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Amarin is listed as a prodrug in the medical review released by CDER recently. New documents have been randomly popping up.
Page 20
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdf
Also in a general search other Pharm D's have referred to Icosapent Ethyl as a prodrug for EPA.
Recently the medical community have come up with different class of prodrugs.
Almost all of the recent prodrug NCE approvals have been either delayed this long or reversed from prior NME status. It'll WILL happen.
Williams
Patent '889 has Reasons for allowance posted 3-27, Notice of allowance and PR should be this Month.
'899 is Amarin's first EPA/Statin combo patent, includes combining EPA with rosuvastatin, atorvastatin or pravastatin. Dosing study results should follow or be included in PR.
Claims:
1. 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.
2. The method of claim 1 wherein said period is a period effective to reduce fasting triglycerides in the subject by at least 50% without substantially increasing LDL-C relative to a control subject taking a concomitant HMG-CoA reductase inhibitor without said pharmaceutical composition.
3. The method of claim 1 wherein said period is a period effective to reduce fasting triglycerides in the subject by at least 55% without substantially increasing LDL-C relative to a control subject taking a concomitant HMG-CoA reductase inhibitor without said pharmaceutical composition.
4. The method of claim 1 wherein said period is about 1 to about 12 weeks.
5. The method of claim 1 wherein said period is 12 weeks.
6. The method of claim 1 wherein the composition is administered to the subject 1 to 4 times per day.
7. The method of claim 6 wherein the composition is present in one or more capsules.
8. The method of claim 1 wherein the subject has a baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, a baseline fasting LDL-C of about 40 mg/dl to about 115 mg/dl and a baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl.
9. The method of claim 8 wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for said period, the subject further exhibits (a) a reduction in fasting non-HDL-C levels compared to a fasting non-HDL-C level at a baseline prior to initial administration of the pharmaceutical composition; and (b) a reduction in fasting VLDL-C compared to a fasting VLDL-C level at a baseline prior to initial administration of the pharmaceutical composition.
10. The method of claim 1 wherein the HMG-CoA reductase inhibitor comprises rosuvastatin, atorvastatin or pravastatin.
Ortho-hydroxy Atorvastatin
Easy suppy chain:
http://www.chemicalbook.com/ChemicalProductProperty_EN_CB01516070.htm
Well vetted for safety:
Quantitative determination of atorvastatin and ortho-hydroxy atorvastatin in human plasma by liquid chromatography tandem mass spectrometry and pharmacokinetic evaluation.
http://www.ncbi.nlm.nih.gov/pubmed/21069099
After therapeutic dosing study Amarin has enough information to file 505 (b) (2) requesting 5 yrs of NCE exclusivity. This dosing study is complete and results promised before the end of Q2.
Amarin Announces Completion of Dosing in a Fixed-Dose Combination Study With Vascepa(R) and a Leading Statin
BEDMINSTER, N.J., and DUBLIN, Ireland, Dec. 17, 2012 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that it has completed dosing and pharmacokinetic sampling in a study to test a fixed-dose combination of Vascepa® (icosapent ethyl) capsules and a leading statin. The clinical name for this combination product is AMR102. Prior to commencement of the study, Amarin opened an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration which became effective after the standard 30-day review.
The purpose of this AMR102 study is to determine the bioavailability of the EPA (eicosapentaenoic acid) and statin components when taken as a fixed-dose combination product, relative to the individual reference agents taken concomitantly. Statin bioavailability from both the fixed-dose and concomitant regimens will also be compared with that from the reference statin taken alone in healthy subjects. Additionally, pharmacokinetic data from this study will be examined to explore relationships between in vitro dissolution data and in vivo pharmacokinetic data. The study is designed as a randomized, open-label, multiple dose, parallel-group study in 48 healthy subjects conducted at a single site in the United States.
"This study is aimed at expanding the potential commercial application of Vascepa by leveraging the clinical successes of the MARINE and ANCHOR trials, namely effective triglyceride lowering without increasing LDL-C," stated Joseph Zakrzewski, Amarin's Chairman and Chief Executive Officer. "Amarin's goal is to identify ways for patients to simplify their lipid management by developing a single therapy that offers the powerful triglyceride lowering effects of Vascepa combined with one of the most prescribed statin products."
