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YB
The medical review is/was part of the Marine NDA review. It does however cover Anchor in everything but the statistical review. The Blanked out portions of the document are probably related to Anchor. When Anchor gets reviewed we'll see many of the same documents posted. These documents started to appear March 6 th, but new documents have trickled in, like the Medical Review document about 4 weeks ago.
Williams
Thanks Livin
Nothing new on the patent front I could find, should see NOA with Statin combo 13417899 any day.
Williams
This document has been posted for about 4 weeks, since after last OB update. The FDA page says March 6th but this is not true. I search these documents daily to find new information, they where not posted March 6th.
Price increase is due to a short covering rally. If the OB gets updated and Amarin gets new fund buying as expected with this news, we could see a full blown short squeeze. Money Makers I believe will not allow HF to naked short and fail to deliver as a means to keep or drive share price down. Amarin's met within the month with the MM I'm guessing was discussed. We certainly could see some forced covering in the days to come.
Vascepa is a prodrug according to the FDA Medical Review page 19, yes this document is new since the last OB update.
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdf
"The drug product from Amarin contains a purified icosapent ethyl. Icosapent ethyl (ethyl eicosapentaenoic acid or ethyl-EPA) is the ethyl ester of EPA. Icosapent ethyl acts as a prodrug for EPA, as it is hydrolyzed enzymatically by esterases, particularly pancreatic lipase, to liberate the free acid EPA"
-----------
Lovaza's active ingrediate is EPA, or eicosapentaenoic acid, it has 0% Icosapent Ethyl/Vascepa.
EPA or eicosapentaenoic acid are interchangeable same chemical.
http://en.wikipedia.org/wiki/Eicosapentaenoic_acid
Icosapent Ethyl, Ethly eicosapentaenoic acid, or E-EPA are interchangeable and the same chemical, they have a covalent Ethly bonded to the ester group. The are the prodrug of EPA.
http://en.wikipedia.org/wiki/Ethyl_eicosapentaenoic_acid
I hope this clears up some of the confusing terms.
Williams
Could someone link this to stock twits so the confusion gets crystal clear before Friday.
Absolutely, it gives short term value to the asset. Long term value is based on the patents and industry monopoly and of course REDUCE-IT.
Sts
There not my words, it's all contained in the Lovaza Equivalence review dated 9-12, Vascepa Equivalence review 4-2013, pharmacology review of Lovaza and pharmacy review of Vascepa.
There is 0% Icosapent Ethyl in Lovaza Equivalence review:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM320011.pdf
Also: OBTAINED
"Omega-3-Acid Ethyl Esters is a natural source drug obtained from the body oil of several fish sources"
Both Equivalent documents measure EPA blood levels, you might be able to achieve the same EPA blood levels with Lovaza if you take 32 Grams per day, however, you still will not achieve the same physiologic effects due to the 16 Grams of DHA you ingested. DO NOT TRY THIS!
Not sure if the FDA has other documents related to NCE changes, but the haven't released anything new as far as policy. NCE has nothing to do with Anchor as it's the same prodrug that separates Vascepa and Lovaza.
I assume we get update this week, but I've been wrong on this timing many times before;). In the FDA responses I get, they're more no comment as before they where haven't made the decision yet. This is new compared to last month for what it's worth.
Williams
JL, I have no pity for the fools.
EPA vs. Icosapent Ethyl eye gtts, just a hypothesis but EPA drops are probably more beneficial as the eyes contain no pancreatic lipase to activate the Icosapent Ethyl. It just smells like fish;(
....
Try it if you have leftover PlusEPA, one small drop...blink a few times...then add a few drops of saline until the oily vision goes away. The EPA lipid floats in your tears and lasts about 12 hours. The fish smell is mild like being at the beach. Don't do it on an op day, might screw up your loop vision.
