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Dr Eric Topol, who is a close associate of Dr. Steve Nissen at Cleveland clinic...and an arch opponent of Vascepa since the failure of the Strength test, betrayed his hostility to Vascepa when he insultingly referred to the results of Reduce-It as "FISHY" ...conjuring up the old saw that Vascepa is just a "fish oil".
Topol's criticism of Vascepa is demeaning and is not to be taken seriously....Nissen and Topol are committed to their story and will never admit they are mistaken...no matter what....
This is academic medical politics at its worst....I know personally, because I was involved years ago in the world academic medical politics and it can be just as brutal as the world of legislative politics.
The issue of whether Vascepa is safe and efficacious in reducing CVD has been settled by the FDA in a unanimous fifteen to zero decision by its experts in 2019...and no serious objections to that decision have occurred since.....Now Amarin should turn its attention and its assets to MD2119, once a day, new patented formulations of EPA and fixed dose combinations of MD2119 with a statin...with the purpose of reclaiming and expanding the U.S. market, which has been stolen from them by generic infringement.
KIWI..QUOTE..."As JL used to say … fast nickels over slow dimes"
This theory depends on high sales volumes...It will be put to the test when China, with its giant population(especially including many people who smoke), approves Vascepa for the mainland...which, as KM stated in the Q2 C.C., was expected to occur this year.
KIWI...The Respect-EPA trial is due to be reported at the AHA meeting on November 5-7,2022...this study should be another confirming link to the positive results from the following studies...
1. Jelis
2. Reduce-It
3. Cardio-link
4. Cherry
5. Mitigate
6. Prepare It, which was trending positive, but had not yet reached stat. sig.
BIO..."Germany has been known to offer 50% or less".... Germany has a choice...They can choose to allow their patients to suffer a increased rate of CVD or pay what other EU countries have determined is a fair price for Vaskepa...Amarin has NO choice...They could not survive as a going concern with a 50% reduction in their price.
If the results of Mitigate are filed as a 'late breaking" study at the AHA on August 23.2022, this would be a probable indication of positive results from the study...and the share price would move up....If not, it would probably mean, the study has been extended to attain statistical significance.
CBB. The study of colorectal cancer prevention with Vascepa being done at at MGH in Boston is scheduled for completion on Oct 31/2022...
https://clinicaltrials.gov/ct2/show/NCT04216251
MGH and Brigham and Women's hospital(where Dr. Bhatt works) are part of a consortium called "Partners"
Amarin shares are in the doldrums...New initiatives are needed...A promising new initiative would be for Amarin to seek approval of MD-2119 from the FDA...once the market for MD-2119 is established, Amarin could seek approval of fixed dose combos of a statin plus MD-2119....
These efforts would prepare the way for even more impetus from the results of the Mitigate, Respect, and Brave studies.
Capt...While the author of the SA article puts a buy recommendation on Amarin, he hedges his bet by discussing just about all of the present negatives and leaving out some of the more important potential positives...including MD2119 once a day formulations and combo formulations with a statin, the Mitigate and Respect studies, and China approval of Vascepa expected this year.
In addition, he puts an artificially low target price of 2 to 3 billion dollars on Amarin.......he also repeats the phrase mentioned in the Q2 report .."we have enough cash for the next 12 months"...which is a standard statement, appearing in every quarterly report....in order to further worry potential investors about the extremely unlikely scenario of bankruptcy. He seems to be advocating for a BO of Amarin on the cheap.
The present Amarin SP is too low for a BP to make a double digit BO offer for the company, which IMO will be necessary for a BO)....It will take additional good news, possibly from MD2119 or the Respect and Mitigate trials or the Healthnet court case or appproval of Vascepa for CVD on China, to raise the SP to the point where a double digit offer will be made by one or more BP's
In the meantime, it is important for Amarin to keep expenses down and maintain stable revenues.
O...WOW!...Imagine what Pfizer could do with adds informing smolkers that Vascepa could minimize the risks associated with smoking cigarettes....QUOTE...
"While smoking cessation should always be recommended, these data raise the possibility that IPE treatment may attenuate CV hazards attributable to smoking.While smoking cessation should always be recommended, these data raise the possibility that IPE treatment may attenuate CV hazards attributable to smoking."
Bio...What's even funnier is that Kennedy screwed up by choosing the ninth circuit for the patent case and Singer screwed up by choosing to emphasize the Graham factors for the appeal...rather than emphasizing the fraud that occurred on the court...and then Ekman screwed up by withholding Amarin support for the EPADI appeal.
The collective wisdom of this board is nothing to be sneezed at.
Capt...QUOTE..." Go for the low hanging fruit first with the 3-year NME then follow on with the NCE new formulation?"
