Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
The future growth of Vascepa scripts:
http://epinephrine24seven.wordpress.com/tag/lovaza/
Differences in Tiers For Drug Reimbursement ( $AMRN $GSK )
February 20, 2013 in Life Science Companies | Tags: $AMRN, amarin, co-pay, Drug Tier System, GlaxoSmithKline, GSK, Lovaza, Vascepa | Leave a comment
Rate This
Drugs are ranked by tier to determine the financial burden its individual client will cover with a co-pay and the insurer will cover.
This system is used to charge lower co-pays for lower costing drugs and higher co-pay for costlier ones. Individual plans vary in terms of the cost a patient would pay for a drug. The numbers or tiers can also vary between insurance plans from one tier which is a flat percentage of the drug cost to six different tiers. Generally, there are four tiers:
Tier 1 is typically for the least-expensive drugs which are generic
Tier 2 is for preferred brand drugs
Tier 3 is for non-preferred brand drugs
Tier 4 is for the most expensive drugs generally used to treat rare diseases
Preferred drugs are ones that the insurer feels they are receiving for a good price and will have a cheaper co-pay for their patients rather than non-preferred drugs. Drugs can switch tiers and sometimes drug companies will themselves pay the co-pay difference for patients between tier 2 and tier 3 to bridge the cost gap between their drug and their competitors drug. This will occur until the company can convince insurers their drug should be a preferred branded drug.
An example of a company currently implementing this strategy is Amarin who this January launched Vascepa (Icosapent ethyl) which insurers have initially placed as a tier 3 drug. Their competitor GlaxoSmithKline’s Lovaza (omega-3-acid ethyl esters) is generally a tier 2 drug for insurance plans. Thus, to help get patients to switch to Amarin’s clinically superior drug, they are paying the difference of the co-pays for Lovaza and Vascepa.
Please do some DD r/t Vascepa's current market share and what will likely happen in December. At $7, this is the best value play WS has ever seen IMO.
Williams
Yes confused,
You help along with this diagram showing parallel pathway, thanks
Will
http://upload.wikimedia.org/wikipedia/commons/thumb/5/58/EFA_to_Eicosanoids.svg/480px-EFA_to_Eicosanoids.svg.png
Thanks JL
Didn't know that EPA competes with AA for both COX and LOX, Thanks.
As far we took it 20+ yrs ago in Endocrine/Physiology was COX1&2's mechanisms of action. I hooked on the science now.
This eicosanoid stuff is fascinating and Dr. Sears is brilliant, obviously. Any reading you could recommend would be appreciated.
Thanks
Will
JL
Yes COX1 & COX2 work to prevent AA from being converted to prostaglandins (not sure about LOX, although that maybe why some get and asthmatic rxn to COX's), but the two mechanisms of EPA work before COX1's or COX2's mechanism of action. EPA inhibits delta-5-desaturase (alpha-Linolenic acid to AA is blocked) and PLA2 (blocking PLA2 preventing the conversion of phospholipids to AA) after a stimulus both which are responsible for the production of AA, one step ahead of COX's.
To my knowledge Cox1 & 2 doesn't reduce the concentration of AA, it blocks AA from being converted into prostaglandins. EPA reduces the production of AA, a step ahead of COX1 & 2...both together should be an additive effect with COX1 & 2 having less AA to "fight" for convertion of AA to prostaglandins.
http://t3.gstatic.com/images?q=tbn:ANd9GcQ9_N3ooeDb_awhYxMRfrdauOzOLkJ_34PSry1pxnFIr6jrfIlQ
You've been studying this a long time so please correct me if need be.
Nuke
No addiction, narcotic receptors ( there's tons of different kinds), located in your brain are responsible for the physical morphine addiction.
I don't recommend "my combo" without your doctors approval.
Aspirin, Ibuprofen, & EPA would lesson your ability to form a clot due to platlet suppression.
Ibuprofen can be hard on your kidneys.
Tylenol is liver toxic.
Still the combo and mechanisms warrant a scientific study.
Williams
Has anyone noticed, after being on Vascepa, how potent ibuprofen is when taken as needed?
I did. It lead me to a couple hours of Biochem and Dr. Sears research.
