AMRN bulls should ask VVUS how their go it alone launch has gone so far. They're in a similar battle of discounting and coupons. There's going to be a lot of myths out there to debunk that Vascepa is not just your standard fish oil.
To all the bulls that taught the LDL raising ability of Lovaza.... keep in mind that current guidelines suggest statin therapy to bring patients to LDL goals before being concerned about triglycerides. Once a patient is maximized to their LDL goal and the statin has had a chance to also lower the triglycerides, a triglyceride lowering agent can be considered. Fibrates remain a standard of care due to their effectiveness and now their costs. Tricor is one of the best selling fibrates to date and has now become available generically. Vascepa will have to compete with this and soon generic Lovaza.
In a trial of Lovaza with simvastatin, patients with high triglycerides were first treated with simvastatin and optimized to their LDL targets before initiating Lovaza. After initiation of Lovaza triglycerides were decreased by ~ 30%, Apo-B ~6% and LDL DECREASED by 0.7% or 3 points from 91 to 88. This scenario follows much of the real world. Statins are the mainstay of therapy and the trial involving simvastatin shows apo-b was reduced and LDL really wasn't moved. Most studies suggest that LDL 100 may start the build of plaques within arteries. Lovaza did not move the LDL to dangerous levels at all which is the general theme I feel AMRN bulls try to suggest.
Fibrates are a pain to take and I believe can not be used by Diabetics
Lovaza was never approved for the Anchor indication despite 2 attempts by GSK ( concerns about LDL )
Vascepa ( at least purified EPA ) is the easiest drug to take to improve ones over all lipid profile
Statins remain the mainstay of therapy to reduce most CV events ...despite what Amarin and others may wish to believe
There will IMHO be a " rollover " of meds as those currently on their 90 supply of Tricor / Trilpix ( Fibrates ) and Lovaza expire and when blood test / lipid panels are scheduled . .... As this happens more scrips for the over 500 TG group will be prescribed .
For the under 500 TG patient ....don't expect a big jump in " off label " scrips ....DS alternatives are still routinely " suggested "
Tier 2 pricing , if achieved ,changes everything
AK, you do know that Lovaza gets significant revenue from off label scripts? Reliant reps were pushing for off label for Lovaza before they were acquired by GSK. Nowadays, we have more and more data showing benefits of EPA, as you know. Vascepa CAN promote the reduction of CV risk markers, and this opens the door for off label... The CV benefits can lead MDs to information like the JELIS results or OCEAN results...
A glass half full prescribing physician would see no problem with Vascepa as a preventative as it has no significant adverse effects. Why wait for REDUCE-IT outcomes if you risk the chance that your patient has a greater than 50% chance of a major cardio event while not on EPA and statin, per the JELIS results.
Vivus is a completely different situation and cannot be compared to Amarin in any way. There are a number of reasons for the difficulty with their go it alone launch. I'm not going to waste time on it here.