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I don't think it is a stretch at all. Here is an sNDA recently PR'd.
Feb 25, 2019
WOODCLIFF LAKE, N.J., Feb. 25, 2019 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) to potentially update the label for BELVIQ® (lorcaserin HCl) CIV 10 mg twice-daily/BELVIQ XR (lorcaserin HCl) CIV once daily to include long-term efficacy and safety data from CAMELLIA-TIMI 61, a clinical trial of BELVIQ in 12,000 overweight and obese patients with cardiovascular (CV) disease and/or multiple CV risk factors such as type 2 diabetes mellitus (T2DM).
...
Physicians like to hear about new drugs from other physicians, not drug reps.
New Opportunities to Improve Management of Patients with or at High Risk of ASCVD Events
Resume
To register for this meeting, click on the ENROLL button. Login using your ReachMD credentials, or create a new Medtelligence / ReachMD account. ...more
Available credits: 2.00
Meeting date: 11 April, 2019
Meeting time: 06:30 PM - 09:00 PM EDT
Meeting location: Philadelphia 201 Hotel
Meeting address: 201 N. 17th Street, Philadelphia, Pennsylvania, United States
ENROLL
Syllabus PDF
Overview
This timely and engaging CME-certified symposium will offer in-depth coverage of important clinical issues and data. Featuring a faculty of leading experts in the management of atherosclerotic cardiovascular disease (ASCVD), the program will utilize case-based learning in a highly interactive format to optimize clinical strategies.
Agenda Topics Include
Update on Determining Risk Status in ASCVD
New Approaches to the Management of Patients at High Risk of CVD Events
Managing Residual Risk Beyond LDL-C Lowering Therapy
Practical Considerations to Manage Residual Risk
Case Simulations on Primary and Secondary Prevention of ASCVD Events
Faculty
Deepak L. Bhatt, MD, MPH
Sergio Fazio, MD, PhD
Michael Miller, MD
Program Schedule
6:30 pm–7:00 pm
Registration & Dinner
7:00 pm–7:10 pm
Welcome, Introductions, Program Overview, and Pre-Activity Test Questions
7:10 pm–7:25 pm
Update on Determining Risk Status in ASCVD
Who is at high risk for CVD events
AHA cholesterol guidelines approach to diagnosis – what’s new
Screening and diagnosis, including fasting and nonfasting blood samples, non-HDL-C assessment, CAC
Risk assessment based on AHA guidelines
7:25 pm–7:30 pm
Discussion and Question & Answers
7:30 pm–7:45 pm
New Approaches to the Management of Patients at High-Risk of CVD Events
Role of lifestyle modification; AHA’s lifelong lifestyle guideline
LDL-C lowering with statin intensification
LDL-C lowering beyond statins: ezetimibe and PCSK9 inhibitors
AHA guidelines for primary and secondary prevention of ASCVD events
7:45 pm–7:50 pm
Discussion and Question & Answers
7:50 pm–8:15 pm
Managing Residual Risk Beyond LDL-C Lowering Therapy
Pathologic mechanisms contributing to ASCVD: TG-RL, inflammation, etc
Genetic evidence for TG-RL causal effects
Limited and poor evidence of outcomes studies on fibrates and niacin
Limited and poor evidence of outcomes studies of EPA/DHA outcomes studies; role of drug, dose, and patient population selection
JELIS and REDUCE-IT outcomes trials
REDUCE-IT outcomes points to pleiotropic effect of EPA
Known effects of EPA to reduce MOA burden in ASCVD
Other opportunities to reduce ASCVD events: Inflammation proof-of-concert (CANTOS and CIRT) Metabolic studies (GLP-1s and SGLT-2s), anticoagulation studies (COMPASS)
8:15 pm–8:20 pm
Discussion and Question & Answers
8:20 pm–8:35 pm
Practical Considerations to Manage Residual Risk
Personalized approach; assessment of how much risk and what is underlying risk
Pharmacologic management algorithms beyond statins to prevent events
Use of EPA to manage residual risk: drug, dose, patient selection
Managing risk pragmatically for success
Dosing considerations/contraindication of dietary supplements
8:35 pm–8:40 pm
Discussion and Question & Answers
8:40 pm–8:55 pm
Case Simulations on Primary and Secondary Prevention of ASCVD Events
Two cases with multiple parts, one primary prevention, one secondary prevention, including diabetes/obesity as a co-morbidity. ARS questions will be used for interactive learning
8:50 pm–9:00 pm
Post-activity test questions, Closing Comments, and Adjourn
Target Audience
This course is designed to meet the continuing medical education needs of the Internal Medicine and Primary Care Physicians and allied health professionals who treat patients with, or at high risk of, ASCVD.
