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biocqr

04/02/11 12:35 PM

#872 RE: Bio_pete #871

FWIW... from the MARINE study...

In addition, the subgroup of patients on background statin therapy had much greater median reductions in TG, which were also statistically significant, than those not on statin therapy.

Importantly, AMR101 did not result in an increase in median LDL-C compared to placebo at either dose (-2.3% for the 4 gram group and +5.2% for the 2 gram group [p=NS]). This is the first and only triglyceride-lowering therapy studied in this population with very high triglyceride levels to show a lack of elevation in LDL-C. Furthermore, there was a statistically significant decrease in median non-HDL-C (total cholesterol less "good cholesterol") compared to placebo with both of the AMR101 treated groups (-18% for the 4 gram group [p < 0.001] and -8% for the 2 gram group [p < 0.05]).

There were also statistically significant reductions in several important lipid markers, including Apo B, Lp-PLA2 (Lipoprotein-phospholipase A2), VLDL-C and Total Cholesterol. These results are particularly encouraging given that no other TG-lowering therapy studies have shown such results. For these achieved endpoints, p-values were <0.01 for most and <0.05 for all. Apo B (Apolipoprotein B) is a sensitive index of residual cardiovascular risk and is generally considered to be a better predictor than LDL-C. Lp-PLA2 is an enzyme found in blood and atherosclerotic plaque; high levels have been implicated in the development and progression of atherosclerosis.

The ANCHOR trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels from 200 mg/dL to less than 500 mg/dL who are also on statin therapy.

http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=533361
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olddogwithnewtrix

04/02/11 1:13 PM

#873 RE: Bio_pete #871

I thought I offered some good examples of why LDL is not "black and white." an individuals ldl profile is much more important. unfortunatly most Drs will write you a script rather than explain to you what's important. Just look at the crazy bacterial resistance we have created. Doogan knows that LDL is the main issue according to heart foundation fda etc. Because of money issues they are not likely to study any of the other markers anytime soon. any well read dr understands the importance of the other markers. treating basic ldl is old school, but amr101 should benifit from that.amr101 might be a bit better than lovaza with a few key markers, that will be a great selling point.

Again... many Drs see a slight increase in LDL as benign with fish oil. amr101 should do well, but lovaza ain't going away.



"If you've got a patient on statins & their not meeting the goal for triglyceride reduction then I can't imagine a doc prescribing Lovaza or Epanova once AMR101 is available."

Not meeting their goals? What are their goals? How would they meet them on amr101(which doesn't does not quite do as well with TGs compared to lovaza and does not come close to epanova -which has no fishy taste) if they didn't meet them on epanova and lovaza?

we just don't know what big boys know. we are not privy to the early studies of the competition. If it were all so simple as not raising LDL we would have been bought for 30+ already.

There is money to be made here for sure. how much, i don't know.