I agree...especially since KM stated at the Q2 C.C. that the FDC (i.e.) NCE was expected to take 3 years...I assume that the NME would take much less time and less investment and Amarin needs the help now.
Bio...This is all the more reason to go directly to a once a day statin-EPA combo in a blister pack.
A blister pack combo could be ready for the market in weeks with Amarin making very little investment in research or manufacturing... and it might be easier to get FDA approval....while a one pill FDC could take years to develop and it could be worked on AFTER THE MARKET WAS ALREADY ESTABLISHED FOR A COMBO STATIN - EPA DRUG.
Bio...QUOTE..." statins do not mix well, and also statins are taken once a day."
An FDC could be made in a blister pack...with various strengths of a statin, to be taken once a day, together with once a day MD2119.
I think it would now be worthwhile for Amarin to discuss with the FDA whether the studies by Mochida on MD2119 in Japan would sufficient for approval in the U.S....or whether additional studies would be required.
If the FDA indicates that more lab studies are necessary, Amarin could complete those with the help of Dr. Bhatt or Dr. Mason in a timely fashion.
Nsleven, Your logic seems reasonable to me...The chemistry of MD2119 is different from that of Vascepa...as is the dosing schedule of once a day vs four times a day...as well as the difference in the levels of EPA in the plasma produced by the two meds....If the Generics decide to market MD2119 "at risk" despite Amarin's patents, IMHO they could lose a lot more cash than they could earn from their infringement.
Dogn...Thank you for this informative study.
It looks as though MD2119 is at least as effective(or more) than Vascepa and at least as safe....and eminently approvable by the FDA!...Amarin should now consider applying to the FDA for approval of MD2119 with an eye to eventually withdrawing Vascepa from the U.S. market and replacing it with MD2119.
Rose...It probably didn't hurt that Pfizer was involved...This is a small indication of the potential of Vascepa with proper management.
Lizzy...This inflation bill is mainly taking aim at much higher priced drugs than Vascepa...I think you are correct that this bill will hurt innovation for expensive drugs and drugs for rare diseases...The US has been the drug innovator for the world and sadly this will now change.
RMB...IMHO The cognitive performance will be the most critical part of the study between the EPA group and the placebo group and this will determine the success or failure of the study.
QUOTE..."The proposed study aims to: 1) investigate the effects of 18 months of IPE vs. placebo on regional cerebral blood flow as measured by arterial spin-labeling MRI; 2) determine the impact of 18 months of IPE vs. placebo on CSF biomarkers of AD pathology; and 3) EVALUATE THE EFFECTS OF18 MONTHS OF of IPE vs. PLACEBO on COGNITIVE PERFORMANCE."
I would be surprised if there were changes in the MRI or CSF... as these come later after the disease is well established due to inflammation in the brain....and this is where Vascepa can help.
Questions for Amarin to seek answers to... regarding MD119...
1. is Vascepa considered a biosimilar to Epadel by the FDA
2. is Vascepa considered a biosimilar to MD2119 by the FDA
3. Would a biosimilar to Vascepa (i.e MD2119) be approved by the FDA for treatment of CVD on the basis of Mochida trials
4. would the FDA approve a fixed dose combo with Vascepa plus a statin without further trials
5. Would the FDA approve a fixed dosed combo with MD2119 plus a statin without further trials
dogn...Since Vascepa and Epadel are pretty much the same drug, this opens the door for Amarin to apply to the FDA for approval of MD 2119 as a once or twice a day med and should stimulate work by Amarin on once or twice a day fixed drug combo drugs with MD 2119.
These drugs would have patent protection.
Amarin should pursue this case, which is hurting Vascepa through infringement on their CVD patents..which insurance companies, pharmacies, and the courts (and even the congress) realize is happening but no one wants to admit it is happening or do anything to correct it.
In the meantime, drug innovation is being stifled...Amarin would be actively pursuing additional indications for Vascepa, if not for this injustice, and American patients are the biggest losers.
ORB..Your letter is most informing...Self interest is a part of human nature...but ,so also, is a concern for the good of others...I hope your letter helps the latter triumph.
Capt....I know what you're going through...I lost a grandson 10 years ago at age 9 from brain cancer...My wife and I are so sorry for this shocking incident, for which you had no chance to prepare...I wish you peace in this terrible time of unbearable grief.
Dr. Nissen is a politically ambitious person who is a frustrated 'wanna be' chief of the FDA and architect of a U.S. single payer system...After a fast start in his career, he has been thwarted in achieving his goals...and has improbably chosen to criticize Vascepa as a means of retaining notoriety...aided and abetted by people like Feuerstein and Herper, who are mainly interested in the volume of subscribers to their newsletter.
