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.
Prepare It study is evaluating Vascepa's effect on:
"morbidity and mortality among subjects at high risk of infection due to COVID-19 (prevention arm), and reduction of the hospitalization rate and complications in patients with a positive diagnosis of COVID-19 (treatment arm)"
Since Lipitor is quite inexpensive, Amarin could price LIPITEPA at a little above the present price of Vascepa alone and it could still be profitable.
styles..I believe that Amarin has patents on a Vascepa plus Lipitor combo in addition to...Vascepa combined with with other statins...in case Pfizer turns out to have less interest in Amarin than some other Big Pharmas.
Docs have been accustomed to writing Rx's for LIPITOR...When the combo drug is introduced, it would be easy for Docs to remember to write Rx's for LIPITEPA...and this might lessen the public perception that Vascepa is just another fish oil..an idea, which seems to have been an albatross in past marketing.
of Vascepa.
styles... How about naming the combo Lipitor+Vascepa=Lipitepa
Docs worldwide are already familiar with Lipitor and adding EPA to the name would make them recall an old standby...with something added to make Lipitor even better.
About Mnd 2119 by Mochida...
1.a new, self emulsifying, superior preparation of EPA with greater bio-availability
2.given twice daily in doses of 1.8 gms. each
3.patent granted in U.S. in December 2019
3.phase 3 trial completed in Japan in July 2021...Japan approval applied for
4.phase 3 trial in China in July 2021...? China approval applied for
5.? US FDA approval applied for
BB...There can be a conflict between drug innovation and drug affordability...The patent laws are intended to resolve this conflict...The 'skinny label' corrupts this resolution.
A question that HW does not deal with is...When a drug company gets a patent approved for a rare disease along with approval for a patent for a common disease...and the rare disease patent expires or is invalidated in court, how can the intact patent be protected from infringement?
The market for the drug with the still in tact patented label is enhanced by educating the public and Doctors about the value of the drug...yet the generic company with the 'skinny label' benefits from the efforts and expenses, put out by the branded company with the still in tact patented label, while making little or no investments of their own.
The generic company with the skinny label will not make the necessary investments to encourage people to use the drug, while the branded company would not innovate if they could not benefit from the fruits of their labor and the spending of their assets.
It is one of the geniuses of capitalism that while people are motivated by personal interests, their work ends ends up benefiting us all.
Rose...Mochida's MND 2119, with or without a combination with Lipitor, could be a blockbuster and especially important for Amarin's recovery in the U.S. market.
Mochida has already applied for approval of the drug in Japan and,since the studies on MND 2119 were done in China, approval in China could follow quickly, especially with Vascepa approval in China being anticipated before the end of this year.
I could see Vascepa gradually being phased out and MND 2119 replacing it, much as Pfizer'a Prilosec was replaced by Nexium.
Ns...I agree with your thoughtful explanation of how the Hickma label for high trigs is NOT a 'skinny label', but instead an 'intertwined label' and, in the same manner that Teva was infringing on Glaxo's CHF label, Hickma has been infringing on Amarin's still valid patented CVD label...The dissent in the Glaxo vs. Teva case seems not to be accounting for this fact.
In the same fashionthat Hickma has been guilty of infringing on Amarin's still valid and unexpired CVD label, Healthnet, which knows from its own prior authorization stats that the vast majority of the gV Rx's are for CVD indications, and not for high trigs, was also infringing as a co-conspirator.
NSl...QUOTE from the Glaxo-Teva infringement case..."Post-MI LVD “is intertwined with heart failure.”...This is IMO the key to the Glaxo vs. Teva case
Even Teva’s expert acknowledged during the case that..."some post-MI LVD patients have CHF."
Also Hickma announced at an analyst meeting that they were predicting selling over a million Rx's for their gV product...despite the fact that the over 500 trigs/dcl indication for gV is 'intertwined with CVD' and is a vanishingly small share of the market(less than 10% as opposed to the CVD indication being over 90% of the market).
These facts lead to the inevitable conclusion that Hickma intended to infringe on Amarin's valid patent for the CVD indication as it has already done.
If we know about this good news from Germany, Pfizer must also know about it....Thanx.
PDude...QUOTE "Pfizer is desperately lacking in new CVD drugs and this is probably a global corporate concern."
IMHO this is the key.
Pfizer is less worried about jobs for their CVD reps in Canada than about their worldwide position in CVD drugs...Hence their interest in Vascepa and, by extension,in Amarin...However, Pfizer is not yet certain of how much to offer for a BO of Amarin...Therefore, their recent deal with HLS is meant to provide them with more information as to what kind of an offer to make....If HLS sales of Vascepa in Canada and Amarin's sales of Vaskepa in Germany give a good sign, they can make an appropriate offer...However other BP's are also watching these factors play out...so Pfizer can't delay forever or Merck, Sanofi etc. may step in with their own bids and then, the price goes up.
