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Not enough was out time for placebo
The FDA presentation is breaking up, anyone else experiencing this?
Thanks Go seek... I needed that. Might need a beer soon. This idiots are referring to ATP3 guidelines...give me a break!
Committee's asking for them to run tons of extra stats.
Tense? The committee is chewing Amarin up...I might have to shut this off
FDA connection up and running....crappy music!
JL, AACE full document link
Read the "Consensus statement" they go into inflammation at the end. This document itself refutes the FDA BD.
https://www.aace.com/publications/algorithm
"AACE Comprehensive Diabetic Algorithm "...but you have to read the full statement. Need a windows PC cause it's an Adobe file.
JL they're gonna get some COX & LOX tomorrow in Amarin's presentation....I hope they ...talk...real... Slow...when ... discussing ...ecosanoids. I was encouraged by the AACE full statement, inflammation, arthrogenic particles, and "very aggressively treating DM 2's with CV history". The 2012 statement didn't contain Omega 3's, the 2013 contained JELIS, pure EPA and cautioned prescription grade Omega 3 EE containing DHA increasing LDL. It also justified treating Trigs as a CV risk parameter. The whole document refutes most of the FDA BD.
Have a good night, I'm gonna hit the rack.
Will
True that JL, Vascepa's potential is mind blowing. WS might not get it until a "ridiculous" offer is made or Vascepa sales are $1 Billion.
Hope you read through the AACE 2013 Guideline document, lots of great stuff encouraging to use of Vascepa.
https://www.aace.com
The 2012 AACE guidelines didn't contain Omega 3 EE, 2013 guidelines do.
New AACE guidelines caution against DHA containing omega 3 EE page 24
Wow!
Amarin could use this document at the Ad Com !!!!
Quote from the 2013 AACE document "In a large clinical trial, highly purified eicosapentaenoic acid added to a statin regimen was associated with a 22% reduction in the risk of CHD in patients with impaired fasting glucose"
These are new, two consecutive years AACE has redone recomendations, I posted 2012 prieviously, these are the new docs.
Very very good for Amarin & Vascepa, let's go save some lives!
Folks here are the 2013 AACE (American College of Endocrinology)
They are new and finally we can access the link one day before Anchor Ad Com.
I suggest you skip to page #9 my points relative to Vascepa
1) Treat Trigs > 500 with fibrates, omega 3 EE, niacin
2) If statin intolerant "try alternate statin, lower statin dose or frequency, or add nonstatin LDL lowering therapies) I assume they mean something that isn't going to spike your LDL levels...like Lovaza or DHA containing EE
3)"Intensify therapies to attain goals according to risk level RX
LDL-C, Non-HDL-C, TG, TC, Apo B, LDL -P
4) keep intesifying treatments to goals to lower LDL-C
"To lower Non HDL C, Trigs Intensify statin or add OM3EE &/or fibrates &/or Niacin
This is it, AACE recomendations for 2013
https://www.aace.com
Enjoy
Williams
After a few beers I readjudicated the Anchor numbers, used the REDUCEIT assumptions, and ascertained certain CV event reduction with the 4 gram dose of Vascepa. I'm sure the FDA will come to the same conclusion...Vascepa does lower CV risk outcomes... Much greater than the REDUCEIT 15% SPA endpoint.
30,000,000 patients 15% CV event reduction per year 4,500,000 million events...(reward) & the risk ...well the FDA doesn't even discuss risks....
The last day...Tuesday October 15 to load up.
Good night , and go long
Williams
You'd hope it was, but not so. Hazard Ratio was greater than expected, but yet approved waiting for an outcomes study to finish 2016ish.
New investigation into all the investigations to see if they have connections to HF/short
That was quite the coordinated attack Friday, especially after the suspicious Put action Thursday.
Biowill,
Also my read, and no one can answer the question without guessing. Risk/Reward pushes it over the top..
Also believe Anchor label "may" contain REDUCEIT indication and pilot new FDA draft guidance of approval without outcome study complete.
