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Unfortunately, I don’t have time to look up GL. Have a lot going on today. Have a great weekend!
Rx Data for 01/03/2020
TRx: 8,755,000 pills or 72,958
NRx: 3,482,000 pills or 29,016
Rx data for 12/27/209
TRx: 8,190,000 pills or 68,250
NRx: 3,422,000 pills or 28,516
We were at 10mm+ pills before Christmas.
Last week was New Years. Nice to see a small bump between two holidays.
Have a nice weekend.
Cam
Preferably under the identity of a new ticker...
Ortakoy, absolutely fantastic synopsis.
Thank you!
Was that a 800k share purchase just a bit ago? Just a casual $19mm. TTE, was that you?
Amarin Price Targets
Accurate to the best of my ability
As of today:
Oppenheimer: $7
Citigroup: $27
Leerink: $29
Cantor: $35
Stifel: $26
HC Wainwright: $51
Aegis: $23
Goldman: $17
Jeffries: $30
Roth Capital: $31
Suntrust: $30
Around 9/24/2018
Oppenheimer: n/a
Citigroup: $17 (was $5)
Leerink: n/a
Cantor: $35 (was $15 after results & $10 day before results)
Stifel: n/a
HC Wainwright: $20 (was $10)
Aegis: n/a
Goldman: n/a
Jeffries: Can't remember
Roth Capital: n/a (was $2 before results before suspending coverage)
Suntrust: $6 (before results)
I wonder where John Boris (Suntrust) is these days? He was a big proponent of ours back in the $1-3 days and I haven't heard a peep from him since... I remember him touting us at $6 when we were around $1.
Anyway, my take is that analysts are always late to the party - raising or lowering PTs after the news hits. So much of our value has yet to be determined - label expansion, new indications, euro deal, etc etc. And some analyst who thinks we are worth $7 based on trial data (from unnamed companies - but we know who) that has yet to be published... which leads him to an inference that we will be an inferior product and thus underwhelming sales is malpractice (from a financial standpoint). Hard to take someone seriously that makes assumptions like these and is obviously chasing a bookrunner position for ACST.
One of the primary PURPOSES of analyst opinions is to attract investment banking business so they can clip 4-7% underwriting fees... That's where they make their money... and yeah, to shake retail hands from time to time. Nothing about our narrative has changed today. I for one was not planning to sell today or tomorrow or anytime soon for that matter - but I do languish when we take dips for no apparent reason.
Our board is way too smart for these analysts. We are usually the first to know anything from PACER or from patent applications or new scientific studies pertaining to EPA, inflammation, etc.
I trust us and the members of EPADI.
Best,
Cam
Maybe. I don’t remember and am tied up in meetings. Had my analyst send me the numbers. Have a great weekend!
SCRIPTS:
I don’t have time to normalize at work so I’ll leave that to someone else.
10-11-19
NRx: 8.740mm
NRx: 4.068mm
ATHs
Cam
This would be huge. Especially given there’s little to no distinction between HSV-1 and HSV-2 other than location... could be INCREDIBLE.
My Rx numbers are not “normalized” - apologies for not knowing the conversion.
Here’s the breakdown for someone that knows:
Count
TRx
1gm: 48,480
0.5gm: 712
NRx:
1gm: 17.93k
0.5g: 263
Quantity:
TRx
1gm: 7.46 million
0.5gm: 135.96k
NRx
1gm: 3.25 million
0.5gm: 54.41k
Source: Bloomberg
9/6 Rx #’s (Holiday week)
TRx: 49,192
NRx: 18,188
Don’t have time to pull Lovaza.
Have a great weekend!
Cam
I know the Davidson family - nice bunch. Very good folk, but I would agree that he will defend his drug. Have to protect the rep.
I have discussed V at length with his son and there’s no turning them to an alternative view!
Keystone - you make a great point. This is an exchange fund. You will diversify yourself, but maintain your basis. After the lock up you will receive the allocation of the fund with the same basis. Your tax burden will be deferred to the selling of this holdings. Very good strategy for concentrated positions.
Best
Cam
In my experience all 401k rollovers are liquidated from provider and sent as cash. You have 60 days to deposit in an IRA before the IRS deems it an irreversible taxable event.
If the 401k has a self directed brokerage account or personal choice retirement account, you MAY be able to do a “like kind” transfer. My guess is this is what you have given you have non standard holdings like individual equities.
Honestly you may consider leaving your 401k as is. Most employers have the employees pay the expenses on the plan through their accounts - in this case they often don’t force you to take your monies out.
Cam
Prescription Data Week 12/07/18 from Bloomberg
Vascepa
TRx: 35,142
NRx: 15,133
Gen L
TRx: 58,066
NRx: 23,394
Lovaza:
TRx: 1106
NRx: 384
Cheers everyone!
Cam
MARKETING EXAMPLE:
Here’s an email sent to my father-in-law to be (cardiologist). He and colleagues are all VERY impressed and excited. (Some images are missing).
Enjoy the read.