Williams
ZBD
You can find EPA in fish oil, but not Icosapent Ethyl. Icosapent Ethyl is "derived" from fish oil unlike Lovaza which is purified fish oil. Somewhere in the process an Ethyl group gets added to the EPA. Two very completely separate chemicals with Vascepa being able to achieve 8 times the blood levels of just purified EPA.
Icosapent Ethyl, Vascepa is a prodrug of EPA with a covalently bonded Ethyl to the Ester portion of the EPA. Vascepa is activated in the GI tract by pancreatic lipase, cleaving the Ethyl and leaving pure EPA to be absorbed. This information is contained in the FDA review document of Vascepa.
Williams
1 gram of EPA is not equal to 1 gram of Icosapent Ethyl. Icosapent Ethyl is a prodrug of EPA, it's able to "sneak" more active EPA into the blood stream than "just over the counter EPA". This is a fact. It's documented in both the Lovaza and Vascepa FDA reviews.
"Fish oil EPA" starts to get digested by pancreatic lipase, while the covalently bonded Ethyl group in Icosapent Ethyl is cleaved leaving EPA to be absorbed at a MUCH higher level. Lovaza 8 Grams EPA blood levels = 80 mcg/ml, Icosapent Ethyl 4 Grams EPA blood levels = 350 mcg/ml. (Found in the FDA review documents).
Trying not to lecture you Akanz, but if you want the same blood levels of EPA it's looking like a 32 gram dose of Pure Artic may be required. (Do not try this, anyone!...except for Adumb & Harper)
Williams
Thanks JL, I think you found a subset of patients that could really benefit from a disease that modern medicine has no treatment for.
Williams
Pharmacist
It's about blood EPA levels. You have to take 6 times the dose of Lovaza to achieve the same Vascepa EPA blood levels. However, in doing so, you've also ingested an equal dose of DHA and thus expect your LDL to sky rocket. 1 gram of common fish oil is like Michael Jordan vs Ryan Seacrest one on one.
The FDA has made this information public.
Williams
Yo
You had me up til the June update. That MAPP is effective immediatly so May 1st IMO means nothing. The FDA has released further Marine Documents since the last OB update...I think that was the hold up. Going out, way out but I really expect it gets done this month.
NCE means almost Jack Sh!t compared to the IP Amarin has amassed this year.
Next week will be a fun ride, swing traders welcome...shorts have dug quite a hole.
JL
Good post. I had a hard time figuring out why Amarin was patenting EPA blood levels, it now makes, sense with the prodrug angle. IP protection from another EPA prodrug, Amarin's building a monopoly. Not sure anyone will be able to be successful, in the EPA market, while Amarin has IP and supply locked.
You where correct on the GIA. IMO co marketing deal before the end of the summer. If Amarin is able to lock IP protection on hydroxy-Atorvastatin/Vascepa combo Amarin has the potential to DOMINATE the world statin market with a combo NCE. As ridiculous as it may be, the company could have a $15+ Billion price tag after.
Williams
Patel
What do we have here?
http://www.amarincorp.com/template/partnering.html
You can't compare EPA dose.
Why?
1)because some of it get's destroyed by the GI tract before getting into the blood as EPA, unlike Icosapent Ethyl which instead of being digested get's converted into EPA.
2) DHA competes for the same sites EPA works
Any comparison's have to be made with EPA levels, the FDA has set this bar with both review documents related to generic production.
8 grams of Lovaza produced EPA levels of 80 mcg/ml, while 4 Grams of Vascepa produced EPA levels of 350 mcg/ml. Even if you took the 32 Grams of Lovaza to produce those EPA levels you'd have to take more to off set the DHA you injested, competing for those EPA receptors. (Lovaza users don't try this you'll get sick, just switch;)
It's all about EPA blood levels, fish oil can't produce Vascepa results. Fish oil can reduce triglycerides but not without spiking your LDL.
