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Yes we need a shareholders proposition on executive compensation to put an end to this
Maybe we should start a GOfundme for Thero and company ??
Yes it does seem rather hilarious ...Thero speaks ...stock drops .... the bonuses are disturbing and insulting to share holders ... Thero and company should realize that improvement in share price will line their pockets just as well if not better
....
OH come on ... I get my weekly mailer ( which must be costing millions) and promptly throw it into the garbage as does every other practitioner - so there ..... they have a cutting edge marketing team - I mean who would have ever thought to send out a mailer to doctors offices ....absolutely brilliant !
Insurance companies like many doctors are clueless on the med and its indications - insurance companies automatically reach for the generic - I doubt if they are even aware of what going on and few understand the difference between EPA and DHA. MOst are probably not even aware of the REDUCE-IT study....of course we have 800 reps that could be filing them in on it ...
Thanks Pharmacy dude
Then you should take your profits now if you think its a dice roll ..investing should be about taking a favorable risk not chance ...that's gambling
WEll you guys are beginning to swing me into HIKMA being found guilty - I was not aware that they were required to state that their product was not for CAD ....
Exactly ... We know some entity is responsible for infringement - and AMRN will work down the line to insurers and pharmacy supply chains etc and that is where the parties responsible for infringement will be found - in the long run it doesnt matter who is responsible for infringement all that matters is that it is found - that it ceases - that the US market is restored ... which is going to happen and is why after doubling my money in several months I have decided not to sell - I do see another doubling if not tripling
Yes we all know that they are infringing by the numbers but there is nothing illegal about being a fool ....
When I read HIKMA's response I found it rather convincing they clearly point out how they are within their legal limits of not inducing infringement ie they dont mention CAD they dont in any way suggest that the med be used for REDUCE IT indications etc . They are simply making a medicine to be used for Trigs >500
So even though we know they know they are making the med to be used for REDUCE IT indications they simply play dumb and say - hey all we do is make the med and state it is to be used for Trigs >500 - where how and why it gets used once its purchased from us is beyond our control.
The gun manufacturer says hey all we do is make the guns - if someone was murdered we have nothing to do with that .....
Yet we know infringement is occurring - and so AMRN and Thero will doggedly work down this chain moving next to insurers and pharmacy supply chains which is where there is clear proof of patent infringement - at which point law suits will evolve insurance companies / pharmaceutical suppliers will begin to back off and the US market will be restored
It seems like the TEVA lawyer makes AMRNS case ?
William Jay of Goodwin Procter, arguing for Teva, said his client had precisely followed the federal Hatch-Waxman Act in carving out uses that GSK had identified as patented in submissions to the Food and Drug Administration.
"The carve-out provision of Hatch-Waxman was designed for just this situation, where the drug is not patented and the vast majority of uses, more than 80%, are not patented," he said.
PharmacyDude what was their conclusion ??? Do you have access to the article ?
Excellent point sstyles ...... that has to weigh over them now - do you risk sabotaging your entire market over one product ?
Once again .... I dont beleive that AMRN will win against HIKMA - AMRN will win the infringement situation by taking down insurance company after insurance company and pharmacy supply chain after pharmacy supply chain in a war of attrition
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Benecard comes right out and says HIKMA's version is for CAD - DIRECT INFRINGEMENT !!!
https://www.benecard.com/generic-for-vascepa-capsules-approved/
May 22, 2020
The U.S. FDA has approved Hikma Pharmaceuticals’ icosapent ethyl 1g capsules as a generic for Amarin’s Vascepa® (icosapent ethyl). The products are prescription-only fish oil derivatives indicated to reduce cardiovascular (CV) risks in certain patient populations.
Specifically, icosapent ethyl is approved as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients who have elevated triglyceride (TG) levels (≥ 150mg/dL) and established CV disease, or who have diabetes mellitus and two or more additional risk factors for CV disease. It is also approved as an adjunct to diet to reduce TG levels in adult patients who have severe (≥ 500mg/dL) hypertriglyceridemia.
Recommended dosing for icosapent ethyl is 2g twice daily, taken with food. Capsules should be swallowed whole. Prior to treatment, the patient’s lipid levels should be assessed, and any additional causes of high triglyceride levels should be identified and managed as appropriate. Patients should engage in appropriate nutritional intake and physical activity before starting icosapent ethyl, and this should continue during treatment.