Best,
Cam
In 8179 statin-treated adults with well-controlled LDL-C (41-100 mg/dL) and CV risk factors including elevated TG (135-499 mg/dL) and either established CVD or diabetes and other CV risk factors1,2
VASCEPA® (icosapent ethyl) 4 g/d demonstrated unprecedented reductions in CV events1
Dear Dr. ——————,
Results for the VASCEPA CV outcomes trial (REDUCE-IT™) have been announced and demonstrated that adding VASCEPA 4 g/d showed a 25% RRR in CV events.1
Primary endpoint:
5-POINT MACE*
Image showing key primary endpoint results from REDUCE-IT
25% RRR
NNT=21
HR=0.75
(95% CI, 0.68-0.83)
P=0.00000001
Secondary endpoint:
COMPOSITE CV DEATH, MI, STROKE
Image showing key secondary endpoint results from REDUCE-IT
26% RRR
NNT=28
HR=0.74
(95% CI, 0.65-0.83)
P=0.0000006
Hard MACE
Image showing secondary endpoint (Hard MACE) results from REDUCE-IT
CV DEATH
20% RRR
HR=0.80
(95% CI, 0.66-0.98)
P=0.03
Image showing secondary endpoint (Hard MACE) results from REDUCE-IT
MI
FATAL OR NONFATAL
31% RRR
HR=0.69
(95% CI, 0.58-0.81)
P<0.001
Image showing secondary endpoint (Hard MACE) results from REDUCE-IT
STROKE
FATAL OR NONFATAL
28% RRR
HR=0.72
(95% CI, 0.55-0.93)
P=0.01
SEE REDUCE-IT RESULTS
Overall adverse event rates were similar across treatment groups
Numerically more serious adverse events related to bleeding; overall rates were low (2.7% for VASCEPA vs 2.1% for placebo, P=0.06), with no fatal bleeding observed in either group and no significant increase in adjudicated hemorrhagic stroke or serious central nervous system or gastrointestinal bleeding
Significantly higher rate of hospitalization for atrial fibrillation or flutter, though rates were low (3.1% for VASCEPA vs 2.1% for placebo, P=0.004)
Significant reduction in key secondary composite endpoint of CV Death, MI, and Stroke1
VASCEPA showed a 26% RRR in the key secondary endpoint, which was a composite first occurrence of CV Death, Nonfatal MI, and Nonfatal Stroke (3-point MACE).
Learn more »
VASCEPA demonstrated significant reductions in CV Death, MI, and Stroke1
Significant reductions across secondary endpoints of first occurrence of CV event:
•
CV death: 20% RRR; HR=0.80 (95% CI, 0.66-0.98), P=0.03; VASCEPA (n=174), placebo (n=213)
•
MI: 31% RRR; HR=0.69 (95% CI, 0.59-0.81), P<0.001; VASCEPA (n=250), placebo (n=355)
•
Stroke: 28% RRR; HR=0.72 (95% CI, 0.56-0.93), P=0.01; VASCEPA (n=98), placebo (n=134)
Learn more »
FDA has not reviewed and opined on a supplemental new drug application related to REDUCE-IT. FDA has thus not reviewed the information herein or determined whether to approve VASCEPA for use to reduce the risk of major adverse cardiovascular events in the REDUCE-IT patient population.
NNT=number needed to treat; RRR=relative risk reduction.
*
5-point MACE was defined as a composite of first occurrence of CV Death, Nonfatal MI, Nonfatal Stroke, Coronary Revascularization, and Unstable Angina Requiring Hospitalization.
References: 1. Bhatt DL, Steg PG, Miller M, et al; on behalf of the REDUCE-IT Investigators. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia [published online ahead of print November 10, 2018]. N Engl J Med. doi: 10.1056/NEJMoa1812792. Bhatt DL. AHA 2018, Chicago. 2. Bhatt DL, Steg PG, Brinton EA, et al. Rationale and design of REDUCE-IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.
FDA-APPROVED INDICATION AND LIMITATIONS OF USE FOR VASCEPA1
•
VASCEPA® (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia
•
In patients with severe hypertriglyceridemia, the effect of VASCEPA on cardiovascular mortality or morbidity or on the risk of pancreatitis has not been determined
IMPORTANT SAFETY INFORMATION FOR VASCEPA FROM FDA-APPROVED LABEL
Data from Two 12-Week Studies (MARINE and ANCHOR) of Patients with Triglycerides Values of 200 to 2000 mg/dL (n=622 on VASCEPA, n=309 on placebo)1
•
VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components
•
In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy
•
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% VASCEPA, 1.0% placebo)
•
Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088
•
Patients receiving treatment with VASCEPA and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically
•
Patients should be advised to swallow VASCEPA capsules whole; not to break open, crush, dissolve, or chew VASCEPA
Please see full Prescribing Information for more information on VASCEPA.
IMPORTANT INFORMATION FOR HCPs ABOUT VASCEPA® (ICOSAPENT ETHYL) CAPSULES
IMPORTANT NEW INFORMATION: REDUCE-IT™ CARDIOVASCULAR OUTCOMES STUDY OF VASCEPA®2*
The effects of VASCEPA on the prevention of cardiovascular events was evaluated in a multi-center, double-blind, randomized, placebo-controlled, event-driven trial (REDUCE-IT, NCT01492361) in 8,179 adult patients at low-density lipoprotein cholesterol (LDL-C) goal, with established cardiovascular disease (CVD) or at high risk for CVD, and hypertriglyceridemia (fasting triglycerides (TG) ≥135 and <500 mg/dL).
