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CBB...I agree...I suspect Denner has already been in discussions with BP's...Now he needs cooperation from the BOD.
Things that Amarin can do now that would not deplete their cash assets.
1. apply to the FDA for approval of MD-2119 for CVD
2..apply to the FDA for approval of of a fixed dose statin-Vascepa combo
3. apply to the FDA for approval of a fixed dose statin MD-2119 combo.
If there is to be a problem with these requests, it would be beneficial to know ASAP so Amarin can do whatever is necessary to rectify the situation.
JRoon..."QUOTE...Zip, what exactly has the BOD done/not done that makes you believe they "don't care"?
The BOD didn't care to support the EPADI , appeal, which stood a chance of overturning the decision by judge Du...thus restoring the U.S. market for Vascepa to Amarin....Their lack of support, predicated on their own interests not to be embarrassed by the mistakes made by their outside lawyers and their own in house lawyer, doomed the case.
Marjac's brilliant appeal brief, to which the EPADI investors had contributed, was ignored by the court...mainly because the Amarin BOD had not supported it.
The BOD does not seem to care about the present roadblock...How does Denner feel about it?
Rose...Amarin has already done much of the work in building the house...Now they need a BP to help fill the house with furniture.
KM was remarkably open in his recent talk at the H.C. Wainright conference...QUOTE
"So fixed dose combination is a very significant initiative. It is supporting the diversification element on our side. When you get a product like VASCEPA with 25% or 30% outcome benefit, it would be a shame not to imagine a full portfolio of products around it....Now because of the cost reduction, and we are very, very cash prudent today, we decided to focus on 1 statin in terms of development and really go sequential in terms of planning....meaning NOT TAKE RISKS to run different phases in parallel."
It is clear that deficient cash is the main factor holding up Amarin's development of a fixed dose combo of Vascepa with a statin or MD-2119 with a statin.
Amarin can not raise cash by selling their low priced stock or by borrowing at high interest rates...one solution is to sell to a BP flushed with cash....IMO pure EPA would have a much greater greater future in the hands of a BP than in the hands of a small cash poor Pharma.
Perhaps my most important consideration for supporting Amarin to be under the aegis of a BP...is that Vascepa is a potentially powerful drug for many conditions, other than just CVD...and Amarin, after the decision of the ninth circuit, has been deprived of enough cash to properly pursue the R&D for these indications.
KM does not intend to talk about fixed dose combos until 2023...QUOTE...(thanks to ggwpg)
"we decided to focus on 1 statin in terms of development....and really go sequential in terms of planning, meaning not take risks to run different phases in parallel because you can do that and save time....
But we are encouraged by the progress we're making. So far, we have made very, very little -- very few public statements because we believe the minute we talk about this, THERE IS COMPETITIVE RISK. But some time in 2023, we will talk not only about the product, what it will bring and the value, but what sort of protection can come with it and so on...
So we are very encouraged with the fixed-dose combination, and it's a significant part of our future fixed-dose combinations in general."
I am betting that the fixed dose combo with statin and MD-2119 makes the most sense.
Capt... "The combination is not. That’s why they’re being cautious. (IMO)"
......Also, MD2119, which, while it has been approved in Japan...has not yet to our knowledge, been submitted for approval to the FDA.
Lizzy...KM mentioned that he was looking at a fixed dose combo bill for the future...What he did not discuss, was whether he would use MD-2119 for the combo instead of Vascepa...or whether he was going to push ahead with MD-2119 as a once a day drug...He did mention something about not discussing trade secrets.
ROSE...Perhaps KM was saving discussion of MD-2119 for the more important AHA meeting on NOV 5-9 when it have a bigger effect.
TTE...The H.C. Wainwright investor conference will be webcast at 9:00 A.M. EST...I expect KM to include an important discussion of Amarin's plans for MD-2119 development in the U.S.
Capt...Apparently a serum EPA level of 150 or more is necessary to achieve 20% or more lowering of CVD events...
The figures on your charts indicate that a dose of 2gms./day of MD2119 should be sufficient to yield this effect. (i.e. from Jelis and R-IT studies.)
Capt...You bring up an interesting topic...I believe the potential importance of MD-2119 to Amarin's future has been vastly underestimated.
