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IMO the future for Vascepa is inevitably one of lower prices and higher volumes...This could be appealing to some BP's, whose business models are currently based on drugs with quite high prices and low volumes...Low priced, life saving Vascepa affords those companies the profile of being moral companies, dedicated to supplying drugs, which are more affordable to enhance the health of multitudes of people.
Even Bernie sanders and Elizabeth Warren, Who are both constantly criticizing BP for their high drug pricing, could approve of that idea.
Vaskepa has been available to "medical tourists" in Hainan island since early 2021....Vaskepa has already been used by a large enough number Chinese residents to allow government officials to have a a good appraisal of the risks and benefits of the drug...The remaining question to be resolved now is the cost to the government for supplying Vaskepa to mainland Chinese patients...vs.the cost of CVD to the nation.
Pdude...Once Amarin lost its case in the ninth circuit, J.T.'s GIA strategy became inoperable...Eckmen and PWO really didn't care about Amarin and KM stubbornly refused to concede what was becoming more and more obvious.
With enough cash, Amarin might have been able to make the GIA plan work, but things changed suddenly after judge DU's faulty decision....and the old management didn't seem to realize that fact.
Pdude...I agree that Denner may have wanted KM to stay. However Europe was not going well and it became obvious that Denner's plan was to sell Amarin to a BP...Both PWO and KM were NOT in sync with that plan...that left Denner with no choice, but to enter into a bitter proxy fight....KM sided with PWO and Denner won the proxy fight in a landslide...Then KM felt he had to resign to save face.
Tatsu...QUOTE..."why is Mochida and Sumitomo running P3 trials in China with it and not Amarin?"
Amarin is still waiting for approval for Vascepa in mainland China....
Future Chinese government approval for MND-2119 will allow Amarin and Mochida to continue their "COLLABORATION" and their "COMMERCIALIZATION" of this new drug in China as per their agreement.
Tatsu...The agreement between Amarin and Mochida,for which Amarin paid Mochida $2 million of their precious funds in 2015,contains the following clause... QUOTE "The COLLABORATION is focused on the DEVELOPMENT and commercialization of early-stage drug products and indications based on the omega-3 acid, EPA (eicosapentaenoic acid)."...I would assume this covers your concerns.....This is NOT just a purchase of MND-2199, but a plan to DEVELOP it in partnership with Mochida and commercialize it everywhere, but in Japan as the agreement spells out.
Why would Amarin have made this investment if it could then be lost due to a change of ownership?...John Thero, the CEO of Amarin at the time, was not stupid.
Sleven...No news of the FDC that Amarin has prevously said that they are working on...This will take additional cash to develop, to seek approval from the FDA and to market...cash that Amarin is not willing to expend at this juncture.
The same factors hold true for a FDC with MND-2119
This is another reason why Amarin has to be sold to a BP.
The Brave study, scheduled for completion in September this year, involves serial spinal taps. These are invasive procedures....Since the study has not been stopped for futility, I assume that there are at least some positive results at this time and that the study is being continued to see if Brave can yield results closer to statistical significance.
With positive results from Brave, even though they may lack statistical significance, the FDA could IMO approve Vascepa, with its placebo like safety profile, for the treatment of such a debilitating condition as Alzheimers disease.
I continue to think that the future of Vascepa will be dependent on low prices and a mass market...in China, in Europe, and in The U.S. and the ROW.... Vascepa has been proven effective in reducing CVD and has been proven as safe or more safe than statins (especially when comblned with statins)...and, in time, Vascepa will join statins in the role of a globally accepted drug.
Amarin may be going away, but Vascepa will NOT be going away!
My take on the present situation with Denner and Amarin
-When Denner came on the scene, PWO realistically regarded Denner as a threat to himself and decided not to play ball...
- KM decided to throw in his lot with PWO and the dye was cast....
-KM was cognizant that Denner's main goal was a sale of Amarin and he decided not to stay if Denner won...
-An inevitable bitter proxy fight ensued between the two sides...
- When Denner won the proxy fight in a landslide, it became inevitable that he would want a majority of his people on the BOD....Most of the old BOD understood that fact and opted to resign.
-Denner didn't reject KM's strategy as much as he rejected PWO, which he made clear during the proxy fight.
-Now Denner will do his best to increase the Amarin price/share while looking to sell the company to a BP.
ramfan...If/when China grants regulatory approval to Vascepa, Amarin will have some business advantages over other manufacturers of EPA.
i.e. Amarin will have a head start, since they are already marketing Vascepa in the U.S., in Europe and in the ROW...This means Amarin will be able to buy larger volumes of EPA than any other manufacturers...This will allow Amarin to request and receive lower prices for their purchases of API while still maintaining profitability.
JR..I disagree that Pfizer is out of the running...Haleon, a non- prescription drug company is 32% owned by Pfizer and they have announced plans to sell their stake in the company...This will provide them with several times the amount of cash they need to buy Amarin without the need for borrowing to make the deal.
Regulatory approval is expected in China by mid year according to AB...This can change the whole picture for Amarin...It can mean...
