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Williams
Do you know what the FDA Medical Review publication is and what's its purpose?
Tnx
yb
Vascepa now covered by Massachussets Medicaid with prior authorization!!!
https://masshealthdruglist.ehs.state.ma.us/MHDL/pubdownloadpdfcurrent.do?id=45
Great strategic analysis.
There was absolutely no other reason to delay the salesforce hiring until the last minute other than a deal was indeed close and that the deal likely hinged on NCE. If that is indeed the case, that also means that there was likely a price deemed acceptable by Joe and his board.
If a deal was acceptable then, it likely could be acceptable now.
In addition, if we go by what Joe is currently saying - that everything will take care of itself if script numbs continue to ramp, supply chain comes together, patent portfolio grows, getting Anchor approved - he is not talking here about ramping earnings per share, he is talking about being a great custodian of the business so that someone can come and take it from there...
I also agree that if there were to be a parternship, it would have happened by now. Why launch solo and then bring in another partner later? Maybe terms would be slightly better after Anchor but that could be negotiated and script numbers would be through the roof right now if we had a salesforce of gt 1000.
Of course big pharma could have balked and walked, and now there are no deals on the table. That is a possibility, but at least through the salesforce launch, there was a deal, IMHO.
12 hours till a new script number.
BRING IT!
You are correct and mgt called it pit that the Anchor safety data was already added to the label. Seems like its an easy gold star for FDA to approve this one somewhat early...
Early Anchor approval could be the wildcard to the story. I have no expert thoughts on the matter. Does anyone?
There will be some inflection but it will not be a hockey stick. They Are not pushing off lablel and off label most of Lovazas market. Part D is kicking in and our label rocks. Look for steady progress until combo, nce and as we move closer to Anchor strategic decisions...
totally agree...
while partner deal isnt a buyout, it is still a significant stock catalyst. he is definitely vetting co promotion strategies and offers.
"The safety results from the ANCHOR trial are included in the current label for Vascepa."
This is from the press release this afternoon.
Is this an updated label?
they have said it consistently in meetings.
Not sure if we get something big yet, but we are indeed potentially due for a label update.
I believe that right now, the reps are not even allowed to tell the docs about the Anchor trial, so this would be a huge upsell opportunity.
If there is any one single weakness to the AMRN story right is is that the Lovaza off label use is massive. While Lovaza script numbs are punching lower highs and lower lows on a weekly basis, they are entrenched and any off label use by Amrn is severely hampered right now by FDA guidance and the fact that FDA holds most all the cards right now.
A label change not only signals opening up of some off label potential, but also could signal that FDA wont convene a panel for Anchor. I know that some you on the board have stated that there is no need for a panel on an sNDA, and I hope that you are indeed right. I just know that mgt is trying to keep expecations low by indicating that they expect a panel.
yb
Could we hear news today on Anchor data being added to the label?
This was intimated to occur after reaching gt %50pct enrollment for reduce-it.
We are there now...
Thanks, although FYI, management is publicly stating to expect a panel, in order to keep expectations low...
no they dont. they can easily give color on the ramp without having to provide hard numbers. there is no expectation of guidance being provided either, none.
Shorts, you got nothing left...
The last thing you had was Q1 consensus numbers being too high. This morning Canaccord became the fifth broker to lower Q1. Q1 revenue consensus now stands at $3.4mm...
Shorts, what else do you have to hang your hat on now?
May NCE?
Gross margin expansion?
Expansion of label to include Anchor data?
17pct w/w growth for last week of April?
AMR102?
Potential notification by FDA later this summer that they will not require a panel for Anchor?
I just received the same email. I registered my email on the Vascepa website after approval and before launch. This is the first email I have received since registering.
Seems like this would be a way to begin reaching out to patients, at least somewhat informed patients, now that docs are becoming aware already.
Here is the email:
Amarin Pharma Inc. is pleased to announce that VASCEPA is now available and can be prescribed by your physician.
VASCEPA is a prescription medicine used along with a low-fat and
low-cholesterol diet to lower very high numbers of triglycerides (fats) in adults without raising LDL (bad) cholesterol.
VASCEPA can be used safely with statins.
VASCEPA has been shown to reduce high amounts of other fatty substances in the blood.
Talk to your doctor today to find out more about VASCEPA, and whether it's right for you.
Your doctor can provide you with more information.
*For the first prescription, the patient will not pay the first $75 of their co-pay. For the next 11 refills prior to 12/31/13, the patient is responsible for the first $25 and the card pays up to the next $75. Prescriber ID# required on prescription. Not for use by residents of VT, nor medical professionals licensed in VT. May not be used to obtain prescription drugs paid for by Federal and State Healthcare Programs including Medicare Part D. This offer is not valid for those under 18 years of age.
† By clicking any of the links you will be redirected to www.vascepa.com
You have asked to receive e-mails from Amarin Pharma. If you have received this e-mail in error, please unsubscribe here.
Important Safety Information
What is VASCEPA?
VASCEPA is a prescription medicine used along with a low-fat and low-cholesterol diet to lower high levels of triglycerides (fats) in adults.
It is not known if VASCEPA changes your risk of having inflammation of your pancreas (pancreatitis).
It is not known if VASCEPA prevents you from having a heart attack or stroke.
It is not known if VASCEPA is safe and effective in children.
What are the possible side effects of VASCEPA?
Do not take VASCEPA if you are allergic to icosapent ethyl or any of the ingredients in VASCEPA.
It is not known if people who are allergic to fish or shellfish are also allergic to VASCEPA.
The most common side effect of VASCEPA is joint pain. Talk to your doctor for medical advice about side effects.
As with all drugs, you may experience a serious side effect when taking VASCEPA.
Take VASCEPA capsules whole. Do not break, crush, dissolve or chew VASCEPA capsules before swallowing.
You may report side effects by calling 1-855-VASCEPA or
the FDA at 1-800-FDA-1088.
For more information, go to www.vascepa.com or
call 1-855-VASCEPA (1-855-827-2372).
UNSUBSCRIBE
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CONTACT US
You can reply to this email, or contact us via postal mail at:
Amarin Pharma Inc.
1430 Route 206, Suite 200 Bedminster, NJ, 07921 USA
Looks like decent outreach by the co to rein in analyst numbers for this first quarter. Roth also lowered estimates the other day as well. The Q1 bogey is getting lower and lower. While all that really matters is the ramp now, not numbers from February, optically not having to deal w a miss and the perception it may create is a positive...
After NCE we may see a deal containing a contingent value right (CVR) that would pay us for Reduce It.
Look at the deal for Genzyme by Sanofi which included a CVR for Lemtrada.
Given that BP has been a bunch of wimps so far, there is no way they will pay up for Reduce It even though it feels like Joe Z wants to be paid for it, at least somewhat...
http://www.bloomberg.com/news/2011-02-16/sanofi-aventis-agrees-to-buy-genzyme-for-74-a-share-in-19-2-billion-deal.html
Thanks Williams.
Great dd.
yb
Williams, Kay et al: do we know if Dr Goldenberg's comments on V being an NCE are consistent w the new MAPP salt policy?
Been thinking about this but not sure myself.
Ty - yb