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Another OB'd patent today for Amarin
http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=202057&Product_No=001&table1=OB_Rx
Amarin Longs, New PDUFA cycle, upcoming Amarin FDA NCE/Exclusivity meetings
The new cycle and new policy's and procedures require the FDA and Amarin to meet and discuss exclusivity. Should happen in the next 60 days. I expect that after all the Marine BS, Amarin should be forthright to investors regarding the outcomes.
Chab
Also note the reduction in TNF inhibitor, perhapse we also have a mechanism to decrease some forms of cancer. ASA has been link to the reduction in colorectal CA's, Icosapent may help in this regard.
http://www.cancer.gov/cancertopics/prevention/aspirin-cancer-prevention/Page1
Nice picture.
Williams
Priority review vs. standard review
First the rules MAPP: http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm082000.pdf
Priority (P) review — Preliminary estimates indicate that the drug product, if approved, has the potential to provide, in the treatment, prevention, or diagnosis of a disease, one of the following: (1) safe and effective therapy where no satisfactory alternative therapy exists; or (2) a significant improvement compared to marketed products (approved, if approval is required), including nondrug products or therapies. Significant improvement is illustrated by the following examples: (1) evidence of increased effectiveness in treatment, prevention, or diagnosis of disease; (2) elimination or substantial reduction of a treatment- limiting drug reaction; (3) documented enhancement of patient compliance; or (4) evidence of safety and effectiveness in a new subpopulation. Although such evidence can come from clinical trials directly comparing a marketed product with the investigational drug, a priority designation can be based on other scientifically valid information.
? Standard (S) review — All nonpriority applications are considered standard applications.
Obviously Vascepa doesn't qualify for priory review.
1)It's on the market already
2)Physcians can prescribe it for ingrown toenails if desired
3)Statins can treat mixed dyslipemia without increasing LDL safely
None of this changes the fact that Vascepa once approved will be the strongest best tolerated therapy for reduction of Trigylerides and reduction of LDL's when approved. When combined with a statin you achieve results no dyslipemia drug has every achieved in both reductions in numbers, safety, and lack of side effects.
So deal with it, it's a standard review that could be approved well before the PDUFA date.
Chab
Yes, and with the annoucement we're likely to see the dosing study. It would also be interesting to see when Amarin times the sNDA for AMR 102...after patent and dosing "perfection" no real need to wait.
This is the indication GSK bought Omacor for and got rejected;)
As it is, assuming current growth rate of sales and cash burn rate, Amarin proves profitability July 12th. 14,500 scripts per week and projected $143,000,000 per year revenue.
I assume rate of sales will increase with Tier 2 effective and 3 month Lovaza scripts running out. Could be as early as June. Not much time to unwind a short position. At profitability, Amarin attracts a new class of fund investment.
Shorts obviously "control" PPS now, but the sun is about to rise and the cockroaches will scurry onto a new easy meal.
Congrats Amarin on Patent number 8426399 issues today.
It should be posted in the FDA OB tomorrow. Number 12 in the OB.
Atlas
2013-04-23 AMRN Amarin Corporation Plc short volume 820022 long volume 1611941 total volume 2431963
So yes, almost 3 millions shares traded back and forth to manipulate. The SEC could care less.
We all know where this end up down the road, $50 + PPS.
Kay, I predict late Weds 8k listing BASF as additional API supplier. PR Thursday AM. Follows with the 4 day communication SEC rule.
Stock should drop 5% on this great news. LOL
No BASF Equateq, just strait BASF language;). I'd be nice to see a BASF/Equateq & BASF/Pronova but not likely with GSK still buying Lovaza API.
Thanks K, yes the timing is right for BASF approval. Lets see what kind of wording we get in the PR.
The drop in price was globally felt due to prank,
http://news.yahoo.com/stocks-briefly-drop-recover-fake-172814328.html
AMRN just doesn't have the ability to recover after being kicked in the nuts so many times by the FDA.
In the last two days AZN has penned two partner deals worth $440 million.
1) Bind Therapeutics $200M
2) Alchemia $240 plus royalty payments
I believe we sign a partner well before PDUFA.
PDUFA V: fiscal years 2013-2017 document.
