Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
BB, I have gotten branded Vascepa in both NY and NJ. In NJ, I had the doctor right DAW just to be safe last week. $9 for 3 month supply.
$NWBO
— 🇩🇰 The Danish Dude 🇩🇰 (@FlemmingBruce) December 7, 2020
Warrants has been extended. February and March.
Assert at own behest!
But in my view, this just adds to the bullishness, even though the waiting ... oh the waiting 😩
Assume something substantial is at large 😳 pic.twitter.com/jtjHJTflTJ
Citi cuts price target from $12 to $7
DRL:
Dr Reddys --Cardio drug Vascepa launch expected in a month or couple of months. Impt because Pharma co Hikma launched, is a limited competition drug with $560m size, 4 players. Revlimid and Copaxone generic also in the pipeline.
— Ekta Batra (@ekta_batra) December 7, 2020
Louie, She was at Amarin for almost 9 years. 8 yrs and 10 months to be exact from her LinkedIn profile. You don't leave such a small cult like company after 9 years going through all the ups and downs..
https://investor.amarincorp.com/contact-us
They can't even update the website and remove Elisabeth from the contact us section...Why the sudden departure for someone that has been at Amarin for over 8 years??? They are either getting BO asap or she sees the writing on the wall that there is no value left in the USA...
They should have changed logos to PFE, NVS, GSK or GILD post FDA approval last December. They have been awfully quiet. LinkedIn and Twitter posts never mention Vascepa. It is really odd. They are either incompetent or have a strategic plan...We should find out something within the next few weeks...Hikma testing out the market with a possible soft launch, hearing on en banc, earnings...
SILENCE since Sept 3...Will Amarin management really go silent straight for two months until earnings around November 4????
Why have they not gone on the offensive since the ruling? Are they incompetent or are they working on:
1. restoring US value through a deal with the generics followed by a BO
2. Straight BO now
3. just focusing on GIA in Europe (terrible idea)
4. Acquiring another company to diversify products (terrible idea). Should not be spending cash in this environment
This game of chicken needs to stop...The generics can get supply if needed but it will take years and years to get to the scale of where Amarin is with cost of goods. They will be losing money now trying to compete with Amarin...Amarin should only be focusing on #1.
$9,975,570 from an offering at $0.816 per share (based upon the average 10 day closing price ending on October 12, 2020) of newly registered common stock
of approximately 12.2 million shares with 30% warrants with an exercise price of $2.00 per share and an exercise period of 12 months (following a 3-month
suspension after issuance), and
· $1,925,00 million from a convertible note which is convertible at $0.85 per share (the “Note”). The Note carries no warrants unless it is converted. If, and only
to the extent, the Note is converted it will carry 30% warrants with an exercise price of $2.00 per share and an exercise period of 12 months (following a 3-
month suspension after issuance).
New offering
Strokes and heart attacks increase when flu-like illnesses rise: https://www.heart.org/en/news/2020/10/08/strokes-and-heart-attacks-increase-when-flu-like-illnesses-rise
Beyond cardiovascular medicine: potential future uses of icosapent ethyl
Beyond cardiovascular medicine: potential future uses of icosapent ethyl https://t.co/qMywWLYVph #cardiology #cardiotwitter #COVID19
— Dr. Deepak L. Bhatt (@DLBHATTMD) October 8, 2020
Mechanisms of action, efficacy, and safety of icosapent ethyl: from bench to bedside
https://academic.oup.com/eurheartjsupp/article/22/Supplement_J/J1/5918446
JPM resumes coverage of AMRN with neutral rating.
ILT, possible leak of pending top line announcement...
Nobody Cares, why even PR...Amarin to Present at the 2020 Cantor Virtual Global Healthcare
DUBLIN, Ireland and BRIDGEWATER, N.J., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) announced today that John F. Thero, Amarin's president and chief executive officer, is scheduled to present at the 2020 Cantor Virtual Global Healthcare Conference on Wednesday, September 16, 2020 from 11:20 - 11:50 a.m. Eastern Time.
