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Dar...It would be nice to have Denner buy 50M worth of Amarin shares and also to have Amarin CEO, Berg, declare a buy back of 50M shares...but I assume that might give rise to suspicions of insider trading.... it would certainly generate a lot of publicity about Amarin...Actually, either one of these moves would be helpful.
At some point, possibly after the German debacle, KM decided he had little to lose by following a GIA strategy and allowing Amarin to slowly bleed to death, while he continued to collect his compensation as CEO...He wasn't anxious for Amarin to be bought by a BP, which would have probably meant the the loss of his job.
PWO had already given up on Amarin and he didn't care either.
When Denner had the courage and the faith to invest 100 million dollars in Amarin, he became the shareholders only hope...this explains his overwhelming victory in the proxy battle.
I just received a call from Amarin yesterday and I voted all my shares in my several accounts and those of my family, for Denner's slate of directors...Denner needs our support to to do his job.
Rose...Will there any penalty exacted on Hikma, if they lose their case?...or is it an all upside, no downside situation for Hikma.
The Hikma vs. Amarin case is an excellent example of a generics company initiating a low risk and low expense litigation, i.e. low expense for themselves, with the purpose of invalidating a drug patent, which addresses a small market... for the end purpose of infringing, off label, on a still valid drug patent, which addresses a larger market... the goal being to score huge profits, without serious risk of adverse consequences...This scam is obvious to legislators and to the courts, but no one really cares....because lower prices today are politically advantageous, even if we have less innovation tomorrow.
DAR...the bi-weekly injections(I.V. infusions)...would mean a trip to a Doc's office every other week or to a clinic...or require a home visit by a nurse...This would add to the already high expense of the drug....It seems impractical....even if it were much more effective than it is reported to be.
QUOTE..."It's given every two weeks as an infusion, so patients will need to visit a hospital or clinic twice a month for the treatment."
Bring on Vascepa!...effectively addresses the cause of Alzheimers (i.e. inflammation of the brain)...effective...placebo like side effects...given orally ...inexpensive.
This Alzheimers drug is marginally effective... has severe side effects...has to be given by infusion... and is very expensive ...It wets my appetite for Vascepa as an Rx for Alzheimers.
Sarissa has followed the time, dishonored, tradition of the old management of Amarin, which was to give shareholders as little information as possible....Amarin's past performance has proven...that in the total absence of any potentially optimistic information about future currents from the captain of the ship, the best policy has been to expect the worst...and to abandon ship.
Amarin has recently been a company that made its shareholders sick and urgently in need of medicine(any good news)...but, according to an old saying, a spoonful of sugar(i.e. potentially good news) can make the "medicine go down in a most delightful way."...(apologies to Mary Poppins)
Amarin is a sponsor of the U.K. heart symposium and I can't find any news about it on their website...Is Amarin keeping the symposium a secret?
Mochida and Amarin agreed to 'collaborate' on EPA products in 2018...
Then, two years later Amarin issued this PR...QUOTE "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."
We do not know...
1. What royalties in the agreement, if any, would be due to Mochida for selling MND-2119 products in the U.S.?
2. Would this agreement cover an Amarin combo product with MND-2110 plus a statin?
3. Would Amarin need FDA approval for either an MND-2119 drug or a combo drug with MND-2119?...If so....
4. Would this 'collaboration' agreement survive a sale of Amarin to a BP?
At the time of the proxy fight, there was a misalignment between the goals of KM and Sarissa...KM wanted to keep Amarin afloat and remain as CEO. Denner wanted to get the price up and then sell the company...KM did himself and the shareholders of Amarin a favor by resigning.
TalShu...Thank you for this instructive post...It has been almost a year since Steve Ketchum said in August 2022...“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”
Ketchum's field is research, not marketing...Berg's field, however, is marketing...Perhaps Berg, in consort with Amarin's legal department, could provide some guidance about the 'ADDITIONAL MARKET EXCLUSIVITY' remark of Ketchum...Does Amarin have a patent on a FDC?....Would the exclusivity depend on a FDC being a new product?...even without exclusivity, a FDC would still carry the 'significant cardiovascular risk outcome benefit' label....as opposed to the generics, which do not have approval for CVD reduction.
KIWI...In order to begin taking Vascepa. the triple by pass patient would have to first have an Rx from his DOC, could access the whole situation....
I have been on blood thinners and Vascepa for 8 years with no bleeding episodes.
jas...I agree with there is a new inconvenience caused by the recent disappearance of the ability to only clic on "newer...but, not "older"... for those posters, who want to retrieve older posts...I came to this board back when J.L. switched us posters from a previous board... after the other board had decreed that there be only very short posts...I hope that IHUB does not implement that as a next decree....I also notice that the adds are getting inconveniently larger, now taking up about a third of the screen...
KIWI...most recent metabolic studies of March 2023...
"CHOLESTEROL 152 mg/dL
TRIGLYCERIDES 60 mg/dL
LDL 71 mg/dL"
I eat no meat, chicken, or fish.
