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north4000, "Do you mean "more than 1 year prior to (effective) filing date of patent application" rather than prior to patent issuance?
See 35 USC 102(b) for statutory criteria."
Yes, I clarified the criteria in a subsequent post. It is true that Pronova allowed a Doctor in the US to have a sample of Omacor/Lovaza prior to their filing of a patent. They allowed the Doctor the details of the mixture and to work with it. I suppose you could say that the Norway-based Pronova wasn't familiar with the patent exemption when they acted in this manner.
I later explained that Amarin has done nothing that would fall in the same category as Pronova.
As far as dry-eye indication, it might be that there is sufficient public information about treating it with O-3 that they might not be able to patent it regardless. I'm not sure if dosing would matter, or the use of EPA without DHA, time to sort through all the publications on the matter.
Finally, BioBill is determined and pugnacious, but he often allows his emotions, e.g. fears, angers, frustrations, etc. get the best of his sensibilities. Don't let emotions drive and dictate sensibilities, rather use rationale and logic to determine your emotions.
BioB, I disagree. Some random doctor who prescribes Vascepa for Dry-eye is not going to invalidate any potential patent there.
I can't speak of the details, it is better left for someone with deeper patent know-how. Give IR a call and ask about it.
Pronova gave this guy their compound, (Lovaza) the details of the compound, gave him the ability to use it and examine it. Amarin isn't doing anything comparable.
You have to check when they have filed for all their patents. If they filed R-IT patents prior to 2013, then they are fine under your interpretation, which I don't consider to be set in stone.
No, BioB, here is a more complete explanation, "case hinged on the provision in patent law which states that a patent is invalid if the invention was "in public use" more than one year before inventor applied for a patent. In 1987, before it sought a patent, Pronova's predecessor company sent samples of the concentrated fish oil used in Lovaza to a researcher for testing."
"a compound is provided without restriction to one highly skilled in the art, that compound's formulation is disclosed in detail, and the formulation is subject to confirmatory testing, no other activity is needed to render that use an invalidating one,"
A sample of Lovaza (aka Omacor ex-US) was provided to a Doctor in the US prior to its patent issuance. Under that technicality, the patent was over-turned on appeal. Vascepa doesn't face that problem.
If Vascepa had any trace of A-Fib tendency it would probably have not been approved for MARINE. You can't sweep Lovaza's warning label under the rug.
No you do not get lots of EPA from DHA. DHA does not infiltrate plaques to make them more stable, it does not lessen pro-inflammation. Stop already with your inane spam. The risk of A-Fib is significant enough to be placed by the FDA on the label.
EPA competes with Arachidonic Acid for the delta-5 desaturase enzyme, which counters pro-inflammatory precursors. DHA does not compete with AA for activity at the enzyme.
Stop with the DHA spam, we've seen it all before going back prior to 2012.
Lovaza = Atrial Fib warning on label. DHA is not the answer for CAD, someone needs to stop spamming DHA. Check out the OCEAN study, used Lovaza... "In other words, the more EPA in the plaque, the less inflamed and more stable it is," said Calder.
The link at the bottom of the post discusses another study done that showed LDL-C was not an indicator of events.
4g of EPA and a statin vs. a statin alone in the USA.
So, isn't the baseline of EPA/AA for those in the statin alone group going to be much lower than compared to the Japanese model?
In other words, the EPA/AA ratio of all patients at baseline in Japan would be higher than all the patients in the R-IT trial at baseline because of the higher frequency of fish in the diet?
To bring EPA level to Japanese levels, they use 4g in R-IT as opposed to 1.8g, ok. EPA/AA in R-IT with 4g should match 1.8g in Japan.
Wouldn't that mean the difference between 4g in R-IT and baseline is greater than Japan, thus wouldn't the benefit be greater?
As little as 25% of premature Coronary Heart Disease is attributable to elevated LDL-C values.
50% of persons who develop CHD are missed with total cholesterol
JELIS-- LDL-C levels dropped 25% in each arm of the trial yet we saw a 19% relative reduction in major coronary events in the group treated with 1.8 grams EPA and statin over statin alone. AND
those patients with a prior history of stroke, saw a 20% relative reduction in recurrent stroke in the EPA/statin group vs. the statin and placebo group
Yes, and I hope Amarin/Kowa reps discuss the reduction in inflammatory markers they saw in ANCHOR/MARINE.
From the article you linked, "Specifically, the measurement of Myeloperoxidase (MPO), Lp-Pla2 and hsCRP were used to generate tiered risk."
JZ was vindicated by the court's decisions. He was right all along and he was right to be agitated by the FDA's capriciousness. Perhaps he was too brash, but he was right and I like the guy.
Couldbebetter, yes, get a Ralph Nader type on the task of exposing US healthcare's use of a product that raises LDL-C as much as 45% in patients while an alternative option that doesn't raise LDL-C is available for patient care. As well as the A-Fib warning.
Where would we be if FDA decided to limit generic lovaza? Over 50K scripts?
Not really a precedent, recently, Judge/court ordered FDA to award Gralise an Orphan Drug status.
http://www.prnewswire.com/news-releases/depomed-summary-judgment-motion-granted-in-suit-against-fda-seeking-orphan-drug-exclusivity-for-gralise-gabapentin-274126691.html
I love the angle the Judge queried, to the FDA, can generic companies file ANDAs for each component in the mixture of Lovaza? Based on their stance, you'd think, yes, however, based on sensibility and reason, no way.
EPA ethyl esters, extracting from algae, Fraunhofer.
http://www.igb.fraunhofer.de/en/competences/environmental-biotechnology/microalgae/epa-ethyl-esters.html
Seambiotic Algae, Nannochloropsis algae species for EPA/DHA
Built by power plant to access their CO2 exhaust. Algae splits CO2 with aid of sunlight to utilize the C and emits O2.
Algae Algae Algae
https://ec.europa.eu/jrc/sites/default/files/final_version_online_ipts_jrc_85709.pdf
All you need to know about farming and what is going on in the EU, Australia, NZ etc.
Baker Brothers will often take a long term risk/reward outlook, they load up a lot on sub $1.00 biotechs with Phase III potential, like their ACAD holding, or now with MSTX (0.50c) in PIII.
I think Baker Brothers are going all in on their confidence in EPA gaining market share and reaching a positive outcome in REDUCE-IT. They may have other reasons, as you speculate, but they are not shy about loading their pockets with cheapies for long term gains.
New 60 minutes topic - LDL-C.
Why does our healthcare system promote an inferior generic product that raises LDL-C over 45% over a superior product that is LDL-C neutral, at worst, to the tune of 70K scripts to 11K scripts? That is the straight-forward, messed up reality we have.
We have a product that should be banned getting prescribed 7:1 over a superior product.
I wouldn't even go so far as to call Sierra a pump-n-dumper, it is a spoof on the markets, it is making fun of the markets. It is like a comic magazine, like Mad Magazine or Harvard Lampoon, or The Daily Show spoofing right-wing news, or the Onion.
Sierra is "entertainment" unless someone is not the sharpest tool in the shed and can't figure that out.
No, Photonz is a supplier of EPA, much like Amarin's other suppliers. They could supply or enter the dietary supplement aisle in the super market but not a prescription based therapy like Vascepa. Photonz is a potential supplier to Amarin.
Since the topic of fishery slowdowns might pop up now that people are interested in REDUCE-IT supply, perhaps we should start looking more at the future of algae farming and how that might become a source for Amarin.
http://www.algaecompetition.com/projects/photoreactor-farm-tower/
Right now, the idea is based on biofuel, and that algae could supply power, that lipid oil, however, could be purified to EPA:
rosemountbomber, here is a study that should be helpful,
read about it here:
http://seekingalpha.com/instablog/2589121-jolk/2224592-epa-goes-head-to-head-against-ezetimibe-zetia-and-outperforms-the-ldl-c-lowering-drug
EPA will work immediately to clean out the inflammatory agents calling for more inflammation in atherosclerotic plaques. EPA busts down the door and clears out the inflammation party, a good old fashioned raid.
EPA also thickens and strengthens the fibrous cap on the plaque and it increases the lumen area, the channel through which our blood flows. This process will begin immediately and improve over time.
If you do not have 4g of EPA, you shouldn't see the same benefit, as was seen in the above study with Zetia. Zetia did not improve the lumen area, nor did it improve the stability of the fibrous cap. The plaque area increased in the Zetia alone arm of the trial.
EPA is associated with Endothelial (skin/tissue/vessel wall) improvement, whereas statins just target or strike a step in the LDL-C pathway. They just negate an enzyme, aka HMG-CoA reductase inhibitors
EPA is sourced by Fish through Algae, i.e. it works its way up the food chain from Algae to Fish
http://cfb.unh.edu/PDF/2004/UNHCFBR-6-2-2004.pdf
If demand increases so much to put pressure on fish farming, then a switch will likely occur to algae farming, to source EPA, and we know this is already happening with the likes of Photonz in New Zealand.
In JELIS, both arms, control and treatment, saw their LDL reduced to roughly the same amount, the EPA group saw greater benefit suggesting it isn't all about LDL.
BID and ASK is halted, will reopen a few minutes prior to halt lift.
SPPI Fusilev has interesting parallel. It was approved in 2008 for a small group of patients, like Vascepa and trigs over 500, a smaller population.
Fusilev was given 7 years orphan exclusivity, so they expire in 2015 for that small population.
Later on, in 2011, Fusilev was approved for a different and much larger population and given orphan status for 7 years, through 2018, which would be like ANCHOR/REDUCE-IT approval.
The big question is how does this pan out? It is clear that the larger population should be protected from generics until 2019.
Can the generics pump out supply of Fusilev to treat both sets of patients or will they have some sort of cap on production?
I think the same case would occur with NCE status for MARINE and ANCHOR/REDUCE-IT. Should generics be allowed to game the system or are there controls to prevent it from happening?
Good review of the thinness of SPPI's one lone composition of matter patent:
http://thetodayonline.com/spectrum-pharmaceuticals-key-drug-fusilev-may-face-generic-competition-soon-2014-07-10/
Really not sure how that works, since REDUCE-IT is a new indication, I don't know if generics can jump in on it right off the bat?
You should figure an increase in revenue in 2015 to offset some of the cash use. So $60M could be $70M or so if sales go up.
Next time you see your CVS pharmacist, point out the flaw in their coverage, maybe he can relay the message. If anyone has coverage that places Generic Lovaza above Vascepa, write or call your insurance agent/liaison and complain that it is more dangerous.
How about focusing some effort on questioning CVS/Caremark about their decision to push Generic Lovaza over Vascepa considering the cost difference favoring Vascepa and the warning label on Lovaza.
It isn't in the S&P, but rebalancing day always spills over, it is big housekeeping day, ARNA had a similar pattern after hours, it isn't anything specific to AMRN.
sts66, Friday was S&P rebalancing and the market saw many similar late day and after hours trades across the board.