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm
PDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES FISCAL YEARS 2013 THROUGH 2017
Review page 6: http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf
"2 The decision as to whether the application is included or excluded from the Program is distinct
from FDA's determination as to whether the drug product contains a "new chemical entity," as defined under 21 CFR 314.108(a). Determinations regarding new chemical entity exclusivity are made at the time of approval of an application."
Amarin's 8k:
"On April 23, 2013, Amarin Corporation plc (the "Company") issued a press release announcing the acceptance for review by the U.S. Food and Drug Administration ("FDA") of the Company's supplemental New Drug Application ("sNDA") which seeks approval for the marketing and sale of Vascepa(R) (icosapent ethyl) capsules for use as an adjunct to diet in the treatment of adult patients with high triglycerides (TG ?200 mg/dL and <500 mg/dL) with mixed dyslipidemia. The sNDA will be subject to a standard review by the FDA and has been assigned a Prescription Drug User Fee Act ("PDUFA") date of December 20, 2013. The PDUFA date is the target date for the FDA to complete its review of the sNDA. However, there can be no assurance that the FDA will complete its review of the sNDA by this date."
The FDA has accepted the application, at approval exclusivity will be given. If the FDA wanted only to provide 3 years seems like that would have happen already. Waiting for Anchor?
Ultimately if Amarin gets NCE after Anchor it provided an additional 1.5 yrs of exclusivity. Interesting stuff.
What firm is the first to upgrade AMRN target price?
Who will be the first with a $50 plus target?
Guessing the lowest will be $25+
Isaeed
Yes this COULD be the case or the FDA waits until Jan 2014 after Anchor PDUFA date December 20, 2013. At this point it's a 50/50 chance. After the May OB update it will be crystal clear, no update indicates the FDA is "saving" the exclusivity decision for Anchor.
Anchor Potential Exclusivity:
2014
2015
2016
2017
2018
REDUCE-IT: 2011,2012,2013,2014,2015,2016...results 2017
AMR 102 Vascepa/statin combo PDUFA cycle could happen 2014
AMRN may not trade at $50 today, but it's clear it will at some point in the next 360 days.
Acceptance of Anchor sNDA is linked to approval of exclusivity. Review pg 6
This could be an interesting next 30 days.
http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf
"Determination regarding NCE exclusivity are made at the time of approval of an application"
Pg 6
http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf
It's a relatively new PDUFA document, not sure what will happen if the FDA accepts sNDA for Anchor indication in the next couple of weeks, but the decision will have been made.
Are those the sum of weekly's or revised monthly #'s.
What?!
Heart Disease Facts
America's Heart Disease Burden
About 600,000 people die of heart disease in the United States every year–that’s 1 in every 4 deaths.1
Heart disease is the leading cause of death for both men and women. More than half of the deaths due to heart disease in 2009 were in men.1
Coronary heart disease is the most common type of heart disease, killing more than 385,000 people annually.1
Every year about 715,000 Americans have a heart attack. Of these, 525,000 are a first heart attack and 190,000 happen in people who have already had a heart attack.2
Coronary heart disease alone costs the United States $108.9 billion each year.3 This total includes the cost of health care services, medications, and lost productivity.
http://www.cdc.gov/heartdisease/facts.htm
In the US every year we have:
7.9 million Acute MI's (get diagnosis of MI)
9 million Angina (go to ER with chest pain)
7 million strokes (go to ER)
The percentages are based on US population of 310 million. Any of the above 3 are considered a primary REDUCE-IT event. In my prior post is the link to the above stats for 2012. I think it's from the NIH.
It's not an either or...it's over after 1800 days. If at 1800 days they don't have enough primary events then it continues until they do. Maybe I'm reading it wrong though?
Great link
First dosing started December 7 2011. 1800 day study. December 2016 finish date?
However study must have 1612 primary events to be complete:
"The primary objective is, in patients at LDL-C goal while on statin therapy, with established cardiovascular disease (CVD) or at high risk for CVD, and hypertriglyceridemia (fasting triglycerides, TG, =150 mg/dL and <500 mg/dL), to evaluate the effect of 4 g/day AMR101 for preventing the occurrence of a first major cardiovascular event of the composite endpoint that includes:
• Cardiovascular (CV) death,
• Nonfatal myocardial infarction (MI),
• Nonfatal stroke,
• Coronary revascularization,
• Unstable angina determined to be caused by myocardial ischemia by invasive/noninvasive testing and requiring emergent hospitalization. [Because of the variability in TG levels, the lower TG qualifying limit is 10% lower than the target of 150 mg/dL, i.e., 135 mg/dL.]"