If once a day 2 grams MD-2119 prove to yield as high serum EPA levels (or higher serum EPA levels) as 4 grams of Vascepa, it could lead to Vascepa being replaced in favor of MD-2119....as a mono therapy or a combo therapy with a statin.
North...re Rx of Alzheimers...." proteins in their neurotoxic aggregating form impair axonal transport, slow synaptic transmission, cause INFLAMMATION, and ultimately, kill nerve cells"
This is where the anti-inflammatory properties of Vascepa can come into play in Rx of Alzheimers.
Pdude...Excellent post ...
Quote..."The arbitration committee sees this regularly and has the power and independence to offer a reasonable price (although 90% of the time it is lower than the rest of EU but that is expected as they are the biggest market)."...
China, being a market, about ten times larger than Germany, is also expected to argue for a lower price....EPA will have global acceptance...as a safe anti-inflammatory drug, to be used for chronic conditions with an inflammatory component.
"Could 2 gms of MD-2119 taken once a day be as effective as one gm of Vascepa, taken four times a day?"
If this is turns out to be the case, Vascepa could be removed from the market and replaced by an even better and patented drug...MD-2119.(i.e. emulsified EPA.)
Amarin needs to do lab studies on this ASAP.
The levels of serum EPA are what are effective in reducing CVD.
We know that EPA levels are higher with 4 gms/day of Vascepa than with 2 gms/day of Vascepa.
Do we have any information as to whether EPA levels are as high with 2 gms/day.of MD-2119...as compared with 4 gms/day of Vascepa?
...i.e. Could once daily 2 gms of MD-2119 be as effective as one gm of Vascepa, taken four times a day?
dogn...QUOTE..."Mochida to Roll Out Once-Daily Epadel on Sept. 12"
Coincidentally, that is the same day as the H.C. Wainwright C.C....Perhaps KM will announce Amarin's intentions with regards to MD-2119 during that call....Also whether Amarin has plans to use MD-2119 in a fixed statin-MD-2119 combo drug.
If Amarin sets the price for Vascepa in the Netherlands at 150 Euros, the price will be negotiated downwards from that point by every European country and will be renegotiated downward every year until Vascepa eventually sells at OTC prices.
IMO Amarin does not have a choice of yielding to blackmail.
If once a day patented esterified Vascepa and/or patented fixed dose statin-Vascepa reclaims the American market, Amarin will not have to give Vascepa away for ever lower prices, as dictated by national health services.
Lizzy...QUOTE..."Dr. Juliano served as the SVP of Clinical R&D at Amarin Pharma"...Its a shame Dr. Juliano didn't think to develop an emulsified EPA at Amarin even before Mochina did...Amarin would have done better to employ the director of R&D at Mochida.
EPA care is a long term proposition...Patients would rather not inject themselves long term...unless they absolutely have to.
Amarin needs to perform a short term lab study of EPA levels in patients taking one 2 gram dose of MD-2119 a day vs. those taking two 2 gram doses of MD-2119 a day...and compare the EPA levels in each group...with those EPA levels known from previous studies to have been effective in reducing CVD.
It may turn out not to be necessary for Amarin to produce a four gram capsule of MD-2119...and just seek FDA approval for the two gram version.
If necessary, MD-2119 can be used morning and night...It is still better than taking four 1 gram capsules a day....especially since many patients taking Vascepa have multiple meds to take each day.
Rose...QUOTE..."Also has anyone heard the timeline before this becomes something available for sale here?"
I assume this will be discussed at the H.C. Wainright conference on September 12....Amarin's initial step will be to seek FDA approval for this self emulsifying drug.
This innovative EPA product divorces Vascepa further away from its public perception as "just a fish oil"...an attitude, which was expressed by judge Du in an interview by a magazine shortly after the trial that gave rise to the "skinny label" debacle.
Is this H.C. Wainright meeting going to be just more boilerplate and pap?...or is Amarin going to announce some really important changes in direction?...The latter is definitely needed and pretty soon.
Amarin doesn't need a firecracker...It needs a bombshell.
Tasty...Well said!....If Congress is interested in saving lives, they should proceed with reform of the H-W act to stop encouraging the practice of "skinny label " infringement, which is discouraging the public from getting information about life saving drugs...as well as discouraging companies from innovating to find new indications for existing drugs... Under the present scenario, once any patent for a drug is successfully challenged, all other indications for the drug in question have lost exclusivity.