This is a very simplified mechanism of action diagram:
http://www.lef.org/magazine/mag2007/images/ss2007_report_epa_dha_04.jpg
More detailed stuff:
http://t3.gstatic.com/images?q=tbn:ANd9GcQ9_N3ooeDb_awhYxMRfrdauOzOLkJ_34PSry1pxnFIr6jrfIlQ
My understanding:When the "membrane Phospholipid layer" of your cells is damaged, this sets in motion a cascade of enzymatic events.
1)Injury & cell damage
2)Increase in Arachidonic Acid production
3)"Arachidonic acid is one of the chemicals released during tissue damage. It is then metabolized into prostaglandin (and cytokines). The action of the prostaglandins is mediated through a G protein, protein kinase A cascade. The prostaglandins block the potassium efflux released from nociceptors following damage, which results in additional depolarization. This makes the nociceptors more sensitive. Aspirin is an effective pain killer because it blocks the conversion of arachidonic acid to prostaglandin."http://neuroscience.uth.tmc.edu/s2/chapter06.html
So where the heck does EPA fit in, exactly. The answer is hard to find, but easy to understand when you find it. FDA documents are blanked out, several studies don't make mechanisms known. Had to dig into Dr. Sears, the man is a freaking genius! JL, always thought you where a little nutty when you mentioned some of this. This is real science not taught to those that need to know and understand these pathways.
EPA's mechanism of action with Arachidonic Acid:
1) EPA inhibits the production of Linolenic Acid production. This is done by inhibiting Delta-5-desaturase enzyme, this is the enzyme that converts alpha-Lionolenic Acid (Omega-6) into AA. The end result is less AA and less prostaglandins production responsible for pain.
2) EPA inhibits PLA2, PLA2 is another enzyme that can convert Free FA to AA. Thus, reducing AA production via a completely separate mechanism from 1.
So, when you combine a COX1 inhibitor (aspirin), COX2 inhibitor (ibuprofen), and EPA you get a MASSIVE reduction in AA production with tissue damage (pain causing event). So how much? Well, the prescription COX2, ketorolac 30 mg IV, is equivalent to about 6 mg of Morphine given IV, without the opioid side effects of respiratory depression, GI, and CNS effects...I'm guessing a premedication dose of 2-4 grams of Vascepa and IV Tylenol/ketoroalc would be very successful in the reduction of postop pain management.
Or a combo aspirin/Tylenol/ibuprofen/EPA mix, maybe the equivalent of 10 mg Morphine IV "over the counter".
Williams
Wow! Check this out if you think negotiations aren't at full speed!
Director, External Reporting, Financial Planning & Analysis
"Minimum of 8 years of relevant professional experience required (Big 4 experience preferred)."
Big 4, why? Why not the big 6? Royalty agreement with the big 4?
http://www.amarincorp.com/careers-dir-external-reporting-financial-planning.html
Might actually be a way to market Brilinta and Vascepa together AZN;)
LOL
28% reduction in cardiac tissue damage after invasive cardiac cath procedure
http://www.clinicaltrials.gov/ct2/show/results/NCT01521845?term=Omega+3&rank=56§=X6015#outcome1
Amarin needs to get aggressive on label expansion.
Why would a Cleveland Clinic Cards Doc down play EPA?
Deepak Bhatt, MD---Canceled an EPA study when at CC, then got a new job. He's running the REDUCEIT study.
Cleveland Clinic Jealous/JELIS? Pun intended.
http://www.clinicaltrials.gov/ct2/show/study/NCT00578578?term=Omega+3&rank=10
394 volume on 62's...really?
Option players, why did those larger numbers pop up for June?
http://finance.yahoo.com/q/op?s=AMRN&m=2013-06
Amarin as an assets has grown each month. BP is not going to get Amarin management or longs to panic, if anything the Omthera move showed Amarin has all the bargaining chips, including I suspect a non dilutive Royalities agreement with Élan. I gather this deal would be enough to pay off Pharma loan and cash reserves to launch Anchor & Combo product. Thanks Élan, Amarin will have your back when we get on our feet!
Williams
AstraZeneca and Abbott end license agreement for the development of Certriad
AZN combo history:
http://www.astrazeneca.com/Media/Press-releases/Article/AstraZeneca-ends-agreement-with-Abbott-for-Certriad
Wednesday, 22 December 2010
AstraZeneca announced today that it has notified Abbott that it will discontinue the development of CERTRIAD (rosuvastatin calcium and fenofibric acid), which was being investigated for the treatment of mixed dyslipidemia. This means the co-development and license agreement with Abbott will end on 22 January 2011.