Williams
NoFan
Invokana increased the risk of CV events and got approval awaiting their CV study.
Vascepa's "design" is to reduce CV events...apple and orange comparison except the Endocrine Committee seems to have balls of steal.
Williams
JL agree, the Ad Com purpose is to throw all the poop on the wall and see what's sticking at the end of the day.
The Ad Committee's job is to introduce new evidence based science/knowledge (something the FDA felt they needed) to review Vascepa. Note, nothing in the reviewer document discussed the Eicosanoid Inflamatory pathway, happens to be important considering the review covers Rx of Non-HDL-C, ApoB, VLDC-C, LDL-C, not just Trigs.
New recomendations admit the short comings of just LDL-C, the FDA knows this has changed and know they don't have the knowledge base, hence "The Committee".
"The committee will discuss the supplemental new drug application, NDA 202057/S-005, Vascepa (icosapent ethyl) Capsules, submitted by Amarin Pharmaceuticals Ireland Ltd. Vascepa is currently approved as monotherapy for the treatment of severe hypertriglyceridemia. This supplemental application proposes concomitant use with an inhibitor of HMG-CoA reductase (statin) to reduce triglycerides (TG), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (Apo B), low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and very-low-density lipoprotein cholesterol (VLDL-C) in adults with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent.
My opinion has not changed, and I believe the FDA is considering a wider than Anchor label (REDUCEIT) when considering the risk benefit. I happened to request it under:
"The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.
Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. These studies are known as phase 4 confirmatory trials. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market."
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
I believe the FDA is considering Vascepa to pilot this draft guidance. The document was posted in June, shortly thereafter, I made my request to CDER.
Williams
In a meeting that took place be document was drafted, Amarin took part.
Here:
http://www.fda.gov/downloads/drugs/newsevents/ucm340568.pdf
Amarin has planned 3 SPA phase 3 studies with the FDA. They've completed 2 and are two years into REDUCE-IT, if the FDA had an issue with the Placebo now would seem to be an odd time to bring this to Amarin's attention.
Amarin has one soft ball voting question, however, the FDA has laid out every bearish argument...including results that "May" overstate Vascepa's Anchor results.
Looking forward to the Ad Com, Amarin's team will have to perform well...or Weds AH will not be pretty.
JL agree with you... I haven't seen criminal manipulation of securities like this since DNDN. However, the end game is REDUCE-IT and it doesn't happen without Anchor. The FDA laid out every bearish argument I could think of, except cancer...which is the card I thought they would play....there is nothing material that prohibits approval. All new guidelines recommend Rx of Non HDL C's over LDL...
I will remain Long.... many... Shares.
I have not traded one single AMRN share in over a year.....
Your Surgical Friend,
Anesthesia/Williams
A close look at '291..." Amarin's Generic and Epanova Patent"
Thank You Study and Zum for the find and drop box.
Claims interpreted by me are strictly my opinion and can not be used by AZN;) :
1) Composition treating Trigs, made of "about" 2200 mg of EPA (selected from a group ie. EE or FA or both), also contains not more than ABOUT 20% DHA by weight of all FA. Add on to statin, a key statement since Amarin found that on top of a Statin EPA lowers Trigs unexpectedly than just the statin alone, even if you doubled the statin dose...this is in the affidavit.
Very specific compare to the loose Lovaza Patent that protected it from generics for years.
2)&3) gonna reduce your Trigs by at least 10-15%
4) Reduces Non HDL C, important because many Lipid Societies have recommended ignoring LDL and Trigs and focus on Non HDL C...claiming it's a predictive value that incorporates both LDL & Trigs. (Europe)
5) Reduces Non HDL C about 5% (very significant and predictive for reducing CV disease risks)
6) Raise HDL-c, good cholesterol
7) 8) 9) phospholipase 2 reduction
10) Increase EPA blood levels by at least 200%, this is HUGE, it prevents engineering an EPA molecule (like some weird FA complex and string it alone as a new compound)
11) 12) 13) more on dose
14) Takes EPA blood levels up to 400%
15) composition contains about 20% DHA of total FA composition
16) treatment length at least 12 weeks
Actual claims wording, thanks Zum
https://dl.dropboxusercontent.com/u/57678878/13685291.pdf
----------------------
This is one of Amarins most important patents thus far. It destroys Epanova and severely limits generics from engineering a product that could even come close to Vascepa EPA blood levels. WS can try to ignore this, but come May, Epanova's PDUFA date, it'll be crystal clear.