Vascepa Mechanism Becomes Clearer... As Do Vessels
https://www.medpagetoday.com/meetingcoverage/esc/88379
See MRC tweet: I agree Hikma is not waiting to launch unless they for some odd reason can come to some type of agreement with Amarin...doubtful though with how this played out.
https://twitter.com/medrescol/status/1302184370405507072?s=21
$AMRN Seeing some chatter on whether generics will wait to enter the market. Answer is no: they have 75-days from the CAFC win to launch, or forfeit 180-day exclusivity. That 6 mo exclusivity is far too valuable to nix. E.g.:
BREAKING: Dyk, Reyna, & Hughes
BloombergLaw: Amarin Patent Appeal Is a Coin Toss With Billions on the Line
Amarin Corp. analysts say investors should bet on the drugmaker’s ability to overturn a devastating patent ruling despite odds that resemble a coin flip.
Analysts expect large gains for the shares if Amarin prevails in the Federal Circuit Court of Appeals, where oral arguments begin Wednesday. The company is challenging a U.S. judge’s decision in March to invalidate patents for its heart pill Vascepa, which wiped out $3.5 billion in market value.
The stock could surge toward $30 to $35 if Amarin prevails, while a loss would send the shares to the $2 to $4 range, Cantor Fitzgerald analyst Louise...
https://news.bloomberglaw.com/ip-law/amarin-patent-appeal-is-a-coin-toss-with-billions-on-the-line
Picture worth a thousand words...
Read more about the final results of the EVAPORATE trial presented at #ESCCongress @escardio https://t.co/OQLT6YLiEA pic.twitter.com/gxD8BI1AkZ
— Amarin (@Amarincorp) September 1, 2020
IP specialists see panel selection as key to Amarin appeal, says Stifel Stifel analyst Derek Archila hosted a webcast with two Intellectual Property, or IP, attorneys to get their thoughts on the Vascepa appeal ahead of the oral hearing on September 2, after which he noted to investors that both stressed the importance of the panel selection and its impact on the outcome of the appeal. Both IP specialists see a roughly 55% chance Amarin can win its appeal, but both also highlighted the low odds of reversals in these type of cases, according to Archila, who added that the attorneys think the odds of winning the appeal can swing from 0% to 70% depending on the panel make-up. With the stock trading at roughly $8, which is his current price target, he sees the market factoring in about a 25% chance of Amarin winning the case, said Archila, who assumes shares go to $4 if the decision is affirmed and $20 upon a reversal. He keeps a Hold rating on Amarin shares.
Read more at:
https://thefly.com/n.php?id=3153505
Patients Take Different Statins, but Vascepa Benefits Are the Same
August 28, 2020
Mary Caffrey , Gianna Melillo
A new analysis from the REDUCE-IT trial finds that cardiovascular benefits of Vascepa are consistent no matter what type of statin a patient takes for cholesterol.
The benefits of taking icosapent ethyl, the purified omega-3 fatty acid sold as Vascepa, were consistent across statins of different strengths and types, according to the latest data from the REDUCE-IT study presented during the 2020 Congress of the European Society of Cardiology (ESC), being presented in a virtual format.
Icosapent ethyl, first approved to treat high triglycerides, has since received a cardiovascular (CV) indication after REDUCE-IT showed that a 4g per day dose reduced the risk of first-time CV events by 25% and first and future events by 30%. Subsequent studies have sought to better understand the mechanisms of how icosapent ethyl produces these results.
In this latest round of data from the study, lead study author Deepak Bhatt, MD, MPH, of Brigham and Women’s Hospital Heart & Vascular Center and Harvard Medical School, sought to examine the relationship between low density lipoprotein (LDL) cholesterol pathways and the CV benefits of icosapent ethyl, by examining whether the there were major differences in benefit by statin type or by statin group (lipophilic vs lipophobic); according to the abstract presented at ESC, 96.1% of the patients in the study fell into one of these statin groups.
