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Perhaps buried somewhere in the media stories is that the subject of the NEJM issue will be presented this weekend at ACC convention in New Orleans March 16-18 in the form of some oral presentations, breakthrough abstracts and posters[still under embargo?].
News: $ESPR Bempedoic Acid Study 1 Results Published in The New England Journal of Medicine Demonstrates Significant LDL-Cholesterol Lowering and Reduced Marker of Underlying Cardiovascular Inflammation, with a Similar Tolerability to Placebo
Bempedoic acid is an oral, once-daily ATP Citrate Lyase (ACL) Inhibitor that reduces cholesterol and fatty acid synthesis in the liver Study 1 is the largest of a comprehensive five Phase 3 study programme investigating the benefits of bempedoic acid in patients requiring additional lo...
Got this from https://marketwirenews.com/news-releases/bempedoic-acid-study-1-results-published-in-the-new-england-journal-of-medicine-demonstrates-significant-ldl-cholesterol-lowering-and-reduced-marker-of-underlying-cardiovascular-inflammation-with-a-similar-tolerability-to-placebo-7846314.html
Odd announcing 2 NDA's and EU submission. Usually, a company would wait to announce filing after it was accepted by FDA.
Looks like we went to 40 first, great buy!
I think back to 80
My wife works for big Pharma, pretty high up the chain regarding trials. She told me to buy this when it was in the high 20's and I didn't and watched it go all the way to 80's.
The crazy selloff was stupid... She like Portolo also. Many big Pharma are using abixiban and this could be a buyout as well...
ESPR is in a crowded space, but the first Esperion was bought by Pfizer and this one could be bought by big pharma as well
80% with recent large insider purchase. Fingers crossed.
What odds do you place on the safety being ok? I listened to one of the recent presentations and management seems highly competent and seemed confident that it would be fine. Thanks.
Congrats and I agree. All Phase I, II, and III results have been all positive so far... Should have another Positive Result any day now and more Analyst upgrades...
yup...went all in at 37 and 38. Good results could easily push this through previous highs.
Pretty sure they have two Phase 3 results coming, one any day in August and one in September.
I still am surprised such a big drop, when is phase 3 results. I should ask my wife as she gave me this puppy
Over 6 Mil shares short w/ volume drying up & Phase 3 catalyst any day. Could spell big trouble for short position. Big gap to $70.50
Good chance this will see the 80’s again. Bought at 37 sold at 46.10. Back in long term at 42.3
This drop is very strange, 1 bil market cap seems cheap
Ameritrade shows Tutes own 103.7% of the float with 15% short. Good Phase III news could send this much higher is the hope.
13G 's last 7 days show accumulation by institutions who own over 10 per cent of float
Good to hear! Looking forward to more Phase III good news
Company speaking today after close, should be good day tomorrow.
Agreed. Bullish on ESPR
nothing has changed but the stock price. Hype equals fear equals sell equals weak shares ripped from the hands of the scared by those conducting the manipulation. We shall see more rationale slowly return.
Did not hold $50.
Expect to see $9.00 in a few days!
Current $54.00
Financials and reports look great
25% Return if it hold $50 today.
Didn’t PFE buy his first Esperian. This could be a jump ball with a couple companies bidding.
Took a while, but finally in at 30 dollar or so higher price than when I was told about it.
Nearly 102% owned by Institutions. Key take away's from recent Healthcare Conferece & Fireside Chat with Esperion:
https://twitter.com/search?vertical=default&q=%24espr&src=typd&lang=en
(scroll down to post by Kaushik)
With that pipeline drop, what might MRK become interested in to combine with a statin? I posted about a possible, inexpensive candidate with an inexpensive biologic product some months ago that has worked well for me.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=129771043
Since then:
In early August 2017, I sent the following letter to John Thero, CEO of Amarin Pharmaceuticals, headquartered in Dublin, Ireland. At UAB you may be aware of the Phase 3 clinical trial Amarin has been conducting under the name Reduce-It---its primary indication differs totally from the trial of UAB. I am not a patient in either arm
of that clinical trial. The treatment arm comprises Vascepa, Amarin's FDA-approved medication for treating hyper-triglyceridemia, a condition I do not have.
Kindly circulate this letter I am sending you to the 2 P.I.s of the UAB trial. It may well be of interest to them for the same reasons the UAB study has been of interest to me. My letter to John Thero should be self-explanatory.
***********************************
"Good morning, John
"My name is [XXXXX]. We own [XXXk] shares of Amarin. I am a Washington, D.C. patent attorney with 25 years experience in patents in Executive and Judicial branches of U.S government(1961-1986), as well as 30 years experience in patent litigation(1986-2016), testifying and consulting as an expert witness in ~ 150 patent infringement suits. I am the Founding Editor of the Federal Circuit Bar Journal. I have degrees in chemical engg from Northwestern University and Princeton University, conferred in 1959 and 1962. I was diagnosed as a Type 1 diabetic in 1957, 60 years ago.