A Complete Response Letter (CRL) for the CERTRIAD New Drug Application (NDA) was received from the U.S. Food and Drug Administration (FDA) on 30 March 2010.
The companies reached this decision after careful review and consideration of the CRL and the resulting regulatory delay, and have determined that the development of CERTRIAD is no longer commercially attractive.
AstraZeneca will continue to focus on other development priorities both within and outside of the cardiovascular disease therapeutic area.
"Certriad" results
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3262365/table/t4-cpaa-2-095/
IMO didn't pass the FDA safety risk test. Amarin, had superior lab results and no safty issues. AZN is just dick'n with Amarin now.
Amarin & Elan Achor launch sounds good to me.
Williams
NCE is a complete non issue with valuation now.
Before IP for combo, NCE had more relevance for longer (5yrs) valuation. Now with combo and Anchor patents rolling in 3 yrs NME for December Anchor (Dec 2013,2014,2015) plus sNDA for end of 2014 combo (Dec 2014, 2015, Dec 2016) NCE now for Marine means NOTHING. (2012,2013,2014,2015, July 2016)
Combo NME Dec 2016
Marine NCE July 2016
IMO it's why we have negotiations picking up.
Williams
Why and how could Élan help Amarin?
http://www.sec.gov/Archives/edgar/data/897448/000110465904009105/a04-3973_1ex4d27.htm
Anyone that listened to the Élan Inverstor CC could pickup the dedication they have for their shareholders. Shareholder in the past, have played "big brother" , probably work at Equateq, and respect Amarin. Élan and Amarin have "plans" to launch Anchor if other deals don't develop, IMO. This is likely a response to AZN's negotiation "style" with the Summer Street/Omthera play.
After reviewing Pronova, and Amarin IP...Omthera is next to worthless IMO.
Williams
How many times have we heard "we won't launch Anchor alone".
Guessing after Anchor approval, Amarin "dilutes" shares to ELN, priced around $30 per share. Money will be used to expand primary care to 1000 reps.
20 million shares @ $30, $600 million & enough to launch Anchor and sNDA combo.
Élan has invested in Amarin throughtout it's history. Élan may also be interested in the Neuro aspects of EPA:AA ratios.
"This could mean that Vascepa was a better treatment than statins...Or at the very least using statins without V was sub optimal treatment.. ". JL I have read many of your posts, I believe that you are in the top 0.1% that understands the science. I also know your not prone to exaggerate, so do these results add to potential BO price in your opinion?
Thanks,
Will
Because the difference for the companies presentation here: page 23 http://www.omthera.com/pdf/OmtheraJPMorganPresentationJan-10-2012.pdf
Lists Trig reductions of 50 to 60 % (est)... LOL on that est thing....
and with real life results of: 31% with 4 gram max dose here: http://www.abstractsonline.com/plan/ViewAbstract.aspx?mID=2974&sKey=a073c55d-dc7b-46a2-a682-4fe610e8400b&cKey=39a148c5-21af-42f5-bf2e-2aa71314190d&mKey=%7B14145D5B-F96B-4354-8237-8F0937744BA4%7D
Someone at Omthera got's some explaining to do...LOL. AZN would like a little discount here for fabrication of the JPMORGAN presentation.
Great question, let's speculate the triglyceride form of EPA as the worse case senerio for Amarin.
What would be the barriers?
There's 16 of them listed in the OB that cover a product called Vascepa. Some patents even cover EPA blood levels;) Although the API would vary slightly from the Trigyleride EPA compared to the E-EPA the active moiety in both is EPA and EPA blood levels measured. Sounds like a great generic alternative to Icosapent Ethyl if AZN would like to wait for Amarin to go generic in 2030. AZN bought a generic product...the triglyceride form happens to be more expensive to make also.