"AMRN stated on the last conference call that the filing with the
European Authorities would happen before the end of the year."
He didn't say it would happen before the end of the year. He said it would happen this year. I doubt they are willing to commit until they know about the FDA timeline.
"We're working on registrations in other parts of the country -- excuse me, other parts of the world, and we anticipate filing in Europe this year as well."
Interesting Deepak Bhatt thread from twitter
Dr. Deepak L. Bhatt Retweeted JACC Journals
About 15% of the patients in the CLARIFY registry (stable CAD) would have been eligible for REDUCE-IT, though that of course doesn't factor in patients with PAD, CVD, or diabetes who may also be eligible. @gabrielsteg @DLBHATTMD
Dr. Deepak L. Bhatt added,
JACC Journals
@JACCJournals
What is the generalizability of the REDUCE-IT trial in patients with stable #cvCAD? Learn more in #JACC. http://fal.cn/iwoH
2 replies 5 retweets 31 likes
Reply 2 Retweet 5 Like 31 Direct message
Josh Socolow
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@Docjoshsoc
Follow Follow @Docjoshsoc
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Replying to @DLBHATTMD @gabrielsteg
But who would really withhold vascepa just because Ldl is greater than 100??
11:07 AM - 26 Mar 2019
1 Like Dr. Deepak L. Bhatt
2 replies 0 retweets 1 like
Reply 2 Retweet Like 1 Direct message
sharinkyTweet text
Dr. Deepak L. Bhatt
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@DLBHATTMD
5h5 hours ago
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Replying to @Docjoshsoc @gabrielsteg
Many physicians would probably extrapolate the results of REDUCE-IT to high risk patients above or below the LDL cholesterol range in our inclusion criteria. Though that high risk patient with LDL >100 likely also needs more to be done to address LDL-related risk.
0 replies 0 retweets 3 likes
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New conversation
Josh Socolow
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@Docjoshsoc
5h5 hours ago
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Replying to @Docjoshsoc @DLBHATTMD @gabrielsteg
Right, so you probably titrate statin and then start. Also the group off statin, would likely get statin and then start. So ultimately the addressable population is much higher than the 15.5% suggests
1 reply 0 retweets 1 like
Reply 1 Retweet Like 1 Direct message
Dr. Deepak L. Bhatt
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@DLBHATTMD
4h4 hours ago
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Yes, clinically I think that would be the logical approach. And yes, for a variety of reasons, the 15.5% is likely an underestimate of the potential patient population who could benefit.
0 replies 0 retweets 1 like
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End of conversation
Access is dwindling for all reps and has been for the last ten years. That is a known fact as more and more physicians become part of large organizations that limit access and legislation has been passed limiting what pharmaceutical companies and their reps can provide to physicians.
I think the stock price will tank until right around 12:15 today and then the stat news guys will look like heroes for their listeners.
Herper had to reach far and wide to find a couple of doubters. Not lipidemologists. Public health is wondering if its real including the MO and a former president of the ACC and a vegan thinks it consistent with the Mediterranean diet and he wants us to change the way we eat.
"Your Walgreens Rx is DELAYED. It's out of stock, but we've ordered more." I just got this and thought I would share.
Some of his previous thoughts from twitter.
Michael Davidson MD
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@mdavidsonmd
24 Sep 2018
More
Congratulations to Amarin and the REDUCE-IT executive committee for the positive and robust benefit. A major step forward for patients with high TG's on statins. Now comes the debate is it TG lowering or Omega-3's or just EPA?
Michael Davidson MD
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@mdavidsonmd
17 Nov 2018
More
Excerpt from my publication help address the question about differences between EPA and DHA. The bottom line is that EPA has been proven to reduce CV event in both JELIS and REDUCE-IT. I think DHA will help but we will have to wait the results of STRENGTH.
The guy that owns the Boston Globe owns Stat News. Adam F. plays a really small role in what Stat News is dong. The idea that he hired Matt H. is ridiculous.
Why would you immediately think that an ADCOM has anything to do with mineral oil? It could just as easily be related to MOA or it could be about the label and how wide the label should be.
Try this to get you started.
https://www.novonordisk-us.com/content/dam/USA/AFFILIATE/www-novonordisk-us/Home/blog/List_vs_Net.pdf
You might want to try doing some background research on gross and net and understand how all of the works. I am surprised someone invested in biotech would not understand how this works.
It is going to take time for Vascepa to surpass the generic cheap Lovaza product but it will happen soon enough.