Amarin looks forward to analyzing the results from this study and expects to communicate such results in the first half of 2013.
http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=727154
Patent '994 PHARMACEUTICAL COMPOSITION COMPRISING OMEGA-3 FATTY ACID AND HYDROXY-DERIVATIVE OF A STATIN AND METHODS OF USING SAME
Imagine a new statin, one with the best lipid, inflamation, and side effect profile ever. Then add 5 yrs of NCE and a patent covering you until 2030...how much is this worth?
Hydroxy atorvastatin is a never approved prodrug of Atorvastatin, it's not in the OB or is it covered by any patent. It's well studied as it is a metabolite of Atorvastatin. The metabolite by itself is not that potent, so it was never investigated as a primary statin, but combined with Icosapent Ethyl the combination is more powerful than any individual or other combination statin.
Amarin should see NOA within 2013 for '994.
Williams
Ty
Dr. Goldenberg's thoughts:
"The active moiety in GlaxoSmithKline’s Lovaza, a similar agent for the treatment of hypertriglyceridemia, is a mixture of omega-3-acid ethyl esters that includes icosapent ethyl (EPA), docosahexaenoic acid (DHA), and a few others. Without requiring GlaxoSmithKline to specify which ester helps to lower triglycerides, the FDA considered the mixture of EPA and DHA as the active moiety that is responsible for the physiological and pharmacological action of Lovaza. Vascepa might have an advantage over Lovaza; it does not increase LDL-C levels, which has sometimes been observed with Lovaza.
The FDA considers Vascepa to be a new chemical entity. It contains only EPA but not DHA, and it does not contain any appended portions of both EPA and DHA that cause them to be an ester, salt, or other non-covalent derivative. Therefore, its active moiety has not been previously approved by the FDA in any other application submitted under Section 505(b) of the Federal Food, Drug, and Cosmetic Act."
-------
First, the FDA considers Lovaza to be a mixture of Omega 3 Ethyl Esters, NO Icosapent Ethyl. Lovaza contains "eicosapentaenoic acid ethyl ester (EPAee)".
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM320011.pdf
Second, the FDA considers Icosapent Ethyl to be a prodrug of EPA, Type one prodrug activated by the GI system. "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"
Pg 20 of Vascepa's Medical review.
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdf
In my opinion he was right about the mixture, wrong about the Icosapent Ethyl in Lovaza. He new nothing of the Prodrug nor did he have access to the two generic formulations for both Vascepa and Lovaza. I'm sure he would agree today that Icosapent Ethyl is a prodrug of EPA, and thus a NCE completely differentiated from anything in Lovaza.
Williams
I like the increasing volume. Helps the big boys get in.
Chab, these are the results that are the basis for AMR 102. The FDA pointed out the statistical synergistic effects of AMR 101 + statin. I'm trying to point out the path for AMR 102 sNDA and approval, if Amarin's around in 2014, this is what they'll be up to.
Williams
Tia, here's the prodrug link for Icosapent Ethyl: "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."
Pg 20 of the FDA's Medical Review for the Marine approval. The review documents started getting posted on March 6.
I haven't found a prodrug that the FDA hasn't awarded 5 yrs of exclusivity to.
Williams
Patent 8431560 Orange Booked today, note first Amarin patent to contain DHA up to 3% (Manufacturer road block for generic production) I have never seen so many things come together so fast for a company.
Claims:
1. A method of reducing triglycerides in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl comprising, administering orally to the subject 4 capsules per day, each capsule comprising about 900 mg to about 1 g of ethyl eicosapentaenoate and not more than about 3% docosahexaenoic acid or its esters, by weight of total fatty acids present, for a period of 12 weeks to effect a reduction in triglycerides in the subject.
2. The method of claim 1 wherein the subject has a fasting baseline LDL-C from about 50 mg/dl to about 300 mg/dl.
3. The method of claim 1, wherein the subject has one or more of: a baseline fasting non-HDL-C of about 200 mg/dl to about 400 mg/dl, a baseline fasting total cholesterol of about 250 mg/dl to about 400 mg/dl, a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a baseline fasting HDL-C of about 10 mg/dl to about 60 mg/dl.