Amarin's R&D patent team is all over this angle, can't comment further on this;)
Results of Epanova: Akanz, JL, Zoobuff, Study, others please comment on data:
Session: AOS.202.02-Lipid and Lipoprotein Metabolism: Clinical HDL and Triglycerides
Presentation: 19030 - Apolipoprotein C-III is Significantly Reduced by Prescription Omega-3 Free Fatty Acids (Epanova) in Patients with Severe Hypertriglyceridemia and Changes Correlate with Increases in LDL-C: A Sub-analysis of the EVOLVE trial
Pres Time: Wednesday, Nov 07, 2012, 10:00 AM -10:15 AM
Location: Room 503
Pres. Time: Wednesday, Nov 07, 2012, 10:00 AM -10:15 AM
Specialty: +202. Lipid and Lipoprotein Metabolism: Clinical
Keywords: Lipoproteins; Lipids; Lipoproteins
Authors: Daniel J Rader, Richard L Dunbar, Univ of Pennsylvania Med. Ctr, Philadelphia, PA; Kevin C Maki, Biofortis Clinical Res, Addison, IL; Terry A Jacobson, Emory Univ, Atlanta, GA; Douglas Kling, Michael H Davidson, Omthera Pharmaceuticals, Inc., Princeton, NJ
Abstract: Background: Apolipoprotein C-III (apoC-III) inhibits lipoprotein lipase activity and hepatic uptake of triglyceride-rich lipoproteins. Elevated levels of apoC-III have been found to be an independent predictor for CHD risk and genetically reduced apoC-III is associated with protection from CHD, making apoC-III a therapeutic target. Omega-3 fatty acid formulations containing docosahexaenoic acid (DHA) have been shown to increase LDL-C in patients with severe hypertriglyceridemia (HTG). Clinical data suggest that eicosapentaenoic acid (EPA) alone, which lowers triglycerides to a similar extent as EPA + DHA, does not raise LDL-C, but also fails to lower apoC-III.
Materials: The EVOLVE trial evaluated 2, 3, and 4 g/d of a novel omega-3 free-fatty acid (FFA) formulation containing both EPA + DHA compared with 4 g/d of olive oil. In 399 patients with severe HTG we evaluated the effects on plasma apoC-III levels and the correlations between change in apoC-III and change in plasma lipids (TG, LDL-C) after 12-weeks of therapy.
Results: Epanova 2, 3, and 4 g/d produced significant median reductions in apoC-III by 9 (p=0.02), 13 (p=0.006), and 15% (p<0.001), respectively, compared to olive oil (+5%). Epanova produced significant (p<0.001) median reductions in triglycerides (TG) of 26, 22, and 31%, respectively, compared to 10% for olive oil, and significant (p<0.001) median increases in LDL-C of 21, 16, 26%, respectively, compared to 10% for olive oil. There was a significant positive correlation between percent changes in apoC-III and triglycerides (r=0.603, p<0.001) and a significant negative correlation between percent changes in apoC-III and LDL-C concentrations (r=-0.28, p<0.001).
Conclusion: A novel omega-3 FFA formulation containing both EPA and DHA significantly lowered apoC-III levels in addition to reducing TG levels. An increase in LDL-C correlated with the reduction in apoC-III. Since EPA alone does not appear to lower apoC-III, these results support the hypothesis that DHA has specific effects in lowering apoC-III and that the mechanism by which DHA increases LDL-C may be related to its effect to lower apo CIII.
Disclosures: D.J. Rader, Omthera Pharmaceuticals, Inc., Modest,Consultant/Advisory Board; R.L. Dunbar, None; K.C. Maki, DSM, Modest,Research Grant; GSK, Significant,Research Grant; Abbott, Significant,Research Grant; Pharmavite, Significant,Research Grant; Trygg, Significant,Consultant/Advisory Board; Omthera Pharmaceuticals, Inc., Significant,Consultant/Advisory Board; T.A. Jacobson, Amarin, Modest,Consultant/Advisory Board; Abbott, Modest,Consultant/Advisory Board; GSK, Modest,Consultant/Advisory Board; Omthera Pharmaceuticals, Inc., Modest,Consultant/Advisory Board; D. Kling, Omthera Pharmaceuticals, Inc., Significant,Employment; Omthera Pharmaceuticals, Inc., Significant,Ownership Interest; M.H. Davidson, Amgen, Modest,Consultant/Advisory Board; AstraZeneca, Modest,Consultant/Advisory Board; sanofi-aventis, Modest,Consultant/Advisory Board; Omthera Pharmaceuticals, Inc, Significant,Employment; Omthera Pharmaceuticals, Inc, Significant,Ownership Interest; Merck & Co., Significant,Consultant/Advisory Board.
EPANOVA
http://www.abstractsonline.com/plan/ViewAbstract.aspx?mID=2974&sKey=a073c55d-dc7b-46a2-a682-4fe610e8400b&cKey=39a148c5-21af-42f5-bf2e-2aa71314190d&mKey=%7B14145D5B-F96B-4354-8237-8F0937744BA4%7D
In my opinion AZN bought a capsule Patent and that's it.