"I now have 4+ years experience with Vascepa that you, Dr. Granowitz, and your patent attorneys may find of interest. Further details are available. I summarize below:
"The EPA/AA ratio is becoming widely recognized as a marker for inflammation in the CV system---my 2016 value of 1.3 is particularly good, probably better than the vast majority of the U.S. population. My 2017 EPA/AA ratio is even better, 1.67. My doctor termed my lipid profile as "excellent," and my cardiovascular risk as "optimally suppressed." Now 80 years old, I have no walking or arthritis difficulties, or other known or common T1 D side effects.
"My Dry Eye Syndrome[DES] disappeared within a week of initial Vascepa dosing in April 2013. It remains entirely gone today.
"Below are the 2016 and 2017 lipid panel marker values for me. I have been prescribed 4 capsules/day of Vascepa[an oral capsule containing 96%(1 gram) of an omega-3 fatty acid known as EPA, or icosapent ethyl], Off-label, since 4/1/2013. Family history of CVD and T1 D are in my background. My father died in 1959 from a heart attack at age 51, experiencing his first heart attack 10 years earlier at age 41; his 3 sisters also died from CV events at a young age. I was told that T1 Diabetes is present in relatives in Norway who I never met. My mother died in 2000, age 92. I have 1 uncle, a much younger sibling of the 17 children, still alive at ~ age 95.
My height: nearly 6', my weight: 177 lbs.
"Medications: Generic Zocor = 40 mg dose > 20 years. T1 diabetic since 1957, 60 years duration. 20 year prescription for 32 units LLY NPH HumulinN U-100 and 7 units of LLY Humalog U-100 with breakfast; 4 units of HumulinN at bedtime.[BP medications and vitamins C, D and E; BP medications for past 20 years have been: 1 12.5 mg tablet Losartan-HCTZ in morning w/breakfast; 2 6.25 mg tablets
Carvedilol, 1 in morning w/breakfast, 1 in evening w/dinner; 1 Bayer 82.5 mg chewable aspirin w/dinner].
"2016 April HbA1c = 6.5; FBG= 111 mg/dL [About the same in April 2017]
2016 Total cholesterol = 144 mg/dL [2017: 125 mg/dL]
2016 LDL-C = 70 mg/dL [2017: 57 mg/dL]
2016 TGCs = 63. " [2017: 60 mg/dL]
2016 HDL = 61. " [about same in 2017]
2016 VLDL = 13. " [about same in 2017]
2016 C-reactive protein = 2.2 mg/dL [2017: 1.4 mg/dL]
2016 APO B = 60 mg/dL; [2017, not measured]
2016 Lp-PLA2 = 216, termed very slightly elevated;[2017, not measured]
2016 EPA/AA Ratio = 1.3; [April 2017 value is 1.67]
2016 Omega-6/Omega-3 ratio = 1.8; [omega-6/omega-3 ratio = 1.6, April 2017]
2016 EPA = 7.0% ; [7.8%, April 2017]
2016 AA = 5.3%; [4.7%, April 2017]
2016 DHA = 2.1%;
2016 Omega-3(EPA + DHA) Index = 9.1%, optimal > 3.2%{April 2017 Index value is 10%] "
***********************************
"Another item that may be of interest, John, in light of my T1 D history. Over the past 2 years, I have slowly reduced the breakfast amount of insulin I had taken daily for many years; now that reduction amounts to ~ 25%[32 U of Humulin N--->24 U; 7 U Humalog--->5 U]. I have done so to avoid the more frequent, serious hypoglycemic episodes I slowly, but surely, had begun to experience over past 4 years. The following excerpt from my April 2017 letter to my PCP, and certain April 2017 articles, may explain why....you may already be aware of the articles:
*****
'You and I have wondered for some time, particularly the past 4 years or so, how my fasting blood sugar levels and HbA1c levels have remained so well maintained.
'The following articles[note the longer one is authored by Chinese researchers] from this past week may present the reason...the 1st link is a summary of the 2nd link:
http://www.medicalnewstoday.com/articles/316756.php
http://www.jci.org/articles/view/87388?key=bbb2df2018c8c18d1e0b
https://www.researchgate.net/profile/Marta_Garcia-Contreras2/publication/305676844_Combination_high-dose_omega-3_fatty_acids_and_high-dose_cholecalciferol_in_new_onset_type_1_diabetes_a_potential_role_in_preservation_of_beta-cell_mass/links/5798cae008aed51475e87894.pdf
'I recall from initial consultations with you, early in my 1st visits as a patient 20 years ago, you thought it was worthwhile to explore whether my pancreatic beta cells, islet cells, were still producing at least some natural insulin. Whatever blood test was performed came back with a totally negative answer to that hypothesis, as I recall.