4. The method of claim 1, wherein said administering effects a reduction in fasting triglycerides of at least about 10% without increasing LDL-C by more than 5% in the subject.
5. The method of claim 1, wherein said administering effects a reduction in apolipoprotein B in the subject.
6. The method of claim 1, wherein said administering effects a reduction in VLDL-C in the subject.
7. The method of claim 1, wherein said administration effects reduction in fasting triglycerides of at least about 20% without increasing LDL-C in the subject.
8. The method of claim 1, wherein each capsule comprises about 950 mg of ethyl eicosapentaenoate.
9. The method of claim 1, wherein each capsule comprises about 975 mg of ethyl eicosapentaenoate.
10. The method of claim 1, wherein each capsule comprises about 1 g of ethyl eicosapentaenoate.
11. A method of reducing triglycerides in a subject having a fasting baseline triglyceride level of 500 mg/dl to about 1500 mg/dl comprising, administering orally to the subject 4 capsules per day, each capsule comprising about 900 mg to about 1 g of ethyl eicosapentaenoate and not more than about 3% docosahexaenoic acid or its esters, by weight of total fatty acids present, for a period of 12 weeks to effect a reduction in triglycerides in the subject compared to placebo control.
12. The method of claim 11 wherein the subject has a fasting baseline LDL-C from about 50 mg/dl to about 300 mg/dl.
13. The method of claim 11, wherein the subject has one or more of: a baseline fasting non-HDL-C of about 200 mg/dl to about 400 mg/dl, a baseline fasting total cholesterol of about 250 mg/dl to about 400 mg/dl, a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a baseline fasting HDL-C of about 10 mg/dl to about 60 mg/dl.
14. The method of claim 11, wherein said administering effects a reduction in fasting triglycerides of at least about 10% without increasing LDL-C by more than 5% in the subject compared to placebo control.
15. The method of claim 11, wherein said administering effects a reduction in apolipoprotein B in the subject compared to placebo control.
16. The method of claim 11, wherein said administering effects a reduction in VLDL-C in the subject compared to placebo control.
17. The method of claim 11, wherein said administering effects reduction in fasting triglycerides of at least about 20% without increasing LDL-C in the subject compared to placebo control.
18. The method of claim 11, wherein each capsule comprises about 950 mg of ethyl eicosapentaenoate.
19. The method of claim 11, wherein each capsule comprises about 975 mg of ethyl eicosapentaenoate.
20. The method of claim 11, wherein each capsule comprises about 1 g of ethyl eicosapentaenoate.
For you Dog lovers R/T NCE
"Lisdexamfetamine is a prodrug that is metabolically converted to produce dextroamphetamine, which is responsible for the drug’s activity. Under FDA’s regulation at 21 CFR § 314.108, a non-ester covalently bonded molecule is considered the active moiety ofa drug and, if not previously approved, it will be considered a new chemical entity entitled to 5 years of exclusivity. A non-ester that requires metabolic conversion to produce a previously approved active moiety is considered a new chemical entity. Because lisdexamfetamine is a non-ester covalently bonded molecule, and because it requires metabolic conversion to produce dextroamphetamine, lisdexamfetamine is a new chemical entity and is thus entitled to 5 years of exclusivity.
Camargo has worked on a number of prodrugs and we have found that FDA is consistent in how it makes the determination."
http://blog.camargopharma.com/index.php/2009/10/26/fda-reaffirms-5-year-exclusivity-for-pro-drugs/
We book another patent today in OB, congrats Amarin. Not updated yet be should show up today.
Something about AMR 102 in the statistal review for the Anchor indication?
Page 117 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000StatR.pdf
"In patients who were on background statin therapy, the placebo-adjusted TG reduction was greater than in patients not on background statin therapy."
-------
This statement happen to be made in the conclusions and recommendations.
-Anchor sNDA will most likely use same medical review document as it contains both Marine & Anchor
-Anchor sNDA will contain separate statistical analysis from the Phase 3 Anchor data
-AMR 102 will use all the same reviews from marine and anchor making it quick.
AMR 102 is the $10 billion per year market.
Icosapent Ethyl has been scientifically accepted as an EPA pro drug.
I don't have time to post all the links but they include the FDA, Physician's, and Pharm. D's.