2 grams of Vascepa per day EPA Cmax = 155 mcg/ml
4 grams of Vascepa per day EPA Cmax = 347 mcg/ml
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000ClinPharmR.pdf
page 37 Pharm. review
Fish oil/Lovaza Cmax
8 grams of Lovaza EPA Cmax = 80 mcg/ml
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-654_Omacor_BioPharmr.pdf
page 8 FDA Pharm. review
Statistical review for Anchor recommends 4 gram dose, it's safe to say 1 gram of fish oil is pissing in the wind with perhapse EPA levels as low as Cmax = 8 mcg/ml (estimate)
43 times lower blood EPA levels than 4 gram dose of Vascepa, do you think that Cardiologists would recommend 1.8 mg of aspirin instead of 80 mg per day? LOL
Someone post this to yahoo,stocktwits and ADUMB...I don't have time today.
Williams
I agree with Adam, all women should take Vascepa. Thanks Adam.
Williams
The prodrug picture
H3C-CH2-O-C=O
/
CH2-(CH2)a few more then-CH3
This is Vascepa the Prodrug of EPA. The Ethyl group CH3-CH2 gets cleaved of by pancreatic enzymes making it a Type IIb prodrug.
HO-C=O
/
CH2-(CH2)a few, but the same as above then-CH3
This is EPA, it lacks the Ethyl group that's covalented bonded to the ester group.
Thus, Vascepa is a prodrug of EPA and a new chemical entity.
Williams
Examiner just being methodical, there's the superiority with Icosapent ethyl...which was unexpected. Amarin's got this. If and when this passes, the IP value alone is staggering.
Very interesting patent action with hydroxy-Avortastatin. 5-5-2013 Final rejection. 12888994
Final Rejections are far from final.
It will be interesting to see the response as Pfizer was mentioned in the rejection.
As stated in the Marine review, no Ad Com because they are no safety issues.
Efficasy has already been reviewed for Anchor indication in the statistic report posted online with the Marine approval documents.
Anchor is the door to combo. It's the real goal of the whole product line dating back to Pronova and earliy 2000's. Just didn't provide the efficasy to be approved. Not the case with lipitor or more importantly the hydrox-lipitor prodrug that's a likely candidate for NCE.
The big three patent apps to watch are :
'899 combo treatment of >500 lipids
'319 combo treatment of >200
'994 hydroxy prodrug combo, likely NCE combo (how much is a new statin that's the most efficacious with the best safety profile?)
Reasonable estimate, we'll see how stocking and discounts play in Thursday. Could we see Amarin take a stab at 2013 estimate?
Earning surprise? IMO yes. Here's why
Speed to Tier 2, and aggressive discount plan has shown Pharmacy's they need to aggressively stock Vascepa.
"Pharmacy Stocking and Messaging Programs
Pharmacy stocking programs for specialty pharmaceutical companies
Are you frustrated by pharmacy policies that prohibit your sales representatives from talking to pharmacists?
When you launch a specialty prescription product, are you able to get enough bottles on pharmacy shelves to support physician demand?
Pharmacists play an important role in the uptake, usage and patient compliance of pharmaceutical products. In today’s pharmaceutical sales environment, however, it can be extremely difficult for brand teams to message pharmacists. Many of the big chain pharmacies prohibit pharmaceutical sales representatives from approaching the pharmacy counter. Independent pharmacies present a messaging and stocking challenge, as you need to approach them individually. Thus, most pharmaceutical sales organizations no longer include pharmacies in their daily call plans.
Multi-Channel Marketing is an Efficient Pharmacy Approach
A multi-channel pharmacy program can reach a substantial portion of your target audience much quicker than traditional methodologies. Even when sales representatives call on pharmacists, they can only see two or three a day. A multichannel communication program can target hundreds of pharmacists every day, in a cost-effective manner. By offering pharmacists a choice of communication channels your important message is much more likely to be heard:
•Telephone calls
•Faxes
•eMail blasts
•Direct mail
This multi-channel process ensures a faster, deeper penetration for your pharmacy messaging and stocking program. Our experienced team of professional multichannel marketers knows how to leverage each channel to optimize your success.
