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Amarin troubles grow as fish oil shows no benefits
The supplement has no heart benefits for patients, which doesn't bode well for the drug company's efforts to market Vascepa.
By Adam Feuerstein
A large study has once again demonstrated the failure of fish oil supplements to reduce heart disease or death in patients at higher risk for heart disease. The negative results of the Italian Risk and Prevention Study, published Wednesday in the New England Journal of Medicine, could not come at a worse time for Amarin (AMRN -2.72%) and its prescription fish oil pill Vascepa.
Amarin is already struggling to convince doctors and patients to try Vascepa, so the last thing the company needs is more definitive clinical evidence ripping apart the theory that daily fish oil intake leads to improved heart health.
Vascepa was not used in the Italian study published Wednesday, but still, the odds of Amarin convincing a large pharmaceutical company to partner up on Vascepa's marketing or acquire the entire company went from low to nearly impossible.
Amarin will release first-quarter financial results and hold an investor conference call after the close of regular trading Thursday. Street consensus for Vascepa first-quarter sales is $3.65 million, according to Bloomberg.
The Italian Risk and Prevention Study enrolled 12,513 patients with multiple cardiovascular risk factors or evidence of heart disease but no prior history of heart attacks. Half the patients were randomized to receive 1 gram per day of n-3 fatty acids (fish oil) or an olive oil placebo.
After five years of follow up, 11.7% of the patients taking daily fish oil died or were hospitalized due to cardiovascular disease compared to 11.9% of patients treated with a placebo. There was also no difference in any of the prospective secondary endpoints.
"On the basis of the results, we conclude that there was no significant benefit of n-3 fatty acids in reducing the risk of death from cardiovascular causes or hospital admission for cardiovascular causes," the researchers conclude.
Eric Topol, a well-known cardiologist at the Scripps Clinic who was not involved in the study, was even more blunt in comments made to TheHeart.org.
"Fish oil does nothing," said Topol. "We can't continue to argue that we didn't give the right dose or the right preparation. It is a nada effect."
Amarin supporters were quick to defend Vascepa Wednesday night, with some taking to Twitter to argue the negative findings from the fish oil supplement study had no bearing on Vascepa because it contains more fish oil manufactured at a higher purity.
Amarin executives will likely make the same argument if/when they're asked to comment on the Italian study during tonight's conference call.
But in the Italian study, daily use of the fish oil supplement resulted in a statistically significant reduction in triglycerides, a type of fat found in the blood believed to have a negative effect on heart health. This is exactly what Vascepa does and is the basis for the pill's approval last year.
Yet now we have another study showing fish oil's role in lowering triglyceride levels, which is only a laboratory measurement, doesn't help patients avoid heart disease or reduce heart-related deaths, not even a little bit.
The evidence against fish oil's benefits is growing, and Amarin will have a hard time explaining why Vascepa, even at a higher dose, should perform any better.
More from TheStreet.com
http://money.msn.com/top-stocks/post.aspx?post=1ee3a6b4-fb54-42f4-b100-7ea9d0b617f1
JBII INVESTORS JUST STIRRED UP THE HORNETS NEST
DONT WORRY ABOUT VOMITING BLOOD, DEAD FETUS, OR SKELETAL ABNORMALITES.
FDA APPROVES ANYTHING. JUST A FEW EFFECTS HERE THE FDA DOESNT CARE ABOUT HAPPENING TO YOU
In pregnant rats given oral gavage doses of 0.3, 1 and 2 g/kg/day icosapent ethyl from gestation through organogenesis all drug treated groups had visceral or skeletal abnormalities including: 13th reduced ribs, additional liver lobes, testes medially displaced and/or not descended at human systemic exposures following a maximum oral dose of 4 g/day based on body surface comparisons. Variations including incomplete or abnormal ossification of various skeletal bones were observed in the 2 g/kg/day group at 5 times human systemic exposure following an oral dose of 4 g/day based on body surface area comparison.
In a multigenerational developmental study in pregnant rats given oral gavage doses of 0.3, 1, 3 g/kg/day ethyl-EPA from gestation day 7-17, an increased incidence of absent optic nerves and unilateral testes atrophy were observed at =0.3 g/kg/day at human systemic exposure following an oral dose of 4 g/day based on body surface area comparisons across species.