Williams
Ajax
Vascepa's peak levels of EPA are higher, Vascepa trough levels of EPA are higher, and Vascepa has no levels of DHA that increases LDL/bad cholesterol.
Omthera has lower peaks and troughs of EPA, but has very high DHA levels that help it lower Triglycerides, but raises bad LDL cholesterol. I can't find the full results of Omethera as the full study hasn't been vetted or posted like Marine & Anchor. According to JZ this LDL bump is why Reliant couldn't get the high trig market or the combo market.
Brig 88
My son is 10 yrs old and was diagnosed with Asperger's & ADHD at the age of 3. He spent the MAJORITY of preschool in the principles office and was "kicked" out of two preschools. He's been on psychiatric medications since he was diagnosed 7 years ago to help control his very liable emotions. These labile emotions are extremely taxing on ALL in the family of any diagnosed child. The divorce rate is 90% for a couple with an Asperger's/ADHD child.
My son is brilliant, good looking, and loving...but has a very difficult time relating to others due to his unpredictable emotions that can be set off by any change in routine. Currently he's taking Atomoxetine, Risperidone, and Fluoxetine. On Friday May 24 th he started taking 2 grams of Vascepa per day. I want to remain cautious with the results at this time, but this is the ONLY time he's mentioned how much his new BIG pill makes him feel so much better.
Please spread the word, any Asperger's/ADHD/Autistic child taking an OTC/Lovaza fish oil off-label needs to try Vascepa. Nothing can replicate the EPA blood levels as the drug, Icosapent Ethyl.
Williams
I was busy yesterday and didn't get a chance to DD this latest Omthera/Epanova and post. Here's my opinion:
Icosapent Ethyl is an FDA approved drug to treat Very High Triglycerides 500 <. It will VERY likely be approved to treat high Triglycerides in December. Fish oil, AKA, Lovaza was denied approval for this high trig market and Combo market because of the increase in LDL. GSK bought fish oil for $1.6 billion dollars from Amarin's CEO back in 2004 planing to launch a combo drug per Pronova:http://www.drugs.com/clinical_trials/study-demonstrating-lovaza-omacor-co-administered-atorvastatin-reduces-non-hdl-cholesterol-6201.html
Now, if you believe this is AZN's only M&A, they should have talked to GSK before spending half a billion dollars on a drug with NO IP protection, raises LDL in Omthera's Marine & Anchor equivalent studies. IMO AZN just opened a can of sardines... Epanova is likely not to get approved until after Lovaza goes generic in 2015, LOL.
Epanova's active moiety is EPA and DHA dissolved in the blood plasma and RBC's, with a "mix of Omega-3's that also might be active" The FDA doesn't grant exclusivity based on API, but on ACTIVE MOIETY. Epanova's API is a mix of triglycerides in a patented protected capsule creating superior bioavailability when compared to Lovaza. Thus, Amarin's API is Icosapent Ethyl an EPA pro-drug. It very well could be defined as a NCE because the ACTIVE MOIETY in Lovaza was ill defined at the point of Amarin's application and the Active Moiety for Lovaza is now defined as a mix of Omega 3's including EPA and DHA. The monograph describes the API and NOT the active moiety. The active moieties for both drugs have just been posted in the September 2012, after Vascepa approval;) Draft Giudance for Lovaza and the completely separate guidance posted for Vascepa in April 2013.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM347002.pdf
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM320011.pdf
"Omega-3-Acid Ethyl Esters is a natural source drug obtained from
the body oil of several fish sources. The Omega-3-Acid Ethyl Esters USP monograph defines the active pharmaceutical ingredient (API) as composed of seven individual omega-3-acid ethyl ester components. The Omega-3-Acid Ethyl Esters Capsules USP monograph
establishes ranges for the two most abundant components (EPAee and DHAee) of the active pharmaceutical ingredient (API) and
ranges for the sum of the two components. The reference product contains lesser quantities of the other five omega-3 acid ethyl esters, although quantitative ranges are not specified in the USP
monographs. The Agency has determined the quantitative ranges of the other five omega-3-acid ethyl ester components based on assay of multiple batches of the RLD using the USP monographanalytical method.