Mochida has already applied for approval for MND-2119 in Japan, but not yet in the U.S.
Rose...When MND-2119 is approved you would be a candidate for the combo with 5 mgm Lipitor and MND-2119 bid.
This would be excellent for people like yourself on low doses of Lipitor, but who could still profit from the benefits of EPA-2119 for further CVD reduction.
Two strengths of a Lipitor-Vascepa combo should cover 80% of the market:
1. Lipitor 10 mgm with Vascepa 1 gm qid and...
2. Lipitor 20 mgm with Vascepa 1 gm qid
When MND-2119 is approved, the combo dose with Lipitor would be EPA MND-2119 with Vascepa bid
Captain...I note that Mochida filed for approval in Japan, although it's study on MND-2119 was done in China...Does Mochida have a marketing partner for MND-2119 for when it gets approval in China or will it be marketed by Eddingpharm or someone else?
Interesting article from Seeking Alpha...
https://seekingalpha.com/article/4453341-amarin-stock-looks-attractive-despite-us-litigations
N. Sleven...I recall that for months before the AHA meeting in 2018, the Amarin SP hovered around $3/sh...A few months before the meeting, Dr. Budoff, in answering a question put to him about the chances of success for R-It, guessed they were about 85%...In the space of a few days after the positive results announced at the AHA meeting, the Amarin SP had risen about 700% before coming down to earth....Of I don't have nearly the stature of a Dr. Budoff, but I would guess the chances of a positive result from Prepare-It 2 are also about 85%.
I would assume that the results of the study are known by the investigators and that they will be published in a peer reviewed journal around the same time as the AHA meeting....Too bad it can't be sooner.
It was a mistake for Amarin to not,by themselves, pursue the rule 60/20 case against Hickma immediately after the fraud came to lite... Now that Marjac has taken up this case for us, will Pfizer, after their BO of Amarin, assign lawyers to work as assistants to him in the case?...it would be a nice gesture.
There is no question at this point that Pfizer is interested in Vascepa...and it follows that Pfizer has to be interested in Amarin.
The only question that remains to be resolved is...How much is Pfizer willing to pay for Amarin?...I assume negotiations are ongoing.
I believe that results in Canada will affect these negotiations.
A p value of .02 is statistically significant...anything less than .05 is SS....The hospitals are filled with Covid patients, with some CVD patients presently unable to get a bed...Sure it would have been nice to have p values of.000001...but let's not be purists. These CVD figures released by Dr. Bhatt are astounding(for a safe and inexpensive drug)... and all Docs should take note.
Dr. Bhatt's report at ESC..."icosapent ethyl was associated with a 40% (HR, 0.60 [95% CI, 0.380.94]; P=.02) reduction in risk of sudden cardiac death and a 56% (HR, 0.44 [95% CI, 0.21-0.89]; P=.02) reduction in risk of cardiac arrest compared to placebo therapy."
This makes Vascepa a blockbuster drug!
Pdude...PI 1. results were released prior to being reported in a peer reviewed journal...Why should it be any different with PI 2. results? ...especially if the results of PI 2. are positive and many lives could be saved by releasing these results earlier?
Rose...I think J.L. and HDG got out in the $6/sh to $7/sh range...My hope is they'll be back once things start heating up again....I learned a lot from both of them.
EXCLUSION criteria for Prepare It 1. study specified..."Previous coronavirus disease diagnosis"
INCLUSION CRITERIA for Cardio-Link study specified "Sars CV-2 POSITIVE and SYMPTOMATIC outpatients"
Prepare-it 1. was about PREVENTION of Covid
Now we await the results of Prepare It 2., which was about TREATMENT of Covid, which will confirm the positive results for Covid patients in the mitigation of their Covid infections(as demonstrated in the Cardio-Link study).
Pdude...I had Afib, which did not respond to two cardioversions ...and only went away after a coronary stent was placed...I have been on Vascepa the seven tears since then, with no return of the Afib...I have also been on Warfarin with no bleeding episodes.
Gesund...Thanks for posting...The Brave study on Vascepa's anti-inflammatory effectiveness in improving Alzheimers, a study started in 2017 at University of Wisconsin and due to be completed in 18 months, should corroborate these findings.
Examiner...Thank you for posting this study, which confirms Cardio-Link...Next to be released is Prepare-It 1, which I suspect, will also confirm...as will Prepare-It 2. and Mitigate release in the near future.
Emergency use authorization by the FDA of Vascepa as med for Covid prevention and mitigation should follow soon.
Bird...excellent suggestion...They might even want to do an interview with Marjac, who knows the history and would give the story a human interest angle as to how little Amarin arose from the ashes...after a negative patent decision...to survive and prosper.