Page 4 of 11
Additional variations consisting of early incisor eruption and increased percent cervical ribs were observed at the same exposures. Pups from high dose treated dams exhibited decreased copulation rates, delayed estrus, decreased implantations and decreased surviving fetuses (F2) suggesting multigenerational effects of ethyl-EPA at 7 times human systemic exposure following 4 g/day dose based on body surface area comparisons across species.
In pregnant rabbits given oral gavage doses of 0.1, 0.3, and 1 g/kg/day from gestation through organogenesis there were increased dead fetuses at 1 g/kg/day secondary to maternal toxicity (significantly decreased food consumption and body weight loss).
In pregnant rats given ethyl-EPA from gestation day 17 through lactation day 20 at 0.3, 1, 3 g/kg/day complete litter loss was observed in 2/23 litters at the low dose and 1/23 mid-dose dams by post-natal day 4 at human exposures based on a maximum dose of 4 g/day comparing body surface areas across species.
GOOD GRIEF, VASCEPA DOES MORE HARM THAN HELP. LOOK AT ALL OF THE SIDE EFFECTS. NOT THE GENERAL ONES ON THE HOMEPAGE BUT THE PDF
NOTHING BUT AN OMEGA SNAKE OIL SCAM HERE
Yes, I see it on the 8K filed 4-22-13. I just noticed GTI on the P2O webpage, wish I could follow more closely.
slide 40
http://jbii.ir.edgar-online.com/fetchFilingFrameset.aspx?FilingID=9233571&Type=HTML
at a glance I liked slide 41
We can now process materials with contaminates up to 30% (PET, PC, Rubber, etc.)
JBI USES MINIMAL EXTERNAL ENERGY TO TURN PLASTIC INTO SPEC FUEL
Only 53 kWh electricity is required to run the fans, pumps and small motors. No electricity is used in the transformation of the plastic to fuel.
Natural gas is only used on start-up to heat the reactor – once the processor is running, the reactor is heated with its own off-gases.
http://www.plastic2oil.com/site/advantage
Basic DD
Reputable independent labs have validated the P2O technology including
http://www.saic.com/
http://www.islechem.com/
http://www.dec.ny.gov/
Looks like GTI is a new partner
http://www.plastic2oil.com/site/announced-partners
http://www.gti-e.com/
Next pr could possibly be...
Other –The kilns for the fourth and fifth processors have been completed, tested and prepared for shipment. In addition, the towers for these two processors are nearing completion, as well, with certain internal components remaining to be installed. The production data we are gathering on processor #3 is critical to decisions to be made regarding timing of assembly and implementation of these two additional processors. As previously discussed, we have an agreement with RockTenn Company to place these two processors at their location in Jacksonville, Florida.
http://jbii.ir.edgar-online.com/fetchFilingFrameset.aspx?FilingID=9460916&Type=HTML
My Wife is an Elementary School Teacher and her school will be another colorcycle participant soon.
Thank you for the ground support Commando911 and sharing with the rest of us.
All they'll see is the Bulls Ass chasing this baby up.
Tic Toc Mr. Heddle will stair step this thing all the way up. Just Watch.
Mass Roll out details are needed, #4 and #5 placement PR coming very soon. CFP next.
Our soon to be CFP move by JBI will be CHECK and coupled with mass roll out and uplisting will be our Check Mate MF move. Thank you Mr. Heddle.
What do we know about these guys?
http://www.plasticpyrolysisplant.com/plastic-pyrolysis-plants-diesel-fuel-conversions
apologize if it's already been discussed on the board.
4 AG PLASTIC DROP OFF LOCATIONS FOR JBI
RIGID PLASTIC POTS,
CONTAINERS
DRIP TAPE &TRAYS
FOR MORE INFORMATION, CONTACT:
STORING PLASTIC
• Save money on your farm
By recycling ag plastic as it’s FREE
• Help the environment by keeping
plastic out of landfills
Madison County Landfill
Buyea Rd., Town of Lincoln
(Drop off at ARC Recycling Center)
Mon. thru Fri. – 7:10 a.m. – 3:00 p.m.
Cazenovia Transfer Station
Constine Bridge Rd.
Fri. & Sat. - 7:10-3:00 p.m
Hamilton Transfer Station
Cranston Rd.
Wed. & Sat. - 7:10a.m.- 3:00 p.m
Sullivan Transfer Station
Bolivar Rd.