-High volumes of sales of Vascepa in China
-Lower prices for Vascepa in China...
-leading to lower prices for Vaskepa in Europe and Vascepa in the U.S.
-leading to an AG in the U.S.
-leading to more profits from the increased volumes, which can fund Amarin to advance new products such as a FDC and MND-2119(which are not presently consistent with Amarin"s recent policy to conserve cash)
This is reminiscent of John Thero's old prediction that Vascepa's destiny is not to be a price play...but a volume play!
Starbucks announced their quarterly earnings figures today...among them were...China Same-Store Sales:up 3% versus expected down 9.86% ....
The Chinese economy is in the recovery stage from the terrible recent Covid pandemic... The health of the people in China would benefit more if the cash was spent on Vascepa instead of on coffee.
Rose...I agree that the drop in SP from about $2/sh to where is is now is mainly based on expectations of a poor Q1 report....To begin to turn things around, Denner will need to initiate some new strategies, providing for future revenues and earnings, to get the SP up before a sale of the company...Cutting expenses was a necessary step...but not enough...Barring unanticipated good news, plans such as a FDC or an AG could be considered in an effort to elevate the SP....Challenging times call for challenging strategies.
A combo drug from Pfizer and Astellos proves effective...
QUOTE..." Pfizer, Astellas Xtandi combo cuts risk of death by 58% in prostate cancer patients
Pfizer (NYSE:PFE) and Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY) said Xtandi (enzalutamide) plus leuprolide significantly reduced the risk of metastasis or death by 58%, compared to the leuprolide placebo combo in patients with a type of prostate cancer in a phase 3 trial."
How about a combo drug with Lipitor plus EPA significantly reducing CVD compared to Lipitor alone!
Denner has not made money by buying companies and the trading them...He has made his money by buying undervalued companies and then selling them.
IMO Attempts to salvage the U.S. market by patented products, dedicated only to the CVD indication should be instituted ASAP.
Rose...I agree that it is time to return to the U.S. market, preferably with a patented product exclusively aimed at the CVD indication.... rather than the high triglycerides indication...which is currently being used by the generic companies as an illegal loophole to infringe upon Amarin's CVD patents.
Now is the time for Amarin to refresh the U.S market with a FDC, containing either a statin plus Vascepa or a statin plus MND-2119 in either a blister pack or a statin sprayed onto an EPA gelatin capsule....I hope AB will be discussing, in detail, the advisability and feasibility of these potential new products for Amarin at the C.C. on May 3.
Nsleven.... "In some embodiments, the statin is sprayed, coated or layered on to an exterior surface of the capsule shell."...
When this spray on version of a FDC...or a blister pack version of a FDC, is chosen for marketing...regardless of the volume of sales or the revenues the new product achieves, it will serve the important purpose of informing patients and Docs that, for optimal results in reducing CVD, a statin and Vascepa should be used together on a daily basis....This is a message that has not yet been widely enough disseminated....linking the name of a widely used statin with Vascepa is a definite plus.
W...Current low trading volumes in Amarin suggest that is not the case....Its in Denner's interest, as much it is in shareholders' interest, to see a increase in Amarin's current stock price.
Rose...I assume the amniotic fluid comes from pregnant woman....The fluid has got to have multiple proteins in it, the effects of which are not known...I'm surprised that Regeneron would even sell such a drug OTC...without evidence of safety or effectiveness...The revenues must be enticing.
Vascepa, as an anti-inflammatory drug has been mentioned as a treatment for the condition of Dry Eyes, which is due to inflammation of the lacrimal gland...However, Amarin has no cash to do studies to prove this, even though there is a large market for the indication....
e.g...Regeneron has been selling 'Regener-Eyes' ,an OTC product for Dry Eyes, in effort to capture this large market.
QUOTE from the FDA..."Be wary of unproven eye drop treatment with amniotic fluid,"
"There is no evidence that amniotic fluid is safe or effective for Dry Eyes."
I, as a retired ophthalmologist, would tend to agree with the FDA...There is no evidence that amniotic fluid is safe or effective for Dry Eyes...Dry Eyes are are "crying out" for studies to be done to show that Vascepa is safe and effective, as IMO, Vascepa definitely is.
Company share repurchases don't always work out well....e.g. https://www.cnn.com/2023/04/25/business/bed-bath-beyond-share-repurchases/index.html
District court Judges, as well as appeals court judges, many of whom have little scientific background, seem quite willing to substitute their judgement for that of the officials at the patent office, who generally have a much better scientific background.
Patent laws allow for an exclusive time period to let brand companies profit as a reward for the their innovations, plus their time, and their treasure, as they work to invent new drugs, test them, and get approval for them.....generic companies are mainly interested in making a profit on the hard work of brand companies... without participating in the expenses or the downside when their inventions fail despite their efforts.
Amarin has a going business... Even if one concedes the U.S. market, Amarin has to be worth more than its present price per share.
Capt..Thanks for posting this interesting article, which expands on the Evaporate study...
A very short summary of the abstract...