•
Patients were eligible to enter the trial if they were at least 45 years of age and on stable statin therapy with fasting LDL-C levels of >40 and ≤100 mg/dL and fasting TG levels of ≥135 and <500 mg/dL. Patients also needed to have either established CVD (secondary prevention cohort), defined as documented history of coronary artery disease, cerebrovascular or carotid disease, or peripheral artery disease, or be at least 50 years of age with diabetes and at least one additional risk factor (primary prevention cohort).
-
Key exclusion criteria included severe heart failure, active severe liver disease, hemoglobin A1c ≥10.0%, planned coronary intervention or surgery, history of acute or chronic pancreatitis, and known hypersensitivity to fish, shellfish, or ingredients of VASCEPA or placebo.
•
70.7% of patients were enrolled based on having established CVD (secondary prevention cohort), 29.3% were enrolled based on being at high risk for CVD (primary prevention cohort).
•
Patients were randomly assigned 1:1 to receive either VASCEPA (4 grams daily) or placebo (4089 VASCEPA, 4090 placebo).
•
The median follow-up duration was 58 months (4.9 years).
•
Overall, 99.8% of patients were followed until the end of the trial or death.
•
The median age at baseline was 64 years (range: 44 years to 92 years), with 46% being at least 65 years old; 28.8% were women.
•
The trial population was 90.2% White, 1.9% Black, and 5.5% Asian; 4.2% identified as Hispanic ethnicity.
•
Regarding prior diagnoses of cardiovascular disease, 46.7% had prior myocardial infarction, 6.1% prior unknown stroke or transient ischemic attack (TIA), and 9.2% had symptomatic peripheral arterial disease.
•
Selected additional baseline risk factors included hypertension (?86.6%), diabetes mellitus (0.7% type 1; 57.8% type 2), current daily cigarette smoking (15.2%), New York Heart Association class I or II congestive heart failure (17.7%), and eGFR < 60 mL/min per 1.73 m2 (?22.2%).
•
Patients enrolled were treated with statin therapy at baseline with most (93.2%) on a high- (30.8%) or moderate-intensity (62.5%) statin therapy, and 6.4% were also taking ezetimibe at baseline.
•
Most patients at baseline were taking at least one other cardiovascular medication including anti-platelet agents (79.4%), beta blockers (70.7%), angiotensin converting enzyme (ACE) inhibitors (51.9%), or angiotensin receptor blockers (27.0%).
•
On stable background lipid-lowering therapy, the median [Q1, Q3] LDL-C at baseline was 75.0 [62.0, 89.0] mg/dL; the mean (SD) was 76.2 (20.3) mg/dL.
•
On stable background lipid-lowering therapy, the median [Q1, Q3] fasting TG was 216.0 [176.0,272.5] mg/dL; the mean (SD) was 233.2 (80.1) mg/dL.
The primary results from REDUCE-IT are shown in the Table below (see CONDUCT OF REDUCE-IT AND ANALYSIS AND REVIEW OF REDUCE-IT DATA).
Effect of VASCEPA on Cardiovascular Events in Patients with Established CVD or at High Risk for CVD with Statin-treated Triglycerides ≥135 and <500 mg/dL in REDUCE-IT
Table showing incidence of cardiovascular events from intent-to-treat population in REDUCE-IT
VASCEPA significantly reduced the following:
•
the risk for the primary composite endpoint (5-point MACE: time to first occurrence of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization; p<0.001), and
•
the key secondary composite endpoint (3-point MACE: time to first occurrence of cardiovascular death, myocardial infarction, or stroke; p<0.001).
Prespecified hierarchical testing of other secondary endpoints revealed significant reductions in the following:
•
cardiovascular death (p=0.03),
•
fatal or nonfatal myocardial infarction (p<0.001),
•
fatal or nonfatal stroke (p=0.01),
•
emergent or urgent coronary revascularization (p<0.001), and
•
hospitalization for unstable angina (p=0.002).
The benefits of VASCEPA were seen on a background of predominately (93.2%) moderate- to high-intensity statin use and median baseline LDL-C levels of 75.0 mg/dL.
The Kaplan-Meier estimates of the cumulative incidence of the primary and key secondary composite endpoints over time are shown in Figure 1 and Figure 2 below.
Figure 1. Estimated Cumulative Incidence of Primary Composite Endpoint Over 5 Years in REDUCE-IT
Kaplan-Meier curve for the primary composite endpoint over 5 years in REDUCE-IT
CI denotes confidence interval. Curves were visually truncated at 5.7 years due to a limited number of events beyond that point in time; all patient data were included in analyses.
Figure 2. Estimated Incidence of Key Secondary Composite Endpoint Over 5 Years in REDUCE-IT
Kaplan-Meier curve for the key secondary composite endpoint over 5 years in REDUCE-IT
CI denotes confidence interval. Curves were visually truncated at 5.7 years due to a limited number of events beyond that point in time; all patient data were included in analyses.