Williams
"Rumors of Briefing Documents focusing on Outcomes study". I doubt that's a rumor...what else would the AdCom talk about all day? Not safety or Efficacy.
Invokana was approved by the FDA on 3-29-2013, it's a DM 2 drug. It was approved despite safety concerns, while waiting for the CV outcomes study due 2017. The lowering of glucose to improve CV outcomes is not proven and more controversial than Lower Trigs, Non-HDL, etc... This is the same Ad Com committee.
In addition, Invokana doesn't have a shadow study like Vascepa's JELIS.
Williams
Amarin's Ad Com is NOT postponed, and WILL NOT be postponed. Amarin's stated this, the FDA echoed it.
Today: The November 5-6, 2013 Allergenic Products Advisory Committee meeting was postponed due the government shutdown because the subject of the meeting is allergenics, which are not associated with user fees. Posted 10-8 at the FDA website.
The actual reasoning for Allergenic Ad Com delay, gives me confidence Amarin Ad Com documents will be posted on time.
High Trigs are an independent risk factor for CVD, those that like graphs:
http://www.ncbi.nlm.nih.gov/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Click%20on%20image%20to%20zoom&p=PMC3&id=3105250_ehr11204.jpg
As Trigs increase, the hazard ratio increases...
AACE (American Association of Clinical Endocrinologists) 2013 Guidelines statement was released April 2013, they where again revised in September but have not been released yet.
High Trigs are considered an independent risk factor, just like LDL. This has already been voted on, Anchor was essentially approved by the AACE in September...the Ad Com is a statutory obligation by the FDA for first in class Trig Rx. In fact, to be consistent with the AACE recommendations the Ad Com is likely to drop Anchor Trig level to 150. Special focus is on diabetics that have a 4x greater risk of cardiovascular mortality, LDL lower than 70, Trigs lower than 150. In the April statement, drugs that increase LDL, Omega 3 EE with DHA, where cautioned & yes at this point they did mention a "new drug" containing only EPA. This April statement was revised in September and has not been posted, but the following Lecture contains the "new drugs".
http://www.franciscanalliance.org/hospitals/indianapolis/services/heart/symposium/Documents/13%20CV%20Symp%20Kovacich%20Updated%20Lipid%20Guidelines.pdf
The Ad Com would look mighty stupid to vote against something already approved by their professional organization.
Why I see Anchor as a non event:
The past few months I have focused my DD on the medical communities perception of need to treat Dyslipdemia. I've found consistent evidence that the treatment of Dyslipdemia will be backed by NIH through ATP 4 guidelines, and Cardiometabolic risk management guidelines in primary care have again been updated in September of this year to match the new ATP 4 guidelines. While none of the official documents are posted, lectures have been given on "proposed" changes.
While I'm certain Anchor will be approved, clinicians will be bound by evidenced based medicine to use the guidelines to best serve their patients. My latest DD shows Vascepa as first line treatment for dyslipidemia, over statins. Something I expect to be echoed in the Ad Com, but if things get "fishy", in the end Amarin will have guidelines and science recommending the treatment of Dyslipdemia with those that have metabolic syndrome to a goal Trig of <150 and LDL of <70. This population is 30 million.
Williams
Amarin's IP advancement 10-3-2013
13/685,291, has Terminal Disclaimers approved 10-3-2013, "Generic" formulation covering up to 30% DHA with set ranges of EPA in escalating mg doses, combined with a statin to treat high Trigs and various lipid particle markers.