I spoke to an acquaintance yesterday, who's brother is scheduled this coming week to have a triple by-pass...The brother had never been prescribed Vascepa...and my acquaintance had never heard of it...I advocated for him to ask his brother to consider Vascepa if possible, before the triple by-pass, or even after it.
ORB...I agree...Patients, who are intolerant to statins,can take a pcsk9 inhibitor to get their LDL down... but then, in addition, they should also take Vascepa....For those, who can tolerate them, statins are much cheaper and easier to take than pcsk9s...and statins come in a variety of strengths, which does make packaging a FDC something of a challenge.
Orb...I have taken 80 mgms. of Lipitor since 2010 when I hard my first heart attack...At that time, I had one stent placed...My LDL, which was well over 200 mgms./dcl prior to the MI, has been normal since being on statins......My second heart attack came eight years ago, with two stents being placed...That was when I started Vascepa and I have been OK since....IMO, patients, who have had an MI and are not taking statins PLUS EPA, are playing Russian Roulette....That is why I am "obsessed" with a FDC...
Let patients know that statins PLUS EPA can reduce incidents of CVD.
capt....This announcement is very important...not only because Vaskepa will now be available to patients in Spain...but also because it heralds the era of further acceptance of Vaskepa as a vital drug for reducing CVD, one of the scourges of humanity.
For most patients taking 'Statin-Vascepa-CVD' FDC, a package with 2 to 4 tabs of 40 mgms. of Lipitor attached to the bottle of Vascepa would be appropriate...For those on 10 or 20 mgs. of Lipitor... they could still buy the Vascepa and Lipitor independently.
An excellent way to alert Docs as to the value of EPA in reducing CVD...is to let them know that, while they already recognize that statins are effective in reducing CVD...statins, taken together with EPA, are EVEN MORE effective...Statins are very cheap and could provided FREE to patients with the EPA...A small package of statins could be attached to a bottle of EPA and marketed as a FDC product with the same price as Vascepa...with the brand name...'Statin-Vascepa CVD'.The increase in prescriptions would more than cover the increased costs to Amarin.
Tats...The statin-Vascepa FDC could be named Vascepa CVD or statin CVD to discourage generics from infringing...It would also be especially helpful if Amarin had a patent on a FDC, which has actually been suggested by previous IHub posters.
A blister pack could contain 20 Vascepa capsules and 10 smaller statin pills in each card with at least 5 cards or more to a box....
I have seen such packages in an OTC blisterpack med...The manufacturing should not be that difficult or expensive.
My daughter has been unable to get her Doc to prescribe Vascepa and uses Pharma EPA Restore instead, which comes in such packages with blisterpacks
The most efficient path to a FDC with a statin plus Vascepa is....from perspectives of research, government approval and marketing, is apparently a blister pack product, which could be accomplished on fast track at relatively small expense...
Why not apply now for approval from the FDA and from the ROW for such a product...A FDC in a single tablet form could be put on the back burner while the blister pack product paves the way to acceptance and profit.
JR...Lilly tiptoed into SGTX, observed its potential...and then decided to go in whole hog.
cbd...CSPC seems huge...The potential market for Vascepa in China is also huge...Perhaps CSPC could make a deal with Eddingpharm to market Vascepa in China.
rose...SGTX recently did a reverse split just to stay on the Nasdaq list...
QUOTE...Sigilon Therapeutics, Inc. (SGTX) will effect a one-for-thirteen (1-13) reverse split of its Common Stock. The reverse stock split will become effective on Tuesday, May 23, 2023"...
Then Lilly bought it recently at a 700% increase in price....WOW!
QUOTE" Pfizer in pact with CSPC to sell oral COVID therapy in China
07:45 AM | Pfizer Inc. (PFE) | By: Dulan Lokuwithana, SA News Editor
CSPC Pharmaceutical Group Limited (OTCPK:CSPCY) (OTCPK:CHJTF) announced a strategic partnership with Pfizer (NYSE:PFE) on Thursday to launch a local brand of the New York-based pharma giant’s oral COVID-19 therapy Paxlovid in China.
In 2021, the FDA cleared Paxlovid for at-home use to treat patients with mild to moderate COVID-19 who are at risk of developing the severe form of the disease.
The drug, comprising the protease inhibitor nirmatrelvir and the older antiviral ritonavir, has indicated an 86% reduction in the risk of hospitalization and death linked to COVID-19 in pivotal trials.
According to the agreement reached on Wednesday, the two companies will join hands to improve access to Nirmatrelvir and Ritonavir in China, CSPC said.
In 2022, Pfizer (PFE) partnered with local drugmaker Zhejiang Huahai to exclusively manufacture Paxlovid for the Chinese market, where demand for the therapy soared in December as the country emerged from its so-called zero COVID policy."
Who is this CSPC Pharmaceutival group, which will be launching Paxlovid for Pfizer in China?...It is a listed company..and I assume they are much larger than Eddingpharm.
Since "long Covid" is known to be a cause of inflammation in the heart, could Vascepa also be launched in China alongside Paxlovid?
Capt....PFE has already demonstrated an interest in Vascepa in Canada...and is the obvious candidate to promote, in China, a FDC with Lipitor(which currently has substantial sales in China)...in conjunction with Vascepa(which has been currently approved in China)....I would be surprised if there were not already some preliminary BO negotiations going on between PFE and AMRN.... and I'm sure PFE could, upon completion of a BO of AMRN, strike a deal with Edding to promote a FDC in China....The potential market would be enormous.
JR...Does this mean that we retail investors have to see Denner buying a load of Amarin shares...and then have to wait 6 months before a sale of the company...If the price is in the double digits, I would be OK with that scenario.
Nsleven ..The most common side effects include abdominal pain, diarrhea, nausea, and vomiting...plus less common side effects...
"Black, tarry stools.
blood in the urine or stools.
burning, "crawling", or tingling feeling in the skin.
difficulty with breathing when exercising.
fever with or without chills.
headache.
large, hive-like swellings on the face, eyelids, mouth, lips, or tongue.
muscle weakness."
However. it is propitious that the anti-infammatory effect is becoming more recognized as a factor in reducing CVD...This recent increase in understanding may spur appreciation for Vascepa's effect(MOA) on reducing CVD.
Capt....Your information makes me optimistic about the future of Vascepa in the U.K...
Omacor, a successful competitor to Vascepa, has been shown to be useless in reducing CVD....Nessen advised AstraZeneca to buy Omacor for millions of dollars and then spend many more millions for a study to prove its effectiveness in reducing CVD... only to see it fail...Somehow, this embittered Doc came to blame Vascepa for his mistakes and, ever since, he has been bad mouthing Vascepa, which was successful in doing what he had tried to do and failed...This unfortunate episode has caused a stain on the history of Dr. Nessen's career.
Capt....Low cost beats high efficacy every time.
Robin...As long as Vascepa is profitable in the U.S....and there is no pricing agreement for EPA in China, I do not expect an AG for the U.S.
With the present Amarin policy of cost cutting, I expect Amarin to show some profits in the next quarters and this should help the stock price to start rising from its present lows.
Ekman and PWO, whom he recommended for COB, had zero interested in Amarin...KM was doing a good job, but he had no interest in a sale of Amarin, which would have meant he would have to give up his position as CEO...Denner was put in a position where he had no choice but to take the actions that he eventually was forced to take... after trying his best and failing to compromise with PWO.
Then, KM besmirched his reputation by threatening to sue Amarin for terminating his position as CEO, which he had voluntarily resigned....He did a relatively good job under adverse circumstances, but then, IMO, he embarrassed himself with this final ploy.
PDude..."The pharmacy is listing the approved uses of IPE."
The pharmacy is NOT listing the APPROVED use" of IPE....but an INFRINGING use!
Perhaps Amarin can direct its infringement suit against the pharmacy(chain) and/or the insurance company covering the IPE for the UNapproved and infringing use for CVD.
In my entire long life, I have not been sued or sued anyone...But this Dr Reddy infringement seems to me, as a layman, to be ripe for a suite...Where is Marjac when we need him!
Nsleven...re Tats suggestion of Dr Reddy attempting to invalidate the CVD patents in response to an Amarin suite against them for their obvious infringing on Amarin's CVD patents...Hikma did already try to invalidate Amarin's CVD patent at the time Judge Du invalidated the high triglyceride patent in 2020... (IMO a grievous mistake by judge DU, brought on by Covington incompetence and a Hikma fraud on the court)... and EVEN SHE decided the CVD patents were valid.
I would welcome a failed Dr Ready challenge of the Amarin CVD patent in an Amarin vs. Dr. Reddy infringement suite...to help the court determine what compensation should accrue to Amarin for the Dr Reddy infringement of the Amarin CVD patent.
Almost all of the well known cardiologists at the 2013 Adcom were NOT impressed by Jelis and INSISTED on completion of the R-IT study BEFORE they would approve Vascepa for CVD!
ramfan.."the insert describing what IPE is would not be considered infringement because they would claim it's just educational."
YES...It would be EDUCATING pharmacy chains and insurance companies to infringe on Amarin's CVD patent!
Capt...I assume that this explanation by Dr. Reddy of the benefits of Vascepa was cleared by their legal department...but I would still like to hear, in court, how Dr. Reddy attempts to explain how this statement is NOT an infringement on Amarin's CVD patent.
With small pharmas, the SP is largely
determined on prospects
for future revenues...
with large pharmas, the SP is largely
determined on prospects
for current revenues...
The market is sending Amarin a message
of no confidence for future revenues.
This explains why Amarin is currently undervalued and why it makes sense for Amarin to sell to a BP.
Amarin has current revenues...with prospects for future revenues from Europe and ROW(including China) plus a future AG and FDC for the U.S. and ROW.
Amarin could have named their epa drug Vascepa CV and avoided the high triglyceride hassle.