In an interview, Bhatt told The American Journal of Managed Care® that the analysis further supports the main findings of REDUCE-IT. “We looked at patients who are on really intense statins, things like atorvastatin and rosuvastatin, or more modest types of statins, such as simvastatin or pravastatin,” he said. “We also bunched it by hydrophobic and hydrophilic statins.”
“The bottom line was, any way you sliced it there was a benefit, a consistent benefit favoring icosapent ethyl versus placebo, irrespective of the actual statin type or category of statin.”
Results. CV outcomes were similar across different statin types (interaction, P = .61) and across lipophilic/lipophobic categories (interaction, P = .51). Hazard ratio (HR) results by individual statin type were as follows, all favoring icosapent ethyl (all 95% CI):
Atorvastatin: HR, 0.80 (0.68-0.94), P = .0054
Simvastatin: HR, 0.76 (0.64-0.90), P = .0017
Rosuvastatin: HR, 0.68 (0.54-0.85), P = .0009
Pravastatin: HR, 0.88 (0.62-1.25), P = .47
Among the 2 main statin groups, the HR on lipophilic statins was 0.78 (0.69-0.87), P < .0001; for lipophobic statins, HR, 0.73 (0.66-0.88), P = .0012.
In the abstract, Bhatt and co-authors wrote that the LDL cholesterol changes and CV risk reduction in the study “appear independent of the type of concomitant statin therapy.”
They concluded, “These data provide clinicians with additional insight regarding concomitant statin therapy considerations when prescribing icosapent ethyl and suggest there are important mechanisms of action for the substantial CV risk reduction observed with icosapent ethyl that are distinct from the LDL receptor pathway.”
Reference
Bhatt DL, Miller M, Steg P, for the REDUCE-IT Investigators. REDUCE-IT outcomes by baseline statin type. Presented at ESC Congress 2020:. Abstract 218514.
Matinas BioPharma completes enrollment in study of lead candidate vs. Vascepa
https://seekingalpha.com/news/3609555-matinas-biopharma-completes-enrollment-in-study-of-lead-candidate-vs-vascepa?utm_campaign=twitter_automated&utm_content=news&utm_medium=social&utm_source=twitter_automated
CAFC probabilities: https://media2.mofo.com/documents/160812-win-fed-circ-patent-reversal.pdf
Does Amarin believe they have a less than 50% probability of this getting this overturned? If so, do they try to settle prior to Sept 2...
NORTHWEST BIOTHERAPEUTICS ANNOUNCES $8 MILLION FINANCING
PR Newswire
BETHESDA, Md., Aug. 11, 2020
BETHESDA, Md., Aug. 11, 2020 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO)("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that the Company has completed a financing on favorable terms for approximately $8 million. The Company anticipates that this financing will help maintain the Company's momentum, and will provide some prudent protection in the midst of the current global economic uncertainties. The financing also further broadens the lock-up of warrants that the Company has been building.
The financing comprised:
• Approximately $7 million from an offering at 32 cents per share of newly registered common stock of approximately 21.8 million shares with warrants averaging 21% (predominantly 20%, with a couple larger investors at 35%) exercisable at 34 cents per share for approximately 5.3 million shares, with an exercise period ranging from 18 to 30 months, and
• $1 Million from a convertible note (the "Note") which is convertible at 34.5 cents. The Note contains no warrants unless it is converted. If, and only to the extent the Note is converted, it will carry 35% warrants exercisable at 34 cents per share.
The financing also broadened the warrant suspensions that the Company has been building and the Company plans to continue expanding:
• An additional approximately 75.5 million existing warrants, outstanding prior to this financing and held by investors in this financing, have been suspended until December 15, 2020 as part of this financing. These warrant suspensions were compensated on a similar basis as the warrant suspensions previously reported. In addition, all new warrants in this financing are suspended until December 15, 2020.
As the Company approaches the read-out of its Phase III trial of DCVax®-L for Glioblastoma brain cancer, the Company is working with a growing team of technical experts and regulatory advisers on various readiness preparations, including manufacturing related preparations. This financing will help the Company maintain its momentum in these very important activities.
"With this significant financing, we believe we are well positioned to execute on our near-term plans and to support the next critical phase of our business strategy," commented Linda Powers, Chairman and CEO of the Company. "We look forward to sharing more detail on these initiatives."
The majority of this financing involved no fees or placement expenses. On the remainder of the financing, the Company paid fees of 6% cash and 4% warrants.
https://www.wsj.com/articles/dont-let-covid-and-the-flu-team-up-to-pound-america-11597007696
Great read
Amarin’s COVID trial...
The morbidity and mortality associated with COVID-19 are due both to the direct toxicity of the virus as well as the body’s robust inflammatory response leading to ‘cytokine storm’.1,2,3,4 Based on data related to the mechanism of action and effects of VASCEPA, it is hypothesized that VASCEPA may play a potential beneficial role in preventing SARS-CoV-2 infection and to potentially reduce clinical severity in patients infected by the virus.4,5,6
The clinical effects of VASCEPA are multi-factorial. Multiple mechanisms of action associated with VASCEPA based on clinical and mechanistic studies support the rationale to test its effects in patients with or at risk for COVID-19 disease. Some of these postulated mechanisms include the following:
Potential antiviral/antimicrobial effects7,8
Fibrosis and cardiac damage mitigation in animal models9,10
Anti-inflammatory effects (acute) in pulmonary/lung tissue11,12
“Most prior clinical trials for COVID-19 have focused on treating patients hospitalized for moderate or severe COVID-19 with experimental agents,” according to Dr. Ambrosy. “MITIGATE COVID-19 is novel in that we will study the effects of pre-treatment with IPE, an FDA-approved therapy for primary and secondary prevention with putative anti-inflammatory as well as antiviral properties, in high-risk outpatients with ASCVD on subsequent risk of viral URI-related morbidity and mortality.”
Amarin Supports Investigator-Initiated Trial at Kaiser Permanente in the U.S. to Study the Effects of VASCEPA® (icosapent ethyl) in Reducing Viral Upper Respiratory Infections, Including COVID-19 and Flu, and the Clinical Severity of Such Infections
Globe Newswire12:12 PM Eastern Daylight Time Aug 07, 2020
DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 07, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), today announced support for an investigator-initiated trial to study the effects of icosapent ethyl (VASCEPA®) (IPE) on laboratory-confirmed viral upper respiratory infection (URI) rates, clinical impact and outcomes, especially with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection which causes COVID-19, in adults with established atherosclerotic cardiovascular disease (ASCVD) who are at elevated risk of experiencing moderate to severe COVID-19.1,2
The trial, dubbed PragMatic randomIzed Trial of Icosapent ethyl for hiGh-cArdiovascular risk adults in The Era of COronaVIrus Disease 2019 (MITIGATE COVID-19), is sponsored by Kaiser Permanente Northern California (KPNC), and is being led by Dr. Andrew P. Ambrosy, Associate Program Director for Research (Fellowship), Department of Cardiology, Kaiser Permanente San Francisco Medical Center, and Dr. Alan S. Go, Regional Medical Director, Clinical Trials Program and Associate Director, Cardiovascular and Metabolic Conditions Research, Division of Research, Kaiser Permanente Northern California.
MITIGATE COVID-19 will randomly assign 1500 U.S. patients aged 50 years or older with established ASCVD and no prior history of confirmed COVID-19 to receive 4 grams per day of icosapent ethyl (VASCEPA) and follow these patients for a minimum of 6 months. The co-primary study endpoints are the rate of moderate to severe laboratory-confirmed viral URI, including COVID-19 and influenza, prompting urgent care encounters, emergency department visits, or hospitalization and the worst clinical status due to a laboratory-confirmed viral URI based on an ordinal scale taking hospitalization, death, supplemental oxygen, and other clinical factors into account. A control group will consist of 15,000 adults meeting the same eligibility criteria who will be passively followed through KPNC’s comprehensive and state-of-the-art electronic health record system for outcome ascertainment.
Current understanding of the biology of COVID-19 is that patients that have or are at high risk for developing ASCVD are at higher risk of death and severe effects from infection, and that the morbidity and mortality associated with COVID-19 are due both to the direct toxicity of the virus as well as the body’s robust inflammatory response leading to ‘cytokine storm’.1,2,3,4 Based on data related to the mechanism of action and effects of VASCEPA, it is hypothesized that VASCEPA may play a potential beneficial role in preventing SARS-CoV-2 infection and to potentially reduce clinical severity in patients infected by the virus.4,5,6
The clinical effects of VASCEPA are multi-factorial. Multiple mechanisms of action associated with VASCEPA based on clinical and mechanistic studies support the rationale to test its effects in patients with or at risk for COVID-19 disease. Some of these postulated mechanisms include the following:
• Potential antiviral/antimicrobial effects7,8
• Fibrosis and cardiac damage mitigation in animal models9,10
• Anti-inflammatory effects (acute) in pulmonary/lung tissue11,12
“Most prior clinical trials for COVID-19 have focused on treating patients hospitalized for moderate or severe COVID-19 with experimental agents,” according to Dr. Ambrosy. “MITIGATE COVID-19 is novel in that we will study the effects of pre-treatment with IPE, an FDA-approved therapy for primary and secondary prevention with putative anti-inflammatory as well as antiviral properties, in high-risk outpatients with ASCVD on subsequent risk of viral URI-related morbidity and mortality.”
Dr. Go further stated, “In my 20+ years as a health services researcher and clinical trialist, this is the first time that a large-scale study will be undertaken using a completely virtual model including patient recruitment and consent, follow-up visits, and outcome ascertainment within an ethnically-diverse, community-based population. Kaiser Permanente Northern California has been at the forefront of telehealth for delivering high-quality clinical care, especially during the current pandemic, and we are pleased to be able to adapt this innovative approach for safely and efficiently testing a potential intervention.”
Alzheimer's: https://www.cnbc.com/2020/08/07/us-fda-accepts-biogens-marketing-application-for-its-alzheimers-drug.html
https://www.statnews.com/2020/08/07/the-fda-accepted-biogens-alzheimers-drug-submission-next-up-a-highly-anticipated-outside-expert-review/
"If approved, aducanumab would become the first medicine to slow the cognitive decline of Alzheimer’s disease. It would also be the first therapy to prove the theory that removing clumps of a toxic protein called beta amyloid from the brain of patients resulted in better clinical outcomes."
Lets not forget Vascepa: https://clinicaltrials.gov/ct2/show/NCT02719327?term=vascepa&recrs=abdf&draw=2&rank=5
The goal of this study is to evaluate the efficacy of a purified form of the omega-3 fatty acid eicosapentaenoic acid (EPA) called icosapent ethyl (IPE), on improving brain blood flow, spinal fluid markers of AD pathology, and cognitive performance in middle-aged, cognitively-healthy Veterans with increased risk of AD. If IPE delays the onset of AD by even 5 years, the incidence of AD would be reduced by 50% in this population and could have a profound effect on Veteran quality of life and healthcare costs.
BO post US Appeal results...that's why they are GIA in Europe until appeal results. It "maximizes shareholder value."
Meaning lets hold off on selling rights to Europe so we can get a resolution on US appeal first and then sell the company at a higher price.
CADTH recommends Vascepa be reimbursed for patients with established cardiovascular disease under certain conditions.
PMPRB notifies HLS that following PMPRB's review, Vascepa's introductory price submission did not trigger the pricing investigation criteria.
HLS reaffirms its peak-year sales forecast for Vascepa.
http://hlstherapeutics.investorroom.com/2020-07-20-HLS-Therapeutics-welcomes-both-CADTHs-recommendation-to-reimburse-Vascepa-R-icosapent-ethyl-for-patients-with-established-cardiovascular-disease-and-PMPRBs-notification-on-its-introductory-price