US population: 310 million
Events per yr
Acute MI 7.9 million 2.5%
Angina 9 million 2.9%
Stroke 7 million 2.3%
http://www.nhlbi.nih.gov/resources/docs/2012_ChartBook.pdf
About 7.7% events per general population
8000 (n) for REDUCEIT @ 7.7% event rate = 616 event
616 events (5yrs) = 3080 events
Not perfect math, all 8000 obviously not enrolled day one. The 7.7% event rate is based on all comers and not patients with current heart disease, so 7.7% is a low rate compare to the REDUCE-IT population.
Assuming JELIS like efficasy, study should show trends by now.
Great link
First dosing started December 7 2011. 1800 day study. December 2016 finish date?
However study must have 1612 primary events to be complete:
"The primary objective is, in patients at LDL-C goal while on statin therapy, with established cardiovascular disease (CVD) or at high risk for CVD, and hypertriglyceridemia (fasting triglycerides, TG, =150 mg/dL and <500 mg/dL), to evaluate the effect of 4 g/day AMR101 for preventing the occurrence of a first major cardiovascular event of the composite endpoint that includes:
• Cardiovascular (CV) death,
• Nonfatal myocardial infarction (MI),
• Nonfatal stroke,
• Coronary revascularization,
• Unstable angina determined to be caused by myocardial ischemia by invasive/noninvasive testing and requiring emergent hospitalization. [Because of the variability in TG levels, the lower TG qualifying limit is 10% lower than the target of 150 mg/dL, i.e., 135 mg/dL.]"
US population: 310 million
Events per yr
Acute MI 7.9 million 2.5%
Angina 9 million 2.9%
Stroke 7 million 2.3%
http://www.nhlbi.nih.gov/resources/docs/2012_ChartBook.pdf
About 7.7% events per general population
8000 (n) for REDUCEIT @ 7.7% event rate = 616 event
616 events (5yrs) = 3080 events
Not perfect math, all 8000 obviously not enrolled day one. The 7.7% event rate is based on all comers and not patients with current heart disease, so 7.7% is a low rate compare to the REDUCE-IT population.
Assuming JELIS like efficasy, study should show trends by now.
JL
Icosapent Ethyl (PlusEPA) bilateral eye gtts today. Had to postpone my experiment due to an URI. Holy crap this works great. If it wasn't for the fishy smell of PlusEPA I would have zero complaints.
1) clears sinuses bilaterally in a minute, to the point I can maximally inhale through my nose almost as fast as through the mouth.
2) eyes are not dry at all, I'll see how long it lasts (a good 12 hrs last time)
3) pH must be well balanced with physiologic pH, no burning with application
Will
Cost per Rep is $200 k, JZ mentioned this is one of the last CC.
Not sure if the posters is correct or not , but in addition to this possible factor the last two weeks posted are holiday weeks. Schools are on break and professionals take their families on vacations. I'd be more concerned if we saw Month over Month numbers down, but since February Monthly's are being kept from retail and we saw no massive volume sell off, I suspect short institutions are using this opportunity to unwind their short positions.
14 with NOA
11 patents, one is an Anchor
25 all in total.
Acceptance of sNDA for Anchor should happen in the next 3 weeks.
Should see price adjustments with Anchor included. I believe it was Jefferies that surveyed Doc's on willingness to prescribe Anchor indication. I'm thinking the street doesn't get behind Amarin until Vascepa has Q2 growth over Q1 results....so August.
'329 has an issue date of 4-30-2013
'744 has an issue date of 4-23-2013
Acceptance of Anchor sNDA could happen any day before 5-11.
Setting a PDUFA for Anchor should also reset targets for Amarin PPS taking Anchor into account.
