from what I'm seeing Bio-Availability data to be published well before a patent approved for combo - or an sNDA for Combo
IMO its a set-up for buyer
The bio-availability study under way will show improved Statin performance on LDL-C than by itself , with EPA/DHA or with DHA alone - And should be out this summer
So its a layup for an acquirer to take it to the next level - but not Amarin
Sentiment: Strong Buy
With all due respect to fellow longs on this Board, could anyone here please supply a logical argument on the premise that if doctors are not prescribing Vascepa in volume to the very high, 500tg and over risk group, and taking away at least 50% of Lovaza's market share over time from that group alone, why would opening up the market to the low to moderate risk TG group, encourage doctors to subscribe Vascepa to them in boatloads?
It 's just not logical to presume doctors are going to prescribe prescription fish oil for the low to moderate risk groups regardless of what Reduce It results are in five to six years from now for the very high risk groups. They will simply more than likely stick with low dosage statins for the moderate to low risk groups. The cost/benefits I do not believe will justify otherwise. Talk to your doctors and see what they say.
While I believe that Vascepa WILL take away substantially from Lovaza's 500mg patient population, even if it does not, it's still likely that docs will prescribe V for the 200 - 500mg population, if approved for that use, as there are few effective meds for that market. Lovaza was a big step up for the 500mg group from available therapies at its inception; while Vascepa is a significant step up from Lovaza, it is not as big an improvement, from what I read and understand, as Lovaza was from existing therapies in 2007.
For patients that are doing well with Lovaza, they and their docs will see little impetus to change meds. Change for that group will be relatively muted, compared to a group that has no good alternatives at present, as Lovaza is contraindicated for the 200 - 500mg audience. I think you fundamentally misread the importance and opportunity of the 200 - 500mg group. 'Low- to-moderate risk' is real risk, and in a population of that size, many folks will carry other risks along for the ride, such as diabetes, which compound the risk and make efficacious treatment essential for long term well-being and in some cases, survival.
Can't happen, they would need to do a clinical trial on the combo. Indeed, FDA would require a reduction of cardiac events as a clinical endpoint, similar to the reduce-it trial. FDA has seen alot of combo drugs for cardiac event reduction fail recently. However, when AMRN gets bought out BP will start this combo clinical trial, possible pending the reduce-it trial.
Add that to sales predictions, through the roof.
Will- Do you think it will matter which statin they use? For example would big pharma want them to wait on this until they take control? Or is amarin covering crestor, generic lipitor separately in the patents and future sNDA.
I agree with you AMR-102 is the real prize.
Sentiment: Strong Buy
They'll use lipitor until Crestor goes off patent...unless AZN partners. Amarin is covering both in patents. That's the point...if BP doesn't want Amarin now, screw em, get the big gun out to make as much money ASAP. Especially without an exclusivity decision....
AMR 102 would decimate the statin market, the reduction in LDL, Lipids and inflamation can't be beaten. The combo would undercut the cost of two separate scripts. The indication would be on the statin level for reduction of CV events....$30 billion world market...not potential market. Statins sold close to $34 billion world wide last year....AMR 102 would lead that market with safety and efficasy.