I'm confident a NDA application for Epanova would be outright denied until generics can compete with Lovaza. Yes the bioavailablity seems supior with Epanova compared to Lovaza but the both have the exact ACTIVE Moiety's with separate API's.
At the time of Epanova's entry into the GENERIC Lovaza market Amarin will have Marine, Anchor and combo all with extensive IP.
If AZN would have paid me $5 million dollars I could have saved them close to a half a billion. Please contact me AZN, I do some contract work in my spare time. The API cost for the pure triglyceride form of Epanova and capsules are much higher than the COGs for both Lovaza and Vascepa by the way.
They key, API is not Active Moiety, Active Moiety's are the defining base for market entry and exclusivity.
Williams
Icosapent Ethyl is an FDA approved drug to treat Very High Triglycerides 500 <. It will VERY likely be approved to treat high Triglycerides in December. Fish oil, AKA, Lovaza was denied approval for this high trig market and Combo market because of the increase in LDL. GSK bought fish oil for $1.6 billion dollars from Amarin's CEO back in 2004 planing to launch a combo drug per Pronova:http://www.drugs.com/clinical_trials/study-demonstrating-lovaza-omacor-co-administered-atorvastatin-reduces-non-hdl-cholesterol-6201.html
Now, if you believe this is AZN's only M&A, they should have talked to GSK before spending half a billion dollars on a drug with NO IP protection, raises LDL in Omthera's Marine & Anchor equivalent studies. IMO AZN just opened a can of sardines... Epanova is likely not to get approved until after Lovaza goes generic in 2015, LOL.
Epanova's active moiety is EPA and DHA dissolved in the blood plasma and RBC's, with a "mix of Omega-3's that also might be active" The FDA doesn't grant exclusivity based on API, but on ACTIVE MOIETY. Epanova's API is a mix of triglycerides in a patented protected capsule creating superior bioavailability when compared to Lovaza. Thus, Amarin's API is Icosapent Ethyl an EPA pro-drug. It very well could be defined as a NCE because the ACTIVE MOIETY in Lovaza was ill defined at the point of Amarin's application and the Active Moiety for Lovaza is now defined as a mix of Omega 3's including EPA and DHA. The monograph describes the API and NOT the active moiety. The active moieties for both drugs have just been posted in the September 2012, after Vascepa approval;) Draft Giudance for Lovaza and the completely separate guidance posted for Vascepa in April 2013.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM347002.pdf
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM320011.pdf
"Omega-3-Acid Ethyl Esters is a natural source drug obtained from
the body oil of several fish sources. The Omega-3-Acid Ethyl Esters USP monograph defines the active pharmaceutical ingredient (API) as composed of seven individual omega-3-acid ethyl ester components. The Omega-3-Acid Ethyl Esters Capsules USP monograph
establishes ranges for the two most abundant components (EPAee and DHAee) of the active pharmaceutical ingredient (API) and
ranges for the sum of the two components. The reference product contains lesser quantities of the other five omega-3 acid ethyl esters, although quantitative ranges are not specified in the USP
monographs. The Agency has determined the quantitative ranges of the other five omega-3-acid ethyl ester components based on assay of multiple batches of the RLD using the USP monographanalytical method.
I'm confident a NDA application for Epanova would be outright denied until generics can compete with Lovaza. Yes the bioavailablity seems supior with Epanova compared to Lovaza but the both have the exact ACTIVE Moiety's with separate API's.
At the time of Epanova's entry into the GENERIC Lovaza market Amarin will have Marine, Anchor and combo all with extensive IP.
If AZN would have paid me $5 million dollars I could have saved them close to a half a billion. Please contact me AZN, I do some contract work in my spare time. The API cost for the pure triglyceride form of Epanova and capsules are much higher than the COGs for both Lovaza and Vascepa by the way.
They key, API is not Active Moiety, Active Moiety's are the defining base for market entry and exclusivity.
Williams
It looks like a lie to aid in manipulation of securities. Did AF sell SS out this AM, to save his ass? Maybe?
SummerStreet Capital you have until 10 EST to correct yesterday's statement.
Although the harm will not be undone I won't waste my time filing a complaint.
My last two SEC complaints have been followed up by the SEC calling me. If you choose to wait until options expire, someone might be visiting BM.
Your not kidding on that skipping a pill fear, my family's two off label scripts will show up this Sunday.
I agree JL, I suspect V's largest market has yet to be tapped r/t EPA:AA ratios. That calm feeling you get when your ratio drops is therapeutic, measurable, and significant.
Williams
In accordance with our Special Protocol Assessment (SPA) agreement with the FDA for the ANCHOR indication, Amarin was required to have an outcomes study substantially underway in order to submit for approval of the ANCHOR indication. The REDUCE-IT cardiovascular outcomes study is substantially underway. In February 2013, Amarin submitted a supplemental NDA (sNDA) requesting approval of the ANCHOR indication. The FDA accepted that sNDA for review and assigned a PDUFA date of December 20, 2013. The SPA does not require that an outcome study be completed in order for the ANCHOR indication to be approved. As of the date of this update, Amarin has not been informed of any change in the FDA’s agreement on this matter. All regulatory approvals are subject to risks and uncertainties. Investors should review Amarin’s most recent risk factor discussion in its Form 10-Q for discussion of such risks.
I'd like to add...Under a SPA agreement the FDA is required to meet with Amarin if there is a change.
I'm guessing after NOA for Anchor combo on Saturday, AZN may not have been the first BP to make a move.
Study
Yup, they sure did.
05-25-2013 Reasons for Allowance '699
No their drug is basically Lovaza in a capsule that ruptures at a more convenient time for absorption. No NCE for a mixture of omega 3's.
I see this as the start of negotiations. A likely play to get some leverage with Amarin after the combo patent. They did however send up the big red flag for Merck and Pfizer.
The Summer Street was likely a timed event to go with the Omathera play.
Hope longs didn't fall for this head fake.
Omthera has no patents listed under it's name, 0, 1 application.
Omrhera has a license agreement with Chrysalis Pharma, the have 4 EPA related patents two for a capsule and two for treatment of IBS.
API maker BioVectra just got purchased by Questcor pharmaceudicals. Not exactally a BASF partner.
It's likely this action was sparked by '899 NOA, Amarin's combo patent.
Notice how it stated that AZN was interested in a Crestor Combo. Omthera has jack for IP protection, it's likely AZN is taking out the little fish before Amarin BID. It's likely going to lead for BP jousting for position, should get more interesting than today.
FDA has rejected a prior EPA/DHA combo that raised LDL in treatment of 200-500. Extremely unlikely a combo would be approved with a mono product that increases LDL.
This is Pronova territory and likely not patentable again. The only way this will help AZN is if they end up with Amarin. I don't see PFE losing the bid.
Omathera's IP
5792795 r/t IBS not trigs, cholesterol, CV dz
5948818 another IBS
7960370 gel cap
8383678 gel cap
No trigs patents, No cholesterol patents, NO COMBO's
No IP for EPA, trigs, cholesterol, CV dz., or Combo
Pre strike to an Amarin bid, or Pfizer has Amarin and AZN trying an impossible end around.
Great way to start a bidding war for Amarin though!
AZN takes out Omthera, why? Certainly not for science...
It's all about EPA levels when related to CV outcomes....period.
4 Grams Vascepa Cmax= 366 mcg/ml; Cmin= 231 mcg/ml
Page 37 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S)
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000ClinPharmR.pdf
What Omthera have?
200 mcg/ml steady state EPA
http://www.omthera.com/pdf/OmtheraJPMorganPresentationJan-10-2012.pdf page 16
Vascepa 4 grams
89 mcg/ml RBC EPA levels
Omthera
Page 18, unknown level but they do admit it's import;)
http://www.omthera.com/pdf/OmtheraJPMorganPresentationJan-10-2012.pdf
IP protection: 1 application
http://assignments.uspto.gov/assignments/q?db=pat&qt=asne&reel=&frame=&pat=&pub=&asnr=&asnri=&asne=Omthera+&asnei=&asns=
13/620,312 METHODS AND COMPOSITIONS FOR TREATING, REVERSING, INHIBITING OR PREVENTING RESISTANCE TO ANTIPLATELET THERAPY 385452-004US (117199)
Congrats AZN...;)
Bull runner's chart for under reported (using last CC to extrapolate)
4013 script # weekly
4013($182)(52 weeks) (2 )*stocking revenue = ~$80 million yearly run
If we hold the Lovaza growth trend, we'll see 8 weeks of strong growth. Lovaza sales double in this next run up.
Very accurate Lovaza statement. As a Vascepa user, I can tell you there's no fish oder, or burps with Vascepa.