'I think it is time, in light of the wake-up call provided by the above articles, to again investigate that hypothesis, inasmuch as I have been taking the off-label prescription of 4 capsules/day of Vascepa[each capsule containing 1 gm EPA or icosapent ethyl] for the past 4 years. You will recall we have discussed my serious hypoglycemic episodes occurring over the past year or 2, even with reduced dosages[by 25%] of HumulinN and Humalog that I have been taking vis a vis the prescribed levels of each I had taken for 20 years.
'I would appreciate an opportunity to talk with you re the above, as well as what further investigation is needed now to determine status of islet cells. Do we have frozen blood available/preserved from past visits in the last 4 years to determine progress, if any, with time as the variable, of my islet cells? I am thinking particularly of blood draws in 2013[before any Vascepa to get a baseline] and each subsequent year, especially 2017.[The answer was no]
'I may present a rare case....a "clinical trial" of one T1 Diabetic. Because the Reduce-it Phase 3 clinical trial being conducted by Amarin, the sponsor, remains randomized and double-blinded as to the company, but not the IDMC, we do not know whether T1 Diabetics have been enrolled in that trial. I do not think they are excluded.'
*****
"At this time, John, neither my present PCP, nor a well known, metro-D.C. endocrinologist that I consulted in late May 2017, is willing to express the opinion that Vascepa is the cause of my 25% reduction of daily insulin dose that I have been forced to experience. Both agree there is a correlation. Both are former NIH research physicians. The endo has no T1 Diabetics that also take Vascepa in his extensive clinical practice.
"In light of facts above, you and patent counsel may wish to explore filing a patent application regarding the use of Vascepa in treatment of T1 diabetes, if Amarin has not already done so. I am aware of one published Amarin application relating to diabetes generally. I have data that documents my use of Vascepa[EPA] in Type 1 diabetes prior to the publication date of the above articles.
"My wife and I travel to Europe beginning this coming Monday for vacation---Northern Italy, Switzerland, ultimately Amsterdam, and return to Washington on Saturday, August 19. Should you find it desirable, I am available for consultation with Amarin anytime."
**********
Since that letter to John Thero in August, I have further reduced the amount of Humulin N in the morning from 24 U to 22 U, and Humalog from 5 U to 4 U.
I plan to continue attempts to reduce insulin dose levels in the future---time is the variable, and FBG levels remain in acceptable ranges so far.
I will have further lipid panel values available this week from blood draw on Tuesday last week. Other numbers resulting from previous, usual blood draws have been in normal range applicable to each measurement.
Merck announced after hours yesterday it will not be seeking to bring it's developmental drug Anacetrapib (CETP Inhibitor) to market.
Merck now has a clear cardiovascular drug candidate void in its pipeline & with MRK’s #Zetia, ESPR is the logical drug candidate 2 fill it.
Long ESPR
Chart looking decent.... MACD upswing...
Presentation on Wednesday, June 7, 2017 at 10:30 a.m. Eastern Time
ANN ARBOR, Mich., May 31, 2017 (GLOBE NEWSWIRE) -- Esperion Therapeutics, Inc. (ESPR), the Lipid Management Company focused on developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today announced that president and chief executive officer, Tim M. Mayleben, will present at the Jefferies 2017 Global Healthcare Conference in New York City on Wednesday, June 7, 2017 at 10:30 a.m. Eastern Time.
Me thinks they will find & announce Partners (US and Europe/Asia) or be bought out by Big Pharma in the next 6 months...
Either way, I expect the stock to be north of $60 by EOY.
Bempedoic Acid also lowers inflammation which could be a huge benefit as well. Same Lipid Experts behind Lipitor (Dr Roger Newton) is behind ETC-1002. I follow AniuStudent on Twitter who has been dead on with this stock. He seems to know a lot about the upside and risks and likes his chances with ESPR. Pfizer has probably nearly 20Bil in cash and cash equivalents. Esperion states that 181 Million People in the US, Europe, and Japan suffer from High LDL-C. At 3,000 a year, it doesnt take much Market share to have a huge winner. 10% of 40Mil Patients with High LDL-C are Statin Intolerent. That market alone is worth Pfizer paying Esperion $4Bil, if Esperion would sell it for that. Drug has a clear path to market and could see $100+ in 2 years with No Buyout. I personally think History is about to repeat itself with Esperion and Pfizer. All the best to all the Longs. Was a good day today.
This big picture is the statins are now mostly patent expired. Now pharma is looking for a new oral branded drug to make up for that.