A change in H-W should appeal to liberals as well as conservatives.
Amarin needs to redirect their limited assets back to the U.S. for the following projects:
1. continue to vigorously pursue legal remedies to mitigate the "skinny label" infringement siuation..
2. pursue FDA approval of a once a day EPA and initiate a marketing campaign for it
3. expedite a strategy for a fixed dose combo of a statin with Vascepa and initiate a marketing campaign for same.
4. expedite a strategy for a fixed dose combo of a statin with a once a day EPA and initiate a marketing campaign for same.
Amarin can not, at this time, afford to sit still and wait for GIA in Europe to bear fruit.
Perhaps Amarin, finding a partner for Europe, might be in order.
The important suit is Amarin vs. Healthnet...If settling the suit against Hickma expedites the suit against Healthnet, then I would be in favor of it.
Both are guilty, but Healthnet is easier to prove.
If BB really want out, perhaps they could sell their position to Denner.
Recent studies published in June of this year revealed that...
"Smoking rate in Germany rises to 33 percent after COVID pandemic"
I wonder if today's news that Vaskepa reduced CVD in smolkers reaches regulators for the national health system in Germany.
"Smoking rate in Germany rises to 33 percent after COVID pandemic
Smolking is even more common in China, where more than half of adult men are smolkers
"New REDUCE-IT® Data Show VASCEPA®/VAZKEPA® (icosapent ethyl) Reduced Cardiovascular Events in Patients Who Are Current or Former Smokers • GlobeNewswire Inc. • 08/28/2022 09:51:00 AM"
I am eagerly awaiting positive results from the Respect and Mitigate studies, but I doubt that Dr. Nissen's ego will ever let him publicly backtrack from his statements that MO played an pivotal role in Vascepa's successful R-IT studies....He will now conjure up reasons as to why Respect and Mitigate are not to be "Respected", even though no MO was used in these studies.
And he will still say the his former junior associate, now a professor at Harvard Medical School, was wrong.
Dr Nissen established his reputation as a disruptor of FDA approved meds by pointing out their side effect profile...e.g.Vioxx)
....somehow, I doubt that he will choose to do that with AZ's Farxiga.
Since Dr. Nessen was unable to challenge Vascepa's side effects(which are minimal), he seized on the MO scam to try to maintain his disruptor reputation.
In some areas, evidence is not the most important determinant of opinion. There are those who are believers in religion and those, who are not... and evidence does not seem to change many minds..The issue of whether MO is important or not in skewing the results of the R-IT study seems to be an example of this phenomenon.
Until your insurance kicks in, Farxiga costs from $250/month to $550/month depending on where you buy it.
Farziga has serious side effects, e.g....headaches, yeast infections,flu like symptoms,rash, allergic reactions,sore throat, loss of voice, excessive urination...perhaps the most serious side effect is hypoglycemia in diabetics
CBB...QUOTE...So, I ask again: "Why are you prescribing Lovaza/generic Lovaza?" ....Answer is that the price of Lovaza is lower than that of Vascepa.
One...Why not presently incorporate Vascepa and a statin into a blister pack and sell it for the same price as Vascepa alone?
In the future , Amarin could sell a once day MD2119 coated with a statin...(or MD2119 plus a statin in a blister pack)...at a higher price.
ILT...the situation in the EU is about negotiation for the lowest price for Vascepa obtainable by the regulators for their national health services... more than about MO...although the Nessen inspired debate on MO is something they can use during the negotiations...even if it is to the detriment of their countrymen.
At the heart of Amarin's case is a conspiracy to infringe against both Hickma and Health net...judge Hall agreed with Amarin, but judge Andrews did not...so why not proceed with the bird you have in hand?...instead of combining the case against Healthnet with the case against DRL, in which Amarin has less evidence of infringement than they did with Hickma?
Amarin can still pursue Hickma(which judge Andrews denied WITHOUT PREJUDICE) at a later date...as well as against DRL.
Capt...We agree that DRL is infringing, but why include them in the case...when they have a slam dunk case against Healthnet?
The Cherry study showed Vascepa to be akin to a "liquid stent"...