The difference between VASCEPA and placebo in median percent change in TG from baseline to Month 4 was -20.1 (p<0.001) and from baseline to Month 12 was -19.7 (p<0.001). At Month 12, the median [Q1, Q3] TG was 175.0 [132.0, 238.0] mg/dL in the VASCEPA group, with 35.9% of patients having TG <150 mg/dL and 61.3% having a TG <200 mg/dL. The difference between VASCEPA and placebo in median percent change in LDL-C from baseline to Month 12 was -6.6% (p<0.001). At Month 12, the median [Q1, Q3] LDL-C was 77.0 [63.0, 94.0] mg/dL in the VASCEPA group, with 35.5% of patients having LDL-C <70 mg/dL and 79.9% having LDL-C <100 mg/dL.
Important Safety Information for VASCEPA from REDUCE-IT (n=4089 on VASCEPA, n=4090 on placebo)
•
Patients were exposed to VASCEPA or placebo for a median of 58 months; 86.9% of patients were exposed for ≥ 12 months, 77.2% were exposed for ≥ 24 months, 64.6% were exposed for ≥ 36 months, 53.6% were exposed for ≥48 months, 29.5% were exposed for ≥ 60 months, and 0.1% were exposed for ≥72 months.
•
Overall adverse event rates were similar across treatment groups.
-
Adverse events and serious adverse events leading to study drug discontinuation were similar to placebo.
-
The one serious adverse event that occurred at a frequency of at least 2% was pneumonia (2.6% in the VASCEPA group and 2.9% in the placebo group, P=0.42)
Treatment-Emergent Adverse Events
Table showing treatment-emergent adverse events from REDUCE-IT
•
Adverse events occurring in 5% of VASCEPA patients and statistically more frequently with VASCEPA than placebo (Bhatt DL, Steg PG, Miller M, et al. N Engl J Med. 2018, Supplementary Appendix):
-
Peripheral edema (6.5% VASCEPA patients versus 5.0% placebo patients)
o
There was no significant difference in the prespecified adjudicated tertiary endpoint of new congestive heart failure, which occurred in 4.1% of VASCEPA patients versus 4.3% of placebo patients.
-
Constipation (5.4% VASCEPA patients versus 3.6% placebo patients)
-
Atrial fibrillation (5.3% VASCEPA patients versus 3.9% placebo patients)
o
This adverse event finding is consistent with an increase in the prespecified adjudicated tertiary endpoint of atrial fibrillation or flutter requiring hospitalization, which occurred in 3.1% of VASCEPA patients versus 2.1% of placebo patients (P=0.004).
-
The rate of treatment-emergent serious adverse events for bleeding was 2.7% in the VASCEPA group versus 2.1% in the placebo group, with a nonsignificant, but trending p-value of 0.06
-
There were
o
No fatal bleeding events in either group,
o
No significant increases in adjudicated hemorrhagic stroke (0.3% in VASCEPA patients versus 0.2% in placebo patients; P=0.55),
o
No significant serious central nervous system bleeding (0.3% versus 0.2%; P=0.42), and
o
No significant gastrointestinal bleeding (1.5% versus 1.1%; P=0.15).
Mineral oil placebo consideration and analysis
In REDUCE-IT, a placebo containing mineral oil was used to mimic the color and consistency of the drug studied. No strong evidence for biological activity of the same mineral oil was identified in connection with FDA approval of VASCEPA in July 2012 based on the MARINE phase 3 clinical trial, in connection with FDA review of the ANCHOR phase 3 clinical trial, or after several years of quarterly review by the Data Monitoring Committee (DMC) for REDUCE-IT after FDA requested that the DMC periodically assess unblinded lipid data to monitor for signals that the placebo might not be inert. While the DMC noted variation in LDL-C measurements in both arms and that a small physiological effect of mineral oil might be possible, the DMC concluded that it was not possible to determine if the LDL-C increase in the placebo arm was a natural increase over time or due to the mineral oil, they found no apparent effect on outcomes and found that this small change was unlikely to explain the observed benefit of VASCEPA over placebo.
Each of the three VASCEPA clinical trials, MARINE, ANCHOR and REDUCE-IT, was conducted under a special protocol, or SPA, agreement with FDA in which mineral oil was agreed with FDA as an acceptable placebo.
As published within the main presentation of the REDUCE-IT results (Bhatt DL, Steg PG, Miller M, et al. N Engl J Med. 2018.), at baseline, the median LDL-C was 75.0 mg/dL. The median change in LDL-C was 3.1% (+2.0 mg/dL) for VASCEPA and 10.2% (+7.0 mg/dL) for the mineral oil placebo arm; placebo-corrected median change from baseline of -6.6% (-5.0 mg/dL; p < 0.001). If mineral oil in the placebo might have affected statin absorption in some patients, this might have contributed to differences in outcomes between the groups. However, the relatively small differences in LDL-C levels between groups would not be likely to explain the 25% risk reduction observed with VASCEPA, and a post hoc analysis suggested a similar lower risk regardless of whether there was an increase in LDL-C level among the patients in the placebo group. Although open label, Japan EPA Lipid Intervention Study (JELIS) previously demonstrated a 19% risk reduction without a mineral oil placebo.