Pro drugs have been controversial in being granted NCE status, yet in recent times all have succeed. (That I'm aware of)
Emend:
http://www.accessdata.fda.gov/drugsatfda_docs/NDA/2008/022023s000_AdminCorres_P2.pdf
Pro drug FDA:
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 aprodrug for EPA, as it is hydrolyzed enzymatically by esterases, particularly pancreaticlipase, to liberate the free acid EPA.
pg 20 in the medical review:
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdf
This pro drug label has nothing to do with the approval of Anchor and is a new development for me. I'm back to NCE can happen at anytime before Anchor.
Williams
COG's just dropped 50% or more with BASF approval.
"The addition of BASF, along with Chemport, will lead to API cost reductions of up to 50% or more."
Well my original theory of a late 8-K is more valid for the 4-19 sNDA with the BASF announcement today. Still the FACT remains, Amarin can add Anchor data to the label when REDUCE-IT is 50% enrolled and that could have been yesterday...for all we know.
We don't have the dosing results yet. Nor do we know if they'll be "positive". Some Earliy graphs from patent application data looks like it's heading in a prodrug Liptor combo. Prodrug's are often given 5 yrs of exclusivity;)
Good thought but...the FDA only mandates label changes for the below reasons I believe. Including Anchor is a marketing angle not a safety of efficasy issue.
The three reporting categories for changes to an approved application are defined in § 601.12: 1) those changes that have a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product, which require submission of a supplement and approval by FDA prior to distribution of the product made using the change; 2) changes that have a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectivenessoftheproduct,whichrequiresubmissionofasupplementtoFDAatleast 30dayspriorto distribution of the product made using the change; and 3) changes that have minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product, which are to be described by the applicant in an annual report.
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM170166.pdf
This particular guidance is for "biological", haven't found the small chemical but I'm sure it similar.
This is really starting to take shape in my opinion.
Here's a 50% reference estimate for REDUCE-IT:
"Consistent with prior comments, Amarin estimates that the study will require approximately 8,000 patients and take approximately 6 years for completion. The Company anticipates that if, as intended, it commences Outcomes study activities in 2011 that it will be positioned to achieve approximately 50% enrollment before the end of 2012."
http://www.streetinsider.com/Corporate+News/Amarin+%28AMRN%29+Reaches+Agreement+for+REDUCE-IT+Trial/6702234.html
sNDA for Anchor could only be applied for after "substantially" underway. This obviously has occurred 4-23 since the FDA accepted the application. Enrolled first patient December 2011...
Same document pg 16
"A preIND meeting was held on 14 July 2008. During the discussion, it was agreed that a single study could potentially suffice for the indication “as an adjunct to diet to reduce triglycerides in adult patients with very high >500 mg/dL triglyceride levels” provided that the results are robust. The agency defined robust results as: results that are statistically significant; results from a study with a low drop out rate; study results that are consistent across treatment centers; and results from a study with a large sample size. The Agency also confirmed requirements for NCE toxicology program."
"NCE toxicology"
Page 20
"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"
"Prodrug" not EPA but prodrug Icosapent Ethyl....sound like NCE;)
Anchor study reviewed pages 28 to 41
Both efficasy and safety for Marine and Anchor in this review.
A review of the data set and the FDA should rubber stamp it. This document is new to my eyes, anyone know when the FDA posted it?
FYI, I believe the FDA has reviewed the Anchor indication. If you read the Medical Review by Dr. Chowdhury the redacted b4 statements all fit.
Also review the last paragraph on pg 10 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdf
"The applicant was told prior to this NDA submission that data from Anchor trial would not be mentioned in the Vascepa labeling until, at a minimum, 50% enrollment of a cardiovascular outcomes trial was reached."
Anchor application accepted PR was 4-23, minus 4days with SEC reporting.
This coincides with the FDA 4-19 change, which I assumed was BASF approval.
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist
I believe Anchor gets added to the label whenever Amarin wants to make the change. (Negotiate)
Read the document.
"This application also contained a study report, but not the dataset, for the ANCHOR trial. This trial was not considered pivotal to the efficacy claims of Vascepa for this NDA. The ANCHOR trial investigated patients with TG between 200 mg/dL and 499 mg/dL despite statin therapy. The applicant was told prior to this NDA submission that data from the ANCHOR trial would not be mentioned in the Vascepa labeling until, at a minimum, 50% enrollment of a cardiovascular outcomes trial was reached."