Although the FDA has granted approval for Hikma’s generic, Amarin is currently in the process of appealing the invalidation of six Vascepa patents. Should Hikma or another generic manufacturer launch an equivalent to Vascepa before a final legal determination is made, they would do so at risk and could be held liable for damages due to patent infringement if Amarin wins its appeal.
Hikma has not announced launch or pricing plans for its icosapent ethyl 1g capsules.
Vascepa first received FDA approval in 2012 and is available in 0.5g capsules as well as 1g capsules.
We need to write a citizens petition to the FDA regarding the inappropriate substitution of gLovaza for vascepa for REDUCE IT Indications and how this is harnming patients
check this out
Benecard comes right out and days HIKMA's version is for CAD - DIRECT INFRINGEMENT !!!
https://www.benecard.com/generic-for-vascepa-capsules-approved/
May 22, 2020
The U.S. FDA has approved Hikma Pharmaceuticals’ icosapent ethyl 1g capsules as a generic for Amarin’s Vascepa® (icosapent ethyl). The products are prescription-only fish oil derivatives indicated to reduce cardiovascular (CV) risks in certain patient populations.
Specifically, icosapent ethyl is approved as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients who have elevated triglyceride (TG) levels (≥ 150mg/dL) and established CV disease, or who have diabetes mellitus and two or more additional risk factors for CV disease. It is also approved as an adjunct to diet to reduce TG levels in adult patients who have severe (≥ 500mg/dL) hypertriglyceridemia.
Recommended dosing for icosapent ethyl is 2g twice daily, taken with food. Capsules should be swallowed whole. Prior to treatment, the patient’s lipid levels should be assessed, and any additional causes of high triglyceride levels should be identified and managed as appropriate. Patients should engage in appropriate nutritional intake and physical activity before starting icosapent ethyl, and this should continue during treatment.
Although the FDA has granted approval for Hikma’s generic, Amarin is currently in the process of appealing the invalidation of six Vascepa patents. Should Hikma or another generic manufacturer launch an equivalent to Vascepa before a final legal determination is made, they would do so at risk and could be held liable for damages due to patent infringement if Amarin wins its appeal.
Hikma has not announced launch or pricing plans for its icosapent ethyl 1g capsules.
Vascepa first received FDA approval in 2012 and is available in 0.5g capsules as well as 1g capsules.
I know HIKMA is implicated in infringement by the proposed sales numbers -but that is a loose connection did HIKMA anywhere at anytime say their med was for CAD ? I am not aware of that and this is why I think AMRN's case is not as strong with HIKMA
I do think its very strong with Healthnet. The infringement situation will come down to insurers and pharmacy chains not HIKMA -
I hope I am wrong as this would bump stock price quicker - but either way this is gong to be solved, the US market is going to be restored and stock price is going to return into the 20's
YOu would think the smart money would be buying up AMRN today .....
I agree - I just find the media to be always spinning rather than reporting
Yes I did see that whalatane
Generic-Drug Labeling Strategy Likely to Survive Teva Rehearing
A U.S. appeals court panel signaled that it wants to ensure generic-drug makers can continue selling low-cost copycat medicines with limited-use labels as long as they don’t actively promote newer uses discovered by brand-name companies.
In an unusual proceeding, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit on Tuesday heard arguments for the second time over a $235 million verdict won by GlaxoSmithKline Plc over Teva Pharmaceutical Industries Ltd.’s copy of its Coreg heart drug. In October, it split 2-1 in upholding the jury verdict that found Teva’s label encouraged doctors to prescribe a generic version for a newer patented indication.
The questioning indicated that the panel may again be split over reinstating the jury verdict, but would make it more clear that this is a fact-specific issue that wouldn’t limit the use of so-called skinny labels in other cases.
Circuit Judge Kimberly Moore, one of two judges who sided with Glaxo in October and is seen as the swing vote, said that merely saying a copycat drug is interchangeable with a branded medicine doesn’t prove the generic-drug maker encouraged doctors to prescribe it for a new patented use.
In this case, though, she questioned whether Teva had gone beyond that, with wording on its labels and old press releases that were easily found, asking if without that information “would this be a different case with a different outcome?”
Labels cover information like the drug’s composition, its uses and side effects. The law encourages generic-drug makers to use “skinny labels” for copycat medicines that include only older uses, but not newly-approved ones.
The panel of the Federal Circuit, the nation’s top patent court, agreed to reconsider the October ruling after concerns about its impact by other generic-drug makers, nonprofit groups, and a former congressman who was a co-author of the Hatch-Waxman Act, which in 1984 created the modern generic-drug industry.
Lawsuits leaning on the October ruling have emerged, including ones over generic versions of Amarin Corp.’s heart medicine Vascepa and of the low-blood-pressure drug Vasostrict, sold by Endo International Plc’s Par Pharmaceutical. Glaxo said those newer cases are different from this one, calling it a “partial label” rather than a skinny one.
Other generic-drug makers “seem to be concerned this is a true skinny label case and the sky is going to fall,” said Glaxo lawyer Juanita Brooks of Fish & Richardson. “This is not a true skinny label.”
Read More: A Skinny Label Is Worth a Few Hundred Million Dollars to Amarin
Judge Pauline Newman, who authored the October decision, said the new ruling should ensure “we don’t cut off at the pass the kind of research” that leads to new treatments. She said it comes down to the balance between “the public interest that’s involved as well as the private interest of the generic producer.”
Teva said it had carved out uses that Glaxo said it patented. Drugmakers can get patents on new methods and “they’re able to enforce that if they’re able to show the generic encourages, promotes or recommends” that use, said William Jay of Goodwin Procter. The other side, however, “hasn’t given the court this morning anything in Teva’s skinny label” that does so.
The Delaware jury had found that, notwithstanding a Teva label that excluded Glaxo’s patented treatment for congestive heart failure, Teva was responsible for inducing doctors to prescribe the drug for that purpose. Jurors said Teva should compensate Glaxo for the $234 million in profits it lost to the competition plus $1.4 million in royalties on the $75 million in Teva sales. The trial court later threw out the verdict.
The Federal Circuit case is GlaxoSmithKline LLC v. Teva Pharmaceuticals USA LLC, 18-1976, U.S. Court of Appeals for the Federal Circuit (Washington).
https://www.bloomberg.com/news/articles/2021-02-23/drug-industry-waits-as-skinny-label-patent-case-is-heard-again
Bloomberg paints this as a + for TEVA !!!!!
SO it is "The Circus " ?
sstyles - I thought HIKMA had no mention of cardiovascular prevention in their label ?
THey are realizing that Biden is now president - all drugs to be given away free and evil corporations should make no money .....
I always use this to my advantage . What happens in most biotechs - initial euphoria over potential - emotion drives stocks up - then time period of determination of whether something will work or not . If it works usually a huge overshot on value - then afterwards reality sets in - there is something that is usually found that is not perfect with the med/ treatment and stock will have drawback into what I call the reality zone - older well established stocks generally trade more to what the true value of the company is - younger stocks with new technology are by nature linked to human emotion- therefore understanding human emotion will allow profit within this arena in the market -- like I have said before there are poker players who memorize every card and can give you the odds at any time of any potential hand - then there are others who simply look at your face and know what the play is ....
MY latest message to an insurance company to their prior auth
CAD - patient meets REDUCE_IT criteria ON maximum statin trigs >150 with known CAD - the only approved med for this is VASCEPA - substitution of generic meds for REDUCE IT Indications is patent infringement and will be prosecuted as such - Health NET is already named in a suit more insurance companies to ff
AS a citizen It is alarming when "legal issues " are not coordinated with reality .... lol
JUdge Du ruled REDUCE IT was irrelevant - yet it is so entwined with her ruling that it is anything but irrelevant
Excellent summary !!
First off they cannot give Lovaza for REDUCE it Indications it may actually harm you by increasing ldl - send to ARMN
Most docs have no idea what company makes what med
I remember there was a doctor on here several years ago that brought this up - tried to warn everyone about living in the ECHO chamber of IHUB and the realities of the world
Agree - sales force should be harnessed up to engage insurance companies and inform them of potential infringement
Sleven - like I previously posted imho chances are much greater to find the insurance company inducing infringement than HIKMA - but it doesnt matter as long as some entity is found responsible - if its the insurance company the rest can be brought into line
Yes you are reading well - I am not seeing - so what does anyone on here see as weak points in their rebuttal - perhaps we are all not seeing and if we are all not seeing then they have a strong rebuttal
Yes I know that but its a very good rebuttal and I am not seeing anyone finding many faults with it ..
MEOWZA
but where do they say be like billy the kid ??
If we had that we might win - they are quite clear in their rebuttal that they said nothing to induce infringement. I think the best we have is projected sales which goes way beyond the market for high trigs alone ... but how is AMRN going to say that speech directed infringement ?