Adam F. and Stat news did a slingshot call back in July with Dr. Matthew Budoff regarding AMRN and whether or not the upcoming reduce-it results would be positive and it was actually quite good. The results will speak for themselves.
You are correct. As an example, when I first got my scripts my physician wanted to see me back in 6 months so she only gave me a six month script.
Now, when I get a new script, it includes one NRx and 11 refills. At the end of that 12 month period or before it is over, my physician requires me to go back in and do lab work and get a NEW prescription. My script starts over. Scripts have always been counted this way.
So there are two oral presentations and the main late breaking data that we do not have any data on yet. Also there will be additional information on these two posters with more details.
Portion of data that is now unembargoed. I am sure there will be more detail on the actual posters.
1060-09 - Increased Residual Cardiovascular Risk in US Veterans and Monerately-Elevated Baseline Triglycerides and Well-Controlled LDL-C Levels on Statins
March 18, 2019, 1:15 PM - 1:25 PM Prevention Moderated Poster Theater_Poster Hall_Hall F
Authors
Sarah Leatherman, Ryan Ferguson, Isabelle Weir, Cynthia Hau, Craig Granowitz, Kelly Harrington, Sephy Philip, Peter Toth, Deepak L. Bhatt, William Boden, VA Boston Healthcare System, Boston, MA, USA, Amarin Corporation, Bedminster, NJ, USA
Abstract
Background: Recent studies have suggested a causal role for elevated triglycerides (TG) in incident cardiovascular (CV) events. Using a large cohort of U.S. veterans with statin-controlled LDL-C levels (40-100mg/dL), we explored whether increased residual CV risk existed in patients with elevated baseline TG levels versus those with normal TG levels.
Methods: We identified veterans receiving a statin but not a TG-lowering agent from the VA Corporate Data Warehouse, a database of the VA electronic health record, from 2010-2015. We compared CV event rates (nonfatal MI, stroke, unstable angina, or coronary revascularization) between the elevated TG (150-500mg/dL) and normal TG (<150mg/dL) groups. We calculated crude event rates, rate ratios, and 95% CI for both groups, and adjusted event rate ratios for baseline blood pressure, HbA1C, glomerular filtration rate, and HDL-C.
Results: We included 439,019 veterans (predominantly male and white) in the analysis cohort of whom 132,203 (30%) had elevated TG levels. These subjects were younger and had higher BMIs. Table 1 details the comparative baseline data and CV event rates. The overall crude and adjusted CV event rate ratios were 1.37 (95% CI 1.34,1.40; P<0.001) and 1.19 (95% CI 1.16, 1.22; P<0.001), respectively.
Conclusion: In this large cohort of veterans, those with elevated TG levels showed a significant increase in CV events despite well-controlled LDL-C on statins and adjustment for HDL-C compared to veterans whose baseline TG was in a normal range.
Portion of data that is now unembargoed. I am sure there will be more detail on the actual posters.
1178-417 / 417 - Burden of Atherosclerotic Cardiovascular Disease Risk in Persons With Elevated Triglyceride Levels According to Statin Use
March 16, 2019, 3:45 PM - 4:30 PM Poster Hall_Hall F
Authors
Nathan D. Wong, Wenjun Fan, Sephy Philip, Craig Granowitz, Peter Toth, University of California, Irvine, Irvine, CA, USA, Amarin Corporation, Bedminster, NJ, USA
Abstract
Background: Persons with hypertriglyceridemia (HTG) have greater risks for atherosclerotic cardiovascular disease (ASCVD), and statin therapy is indicated as initial treatment. Our aim was to estimate ASCVD risk and events for persons with and without HTG, according to statin use.
Methods: We studied 4,986 adults (projected to 113 million) aged 40-79 without ASCVD from the US National Health and Nutrition Examination Survey 2007-2014 classified by fasting triglycerides (TG): <150, 150-199, 200-499, and >500 mg/dL and statin use. We used the ACC/AHA risk calculator to estimate 10-year risk of ASCVD. ASCVD events (in millions, M) expected to occur over 10 years were calculated by multiplying the estimated ASCVD risk with corresponding projected population sizes.
Results: The table shows the mean estimated 10-year risk of ASCVD events by statin use within TG groups. 29% of subjects had TG of >150 mg/dL. Mean overall 10-year ASCVD risk ranged from 7.1% with TG <150 mg/dL to 16.1% with TG >500 mg/dL. 9.1M ASCVD events overall were projected to occur over the next 10-years; 37% or 3.4M were projected to occur in those with TG of 150 mg/dL or higher. Of these, 1.14 million (34%) were projected to occur in statin users.