If Amarin get's this patent, they will have IP for any generic with greater than 30%DHA/70%EPA with or with out statin. Guessing within two Months they have NOA.
Will it be worth the risk to get sued for triple damages for Generics or Epanova? Not likely. This is a crushing blow to TEVA, GSK, AZN, and Par pharmaceuticals.
Williams
OB lists 20 Amarin Vascepa patents, the latest is: 8,546,372 In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of blood lipid therapy comprising administering to a subject in need thereof a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.
Big Deal, right? Yes, those attending The 2013 Cardiometabolic Health Congress (CMHC) is set to take place October 2 - 5, 2013, at the Sheraton Hotel, in Boston, MA.
There's more Vascepa related content and Amarin connections at this conference than I could cover in a post. Amarin has four MD speakers that are presenting, some numerous times like:
Deepak L. Bhatt MD, MPH, FACC, FAHA, FSCAI, FESC, FACP, FCCP, is Chief of Cardiology at VA Boston Healthcare System and Director of the Integrated Interventional Cardiovascular Program at Brigham and Women’s Hospital and VA Boston Healthcare System. He is also a Senior Investigator in the TIMI Study Group and Professor of Medicine at Harvard Medical School. (Brigham and Women’s Hospital, own the only RESOLVIN patents issued)
He's running the REDUCE-IT study, and lecturing on it.
The one to focus on is:Dr. Eckel is the Charles A Boettcher II Endowed Chair in Atherosclerosis, Professor of Medicine with appointments in the Division of Endocrinology, Metabolism and Diabetes and the Division of Cardiology, and Professor of Physiology and Biophysics at the University of Colorado School of Medicine Anschutz Medical Campus, and Director of the Lipid Clinic at the University of Colorado Hospital. He is also the Program Director of the National Center for Research Resources (NCRR) Discovery Translation component of the Colorado Clinical Translational Sciences Institute, and previously served as Program Director of the Adult General Clinical Research Center at UCD for 15 years. In addition, Dr. Eckel previously was a member of the Scientific Advisory Council of the National Institute of Diabetes, Digestive and Kidney Diseases at the National Institutes of Health (NIH) and Past President of the American Heart Association. His NIH funded research has focused on the pathogenesis and treatment of lipid disorders, obesity, the metabolic syndrome, diabetes, and obstructive sleep apnea. Studies in animals and humans are directed towards dissecting the impact of nutrition/hormones on lipid and carbohydrate fuel partitioning and energy balance.
In humans, Dr. Eckel has examined the nutritional/metabolic predictors of weight change, lipid disorders, inflammation, and atherosclerosis. In the laboratory, he uses genetically modified mice with tissue-specific overexpression or deletion of lipid-related gene expression and tissue culture to address similar issues in more extensive and mechanistic detail. Overall, Dr. Eckel’s research is targeted to uncovering basic mechanisms of how metabolic diseases relate to cardiovascular and pulmonary disease in hopes that the data to be gathered will lead to more favorable diagnostics and therapeutics to follow.
Back to the new OB'd patent, it includes reduction of apolipoprotein B and reduction of VLDL-C both these are Anchor indication topics.
The committee will discuss the supplemental new drug application, NDA 202057/S-005, Vascepa (icosapent ethyl) Capsules, submitted by Amarin Pharmaceuticals Ireland Ltd. Vascepa is currently approved as monotherapy for the treatment of severe hypertriglyceridemia. This supplemental application proposes concomitant use with an inhibitor of HMG-CoA reductase (statin) to reduce triglycerides (TG), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (Apo B), low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and very-low-density lipoprotein cholesterol (VLDL-C) in adults with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent.
Looks like the FDA is allowing Anchor related patents into the OB before PDUFA.
Well said, Merck, AZN and GSK are imploding now...Amarin doesn't need any help to successfully lauch Anchor. Vascepa in conjunction with a statin safely lowers Trigs & Lipids as efficaciously as DOUBLING the statin dose....except with out the side effects and fact statin dose could be maxed already. This is actually stated in patent ap # 13540319 (combo patent) which was mailed notice of allowance in September 2013.