-Anchor gets added to the label any day
-sNDA official approval to follow at or before PDUFA
Can't believe I missed this paragraph;)
Williams
The formulation change for the Lipitor molecule is interesting in that it very well might be classified as a NCE. It's an active metabolite, another FDA debate:) COOL STUFF!
Brilinta/Vascepa scripts sales comparison:
Cafepharma:
Re: Brilinta is Poised for Greatness!
Quote:
Originally Posted by Anonymous
It is the next Plavix, a true revolution in pharma!
Amarin has launched Vascepa with 250 sales reps, and in 6 weeks surpassed Brilinta weekly sales. Brilinta failure to launch is the US ASA culture, Astra will never change "the culture".
http://www.cafepharma.com/boards/showthread.php?t=525548
6 weeks in March 8 th Vascepa weekly 1500
Brilinta Q1 $15 million at $130 per script 115,385/13 weeks in Q 1 8,875 actual average scripts (this does include stocking)
IMS numbers off by 5.9 times?
Anyone have real Brilinta IMS weekly averages?
LOL, JL you attract the crazies where ever you go. Amarin will do want DNDN said they where going to do. No show, no BS....they say it they do it. Like the Statin Vascepa combo patent...gonna happen soon.
Genius
Normally generics want to be the first to file, but because exclusivity for Vascepa is protected a in a many ways we could see a large generic sign an "early" partnership deal. Especially if BP doesn't make a move soon on M&A.
If generics defeated all Amarin's patents tomorrow they would not be able to under price Amarin in the market, it wouldn't be worth it to even try...and they would just waste attorney fee's. Amarin has a Monopoly on Icosapent;).
Earliy TEVA rumor could hold true for a partnered Anchor launch, Pfizer, Merck, GSK, and AZN would look pretty stupid.
Williams
Study,
Agree, it not if, it's when. It very well might be after Anchor, which of course extended our exclusivity long term with the exclusivity starting Dec 20 at Anchor PDUFA. New MAPPs are still popping up so timing is impossible.
Also new documents have been posted on Marine approval, many redacted pages r/t NCE.
I was also excited to see Brilinta ($130/script) sales come in at $15 Million with script number similar to Vascepa's($190/script). Yes, an apple to oranges comparison, but still cool. $15 million happens to be TOP sales estimate for Vascepa Q1:)
Shorts have dug a seriously big hole.
Lovaza's CAS number change?
http://www.druglead.com/cds/omega-3-acid-ethyl-esters.html
308081-97-2 to 0086227-47-6
Kay? any digging you can do?
Genius,
An OK this May would be at the original time of approval...so 4 yrs of exclusivity LOL...but Anchor would provide us with 3 yrs NME at approval in December.
If the FDA decides to stick their thumb up their butt, per protochol, they'll wait for Anchor and we start from there. Know one knows....
My opinion is it will happen, when...WFK?
Will
Yes,
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122886.htm
New "COVER FORM FOR THE TECHNICAL REVIEW
OF DRUG MASTER FILES"...looks like a form cover sheet to help the FDA organize. As noted in the last post it mandates CAS and chemical name organizing into categories of "new" chemicals and chemical that have already been approved.
At least in my research I never noticed a CAS number for Ethyl Esters of Omega 3. All three Worldwide agency's for naming chemicals have separated Lovaza and Icosapent Ethyl, in my opinion, evidence of the FDA's final conclusion to Vascepa NCE status.
Will
NEW FDA MAPP posted
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/ucm079564.pdf
Info R/T Vascepa and Lovasa ***CAS number, USAN***
Omega 3 FA, Fish oil, Lovaza (0086227-47-6, USAN Omega-3-acid Ethyl Esters)
http://www.drugs.com/international/omega-3-acid-ethyl-esters.html
Icosapent Ethyl Vascepa (CAS# 0010417-94-4, USAN Icosapent)
http://www.drugs.com/international/icosapent.html
CAS, USAN and IUPAC are all on the same page, Vascepa and Lovaza are two separate chemicals.