FDA needs pressure
Their lack of decision/communication has destroyed the ability for Amarin to raise money. I'm going political and sick of this waiting. Anyone interested in a Citizens Petition?
sts
Those SPA #'s are someones research, not all NDA also include sNDA. They where all in 2012 if i stuble on link agin I will post.
PLAC test should be somewhat covered. Look on their website for your state and the CMS coverage...are you in Florida?
I believe Mayo has been doing this study for quite sometime, probable why the stock hasn't taken off.
Low
What's low 11 weeks into a launch? How accurate are IMS? Where are the February Monthly updates? We got January's immediately from AF.
The last two weeks happens to be spring break, expect an uptick Monday.
You are wrong. Short term valuation is dependent on NCE. No BO, Partnership, or financing without it. Pharmaco has Amarin by balls.
The lack of FDA communication and no NCE decision destroys the ability for Amarin to follow through on their business plan. We are at the mercy of the FDA's incompetent speed.
Sales are growing at an acceptable rate, and I'd bet 30%+ what IMS is able to track.
Amarin will not be able to hire enough Reps to launch Anchor appropriately without a yes or a no NCE decision.
Patents Lin...
AAPL's getting their ass handed to them in court.
FDA's non decision is the major reason AMRN's trading at 6 and not 26. No real recourse with inaction just sit and wait it out.
Example of IMS inaccurate #
Lovaza's Q4 volume was 137k script average per week using GSK sales.
IMS consistently under reported this by 30%.
Does anyone have February Monthly updated sales data?
March Monthly's should be out May 1st.
Kay
sNDA 004 I speculate will happen 4-26.
I'm anxious to hear how BASF is referred to.
1)BASF
2)BASF-Callanish
Acceptance of Anchor sNDA should happen before 5-10.
Price will continue to fall until either Weekly script rise >20% again or Feb. update monthly's are leaked.
Notice AF's quietness on Amarin. He had the Jan. Monthly updates but failed to comment on Feb.
All speculation...though
Will
JL
First nice heart pun;). Second, if I was a Cardiologist, every patient would get a PLAC test. If I was an Internal medicine/family practice all high risk patients would get be tested.
Seems to be underutilized at the moment.
Will
Chab great find!
Plactest, FDA approved
http://www.plactest.com/
Vascepa significantly decreases Lp-PLA(2) and is FDA approved.
Both discussed recently at the NIH.
NIH recommendations for the treatment of hypertriglycermia are about to tighten, some practitioners even discussing 100 as a target for triglycerides. Now that practitioners have a test to separate high triglycerides as a secondary cardiovascular marker and the Plactest as a true indicator I suspect Vascepa is going to get some NIH love.
The video explains it:http://investorshub.advfn.com/boards/read_msg.aspx?message_id=86976917
Yes, very good news indeed. I would like to stress, BASF. Not BASF Equateq or BASF Pronova...but BASF. BASF is a contracted supplier of Vascepa, a partner, not a generic potential competitor. BASF is interested in Patented API as numerous documents can be found on their website discussing such matters. They are the worlds largest chemical company and an Amarin partner. Don't underestimate their intention of completely controlling the pharmaceutical Omega 3 industry by making a bid for Amarin.
Pronova currently has the capacity to supply Equateq with crude concentrated EPA and speed the production of the final patented DHA/EPA separation method.
Another great job by Amarin's management.
The sky is falling!
Not...
No generics
25 patents NOA or booked
In 2012 83% 97 out of 117 SPA's approved. Those not approved had either efficasy or safety issues, we know this is not the case with Vascepa. SPA is basically a contract for approval, Vascepa has met all it's obligations.
Anchor will happen
Bigger than Anchor...Combo Vascepa/Atorvastatin.
NCE nondecision is a huge kick in the balls every month since July PDUFA. Nothing we can do except be prepared next month for another blow.
CT order 4-17-2013
R/T Pharmacon payments in 2017
No Kay, that was the first change, 001. The second was adding Catalent Parma to Banner as the two capsulators (last page of label 000 compared to 002). Those are the only two encapsulation companies Amarin has contracted.
We don't know what the "04/12/2013 003 Manufacturing Change or Addition" letter, label or review is blank for now. It took several days for 002 new label to be posted.
It's most likely an acceptance of one of Amarin's API suppliers.
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist