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.
Posted on yahoo, by jules:
31 minutes ago
Dr. Angelos Hartsiotis
European Head of Commercial Trade & Pharmacy Operations at Amarin Corporation
I have always worked with cardiology-related products in a career spanning multiple countries and cultures. It is work that has always felt meaningful to me. So when I heard about Amarin preparing to enter the European market with a cardiovascular treatment for patients living with residual cardiovascular risk, I was eager to be involved.
According to the European Society of Cardiology, cardiovascular disease is the number one cause of death in Europe, representing a severe public health and financial burden (ESC Cardiovascular Realities 2020 - https://www.flipsnack.com/Escardio/esc-cardiovascular-realities-2020/full-view.html). At Amarin, I saw a wonderful opportunity to get in at the ground level and build something up ‘from scratch’ - a true rarity in this industry - while contributing significantly to the fight against this disease.
Our sole mission as a company is to support patients and improve cardiovascular health, and as someone who strives for purpose and meaning in what I do, this really resonates with me.
The opportunity to be part of something bigger
Before joining Amarin, I’d worked in various places and functions where I brought to market products around lipid management, blood pressure management and acute cardiology.
I’m proud to say I’ve helped reduce cardiovascular risk for millions of patients, improving their quality of life and often even saving them.
What brought me to Amarin was the company’s focus on developing and offering therapeutics to improve cardiovascular health.
In my current role as European Head of Commercial Trade and Pharmacy Operations at Amarin, I extend on this experience by overseeing infrastructure in each country to enable our products to reach patients. I work closely with wholesalers and pharmacies, not only to make sure that our products will be at the right place and at the right time, but also to enhance patient education around relevant diseases and support patient adherence to treatments.
Over the years, I have learned that the most important element of a successful career is to stay happy with what you do. I have managed to do this at Amarin firstly by being passionate about my work, and secondly, by being proactive, calm and honest. These are also traits I see in the colleagues around me, which creates even more enthusiasm.
Our focus is our strength
The fact that we concentrate on one therapeutic area – cardiovascular health – allows us to really focus and be incredibly effective. Amarin is also a lean organization and what we deliver is visible. There is a frequent interaction with the company’s most senior executives and constant kind and fair feedback. All of this allows for a fast pace in moving forward.
But I have to say that one of the biggest drivers of our success is the people. In a multicultural, cross-functional, diverse, and inclusive environment, our people embrace change and welcome challenges. There is a willingness to take calculated risks and celebrate others’ success. In this environment, even if you make mistakes, you don’t waste time feeling bad about it: you simply move onward and upward.
Capt, I suggest this phrase:
"in matters pertaining your company,"
should be:
"in matters pertaining to our company"
It needed to the word "to" and we are the company owners
Thanks, for all your work.
Good deal and thanks again. There are some good questions there, and I hope they consider them.
IMO, once yurp and china sales kick in, the investment community will look more favorably at the equity.
The label is very broad, and maybe the med folks over there will get behind V, doctors in the U S don't pay much attention to it.. My personal doc doesn't believe one word of it, but my cardiodoc is a big fan. You have to ask him tho, he doesn't push it.
Capt, thanks for all your efforts.
Is the plan to email that to them and ask to to be included??
Fly, if the company sales/bottom line increase, the stock will go up - that's not called promotion.
A good CEO doesn't need/nor should he, be talking about the stock price. When he improves sales, as will happen, the stock price will take care of itself.
When a CEO is hired, you can bet his job description (written by the company) says nothing about stock prices.
I think a lot of you Capt, you're a good guy, but that's very childish to ask that question. The CEO's function is to grow the company sales/profits. He should attack crooks trying to steal the company assets, he did that and then gets blamed for what inept lawyers, and ignorant judges did.
Everybody that trashes him and the company in public is harming the stock holders, by driving away potential buyers. There are some good posters here, trying to aid the company and 3 times as many, trying to harm the situation. As sales improve, I hope that starts to go away.
Capt - I see one question there about AMRN "defending the stock price."
That should be removed - that's not a company function.
Most of the form 4's are insiders selling a small amount of stock to pay the taxes on vested stock units. I think all of the insiders hold large positions of the stock.
Somebody buying some nice sized pieces this morning - maybe the shorts starting to cover.
Let's hope the sector correction is over, all my biotechs up, for a change
Looks like great progress, to me. Thanks for posting.
Clovis Oncology to Announce First Quarter 2021 Financial Results and Host Webcast Conference Call on May 5
Wed, April 21, 2021, 1:00 PM
Clovis Oncology, Inc. (NASDAQ: CLVS) will announce its first quarter 2021 financial results on Wednesday, May 5, 2021, before the open of the US financial markets. Clovis’ senior management will host a conference call and live audio webcast at 8:30 a.m. ET to discuss the Company’s results in greater detail.
The conference call will be simultaneously webcast on the Clovis Oncology website www.clovisoncology.com, and a replay of the webcast will be available for 30 days.
Dial-in numbers for the conference call are as follows: US participants 877.698.7048 International participants 647.689.5448, conference ID: 3219208.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing, and commercializing innovative anti-cancer agents in the US, Europe, and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops with partners diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado; please visit www.clovisoncology.com for more information, including additional office locations in the US and Europe.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210421005869/en/
Contacts
Clovis Investor Contacts:
Anna Sussman
303.625.5022
asussman@clovisoncology.com
Breanna Burkart
303.625.5023
bburkart@clovisoncology.com
When it's going to be months before V is sold in yurp, why are you guys ragging on the company for not answering some reporter in a hurry?? The readers (public), have a short memory, so when you want the story to be accurate, is when the consumer is going for his wallet.
I'm really pleased that the whiners here are NOT part of Amarin, and hope you never will be.
The lawyers are located in CA - most likely they are the party that picked the 9th circuit.
Looks like the big players are rotating out of biotechs, all of the biotechs I watch have gone dead - even SEEL.
Ggw, what the mkt place is looking for is increased sales/profit. The plaque thing is at least 4 years away from changing those #'s. You can put out 100 PRs about it and won't move the stock price.
Raf, seems to me that it's updated data that confirms earlier studies, and points out that more/larger studies need to be made.
I wouldn't expect it to help the stock price any, if/when larger studies confirm and the fda buys the story - then the stock moves.
ROFL - good one.
Yup:
were presented as Late-Breaking Science at European Society of Cardiology (ESC) Preventive Cardiology 2021, the Annual Congress of the European Association of Preventive Cardiology, on April 17, 2021, 3:50 PM CEST
GlobeNewswire
VASCEPA® (Icosapent Ethyl) Reported to Impact Vulnerable Coronary Plaque Features in New Analyses of EVAPORATE Study Presented as Late-Breaking Science at ESC Preventive Cardiology 2021
Amarin Corporation plc
Sat, April 17, 2021, 6:50 AM
Study quantified coronary plaque changes in patients administered 4 g/day of VASCEPA® (icosapent ethyl) on top of statin therapy
Effect on coronary plaque stabilization reported to be significant at 9 months and sustained at 18 months
DUBLIN, Ireland and BRIDGEWATER, N.J., April 17, 2021 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that further analyses from the Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides on Statin Therapy: EVAPORATE Trial were presented as Late-Breaking Science at European Society of Cardiology (ESC) Preventive Cardiology 2021, the Annual Congress of the European Association of Preventive Cardiology, on April 17, 2021, 3:50 PM CEST (Central European Summer Time) by Andrew Buckler, Founder and CTO of Elucid. As previously reported and published in the European Heart Journal, VASCEPA® (icosapent ethyl) demonstrated significant, 17% regression of low attenuation plaque (LAP) volume on multidetector computed tomography (MDCT) compared with placebo over 18 months. The Effect of Icosapent Ethyl on Changes in Coronary Plaque Morphology: EVAPORATE analyses presented at ESC Preventive Cardiology 2021 demonstrated that with administration of 4 g/day of VASCEPA on top of statin therapy, there was an observed change in plaque stability occurring at 9 months and sustained through 18 months.
“The EVAPORATE plaque morphology study provides valuable insight into how we can utilize scientific imaging to examine the mechanisms at work that may contribute to observed clinical trial results,” commented Matthew Budoff, M.D., Director of Cardiovascular CT at The Lundquist Institute and Professor of Medicine at the David Geffen School of Medicine at UCLA, the study sponsor. “The results suggest consistent benefits of icosapent ethyl on clinical cardiovascular outcomes as observed in the REDUCE-IT® cardiovascular outcomes study, and on plaque progression and plaque vulnerability as observed in EVAPORATE.”
wuflu booster shots:
Pfizer, Moderna Say Booster Shots Probably Needed
Ralph Ellis April 16, 2021
Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.
People who've received both doses of the Pfizer-BioNTech or Moderna coronavirus vaccines will probably need a booster shot this year, top executives for those two pharmaceutical companies said this week.
Pfizer CEO Albert Bourla said people who've gotten both doses would likely need a third shot within 12 months and might need an annual shot thereafter.
"There are vaccines ... like polio that one dose is enough, there are vaccines like pneumococcal vaccine that one dose is enough for adults, and there are vaccines like flu that you need every year," Bourla said on a CVS Health Live event, "Race to Vaccinate." "The COVID virus looks more like the influenza virus than the polio virus."
A top Moderna executive said the United States is in a good position to move into booster shots because of its vaccine rollout, whereas many other nations are still getting first vaccinations.
"It is likely that the countries that have already achieved high vaccine coverage are going to be ready to shift their focus to boosters in 2022 and possibly even starting at the end of this year," Corinne M. Le Goff, PharmD, Moderna's chief commercial officer, said during a call with investors, Business Insider reported.
Moderna CEO Stéphane Bancel made similar comments to Business Insider this week.
"I hope this summer to get the vaccine authorized for a boost so that we can help people getting boosted before the fall, so that we all have a normal fall and not a fall and winter like we just saw in the last 6 months," he said.
Johnson & Johnson CEO Alex Gorsky told CNBC in February that people may need to get vaccinated against COVID-19 annually, just like seasonal flu shots.
And David Kessler, MD, of the Biden administration's COVID response team told a congressional committee on Thursday that Americans should expect to receive booster shots to protect against coronavirus variants, CNBC reported.
"We don't know everything at this moment," he told the House Select Subcommittee on the Coronavirus Crisis.
"We are studying the durability of the antibody response," he said. "It seems strong but there is some waning of that and no doubt the variants challenge ... they make these vaccines work harder. So I think for planning purposes, planning purposes only, I think we should expect that we may have to boost."
The CDC says almost 126 million people in the U.S. (37.9% of the population) have received one dose of vaccine and that 78.4 million people (23.6% of the population) are fully vaccinated.
Earlier this month, Pfizer said studies show its vaccine is 93.1% effective 6 months after the second dose. Moderna said studies show 90% effectiveness in its vaccine after 6 months.
Sources:
CVS Health Live: "Race to Vaccinate."
Business Insider: "Americans might start getting a 3rd booster shot for Moderna vaccines this year."
CNBC: "Pfizer CEO says third Covid vaccine dose likely needed within 12 months."
CDC Vaccine Tracker.
Insync, there are a lot of shorts on this board, they are little better than criminals, IMO. That one is going on mute.
Thanks Raf, at least V is up a little.
ROFL, good one Raf..
Good job, thanks for posting.
Good post Mike, I agree with you, and am going to start putting all these shorts on mute - it's gotten out of hand.
From Tipranks, today:
announced the departure of CEO John F. Thero. Thero who will retire on August 1, has been with Amarin for twelve years, and at the helm for the last seven.
Karim Mikhail will take over his role. Mikhail is currently the head of commercial for Europe and joined Amarin in 2020.
Mikhail held various executive roles at Merck and has considerable expertise in bringing to market lipid therapies in the EU. Between 2014 and 2018, Mikhail acted as global commercial leader in charge of all key details for Merck's $4 billion lipid franchise.
At Amarin, Mikhail has overseen the European pre-launch and commercialization of VAZKEPA - the company’s high triglyceride treatment - which was granted regulatory approval in Europe on March 30.
Amarin is gearing up for a big commercial push in the region, with Germany anticipated as the first port of call for the launch. The European team numbers around 50 at present, which Amarin hopes to boost up to 200 by the end of the year.
Northland analyst Carl Byrnes thinks the drug could be a success in the region.
“The market opportunity in the EU for VAZKEPA is sizeable,” Byrne noted, “As cardiovascular disease is the number one cause of death in the EU, equating to an economic burden exceeding €210B. We approximate peak sales potential of VAZKEPA in the EU to readily exceed €2B, reflecting premium pricing and unmet medical need.”
Overall, Byrnes is bullish on Amarin’s prospects; his $15 price target suggests gains of 182% over the coming months. The analyst has an Outperform (i.e. Buy) rating on the shares. (To watch Byrnes’ track record, click here)
Most of Byrnes’ colleagues agree. Based on 6 Buys and 2 Holds, Amarin qualifies with a Strong Buy consensus rating. There’s plenty of upside projected too; At $10.43, the average price target implies 12- month gains of 105%. (See AMRN stock analysis on TipRanks)
J&J vaccine:
Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.
The FDA and CDC has recommended that use of the Johnson & Johnson COVID-19 vaccine be paused after reports of blood clots in patients receiving the shot, the agencies announced Tuesday.
In a statement, FDA said 6.8 million doses of the J&J vaccine have been administered and the agency is investigating six reported cases of a rare and severe blood clot occurring in patients who received the vaccine.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices on Wednesday to review the cases.
https://www.medscape.com/viewarticle/949174?src=wnl_newsalrt_210413_MSCPEDIT&uac=362266DV&impID=3308590&faf=1
Looks like there's going to be one Ho there:
Victoria Ho - Head of Medical Capabilities and Excellence EUR/INT Jazz
Last time I looked, Thero had a huge AMRN stock position, so anybody thinking he didn't care about the stock price, isn't very bright.
Thanks for the cogent post, Jasbg. Most of the company problems stemmed from 4 libs - most folks seem to forget that.
Thanks Raf, I was one of the 24% - looks like there's not much faith in a lib ever paying attention to the law.
Good job, Captain, thanks for all your efforts.
Good post, and there are many others on this board, that are not stockholders. Anywhere there are large piles of money, you will have lowlifes trying to get at it.
New Side Effects With AstraZeneca and Janssen COVID-19 Vaccines?
Sue Hughes
April 09, 2021
In addition to the unusual blood clots linked to the AstraZeneca COVID-19 vaccine, which have received extensive attention in the past couple of weeks, other safety signals are also being investigated with this vaccine, and now with Johnson & Johnson's Janssen vaccine as well, the European Medicines Agency (EMA) reports.
Highlights of the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) meeting April 6-9 include that the agency has started a review of a safety signal to assess reports of capillary leak syndrome in people who were vaccinated with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).
It also reports that PRAC has started a review of a safety signal to assess reports of thromboembolic events with low platelets in people who received the COVID-19 Vaccine Janssen.
Capillary Leak Syndrome with AZ Vaccine
An EMA press release issued today notes that five cases of capillary leak syndrome, characterized by leakage of fluid from blood vessels causing tissue swelling and a drop in blood pressure in individuals receiving the AstraZeneca vaccine, were reported in the EudraVigilance database.
"At this stage, it is not yet clear whether there is a causal association between vaccination and the reports of capillary leak syndrome. These reports point to a 'safety signal' — information on new or changed adverse events that may potentially be associated with a medicine and that warrants further investigation," the EMA states.
PRAC will evaluate all the available data to decide if a causal relationship is confirmed or not, it adds.
Thromboembolic Events with J&J/Janssen Vaccine
Four serious cases of unusual blood clots with low blood platelets have been reported postvaccination with COVID-19 Vaccine Janssen, EMA reports. One case occurred in a clinical trial and three cases occurred during the vaccine rollout in the US. One of them was fatal.
COVID-19 Vaccine Janssen is currently only used in the US, under an emergency use authorization. COVID-19 Vaccine Janssen was authorized in the EU on March 11. The vaccine rollout has not started yet in any EU member state but is expected in the next few weeks.
The Janssen vaccine uses an adenovirus vector, as does the AstraZeneca vaccine.
PRAC is investigating these cases and will decide whether regulatory action may be necessary, which usually consists of an update to the product information, it adds.
Just be patient, we'll have our day..
Brain problems:
News > Medscape Medical News
'Beyond a Reasonable Doubt': COVID-19 Brain Health Fallout Is Real, Severe
Sarah Edmonds
April 07, 2021
COVID-19 survivors face a sharply elevated risk of developing psychiatric or neurologic disorders in the six months after they contract the virus — a danger that mounts with symptom severity, new research shows.
In what is purported to be the largest study of its kind to-date, results showed that among 236,379 COVID-19 patients, one third were diagnosed with at least one of 14 psychiatric or neurologic disorders within a 6-month span.
The rate of illnesses, which ranged from depression to stroke, rose sharply among those with COVID-19 symptoms acute enough to require hospitalization.
"If we look at patients who were hospitalized, that rate increased to 39%, and then increased to about just under 1 in 2 patients who needed ICU admission at the time of the COVID-19 diagnosis," Maxime Taquet, PhD, University of Oxford Department of Psychiatry, Oxford, United Kingdom, told a media briefing.
Incidence jumps to almost two thirds in patients with encephalopathy at the time of COVID-19 diagnosis, he added.
The study, which examined the brain health of 236,379 survivors of COVID-19 via a US database of 81 million electronic health records, was published online April 6 in The Lancet Psychiatry.
High Rate of Neurologic, Psychiatric Disorders
The research team looked at the first-time diagnosis or recurrence of 14 neurologic and psychiatric outcomes in patients with confirmed SARS-CoV-2 infections. They also compared the brain health of this cohort with a control group of those with influenza or with non-COVID respiratory infections over the same period.
All study participants were older than 10 years, diagnosed with COVID-19 on or after January 20, 2020, and were still alive as of December 13, 2020.
The 14 psychiatric and neurologic conditions examined included intracranial hemorrhage; ischemic stroke; parkinsonism; Guillain-Barré syndrome; nerve, nerve root and plexus disorders; myoneural junction and muscle disease; encephalitis; dementia; psychotic, mood, and anxiety disorders; substance use disorder; and insomnia.
The investigators used hospitalization, intensive care admissions and encephalopathy as an indication of the severity of COVID symptoms.
The study benchmarked the primary cohort with four populations of patients diagnosed in the same period with nonrespiratory illnesses, including skin infection, urolithiasis, bone fractures, and pulmonary embolisms.
Results showed that substantially more COVID-19 patients were diagnosed with a neurologic or psychiatric disorder than those with other respiratory illnesses.
"On average, in terms of the relative numbers, there was a 44% increased risk of having a neurological or psychiatric diagnosis after COVID-19 than after the flu and a 16% increased risk compared to other respiratory tract infections," Taquet told reporters.