Enjoy
Will
What is the catalyst for a partner or BO?
IMO it's '889 NOA, it should come before June.
Reasons for Allowance was on 3-27-2013
'899 Is a combo patent listing rosuvastatin, atorvastatin or pravastatin. Shortly thereafter I see Amarin rleasing combo data.
'899 Claims
1. 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.
2. The method of claim 1 wherein said period is a period effective to reduce fasting triglycerides in the subject by at least 50% without substantially increasing LDL-C relative to a control subject taking a concomitant HMG-CoA reductase inhibitor without said pharmaceutical composition.
3. The method of claim 1 wherein said period is a period effective to reduce fasting triglycerides in the subject by at least 55% without substantially increasing LDL-C relative to a control subject taking a concomitant HMG-CoA reductase inhibitor without said pharmaceutical composition.
4. The method of claim 1 wherein said period is about 1 to about 12 weeks.
5. The method of claim 1 wherein said period is 12 weeks.
6. The method of claim 1 wherein the composition is administered to the subject 1 to 4 times per day.
7. The method of claim 6 wherein the composition is present in one or more capsules.
8. The method of claim 1 wherein the subject has a baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, a baseline fasting LDL-C of about 40 mg/dl to about 115 mg/dl and a baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl.
9. The method of claim 8 wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for said period, the subject further exhibits (a) a reduction in fasting non-HDL-C levels compared to a fasting non-HDL-C level at a baseline prior to initial administration of the pharmaceutical composition; and (b) a reduction in fasting VLDL-C compared to a fasting VLDL-C level at a baseline prior to initial administration of the pharmaceutical composition.
10. The method of claim 1 wherein the HMG-CoA reductase inhibitor comprises rosuvastatin, atorvastatin or pravastatin.
Hummmm. I smell fear. If Brilinta and Amarin had neck in neck weekly's...and Brilinta's monthly scripts cost $130...q1 sales for the two could be quite similar. It's time to start to worry about that short position.
Can anyone get Brilinta weekly numbers? I though Vascepa and Brilinta were neck in neck about a month ago.
Brilinta fished of Q1 in the US with $15 million in sales. $130 per month for a script. Could IMS numbers be off that much with Vascepa?
Please some get the weekly's for Brilinta and post.
When it comes to exclusivity no ones sure of anything. NDA and sNDA are all under the 502, both have the same PDUFA guidelines. I did email the FDA a few questions well see if they get back to me or a get the same form email.
I'm 50:50 on when, but 100% sure it's a yes (just my humble opinion though;).
Dew
When 3 or 5 yrs of exclusively expires for a drug generics don't magically appear....they have defeat patents. By the end of 2013 Amarin will the 20 plus Marine Patents, numerous Anchor, and a couple combo patents. Well earned patents can't be dismissed. 2030.
Some of those patents cover capsule makeup to prevent oxidation. Amarin has set up mine field...you can just blow through and run to the other side.
Will
Assuming sNDA filed at the FDA was BASF, timing would coincide with both Chemport and BASF announcements in December, what excuse would Amarin have for not filing an 8-K in the 4 business day window?
FDA APROVAL of an API supplier is no doubt a must 8-K.
Thoughts?
Zip
In addition to what you said, there's the new PDUFA program. Effective 11-1-2012, pg 6 implies at the acceptance of an application the FDA will have decided it's exclusivity status.
Thus, the FDA has decided. Indication Anchor or Marine doesn't change the molecular formula or touch on any new MAPP documents. We either hear this month or the FDA disregards it's own rules.
http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf
There is no competition for Vascepa with OTC or generics (in the next 17 years)...PERIOD.
All pure EPA OTC is oxidized. This is bad, as the oxidized compound doesn't have the potency as Vascepa.
How do you know it oxidized? It will smells like fish. Pure, unoxidized EPA has no smell.
PlusEPA smells like fish, it's oxidized. 1000 mg doesn't the same potency as Vascepa, simple pharmacology 101.
Amarin, I expect that BASF annoucement before the end of the day. The FDA has realized this change on 4-19, out with the 8-K and make it flashy. Drop Pronova in the annoucement, so we can light a fire under GSK:)
AM announcement for BASF API supplier, tonight you should see the 8k