CBB...QUOTE "Cardiologist goes toe to toe with drug companies - Nov 1, 2005... Dr. Steven Nissen was the first physician to link Vioxx to increased risk of heart attack and stroke."
Dr. Nissen achieved success and notoriety from his successful attack on Vioxx... He is eager to preserve and extend his reputation by attacking other drugs...With the failure of his Strength test, which cost Astra Zeneca over a billion dollars i.e. from their ill advised purchase of Omacor and the subsequent AZ study which failed to show reduction of CVD.
Vascepa,which, to Nissen's consternation, actually succeeded in reducing CVD, looked like a good candidate to attack...in order to restore Nissen's reputation.
The Brave study is involved in Vascepa's ability to delay the onset or reduce the incidence of ALZ in cognitively healthy indivduals....QUOTE
"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."
Most previous studies have focused on whether reduction in already established amyloid plaques in the brain can improve ALZ once it is present...and they have failed....This study seems to have a greater chance of success since the anti-inflammatory effects of Vascepa should be helpful in delaying or reducing ALZ.
Amarin's Marine patents for very high trigs were invalidated by Judge Du...Generics are now capitalizing on this invalidation by the court by infringing on Amarin's R-IT patents and selling Vascepa for the CVD indication...Could they use the same strategy if the FDA approves Vascepa for the Alzheimer's indication?
Rose...Since the Brave test was started 5 years ago, I have a feeling it will end on schedule in Jan 2023...and I agree with sleven that it is an invasive study (e.g. it includes serial spinal taps) and it would have been stopped by now if there was no evidence of effectiveness....The following is info on the study...
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Icosapent Ethyl on Alzheimers Disease Biomarkers in Preclinical Adults
Actual Study Start Date : June 8, 2017
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023
Even though BRAVE is a small study...considering the severity of Alzheimers and the safety profile of Vascepa, IMO the FDA would react positively to a statistically significant result.
Bio...In the case of a combo with a Statin and Vascepa, a blister pack would seem to have the edge over a fixed dose combination.
1.It requires less research
2. It would be easier to manufacture
3. It could employ several different doses of statin combined with 4 grams of Vascepa
4. it would be easier to get FDA approval
5. It requires less investment of cash from Amarin
6. It further enhances the protection of the Vascepa EPA from oxidization...and thereby enhances shelf life
Bio...QUOTE..."REDUCE-IT randomized 8179 'STATIN -TREATED PATIENTS'(i.e. in combination with Vascepa or placebo) with qualifying triglycerides ≥135 and <500 mg/dL and low-density lipoprotein cholesterol >40"....
R-IT was a phase 3 study, which already showed that a combination of treatments with a statin plus Vascepa was safe and effective in reducing CVD.
This 'combination' has already received approval from the FDA...This IMO makes it unlikely that the FDA would now demand that Amarin repeat this study in order to have an approval of an NDA for a STATIN-VASCEPA combo drug.(especially if presented in a blister pack)
Nsleven...Statins are known globally as an effective treatment for CVD... Vascepa is less well known...Vascepa, being associated with a Statin in a combo drug, would help it to get better known and would also help Vascepa sales...In addition, a combo drug, priced at about the same as Vascepa (Amarin could add little or nothing to its selling price for its inexpensive expense for the statin), would be profitable IMHO.
North..In my layman's view, if Amarin combines Atorvastatin and Icosapentethyl and sells it as 'Statinplus'...and Amarin has a valid patent on the combo....would not the company selling a combo drug, combining a generic statin with gV, be infringing on Amarin's patent....KM and I believe the generic company would be infringing...Please explain why KM and I, who believe that Amarin would have exclusivity(as KM said today) I are wrong.
Rose..."QUOTE friom KM..."The fixed dose combination or FDC product is in the early stages of development. If successful, the combination therapy would be a game-changer for patients since it will carry the most significant cardiovascular risk outcome benefit label and would hopefully "PROVIDE ADDITIONAL MARKET EXCLUSIVITY"
I am wondering why this is still in "the early stages of development"...rather than having been initiated immediately after the Du decision and the subsequent failed appeals....Someone in management was asleep at the switch.
ILT....I believe that Lipitor is the statin with the longest history and the largest volume of sales and would be a good fit for a combo drug with Vascepa...Crestor would also be a good fit.
I have been on 80 mgms of lipitor daily. supplemented with 4 gms of Vascepa 4 times a day...in addition to several other meds...I would be eager to switch to a combo drug.
Amarin could call its statin-Vascepa combo..."super Vascepa"
mr main...Amarin holds the patents on fixed dose combos...The generics would be infringing on Amarin's patents if they used their gV in a fixed dose combo.