Conclusion: Over one-third of projected ASCVD events (3.4M) occur in persons with TG of >150 mg/dL, including 1.14M events among statin users. There is urgent need to address this under-recognized excess risk and examine the capacity of lifestyle modification and other therapies to attenuate ASCVD risk.
TerraPharma is posting them over on twitter right now.
The earnings estimate changed on 2/28. Why are you posting it now?
You can do a google search for part d plans and search for updates for 4/1/2018, 7/1/2018 etc to see the updates that have occurred.
6 hours without additional information did not seem very transparent to me. I'm letting it go.
Tell that to my husband who takes care of his own part B premium payment. LOL, He is not happy. I told him if he has a problem with it, we should divorce, so he is pondering it. Problems for 2018 and probably for a few years into the future. There are really tough problems to have, making all this money. The consequences from large gains can add up. Taxing Social security and no exemption or reduction for property taxes on the house are a few more for retirees.
If the Amarin rep sucks and you have stated this in the past, you have to wonder why you would quote an Amarin rep with something, and then bash them for what they said.
I don't know you as a poster but this seems very disingenuous to me. IMO, you should always verify before you quote something like this that that could be market moving, as a fact.
Yes, Vascepa has been on there since 2017.
Where are you seeing this?
I am not a tax expert either. I know it hit me pretty severely one year and I think my total income was in the 250k to 300k range with a good chunk of that being capital gains from stock.
I think that is when it phases out, not when it phases in.
Table 3. 2019 Alternative Minimum Tax Exemptions
Filing Status Exemption Amount
Unmarried Individuals $71,700
Married Filing Jointly $111,700
In 2019, the 28 percent AMT rate applies to excess AMTI of $194,800 for all taxpayers ($97,400 for married couples filing separate returns).
AMT exemptions phase out at 25 cents per dollar earned once taxpayer AMTI hits a certain threshold. In 2019, the exemption will start phasing out at $510,300 in AMTI for single filers and $1,020,600 for married taxpayers filing jointly (Table 4).
You can see changes to formularies quarterly online. They may not print and send out these changes but they occur.
The yearly income you are quoting would be your total income which would include both your earned income and your gain from selling your stock. So you would probably not want to sell 1M in a year because your gains would probably put your total income over the 470K threshold and some of your gains would be taxed at 20%. Also, depending on what else you have going on in your return, there is a different tax that can kick in called Alternative Minimum Tax (AMT) where higher income levels that requires you to pay a higher percentage on your income. I know that has changed some with the recent tax law changes.
One other tidbit, when you sell and have a large gain, pay the tax in the quarter you sell the stock or you likely get hit with penalties.
I am not an expert on this so as others have suggested you should consult a tax professional before selling large gains.
It is good that all of your gains are long term. That will lessen the tax consequences. Any time you sell stock you should try to average it out over several years if you can. If you have other holdings that are at a loss it would be good to go ahead and sell them and take any losses to offset the gains in a year that you have gains. If a company is bought out and it is not a stock exchange type deal there is really not much you can do about it except pay the taxes. If AMRN stock was exchanged for another stock as part of a deal you could just sell it off over time to supplement your income or diversify your portfolio. That will be part of your personal preference as to whether you really want to be invested in the acquirer.
If and/or when a deal occurs I am sure we will get into much more discussion about it. We will cross that bridge when we comes to it and it would probably be time at that point to seek advice from a professional you trust. As you can imagine the CELG boards totally changed focus once their deal was announced. Their stock price still has not approved the terms of the deal due to uncertainty.
Every formulary I have ever seen has a big update at 1/1 but is updated quarterly for approvals at the FDA.
Is it really no coverage? I have BCBS Illinois through large corporation but the plan is a high deductible plan. Vascepa is considered covered for me but it is part of my deductible so I am paying down my deductible as I get my Vascepa script each month.
I truly do not understand why posting information from yesterdays official sec filings regarding what indication they will seek doesn't fit into your board narrative.
I purchased my first shares of AMRN in 2012. I currently have 37, 852 shares so I will post here if I want.
Anchor patient population would be the low end of the range for indication. Reduce-it was designed to show much more and AMRN is asking for more in their filing.
From 10-K The indication we intend to seek based on the final positive results of REDUCE-IT pertains to use of Vascepa to reduce cardiovascular events in at-risk patients. While the current FDA approved indication for Vascepa is biomarker based (i.e., lowering triglyceride levels), the indication we will seek based on REDUCE-IT results will be outcomes based (i.e., lowering cardiovascular events).
It is believed that the effects of EPA are not due to a single mode of action, such as triglyceride lowering, but rather to multiple mechanisms working together. Studies in the scientific literature explore potentially beneficial effects of EPA on multiple atherosclerosis processes, including endothelial function, oxidative stress, foam cell formation, inflammation/cytokines, plaque formation/progression, platelet aggregation, thrombus formation, and plaque rupture. With respect to triglyceride levels, our scientific rationale for the REDUCE-IT study was supported by (i) epidemiological data that suggests elevated triglyceride levels correlate with increased cardiovascular disease risk, (ii) genetic data that suggests triglyceride and/or triglyceride-rich lipoproteins (as well as low-density lipoprotein cholesterol (LDL cholesterol), known as bad cholesterol) are independently in the causal pathway for cardiovascular disease and (iii) clinical data that suggest substantial triglyceride reduction in patients with elevated baseline triglyceride levels correlates with reduced cardiovascular risk. The REDUCE-IT study was designed to determine the clinical benefit, if any, of stable EPA therapy in statin-treated patients with elevated triglyceride levels.
I could see where the FDA might want to do an ADCOM to try and nail down what the actual indication would be. Would a clinician use two or more risk factors to prescribe or would they, want to prescribe for trig> 150, trig > 200 or would you go with some sort of other test such as the EPA/AA ratio. There is clearly no safety issues and the clinicians are going to treat. It is just a matter of what the indication will be for approval of the sNDA and ultimately for insurance purposes.
Standard or priority review from 10-k
Regulatory Pathway for REDUCE-IT Data
We intend to submit an sNDA to the FDA before the end of March 2019 seeking approval to expand the label for Vascepa based on the effects of Vascepa demonstrated in the REDUCE-IT study. The FDA’s determination of standard or priority review will be made when the sNDA is submitted. At this time, we are planning for a standard review with a PDUFA date which is approximately 10-months after the date of the sNDA submission.
Power Lunch CNBC right now John Thero.
Jefferies - Easy and great tuck-in for pharma global salesforce
Michael J. Yee, Andrew Tsai, Kelechi Chikere, Ph.D., Arshad Haider
THANKS to ROBCOS on Investor village board for this -
Key Takeaway
AMRN put up a very strong Q4 and is working hard to file the sNDA to expand the label by 10x to a broad CV population this Q.
Next steps are FDA review, pot'l ADCOM (we expect one), and continued upwards trajectory of scripts each Q. Feedback from docs has been quite (+) on physician and patient interest (see prior notes here) and we continue to think Vascepa checks many boxes as a wholly-owned potential blockbuster that would do even better in the hands of big pharma global distribution.
Insights
Q4 strong and underlying demand keeps growing into Q1 despite perceived pot'l seasonality?
Despite AMRN cautioning to expect a "typical" Q1 seasonality, IMS scripts oddly are up +8-9% Q/Q and are tracking to +10-15% for Q1 (similar to +13% in Q4), suggesting $80M in Vascepa sales for the quarter (up from $77M in Q4). Over the past couple of years, Vascepa sales have declined by $5-10M Q/Q in Q1 (on -4% decline in scripts). While Q4 sales were sequentially higher than third-party data (+40% vs +13%), management confirmed that the Q1 weekly script data has tracked fairly accurately to AMRN's internal tally. We expect our estimated $80M in Q1 sales to be slightly offset by increased G2N and a higher capture rate.
Street continues to wonder about potential M&A opportunities - they're not under Irish takeover provisions...
Although based in the UK and tax-domiciled in Ireland, AMRN is not subject to Irish nor UK takeover codes since its 'central management and control' resides outside of the UK. There are several UK shareholder takeover provisions that do not apply to AMRN, including the following: (1) If there is "untoward movement" in AMRN's share price due to buyout speculation, the potential bidder is required confirm the news publicly, (2) an institution purchasing shares that carry 30%+ of the voting rights or a shareholder increasing their stake to 30-50% must make a cash offer at the highest price paid by them in the 12 months before the offer was announced.
We raised our 2019 estimates to $380M and remain above guidance of $350M
We continue to believe that 2019 sales guidance looks conservative since Q4 sales of $77M implies an annualized run rate of $310M already, which does not account for the full effect of AMRN onboarding 250 salespeople back in YE:18. In addition, guidance suggests a $80M+$85M+$90M+$95M trajectory, even though sales grew by $20M+ Q/Q to $77M in Q4. We acknowledge there should be quarterly variability, but the general growth trajectory reflects some conservatism by management. We could see AMRN raising its sales guidance later in the Summer as the quarterly trajectory becomes clearer. Anectdoally, AMRN believes prescription patterns change once the targeted physicians are called 5-7 times. By March, the company expects its 400-person salesforce to call nearly all 50,000 physicians at least once regarding REDUCE-IT (and most will be called 2-3x).