QUOTE..."The EVAPORATE trial demonstrated that IPE significantly reduced plaque burden. No study to date has assessed the impact of IPE on coronary physiology. Fractional flow reserve (FFR) derived from coronary computed tomography angiography (CTA) data sets (FFRCT) applies computational fluid dynamics to calculate FFR values in epicardial coronary arteries. Our objective was to assess the impact of IPE on coronary physiology assessed by FFRCT using imaging data from EVAPORATE....
Conclusion...
Icosapent ethyl demonstrated significant benefits in coronary physiology compared with placebo. This early and sustained improvement in FFRCT at 9- and 18-month follow-up provides mechanistic insight into the clinical benefit observed in the REDUCE-IT trial. Furthermore, this is the first assessment of FFRCT to determine drug effect on coronary physiology assessed by FFRCT using imaging data from EVAPORATE."...
We are getting ever closer to the mechanism by which EPA(Vascepa) reduces CVD.
P.S....to Dr. Nessen...MINERAL OIL HAD NOTHING TO DO WITH THESE FINDINGS!!
Rose...For many reasons, this time seems right for negotiations for a sale of Amarin...I would not be surprised if negotiations were presently going on with one or more BP's.
W.S. has priced Amarin as though it was a start up company, but it is NOT a start up.
Neither insurance companies nor government programs are going to continuously pay hundreds of thousands of dollars per year per patient for drugs, especially in this difficult economic environment...There will inevitably be a movement towards lower priced drugs.
PFE could easily buy Amarin for a tiny fraction of the $43 billion it paid for Seagen, an amount, which was largely earned from recent cash earnings from Commiraty and other products.
"Pfizer's net debt of $1B does not even account for PFE’s ~$10B stake in HLN, which can be monetized at any time... Accounting for the HLN stake (on an after-tax basis), PFE has NO net debt, but rather has net cash of $5-10B."
Seagen was bought for its high priced molecules for cancer...It would be nice for Pfizer to offset this with Amarin's low priced EPA molecule for CVD
Capt...in a form 10K, Amarin released the following about the agreement with Mochida..."We exercised certain rights under the agreement, resulting in payments of $1.0 million in each of January 2020 and December 2020, respectively, to Mochida."
I assume Amarin was speaking of the agreement signed with Mochida in 2018...
The 10 K says Amarin paid Mochida $2 million for some "rights under this agreement"...but we have never been told what these "rights" were....Even though it seems like this may now be vital information.
I hope a question is asked about this Mochida agreement to AB at the next C.C.
Capt...This increased efficacy of MND-2119 in getting EPA into the bloodstream opens the the door for a ONCE A DAY combo drug containing a statin plus MND-2119,which would be equally effective as the present four times a day Vascepa dosage regime....and would markedly improve patient adherence.
Vascepa plus MND-2119 would be patent protected in the U.S. and could be marketed under the name ANTI-CVD...This new product could be priced about the same as Vascepa, with Amarin absorbing the price of the statin.
it should not be difficult to get FDA approval for the drug.
After the excellent results of the R-It study were released, GIA became a viable strategy to promote Vascepa in the U.S. and worldwide...but once Judge Du made her totally unexpected decision, Amarin management was shocked and paralyzed and failed to recognize that everything had suddenly changed...Then J.T. plus Ekman plus PWO were slow to wake up and realize that a new strategy was needed...A change in management then became necessary to put into place this new strategy....Enter Sarissa and Denner.
Prior to Judge Du, J.T. would not have accepted an offer for Amarin of $50/sh...Now Denner can accept an offer of $10/sh
Sleven...I believe that by appointing AB as CEO, Denner has signaled a renewal of interest in Vascepa for the U.S. market, either as a solo dug or as a combo drug with a statin plus EPA .
Sleven...Sarissa is an activist investor who invested many millions of dollars from his fund in Amarin due his understanding of the science and economics related to Vascepa...He has had previous success in buying troubled companies and fixing them, and selling them....IMO, PWO and KM had not demonstrated these skills and that is why I voted for Sarissa in the ensuing proxy fight in preference to the old board....I shared the belief with Denner that Amarin needed to be sold to fully develop the potential of Vascepa.
Sarissa was Amarin's largest shareholder, and believed that Amarin needed to go in a different direction...Denner was asking for two or three seats on the board, but PWO was intransigent...so Denner had no choice but to take the course that he eventually took...especially after PWO started appointing his own new people to the board.
CBB...I agree on Eddingpharm..AB needs to have a talk with them to find out whether they are still interested in promoting Vascepa in China...or whether they would prefer to get back their $15 million up-front payment to Amarin when they signed their agreement with Amarin in 2015...and have another firm in China take over the Vascepa portfolio.
QUOTE from SA article..."With several large M&A deals involving biotechs being acquired so far in 2023, RBC Capital Markets says such activity could be on the rise ahead.
Given recent M&A activity, we "remind investors that there remains M&A appetite among large pharmas, and to continue to propel the small/mid-cap biotech space off of its recent lows."
I agree that a Eurocetric BP could benefit from buying Amarin, especially at these ridiculously low prices.