CONDUCT OF REDUCE-IT AND ANALYSIS AND REVIEW OF REDUCE-IT DATA
FDA has not reviewed and opined on a supplemental new drug application related to REDUCE-IT. FDA has thus not reviewed the information herein or determined whether to approve VASCEPA for use to reduce the risk of major adverse cardiovascular events in the REDUCE-IT patient population.*
REDUCE-IT results were first presented at the 2018 Scientific Sessions of the American Heart Association (AHA) on November 10, 2018 in Chicago, Illinois and concurrently published online in The New England Journal of Medicine (NEJM).2
REDUCE-IT was sponsored by Amarin Pharma, Inc. and its affiliates and conducted under a special protocol assessment agreement with FDA.
•
The REDUCE-IT steering committee, consisting of academic physicians, and Amarin representatives developed the protocol (Bhatt DL, Steg PG, Miller M, et al. N Engl J Med. 2018.) and were responsible for the conduct and oversight of the study, and data interpretation.
•
The primary, secondary, and tertiary adjudicated endpoint analyses were validated by the data monitoring committee independent statistician.
Further REDUCE-IT data assessment and data release could yield additional useful information to inform greater understanding of the trial outcome:
•
Further detailed data assessment by Amarin and regulatory authorities will continue and take several months to complete and record
•
The final evaluation of the totality of the efficacy and safety data from REDUCE-IT may include some or all of the following, as well as other considerations:
•
New information affecting the degree of treatment benefit on studied endpoints
•
Study conduct and data robustness, quality, integrity and consistency
•
Additional safety data considerations and risk/benefit considerations
•
Consideration of REDUCE-IT results in the context of other clinical studies
VASCEPA may not be eligible for reimbursement under government healthcare programs (such as Medicare and Medicaid) and certain commercial plans to reduce the risk of major adverse cardiovascular events in the REDUCE-IT patient population. We encourage you to check that for yourself.
IMPORTANT INFORMATION FOR HCPs ABOUT CONTINUED UNCERTAINTY AROUND THE BENEFIT, IF ANY, OF LOWERING TG LEVELS AFTER STATIN THERAPY IN PATIENTS WITH HIGH (200-499 mg/dL) TG LEVELS
•
In REDUCE-IT, cardiovascular benefits appeared similar across baseline levels of triglycerides (less than 150 mg/dL, 150 to 199 mg/dL, and 200 mg/dL or greater).
-
Additionally, the reduction in major adverse cardiovascular events with VASCEPA appeared to occur irrespective of an achieved triglyceride level above or below 150 mg/dL at one year, suggesting that the cardiovascular risk reduction was not tied to achieving a more normal triglyceride level.
-
These observations suggest that at least some of the impact of VASCEPA on the reduction in ischemic events may be explained by metabolic effects other than triglyceride lowering.
•
VASCEPA is not FDA-approved to lower TG levels in statin-treated patients with mixed dyslipidemia and persistent high (≥200 mg/dL and <500 mg/dL) TG levels due to current uncertainty regarding the benefit, if any, of drug-induced changes in lipid/lipoprotein parameters beyond statin-lowered LDL-C on cardiovascular risk among statin-treated patients with residually high TG.
-
Other cardiovascular outcomes trials (ACCORD Lipid, AIM-HIGH, and HPS2-THRIVE), while not designed to test the effect of lowering TG levels in patients with high TG levels after statin therapy, each failed to demonstrate incremental cardiovascular benefit of adding a second lipid-altering drug (fenofibrate or formulations of niacin), despite raising HDL-C and reducing TG levels, among statin-treated patients with well-controlled LDL-C.
Other cardiovascular outcomes trials that studied fish oil or mixtures of omega-3 acids that include the omega-3 acid, DHA, have reported negligible impact on cardiovascular events.
No head-to head, randomized, well-controlled studies have been conducted to compare the effects of VASCEPA with other FDA-approved TG-lowering therapies.
POTENTIAL MECHANISMS OF ACTION
Mechanisms responsible for the benefit shown in REDUCE-IT were not the focus of REDUCE-IT, but the banked samples and array of biomarkers measured leave room for mechanistic insights through future analyses. Potential mechanisms discussed in Bhatt DL, Steg PG, Miller M, et al. N Engl J Med. 2018., include TG reduction, anti-thrombotic effects, anti-platelet or anticoagulant effects, membrane-stabilizing effects, effects on stabilization and/or regression of coronary plaque and inflammation reduction. More study is needed to determine to what extent, if any, these effects or others may be responsible for the CV risk reduction benefit demonstrated with use of VASCEPA in REDUCE-IT.
*This information is intended to ensure Amarin meets its continuing obligation to update healthcare professionals regarding off-label use of VASCEPA to assure that its communications remain truthful and non-misleading, consistent with the federal court approved settlement under Amarin Pharma, Inc. et al. v. United States Food and Drug Administration et al., 119 F.Supp.3d 196, 236 (S.D.N.Y. 2015).
Disclosure References: 1. VASCEPA [package insert]. Bedminster, NJ: Amarin Pharma, Inc.; 2017. 2. Bhatt DL, Steg PG, Miller M, et al. N Engl J Med. 2018. Bhatt DL. AHA 2018, Chicago.
Adverse events should be reported by calling 1-8?55?-?VASCEPA or by contacting the FDA: 1?-?8?0?0?-?F?D?A?-?1?0?8?8.
View the full VASCEPA privacy policy here.