Health services should be prepared for an increase in psychiatric and neurologic issues in the months to come, he said, adding that further investigations are needed into why, and how, the coronavirus affects brain health.
Largest Study to Date
Although previous research suggests a link between the two, this is the largest study of its kind, examines a wider range of neurologic outcomes, and spans the longest timeframe to date, said study co-investigator Paul Harrison, BM BCh, associate head of the University of Oxford Department of Psychiatry.
There was a lower incidence of mood and anxiety disorders vs neurologic disorders in patients with severe COVID-19 symptoms, a finding that Harrison said may indicate pandemic-related psychological stress is driving these disorders vs biological factors.
"This paper follows up on an earlier study we did where we found much the same association, and our view is that a lot of the mental health consequences of COVID are…to do with the stress of knowing that one has had COVID and all the implications that go with that, rather than it being a direct effect, for example, of the virus on the brain, or of the immune response to the virus on the brain," he added.
In contrast, neurologic diagnoses were more likely to be "mediated by some direct consequence of the COVID infection," he added.
Psychosis and dementia, for instance, were less frequent in the overall COVID-19 population but became much more frequent among those with severe symptoms. The research team said these findings, along with those related to the incidence of ischemic stroke, were "concerning."
"We found that 1 in 50 patients with COVID-19 go on to have an ischemic stroke in the 6 months after the COVID-19 illness," Taquet told reporters. "And that rate increased to 1 in 11 patients if we look at patients with encephalopathy at the time of the COVID-19 diagnosis."
Rates of brain hemorrhages also rose sharply among those with acute symptoms. Just over 1 in 200 total COVID patients were diagnosed with this neurological condition, but that jumped to 1 in 25 of those who experienced encephalopathy at the time of their COVID-19 diagnosis.
Need for Replication
Study co-author Masud Husain, PhD, University of Oxford Cognitive Neurology Department, told reporters that while there is evidence from other neurologic studies that the virus can access the brain, there has been little sign the neurons themselves are affected.
"There isn't much evidence that the virus itself attacks neurons in the brain, but it can cause inflammation, and it can activate inflammatory cells in the brain," he said.
"And those effects are probably very important in some of the biological effects on the brain. In addition, of course, we know that the virus can change clotting and the likelihood of thrombosis in the blood, and those effects can also impact upon the brain," he added.
Harrison said it would be helpful to replicate the results garnered from the US database in other populations.
"It goes without saying that replication of these results with other electronic health records and in other countries is a priority," he said, adding that investigations are essential into how and why the virus affects brain health.
Harrison cited a UK Research and Innovation-funded study called COVID CNS that will follow patients with neurologic and/or psychiatric issues during acute COVID in hopes of exploring possible causes.
Beyond a Reasonable Doubt
Commenting on the findings, Sir Simon Wessely, Regius chair of psychiatry, King's College London, UK, said in a release: "This is a very important paper. It confirms beyond any reasonable doubt that COVID-19 affects both brain and mind in equal measure."
Some of these effects, including stroke and anxiety disorders, were already known, but others such as dementia and psychosis were less well known, he added.
"What is very new is the comparisons with all respiratory viruses or influenza, which suggests that these increases are specifically related to COVID-19, and not a general impact of viral infection," Wessely said. "In general, the worse the illness, the greater the neurological or psychiatric outcomes, which is perhaps not surprising.
"The worst outcomes were in those with encephalopathy — inflammation of the brain — again, not surprising. The association with dementia was, however, small and might reflect diagnostic issues, whilst so far there doesn't seem early evidence of a link with Parkinsonism, which was a major factor after the great Spanish Flu pandemic, although the authors caution that it is too early to rule this out."
Lancet Psychiatry. Published online April 6, 2021. Full text
For more Medscape Psychiatry news, join us on Twitter and Facebook
If I thought management was as bad as you do - I would sell the stock and never look back.
This board is a lot worse that yahoooo, more shorts and endless whining.
Thanks Capt, good job.