In December 2019 the Cardiolink study reported...QUOTE "Giving patients icosapent ethyl, or Vascepa, led to a 52% reduction of the total patient-reported symptom outcome prevalence score as compared with a 24% decline for outpatients who received usual care."...i.e. patients, who were on Vascepa, did twice as well with their symptoms from Covid as patients, who received usual care.
This has influenced me to believe that Prepare it 1. plus Prepare it 2. will have similar('incredible') successful results.
Mr.1979...I'm aware that when the patent for Pfizer's blockbuster drug, Prilosec, expired, Pfizer tweaked the formula and got approval from the FDA for Nexium as a new drug...Prilosec is still for sale, but alongside is Nexium, which has a larger market than Prilosec.
sstyles...Amarin might apply to the FDA for approval of MND2119 for the high trig indication...which is the basis of the Mochida study, which Mochida recently applied for approval of to the Japanese FDA.(but only for 2 grams a day, not 4 grams a day}
Duke MND2119 is a new formulation of purified EPA from Mochida wth 2 grams per capsule rather than 1 gram.
Amarin is a partner of Mochida and can market this formulation
MND2119 will need approval by the FDA before being sold in the U.S.
MN2119 might qualify as a new drug and thwart the generics.
Amarin might market MND2119(probably under a new name) along with Vascepa (as is the case of Pfizer's Nexium and Prilosec.)
Cardio-Link vs. Prepare-It 1. and Prepare-It 2.
All 3 studies start with patients testing positive for Covid
C-Link studies already reported that the V group had less symptoms than the placebo group over the 14 days of the trial.
P-1 is geared to show whether the V group had less hospitalizations than the placebo group over the 60 days of the trial.
P-2 is geared to show whether the V group had less hospitalizations and deaths over the 28 days of the trial.
Alz can have a long, drawn out course, making life miserable for the patient and for his or her family...Any drug, even one that only mitigates the course of Alz, would be in great demand...especially if it was inexpensive and had no significant side effects(like Vascepa).
Judge Du famously said in an interview with a magazine after the Amarin trial, in which she invalidated nine Amarin Marine patents for high triglycerides(but left the Amarin Reduce It patents for CVD in tact)...that she "learned a lot about fish oil during the trial".
Perhaps it is time for Amarin to emphasize the facts that Vascepa is an esterified extract of fish oil, preserving the benefits of fish oil, while eliminating the non effective and even counter effective elements to be left out of the natural fish oil.
Perhaps Pfizer is also interested in this oncology study...
"OMega-3 Fatty Acid for the Immune Modulation of Colorectal Cancer (OMICC)
ClinicalTrials.gov Identifier: NCT03661047
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : May 12, 2020
See Contacts and Locations
Sponsor:
Mingyang Song
Collaborator:
Harvard School of Public Health
Information provided by (Responsible Party):
Mingyang Song, Massachusetts General Hospital
Brief Summary:
This is a prospective, double-blind, placebo-controlled, randomized clinical trial to assess the effects of daily 4-gram marine omega-3 polyunsaturated fatty acid (MO3PUFA), through treatment with AMR101 (VASCEPA, icosapent ethyl) on the tumor immune microenvironment and gut microbiome in patients who are diagnosed with colorectal cancer or with a colorectal mass or polyp suspected to be a cancer or advanced adenoma and will undergo surgical resection or interventional endoscopy at the Massachusetts General Hospital (MGH). It uses the novel "window-of-opportunity" clinical trial design to take advantage of the window of time between cancer/mass/polyp diagnosis and surgery to examine the effect of therapeutic agents on tumor pathologic and molecular features unperturbed by prior therapies.
Condition or disease Intervention/treatment
Colon Cancer Drug: AMR101 (VASCEPA, icosapent ethyl) Phase 2... Detailed Description:
This research study is evaluating the effect of AMR101, as a chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of colorectal cancer, colorectal mass or polyp(s).
AMR101 is made of a marine omega-3 fatty acid, which is a family of natural substances found in the oil of certain fish, such as salmon and mackerel. Marine omega-3 fatty acid cannot be produced in sufficient amount by the human body and has to be obtained through diet or supplemented to maintain normal function in the body.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits during which participants will complete a lifestyle questionnaire and a nutritional survey. A drug diary will be provided to be completed. Measurements will be taken, and blood and stool specimens will be collected. Tumor, colorectal mass, or polyp tissue will be collected for research purposes at the time of surgery or interventional endoscopy.
AMR101 administered daily, orally for up to 30 days and it is expected that 36 participants will take part in this study.
Study Design
Go to
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, placebo-controlled, stratified, randomized clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: OMICC: OMega-3 Fatty Acid for the Immune Modulation of Colorectal Cancer
Actual Study Start Date : November 30, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2023"