Fri. & Sat. - 7:10 a.m-3:00 p.m
CONTAINERS ACCEPTED!
THE MADISON COUNTY LANDFILL
RECYCLING HOTLINE:
1-800-721-2208
FREE
No Drop Off Fee
http://www.madisoncounty.ny.gov/sites/default/files/4-12-13_ag_plastic_advertisement.pdf
New York City adds rigid plastics to recycling program
Now, thanks to new optical technology that allows the city’s primary recycling contractor, Sims Municipal Recycling, to identify and separate rigid plastics by type, the city hopes to spare approximately 50,000 tons of waste each year from ending up in landfills — as Bloomberg put it, enough plastic to fill a football field to a height of seven stories. Taxpayers can expect to save about $600,000 a year in export costs, not to mention untold amounts of guilt, by not having to dump the plastic in landfills.
http://www.plasticsnews.com/article/20130424/NEWS/130429956/new-york-city-adds-rigid-plastics-to-recycling-program#
NYC considers 10-cent charge for plastic bags
http://www.sfgate.com/news/science/article/NYC-considers-10-cent-charge-for-plastic-bags-4746649.php
These numbers will be reality early next year IMO. John is a perfectionist. I hope #3 is the one for the Mass Roll Out. I am most curious on how the MRO plays out whether JBI sells or operates. Either way there needs to be very detailed auto cad field drawings, skilled labor, multiple manufactures, field tech supports for start up and operation. I wonder if there will be Molecular Analysis Equipment on each site too, probably. I say by EOY 2014 we are talking about #12,#13,#14 placement and all the noise goes away here.
Appreciate the history, US Steel makes sense. We should hear a lot more about the petcoke next year. John is an efficient closed loop guy and wants every bit of this process to be as energy efficient as possible. We went from processor 1 DOS to processor 3 Windows 3.1. Look out plastic to spec fuel community.
Add me. Rick Heddle wears the Big Boots. JBI got kicked while they were down before they were even able to stand. Mr. Heddle is going to kick back with those Big Boots.
Where is the petcoke going to? And when uptime increases as expected, where will the increased amounts of petcoke go? I think we hear some positive news regarding a BUD user soon.
http://www.plastic2oil.com/site/fuel-products
JBI produces Petcoke through the P2O process and will be seeking a BUD (Beneficial Use Determination) to sell this product to end-users
What a beautiful gams of chess John is playing. John vs JBI, I was not expecting the D. Trump move, genius, next move checkmate.
Drive safe. I think the intermodal question will be an issue when the supply and demand comes into play. Obviously the supply is our issue which I believe #3 should initiate the move by Q1-2014. BOD, #3 results, rock ten update, #4 and #5 are probably more important q's. Appreciate the boots on the ground.
JBII
Intermodal would be better and an update on that progress would be nice. Mentioned at the 2011 agm I believe or 2010.
Expecting update on RockTenn Jacksonville FL #4 and #5 units being built.
Plus Crayola's castoffs. Wonder what the quantity and schedule is with that. John did not want to speculate. But I am sure its a nice consistent quantity looking at all of Crayola's plastic products. End of school year for markers yipeee. Castoffs, hell yah.
Another Nice Crayola article mentioning JBI INC. Throwing the rest of my dust at this one today as I did last week and the week before. Im content with what I have but JBI is my Crack. I feel this is the beginning of mass media attention and CFP around the corner with number 3 by eoy. BOD seating will happen, its small issue compared to what JBI has already dealt with.
Nice! Looks more than 100 lbs. A consistent flow with great exposure is what I see. Proof of concept through major media is transpiring in front of our eyes. Been buying weekly in the .30's. Sweet.
Like A Supernova
Sounds like #4 and #5 are almost complete. Question is where?
LOL, True. Let me rephrase that to I hope JBI Inc. pushes the MASS ROLL OUT button.
Looks like Beasts #4 and #5 location news is on the horizon, hopefully Jacksonville FL to show the Rock Tenn deal is alive after 2 years of the contract. I am certain that after John reviews the data of #3 he will push the MASS ROLL OUT button. CFP is soon but I feel another pipe is needed.HTF will expedite CFP and I will guess eoy in first quarter fins 2014. Im in and long. Im done buying here and comfortable with what I have whether they flop or shoot to the moon.
I Also Agree.