Additionally, if this drug can lower ldl and increase hdl similarly to statins which fish oils cannot decrease ldl significantly (fish oil is best for hdl increases) then it can become the first line over statins or be pushed to use in combo with statins as initial therapy it will greatly increase the value of this drug.
Lipid panels are complex and confusing. Ldl is always your primary goal assuming triglycerides are not super high. Then comes hdl as a priority.
You took a while to show up with that observation..."fancy" indeed!! No OTC fish oil is comparable in EPA content or purity or non-oxidized content.
You are likely correct with your MOA comparison. But I sense you know as little about Vascepa as I know about ESPR's medication.
Do you reject my price comparison, and advantage of same in Vascepa's court? Do you disregard the lipid panel results I showed you, including LDL-C and HDL? Do you think that the ESPR medication will demonstrate a similar EPA/AA ratio, or EPA + DHA index value in commercial use, or are those ratios/values unimportant to you? Cardiologists do not reject them as unimportant. I confess ignorance of whether those ratios and indices are achieved by ESPR's medication ....educate me if you can.
Vascepa is fancy fish oil. This drug is a totally different mechanism. Also ldl and hdl are affected differently with this new drug compared to fish oil. Not apples to apples.
Boxer Capital, LLC has filed a new 13G, reporting 5.3% ownership in $ESPR - https://fintel.io/so/us/espr
I posed the following rhetorical question last Sunday, the 19th, before becoming aware of the results reached by ESPR on Monday, the 20th. I have not reached any contrary answer to the question as yet.
"Should I be interested in any of the companies that have reacted negatively to the results posted by AMGN for Repatha, apart from other entities/items present in respective pipelines"?
Currently I am not interested. My own monthly cost for AMRN's Vascepa is much lower---$37/month co-pay for my off-label prescription---than the prognosticated cost of Repatha[$14,500/year] or ESPR's treatment drug[estimated $3000/year]. The benefits of Vascepa for me seem to = or exceed anything Repatha or competition, including ESPR, would offer in CVD arena. My 2016 lipid panel data is posted on the Amarin IHub board. The data is from blood samples taken at my last annual physical in March 2016, and will be up-dated in March 2017. I will be 80 years old in April 2017.
The EPA/AA ratio is becoming widely recognized as a marker for inflammation in the CV system---my value of 1.3 is particularly good, probably better than the vast majority of the U.S. population. My doctor termed my lipid profile as "excellent," and my cardiovascular risk as "optimally suppressed."
Below are the current lipid panel marker values for me. I have been prescribed Vascepa[an oral capsule containing 96%(1 gram) of an omega-3 fatty acid known as EPA, or icosapent ethyl], Off-label, since 4/1/2013.
Generic Zocor = 40 mg dose > 20 years. T1 diabetic since 1957.
HbA1c = 6.5; FBG= 111 mg/dL
Total cholesterol = 144 mg/dL
LDL-C = 70 mg/dL
TGCs = 63. "
HDL = 61. "
VLDL = 13. "
C-reactive
protein = 2.2 mg/L
APO B = 60 mg/dL;
Lp-PLA2 = 216, termed very slightly elevated;
EPA/AA Ratio = 1.3;
Omega-6/Omega-3 ratio = 1.8;
EPA = 7.0% ;
AA = 5.3%;
DHA = 2.1%;
Omega-3(EPA + DHA) Index = 9.1%, optimal > 3.2%
Vascepa also obliterated the DES I once had within days of 1st dose in April 2013. DES remains gone today. Vascepa has no known side effects. AGN and SHPG should be concerned also to the extent reliance is had for their respective DES treatments to be accretive to revenue and earnings.
Is DES one of the secondary or tertiary indications/utilities for which Amarin may file with the FDA per its 1st Amendment settlement with FDA last year? Further background of Amarin and Vascepa may be found here:
http://www.fdalawblog.net/Amarin%20%2800193135%29.pdf
http://tinyurl.com/zyduacf
http://tinyurl.com/jabzuvw
http://tinyurl.com/jumnoej
http://tinyurl.com/zoxx9x4
http://tinyurl.com/zb8rnqu
http://tinyurl.com/jnx6w6p
Read results, conclusions and discussion sections from the following:
http://www.internationaljournalofcardiology.com/article/S0167-5273(16)33563-X/fulltext
I will post more on your costs analysis later. Suffice to say I copay $111 every 3 months for my prescription, off-label, for an already FDA-approved drug from Amarin[AMRN] called Vascepa[an omega-3 fatty acid containing oral capsule, 96% EPA = 1 gram, taken 2 capsules in morning with breakfast, 2 with dinner].
Time to load the $41s stopped making new lows on the 15-minute
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