You may unsubscribe or change your contact details at any time.
VASCEPA is a registered trademark of the Amarin group of companies.
©2018 Amarin Pharma, Inc. 1430 Route 206, Suite 200, Bedminster, NJ 07921
All rights reserved. VAS-01332 11/18
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Price action today – how can you explain it? Let’s look at the list of potential candidates:
Shorts? A quest to crush options holders so that the writers don’t have to relinquish their shares? Data baked in pre-AHA? A ludicrous over-reach of a lawsuit? Stop-loss raiding? Mineral oil issue?
Probably a dash of this and pinch of that.
Each one sounds just a ridiculous as the next given the compendium of data that was unleashed last Saturday. Indeed, the data was amazing, but the slightest overhang gave the Wall Street goons just the slightest ability to create a cloud over our beautiful golden egg. Those expecting a 50% pop were met with – “meh.” Yep, the MO uncertainty sucked the momentum out of the room and with it a lot of Johnny-come-latelys that thought to make a quick buck from a Friday purchase. Yesterday and today sellers sold, buyers bought… but more sellers than buyers so price fell. Then came the “oh shit we fell through $18… now $17 (which held yesterday) and now $16, $15…”. Throw in a meaningless – AND I MEAN MEANINGLESS – lawsuit… and you have everyone wondering how could this happen to AMRN… again??
We capitulated. Margin calls occurred. Some fund(s) exited. It’s all day to day. We’re all pissed because even though we weren’t planning to sell today, it feels REALLY good to know you can when the price is where you want it… $20 feels so good…. But either way, some buyers got in at great prices today. If you followed the volume, there was plenty of accumulation – plenty. Investing takes discipline and nerves of steel. Don’t let this rattle your cage.
Here’s what it could be: Wall Street thinks AMRN is going this alone (or a buyout won’t be for another several months). That’s what I think this is all about (IMO). The premium that came pre-data has evaporated because there’s money to be made elsewhere while the company cleans the engines, hires the sales team, and gets their galleon of promo material ready for the greatest war on heart disease in history ( yo. TIME is once again an uncertainty. Wall Street wants to see an uptick in Rx. It’s all about the money. Does the drug sell and do Docs actually care about this FUD that’s been spread. We know the answers to this. And hopefully no one wanted to sell today. It’s a market cap story. Always is. The day to day fluctuation of our price has no bearing on what the company will be worth based on sales (and some multiple) down the road. If AMRN thinks they can do $1bln in sales next year (and they do), then guess what… we won’t be at $15.
For now we have a lack of certainty – that lack of what’s next is driving folks to the exits.
If buyout is not on the table (For the record, offers will come – just don’t know if price will be what JT & board accept), then it’s all about sales and execution.
That’s what’s next. Selling this thing and educating the ones that haven’t heard and convincing the ones on the fence.
The data is why I’m holding. Not today’s price. I’ve been a shareholder for 6 years. What’s another 12-24 months?
Cam
Unless someone is Wiley enough to trace his IP address and unearth his identity!
Gah I wish I were good with computers.
DDI - Drug-Drug Interaction
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3691435/
Drug–drug interactions (DDI) can cause profound clinical effects, either by reducing therapeutic efficacy or enhancing toxicity of drugs. DDIs are one of the major causes for drug withdrawal from the market (1). These factors when considered together with an increasing frequency in polypharmacy has prompted regulatory agencies, including the Food and Drug Administration (FDA) and European Medicines Agency (EMA), to publish guidance documents for industry that are designed to help pharmaceutical researchers characterize and better understand DDI potential for a new molecular entity (1,2). While DDI can result in alterations of either drug pharmacokinetics (PK), pharmacodynamics (PD) or both, it is the PK interactions that have been the main focus for both the US and EU DDI guidelines. PK drug interactions, typically characterized by alterations of plasma concentration–time profiles, could be mediated via mechanistic changes in processes of absorption, distribution, metabolism, and/or excretion (ADME) of a drug substance (victim) by another compound (perpetrator) when they are given concomitantly.
Stock price thoughts for tomorrow? What will be, will be, but very curious what several of you believe will happen.
My guess is open >$25 and close near $27.
MINERAL OIL is NOT a new concern nor should it be. These pieces were ready for publication BEFORE embargo was lifted.
STAT SIG on all SEs. That’s amazing. That’s the news. And that’s what matters. Especially the fact the RRR are amazing. This wasn’t a “close call”
I believe we are up on Monday. How much? No clue.
Talked to my PCP about off-label Rx today. I’m 32 and in great health. Wouldn’t do it for me... said he’s got to have a diagnosis code.
Naturally I launched into my diatribe of off-label benefits, lack of side effects, etc. He made some comment about V converting my trigs into something... bad cholesterol I believe...
I was pretty frustrated...
Interestingly enough, KOWA rep was in here. Heard her selling the outcomes study hard to one of his partners - (I identified her due to Livalo). My PCP isn’t biting until AHA.
he also said “I’m not big on Omega 3s. I’m also not big on drug trials sponsored by the company. You never know What they aren’t telling us...?”
I mean, WTF??? The uphill battle is real for these reps till AHA and more marketing campaigns from AMRN
Big guys are buying. Big guys are selling. One month away from next binary and some have other places to make money.
