2%
IBB down 1.32%
I think that speculation and various what-if scenarios do have an impact when there are upcoming binary events. These message boards do have casual visitors, those with large dollars and those without. Besides the casual observers there are also word bots that could easily have picked up on 'large number of dropouts' to make AMRN tank. This is a traders paradise.
This message board is hard enough to read as it is, without having topics and threads and posters that can be easily ignored. I believe that the board going on and on about scenarios where assumptions have turned into facts does shareholders a disservice.
A well run study w/400+ sites, with a safe effective drug will not have the dropouts and nonsense that are being tossed around here. IMO, Assumptions vs actual facts have gotten the better of this message board. Either you trust this company to have run this study properly or you don't. In or Out.
I think you are looking for a literal correlation.
The drug is safe and effective. That is a fact.
I spent five days away from this board and I come back to all this speculation about deaths and high drop out rates. After seeing nothing from AMRN regarding this, it all seems ridiculous to me. I checked the FDAble.com database and there is not one death related to Vascepa where Vascepa is considered the primary cause of death. That tells me all I need to know.
Yes, I am losing coverage due to his retirement and I am not old enough for Medicare. I can either go on an ACA plan or get into COBRA through his employer for 18 months and move to ACA plan later. I still do not have a rate yet not the COBRA but the ACA plan is $635/mth with big out of pocket.
Either way it will be costly and there is no good solution but I am not going to go without coverage. Luckily I have dividend income and can afford the coverage or I would be looking for a job.
I'll gladly pay the 223 to stay on Vascepa. I would love AMRN to get a real indication for 200-500 in the coming years for two reasons, both financial. My drug costs and my investment.
I have an employer group health plan, BCBSIL trigs 200-300 range, first with prime therapeutics and now with express scripts. I get a little discount from insurance but my out of pocket is 223/month. Nothing changed from move from prime therapeutics to express scripts.
My husband is retiring and I am moving to an ACA plan at the end of the month and all the plans available in my area are showing Vascepa as covered but as Tier 6.
Insurance companies only care about their cost within the current plan year. Amarin needs to get a real indication from the FDA for triglycerides 200-500 before insurance companies will cover these drugs. At that point, they will then need to go back to the individual plans and negotiate price.
Until then, Vascepa will continue to be for those with triglycerides > 500 who also take a statin or for those patients with resources willing to pay out of pocket.
"McKesson drug dispenser, United Health Group..Insurance...and CVS....None of these companies have the customers well being as their primary concern... "
Add Express Scripts and all the pharmacy benefits administrators to your list and what do you get? You get a list of companies that do not provide heath care. They just shuffle health care from providers to the patients and supposedly negotiate on your behalf. What these companies really do is take profit out of the healthcare system to benefit shareholders.
Here is a good summary AKCA / IONS
Akcea falls after FDA panel discusses 'safety concerns' of volanesorsen Akcea Therapeutics (AKCA) and its controlling holder Ionis Pharmaceuticals (IONS) are moving lower after an FDA panel posted its briefing document ahead of Thursday's meeting to discuss Akcea's volanesorsen. The document reads, "Despite the magnitude of the effect observed on TG, the volanesorsen review team remains uncertain whether the benefits of volanesorsen outweighs its risks, considering safety concerns with this product. Although the reviews highlight several safety/tolerability issues, the primary focus for both the applicant and the reviewers has been the risk of thrombocytopenia and resulting potential for serious bleeding." It adds, "After the NDA review was well-underway, the applicant unexpectedly submitted an amendment that proposed a new dosing and platelet monitoring strategy for labeling that had not been implemented in any of the clinical trials... Regarding platelet monitoring, the review team (including the hematology consultant) questions the feasibility and effectiveness of a monitoring scheme of this intensity for a lifelong therapy. At present, we have no evidence that the risk of severe thrombocytopenia diminishes with time." Shares of Akcea are down 12% in premarket trading, or $2.67, to $19.00 while Ionis is down 2.5% to $43.22.
Read more at:
https://thefly.com/landingPageNews.php?id=2727489
ARNA"s drug is better and tomorrow will be an interesting day for both ARNA and CELG, as CELG has earnings and tries to explain Ozanimod's path forward.
It was not part of a quarterly payment to KOWA. They are accruing dollars in reserve for the tail payments, to pay KOWA after the deal is done. I did not look but I would say there is probably a corresponding increase in accounts payable on the balance sheet.
Kudos to AMRN management
After Q4 results, I sent some notes back and forth with Elisabeth Schwartz about their earnings report. AMRN had only reported and has only reported GAAP earnings. If the one time non cash tax item had been excluded from Q4 results to create a non-GAAP earnings report, AMRN would have actually beat analyst estimates. Elisabeth expressed that management did discuss these items on the call which I agreed with. I expressed to her that the analyst do not care about the discussion because they do not go to the trouble of excluding these items if management doesn't do it for them. She told me she would discuss with CEO and CFO and appreciated the request.
First quarter results just came out and they actually did a non-GAAP EPS and Statements. Low and behold, AMRN beat earnings on a non-GAAP basis. Not sure if anyone else noticed that they added this to their press release but I wanted to give AMRN management kudos for listening to an AMRN retail. IMO, This should lead to more stability in the quarterly earnings results.
""Companies commonly supplement their reported earnings under U.S. generally accepted accounting principles (GAAP) with non-GAAP financial measures that they believe more accurately reflect their results of operations or financial position or that are commonly used by investors to evaluate performance. A non-GAAP financial measure is a numerical measure of a company’s historical or future financial performance, financial position or cash flows that includes or excludes amounts from the most directly compa- rable GAAP measure. Non-GAAP financial measures are used by companies to bridge the divide between corporate reporting that is standardized under GAAP and reporting that is tailored to a particular industry or circumstance. "
Victoza did run and complete a CVOT. All new diabetes and obesity drug are required to run them.
Triglycerides cross the blood–brain barrier and induce central leptin and insulin receptor resistance
Apologies if this has previously been posted. Looks like a great reason to treat trigs greater than 200.
Conclusions:
Triglycerides cross the blood–brain barrier rapidly, are found in human cerebrospinal fluid, and induce central leptin and insulin receptor resistance, decreasing satiety and cognition.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5880581