Pharmacy Stocking Programs are Critical to Launch Success
Failure to stock enough pharmacies can severely impair a new product launch. For specialty pharmaceutical products, pharmacy stocking can be a difficult challenge. Many pharmacies, especially the chains, won’t even think about stocking your product if you can’t show a realistic plan for achieving $100 million in revenue. Instead, you hear the dreaded words, “we’ll order it when we see a prescription.”
To successfully overcome these challenges, you need a strong special offer and a targeted multi-channel communication program that will quickly announce the benefits of stocking your product:
•Speedy dissemination of your time-sensitive pharmacy stocking message maximizes reach and frequency to a large portion of pharmacists.
•Support of your sales representative efforts by targeting pharmacies near their called-on physicians.
•Ensure deep penetration of your message to big chains and independent pharmacies.
•Clarify the pharmacy landscape for your prescription product by mapping stocked locations
•Sharing your products unique value proposition and reimbursement status with pharmacists"
http://pharmakinnex.com/pharmacy-stocking-programs
Also results of Q1 come on Option expire day, the trap is set:)
30,000 Retail pharmacy's stores across the US, this only includes the top 10chain stores.
http://en.wikipedia.org/wiki/List_of_pharmacies
30,000 ($180) $5,400,000 per 1 stocked bottle per store.
Brilina IMS number where destroyed by Vascepa Q1, Brilinta $130/mo
First Q Brilinta sales $15 million
Highest Vascepa Q1 is $15 million
Stocking plus underreporting could have Sales >$15 million for Vascepa
Enjoy:
http://www.astrazeneca.com/cs/Satellite?blobcol=urldata&blobheader=application%2Fpdf&blobheadername1=Content-Disposition&blobheadername2=MDT-Type&blobheadervalue1=inline%3B+filename%3DDownload-presentation.pdf&blobheadervalue2=abinary%3B+charset%3DUTF-8&blobkey=id&blobtable=MungoBlobs&blobwhere=1285646638984&ssbinary=true
pg 9
Yes link: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000ClinPharmR.pdf
Good pharmacology data r/t prodrug activation, EPA levels ...
New FDA document out r/t Marine use, reading now.
So far supports Icosapent Ethyl prodrug and has data r/t hydroxy atorvastatin. Also contains Anchor data.
Clinical Pharmacology Biopharmaceuticals review
Scleroderma, I cringe when I see that on the problem list! Brilliant off label, I hope someone has the foresight to do a clinical trial. Potential Orphan drug status?
Thanks Zoobuff
I have an autistic son, kicking around the idea of getting a script. I really hope researchers look into the neurochemical benefits that Icosapent Ethyl could provide in the Eicosanoid pathways. Although anecdotal, some have achieved complete reversal of autistic symptoms with diet changes alone. I have a great relationship with our Peds Phychiatrist and we love to take about the science...haven't discussed Vascepa yet, but I plan to next time with articles and Eicosanoid pathways in hand. JL do you have any recommendations on inflamation studies related to neuroscience?
Thanks
Williams
"I don't think"...I agree, you don't think. At the current growth rate Amarin is paying all the bills and hanging onto the >$250,000,000 in cash by the end of the summer. On track for 20,000 script per week in August, which gives Amarin $200 M in a 52 week projection. Zoobuff is correct with the 3 mo scripts, we should start to actually see accelerated growth > than the almost 17% this week.
We'll also see if Vascepa, has a similar Q1 to Brilinta...both were tracking the same weekly's early March. We could see a much larger stocking number with the continued week over week growth.
Doc
Any off label scripts for Vascepa r/t ADHD or Depression? Small studies have been promising.
Will
Looking at the week trends and seeing the slow down in grow during spring break, I would look to expand sales team now into the December Anchor Approval. Using Rick Shalaby's PDI contacts and using PDI sales team contract with Amarin sales members leading the teams. Double sales team at this point, is looking like double growth. Great time to double down JZ.
The science is definitely leading in that direction. Some are questioning the potential success of REDUCEIT, I suggest they review pg 19 of Amarin's April presentation.
http://files.shareholder.com/downloads/AMRN/2186131830x0x651653/CC47C992-CAF5-4A08-8DC6-F1DBF0AD5DB7/Amarin_Investor_Presentation_April_2013.pdf
Reviewing the JELIS or Cohort data you can easily see as time passes the event lines diverge. This is a reduction in CV events and more importantly (to insurance companies) less money spent on expensive cardiac related events. If you develop a drug that SAVEs lives and health care dollars you get a MEGA block buster...ie > $10 B in sales per year.
US REDUCEIT population, 70 million, 10 % market penetration 7 M or $14 Billion in sales. 2 to 3 times World REDUCEIT population and you get around $30 Billion, which happens to be the current World statin market.
No drug ever, has had this potential!
Billions just a goal, I too would only make a couple million:)
Akanz
AMR 102 Lipitor/Vascepa would be a 505b2 standard review. Need dosing studies...which appear to be done. (good results, adequate Lipitor and Vascepa levels) Also need Patent, if your read the 505b2 guidelines...I'll post later. Combo patent should get NOA for '899 this month. sNDA June, 74 day reply Aug, 10 month PDUFA...June 2014 at the earliest.
Interesting to note patent '994 is a metabolite of Lipitor and would be considered a completely separate drug. This poses an interesting dilemma for Amarin as it could be considered a NCE. Separately this molecule isn't as potent as Lipitor, but combined with Vascepa it's synergistic effects equal the non NCE Lipitor molecule. Not a bad problem to have when your the owner of both patents.
Good to hear from you;)
Williams
Long term guidance
Here's a few examples of other bioteck sales/market caps:
Amarin Marine Valuation based on 2014 sales high projection:
AMRN $687 M/ $1.02 B
VRTX $1.53 B/ $16.5 B
REGN $1.38 B/ $25.7 B
JAZZ $585 M/ $3.4 B
ILMN $1.21B/ $8 B
ALXN $1.23B/ $19.2B
BMRN $512M/ $9.26B
AMRN $22.6 to $128 PPS
Amarin with 5% market penetration of Anchor is $4 B sales/ yr
CELG $5B/ $50.9B
AMRN 333 PPS LOL
22.6 to 333, I'll take $50:)
Fast track combo patent '319 4-29-2013...odd, what's the rush?
'899 combo should get NOA this month, what's the main difference between the two? '899 treats 500 and up. (A method of treating a subject having baseline fasting triglycerides of at least 500 mg/dl comprising, administering to the subject an HMG-CoA reductase inhibitor and 4 g per day of a pharmaceutical composition comprising at least 96% by weight ethyl eicosapentaenoate for a period effective to reduce fasting triglycerides in the subject by at least 45% without substantially increasing LDL-C relative to a control subject taking a concomitant HMG-CoA reductase inhibitor without said pharmaceutical composition)
While the newly fast tract '319 treats 150 to 500. (1. A method of lowering triglycerides in subject having baseline fasting triglycerides of 150 mg/dl to 500 mg/dl comprising administering to the subject an HMG-CoA reductase inhibitor and about 4 g of a pharmaceutical composition comprising at least 90%, by weight of all fatty acids present, ethyl eicosapentaenoate per day to effect a reduction in fasting triglycerides and LDL-C in the subject relative to a second subject receiving the HMG-CoA reductase inhibitor without said pharmaceutical composition.
Amarin's packaging IP IMO.
They waited the full 40 days after Q1, perhapse gathering data for a Q2 guidance.
Ajax, If granted with Anchor it should start at approval date given Vascepa Exclusivity until Dec 2018 and a free year of Marine.
I think the delay was more policy driven and the answer could come anytime.
We should also see switch overs from 3 mo Lovaza's to Vascepa's starting to add up. Feb,March,April...I'm looking for the percent increase to start to pickup. A 1000 script per week gain is due in the month of May:)