We thought we’d see a pre-trial run-up. We got nothing! Down 32% from 52-week high in January...
Agree it sucks it doesn’t go up every day...
Praying for ROBUST SEs!!!
-Cam
I say this every quarter, but I am very excited for Q3 13-Fs. (Not nearly as excited as I am for AHA... )
https://www.statnews.com/2018/10/08/fish-oil-matinas-amarin/
By ADAM FEUERSTEIN @adamfeuerstein OCTOBER 8, 2018
Matinas BioPharma (MTNB) shelved development of a prescription formulation of fish oil three years ago. The tiny company, with a stock that trades for pennies, decided investors would be more interested in its drug delivery technology and a small pipeline of anti-infectives.
But then Amarin (AMRN) happened. Amarin’s stock price soared to all-time highs — adding nearly $5 billion in market cap — on the readout of a large clinical trial showing its proprietary fish oil drug, called Vascepa, cut the risk of bad cardiovascular events like heart attacks and stroke in patients by an astounding 25 percent.
Vascepa looks to be the next cardiovascular blockbuster, so not surprisingly, Matinas is resurrecting its own fish oil drug, seeking a cut of Amarin’s success. Easier said than done.
“We’re so thrilled for Amarin because they took advantage of the opportunity to create a new class of drug where they have the opportunity to treat 64 million patients per year. And we stand just behind them with a better drug.”
That’s Matinas CEO Jerry Jabbour, speaking at a microcap investing conference on Oct. 1, just days after Amarin announced positive results from the Vascepa cardiovascular outcomes trial. Jabbour’s boast contributed to a doubling of Matinas’ stock price — although shares still trade under $1.
Jabbour’s claim is based on a clinical trial conducted by Matinas three years ago in which 40 patients with elevated levels of triglycerides were treated with either Matinas’ MAT9001 or Amarin’s Vascepa for 14 days. The result: MAT9001 beat Vascepa, lowering patients’ triglyceride levels by 33 percent compared to 11 percent.
Optically, these results look good for MAT9001, which consists of a purified form of the omega-3 fatty acid DPA. (Vascepa is purified EPA.) However, Matinas would probably find it hard to replicate the data in a larger clinical trial. Consider Vascepa’s performance. In the Matinas study, Amarin’s drug lowered triglyceride levels by 11 percent in 14 days.
However, in two Phase 3 clinical trials conducted by Amarin, Vascepa lowered triglyceride levels by 33 percent and 22 percent, respectively, after 12 weeks. Combined, these trials enrolled more than 850 patients with elevated triglyceride levels at baseline.
Amarin used one of its Phase 3 trials to win Food and Drug Administration approval for Vascepa to treat patients with very high levels of triglyceride. And now, the company is likely to win further FDA clearance to expand Vascepa’s label to include claims of a long-term cardiovascular benefit based on the results from its 8,000-patient outcomes study.
Matinas has yet to run a Phase 3 study of MAT9001.
“Could Vascepa have underperformed in our study and MAT9001 overperformed? Absolutely, but we still think the drug is worth investigating further,” said Jabbour, when I interviewed him last week and asked him if his presentation at the microcap investor conference oversold his drug’s capabilities.
“At best, we have a very small data sample that shows our drug head to head against Vascepa,” he added.
Matinas had $9 million in cash at end of the second quarter, not enough to push ahead with a new clinical trial on its own. Jabbour said he doesn’t want to sell more stock to raise money. Instead, he’s hoping to find a big pharma partner willing to license MAT9001 and take on the expense of running a Phase 3 clinical trial to get the drug approved.
A pharma partnership would also lend credibility to the commercial potential for MAT9001, which Jabbour calls a “super omega-3” and is not accounted for in Matinas’ current $125 million market value.
But even if that happens, MAT9001 won’t really compete against Amarin and Vascepa until it runs its own large cardiovascular outcomes study.
“There is not enough data available regarding Matinas’ product to reach any reasonable conclusions except that more study is needed,” an Amarin spokesperson said, in response to questions about the MAT9001 study. “If they decide to commence an outcomes study to complete with Vascepa, they will need at least $300 million and seven years to do so (after they have approval from FDA to start such a study). We are flattered that they recognize Vascepa as a market leader. If Matinas truly believed that the data are valuable, it is surprising that they did not have more of a serious effort in recent years around advancing their compound.”
Matinas can talk a big game, but there’s still a lot to prove.
Amarin Jobs:
Any word on the hiring progress? Has the company extended offers to new sales reps?
TIA,
Cam
I’m game to go! Hopefully I make the list... been around a LONG time
Mercator21, you are missed! Come join us on here for a brief quip or 2. For old times sake!
I live in Raleigh, NC. On Monday, I woke up at 6am - checked my phone (as I had done every morning for the last few months) and saw that I had a message from PharmacyDude. We correspond often, but I knew that news was out...
I thought: Shit. This is it. We didn't do it... if we had had a successful result, surely he would have called me...
So I opened the message. It read "25% RRR"
No exclamation point. No PR link. Just the sweet sweet numerals followed by an acronym I know all too well.
So of course I called him and told him this couldn't be right. Surely it was a typo... And then he said, "no cam... the stock is trading over $10 right now"
WHAT?! ARE YOU SERIOUS...
