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meow, what the fk are you smoking
Raf, listening to OA re the Flynn case. I noticed the judges are speaking over Sidney Powell, I'm wondering if that is typical or is a power grab?
biob, thanks
Marjac, OUCH
this is a partial free teaser from the website:
When do Vascepa patents expire, and what generic alternatives are available?
Vascepa is a drug marketed by Amarin Pharms and is included in one NDA. There are fifty-six patents protecting this drug and three Paragraph IV challenges.
This drug has two hundred and sixty-six patent family members in fifty countries.
The generic ingredient in VASCEPA is icosapent ethyl. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page.
US ANDA Litigation and Generic Entry Outlook for Vascepa
A generic version of VASCEPA was approved as icosapent ethyl by HIKMA on May 21st, 2020.
Postes, did you read my last post. The vascepa patent was updated Aug. 4th
I'm not sure what it means but to read the information you have to subscribe to the website. Any suggestions on how to get around it to find out the details.
Does anyone on this board have a subscription to www.drugpatentwatch.com?
www.drugpatentwatch.com/p/tradename/VASCEPA
Aug 04, 2020 · The generic ingredient in VASCEPA is icosapent ethyl. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page. US ANDA Litigation and Generic Entry Outlook for Vascepa. A generic version of VASCEPA was approved as icosapent ethyl by HIKMA on May 21 st, 2020. Start Trial
Suppliers / Packagers: 1
NDAs: 1
Applicants: 1
US Patents: 25
Postes, by the time the appeal is completed and if we lose the appeal you better believe that both generics will start marketing their GV ASAP. I no longer have faith in JT and his rhetoric. Please God get me even and I'll never do it again, I promise!!
Raf, thanks listening now...govt attorney is stumbling with her words. She's on the defensive and sounds lost for words. excellent!
Marjac:
Is there another dept. above her that you can contact other than the judicial council to pursue the misconduct complaint?
raf, when I tried to open link it was blurred.
Capt, when the cost of vascepa is lowered in Canada, I'll use the Canadian pharmacy I've used in the past to buy Vascepa, that's if it's available to USA citizens.
Kiwi,
is there any way of finding out if you're in the study? Please keep us posted on progress. Maybe that's why Kaiser is offering Vascepa at lowest cost available to insured consumers???
Part 2
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.”
For more information about Amarin’s COVID-19 research, please visit the COVID-19 Related Materials section on Amarin’s publications page at https://investor.amarincorp.com/publications.
About Amarin(AMRN)
Amarin Corporation plc (AMRN) is a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to cost-effectively improve cardiovascular health. Amarin’s lead product, VASCEPA (icosapent ethyl), is available by prescription in the United States, Canada, Lebanon and the United Arab Emirates. Amarin(AMRN), together with its commercial partners in select geographies, is pursuing additional regulatory approvals for VASCEPA in China, Europe and the Middle East. For more information about Amarin(AMRN), visit www.amarincorp.com.
About Cardiovascular Risk
The number of deaths in the United States attributed to cardiovascular disease continues to rise. There are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds), in the United States. Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. Cardiovascular disease results in 859,000 deaths per year in the United States.13 In aggregate, this is more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, one every 13 seconds in the United States alone.
Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.14 Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.15,16,17
About REDUCE-IT
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
GLOBENEWSWIRE 12:12 PM ET 8/7/2020
Symbol Last Price Change
AMRN 7.17down +0.12 (+1.7%)
QUOTES AS OF 12:12:15 PM ET 08/07/2020
DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 07, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc(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
Tal, thanks, I missed that important factor.
I hate to burst everyone's high, but the identical article that was posted earlier today by HK was first published on June 5 (updated June 17) by another publication SSRN. Please see below.
Federal Judge Invalidates Icosapent Ethyl Patents–But Based on a Common Statistical Mistake
G Curfman - Available at SSRN 3618671, 2020 - papers.ssrn.com
In a recent decision that stunned many in the legal and pharmaceutical communities, the chief judge of the US District Court of the District of Nevada in Las Vegas, Judge Miranda Du, struck down 6 key method-of-use patents for the omega-3 fatty acid preparation …
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Suggestion to the board. Use every search engine available to search the headlines of the article eventually it will get picked up on the first page when people do a search for Judge Miranda Du.
Just sayin.....
HK, Thanks so much for sharing, I tried to print but not permitted. This article addresses all opinions that have been discussed in this forum multiple times. Awesome
BB, Thanks, I'm just catching up on posts, I really wasn't dreaming about Hikma's projection. Please note the amount is basically the same as the slide deck Hikma presented at the AHA in Nov 2019.
So when JT recently stated during the cc that Hikma isn't prepared to go to mkt, he was feeding us some BS. It's public knowledge that Hikma has had a manufacturing agreement in place for some time now.
Once again it comes down to the outcome of the appeal. I curse Judge Du every day.
BB, thanks will review later.
BB, very timely and awesome information, the PFE/BMY win may have some influence in the Amarin vs H/R appeal.....crossing fingers, arms, toes etc
BB, I agree that AMRN has made some questionable statements that don't jive with public information. Such as generics are incapable of launching GV depending on the outcome of an appeal. I totally recall that at the Nov 2019 AHA conference someone from this board was in attendance and mentioned that Hikma or it's third party supplier presented a slide deck with GV projected sales of $750 million in domestics sales for GV. Raf doesn't recall but somewhere in the archives there's a clip of Hikma available I haven't located yet but will eventually.
I respect all your efforts and am all for going after all resources to try and force AMRN to come clean. But at this juncture it's not happening, at the risk of some self disclosure I have extensive background in all facets of the stock market. Amarin will not and should never disclose private talks with potential buyers.
BB, ain't happenin...
Pfizer/Bristol Meyers won a patent suit against generics...Yahooooo there is justice after all. There is hope for our little one product company, the little engine that could!
Sts66, good grieve, NDA violation has serious ramifications. No public company would take that risk, unless they're slimy. E.g. Kodak!
BB,
https://seekingalpha.com/article/4364104-amarin-corporation-plc-2020-q2-results-earnings-call-presentation?utm_medium=email&utm_source=seeking_alpha&mail_subject=amrn-amarin-corporation-plc-2020-q2-results-earnings-call-presentation&utm_campaign=rta-stock-article&utm_content=link-2
This link will take you to the cc
BB, please share the private agreement you're referring to, is it the employment agreement with Karim Mikhail?
raf, correct me if I'm wrong but during the AMA conference back in Nov 2019 Hikma made a presentation that shocked everyone with there forecast of a generic vascepa of somewhere in the neighborhood of $750 mill annual revs. Also, Hikma's FDA approval of ANDA for GV came shortly after Du's disastrous decision. I believe Hikma was fully prepared to win the court case. Plus they have a supplier lined up. Not so sure about Dr Reddys since they have been extremely quiet during all this time.
Bhatt is speaking English
raf, any instructions available to listen in English?
jas, thanks for sharing, very interesting
HK,
your list pretty much covers the stock slump scenario. I believe the order of events and outcomes will definitely determine how JT is playing this out. The entire future will be determined depending on the outcome of oral argument, if they sound promising enough to move to the next level maybe they'll move forward with DTC, they'll drag their feet regarding the EU until the appeal is final that will determine if JT decides to GIA in the EU, if we win appeal my fear is JT will feel empowered to GIA which would be a major mistake. The more time that goes by with never-ending legal battles the value of the company will diminish. It's similar to a premium a person is willing to pay for a stock option with a certain strike price, the closer you get to expiration the premium goes away until it gets to par so I hope AMRN's options haven't expired worthless!
As many in this forum have stated it's a waiting game.
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Johnking, thanks for posting HAMOA's positive refresher course. Holy Cow, I need some encouragement at this juncture.
mrmain, don't get me started, I'm not getting into a political pissing contest with ANYONE! Not the time and place.
mrmain, are you referring to sleepy plugs? lol