The big picture is a masterpiece in the making.
Williams
JL Looks like the Cardiologists in Indy get it. Check this out:
http://www.franciscanalliance.org/hospitals/indianapolis/services/heart/symposium/Documents/13%20CV%20Symp%20Kovacich%20Updated%20Lipid%20Guidelines.pdf
I found a few connections with Endocrine Lipid recommendations changing again in 2013, despite new recommendation only a year ago. It also appears they have coordinated guidelines with ATP4 guidelines. I'm finding a few presentations on "the changes".
Amarin is not a $100 stock
But it will be in 2 years.
Perhaps you should research ATP4, and understand that some have started lecturing on changes from ATP3. Vascepa appears to be the first line treatment for high trigs, over statins and fibrates. The Ad Com panel likely has these new guidelines. It wouldn't matter if they voted 200-0 not to approve Anchor...the FDA has to rule with the NIH fueled recommendations. You'll understand October 17.
In addition, ATP4 guidelines will focus on inflamation markers and less on LDL...big change in Vascepa/Anchor favor.
http://www.franciscanalliance.org/hospitals/indianapolis/services/heart/symposium/Documents/13%20CV%20Symp%20Kovacich%20Updated%20Lipid%20Guidelines.pdf
You should review this presentation...it may alter your "opinion".
More Dr. Kovacich and ATP4 and Amarin
Note AZN, Amarin, Pfizer and Merck...No GSK
http://www.franciscanalliance.org/hospitals/indianapolis/services/heart/symposium/Documents/symp%20broch%202013%20final.pdf
The smoking ATP4 gun and Vascepa!!!! I new it would leak...good luck on Monday shorts!
http://www.franciscanalliance.org/hospitals/indianapolis/services/heart/symposium/Documents/13%20CV%20Symp%20Kovacich%20Updated%20Lipid%20Guidelines.pdf
Endocrine Guidelines for treatment of Lipids just voted and changed two weeks ago Sept 2013. They where just updated last year Sept. 2012. Meeting minutes kept private due to cofidentiality issues. They worked with ATP4 to maintain consistancy. I've found some evidence pointing towards "new drug".
ATP-IV Guidelines: Individualization key to cholesterol management
FacebookTweetShareAugust 9, 2013
PHILADELPHIA — Dave L. Dixon, PharmD, BCPS, CDE, CLS, and Evan Sisson, PharmD, MHA, CDE, both of the VCU School of Pharmacy in Richmond, Virginia, stressed the importance of individualizing patient goals and therapy at the American Association of Diabetes Educators Annual Meeting and Exhibition.
Although statins remain primary treatment option for high cholesterol, Dixon and Sisson discussed how combination therapy with drugs like niacin and fibrate, as well as new drugs in the pipeline, will allow for individualization for patients who haven’t achieved their non-HDL goals.
===========
http://www.healio.com/endocrinology/highlights-from-aade-2013/atp-iv-guidelines-individualization-key-to-cholosterol-management
Ajax...I was thinking the same...but that's the game...manipulate...FUD...scrape up as many shares as possible...this is going to ROCK!
NOA for 13/768,906----covers doses as high as 5 grams of EPA and up to 5% DHA Fatty Acid or Ester form, Inflammation markers including hs-CRP, gives no lower range for trig treatment (ie Anchor 200-500, or Marine 500<)
JL
Hopefully ATP 4 guidelines will surface before 2014:) I believe they will focus on these biomarkers.
https://www.acli.com/Events/Documents/Tue22812%20-%20Lipidology%20-%20Pamela%20Morris.pdf
ATP 4 guidelines are coming.
https://www.acli.com/Events/Documents/Tue22812%20-%20Lipidology%20-%20Pamela%20Morris.pdf
Page 2 say's it all:
-New Lipid guide lines (as low as 150 trigs)
-Role of Biomarkers (those Biomarkers that Vascepa lowered in Anchor)
-Low levels of LDL-c (we know generic Lovaza doesn't cut it)