And here we are. All of us as happy as we could ever be. An insanely successful trial that is EXCEPTIONALLY stat sig.
This is all particularly sweet for me. I got a divorce back in 2012. At the time I owned several thousand shares of AMRN (my first purchases occurring >$10 :*( ). Naturally, I opted to keep the shares in our separation and I thought I'd make everything I was losing back on the drug. Fast forward 12 months... ADCOM... couldn't pick myself off the floor for two straight days.
So I've held and held, purchased shares, sold some shares, and purchased some more. In fact, I'm very fond of my tranche at $0.80 - took some gumption to buy during those days when I thought we might have to pay the company electric bill. I didn't post on ST or here often, but when I did it was often to shed some light on stock valuation or trading or asking questions to further my medical knowledge... and yes, at times to calm my own sense of panic.
Thank you to everyone - for everything. PharmacyDude and I have formed a great friendship during this (which is a benefit I'm very fond of) and I think highly of all the long-timers (you know who you are). It's great to be a part of something like this... especially when it would have been so easy to sell and move on to "more certain" investment names.
I travel quite a bit for work - NYC, Richmond, Asheville, Charlotte, Atlanta, New Orleans... If any of you live in those places, let me know. Would love to grab a drink!
Best,
Cam
I remember this post all too well.
If we're waiting to divulge identities until the Vegas meet and greet - fine. We need to set a date. I suggest sometime after AHA. Perhaps early december?
I don't need to be out there for any long amount a time. Just a minute to have drinks with all of you and then fly back home.
Again. WHAT A DAY!
SO...
When do we start telling each other who we really are??? I’ve been waiting to get to know you folks for so long. Is it stupid to want this?
RAF, you live in CLT yes? I’m there for biz all the time.
PharmacyDude and I have already met in person (several years back) and have had 10 calls in the last week alone lol.
My guess was $7/8 best case. I love being wrong.
What. A. Day.
Cam
Re: Rep Pay
We have no idea what bonus structure looks like. That’s where the money is made. A drug that sells itself doesn’t need a great base + beni’s when reps can make money hand over fist without having to be great sales people.
Correct.
RAF,
We have yet to hear your prognostication on SP if results are good... What say you? Let’s say it’s best case scenario and RRR is 25%+...
Cam
RAF,
This is a fun game to play. IMO, the BEST case scenario for the day of the announcement is $8-9. Why? I think there is way too much overhead supply that is chomping at the bit to get out. THat, coupled with some uncertainties about “next steps” will prevent us from meteorically rising. Remember, you are the rare retail investor that’s done your homework... You get the science, you believe in the future value of the company, you get what the market potential could be, etc. Most investors will see their shares double overnight and think “EUREKA! I’ve made a fortune! I need to sell and find the next one!” This, coupled with funds that trade according to “size & style” philosophies, will create a good bit of profit taking (or break even selling) on V-Day.
Once the initial dust settles, I believe we will gravitate to the actual market cap that is representative of the future opportunity AMRN presents. Seriously no reason why we can’t be $15-20 by end of year. Personally, I like Gabor’s estimate of $36 . As more data points come out, we will go up. As docs learn about the data and start to prescribe in droves, we go up. As Wall Street gains confidence in the business plan that AMRN has laid out to capitalize on this, we go up. They aren’t going to give us our full credit until the company proves that it can monetize the data to its advantage in a way that makes sense to attribute a FORWARD LOOKING multiple to the stock.
What we do know is that Wall St. hates uncertainty. The trial is blinded. No one knows a thing, despite what most are thinking at this point. Bets are on the table and the cards will fall for us or against us. We have traded like an option for years now. I’m personally manifesting a positive outcome
Best of Luck,
Cam
Interesting. Thanks for the feedback.
JF,
Interesting tidbit about TDA. I'm curious if this is a volatility related measure? Perhaps they don't want clients trading on margin for a pending binary event?
Here are the TD rules on "Day Trading buying power"
Top of Page 6: https://www.tdameritrade.com/retail-en_us/resources/pdf/AMTD086.pdf
The action of late has been very strange. Supply and demand at strange price points. There's certainly been plenty of accumulation as MMs have knocked prices down on small volume - buyers have stepped shortly after - price is marked down again... rinse-repeat.
The next 30 days will be very interesting. If announcement comes at end of August, I will be interested to see 13-Fs mid-month.
CJR
This is a very interesting post.
“You might buy puts, but you feel very comfortable with a naked short.”
So you might take a negative position with limited downside but you actually feel extremely comfortable with unlimited downside...
Let’s say you shirt this now. You sell 10,000 shares at 2.95... study flops - stock goes to $1... you make 19,500 less borrowing costs.
Flip side: you short 10,000 shares - study is a success (in any regard) - stock goes to $6-7. You’re out $30-40,000.
Risk reward seems pretty off on a naked short.
Full Rx #s
Week 9/08
V:
TRx: 23,022
NRx: 8227
L:
TRx: 3,905
NRx: 1453
GL:
TRx: 50251
NRx: 17778
His math makes sense to me given he's speaking in terms of the the percentages. You could say 22% more events than already analyzed or 18% of the remaining event total.