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Duh! Yep looks like that's done. I still think they have a tuff time getting quality API for less than Pronova able to generate.
Inflamatory responses to your blood flowing through HD surfaces. V calms the Inflamatory eciosanoids cascade...that's my theory.
Generics can enter the market after they figure out how to get around Lovaza's last standing OB patent, #7732488, pertaining to removing dangerous environmental pollutants. Once they have engineered a way around the claims, they have to economically produce API cheaper than BASF/Pronova so they can launch a Generic that undercuts Lovaza's price. The above task will not be worth the cost or effort after Anchor approval. Apotex, TEVA and PAR can then fight over the small population.
Pharmaceutical composition comprising low concentrations of environmental pollutants
Abstract: The invention relates to a process for decreasing the amount of environmental pollutants in a mixture comprising a fat or an oil, being edible or for use in cosmetics, the fat or oil containing the environmental pollutants, which process comprises the steps of adding a volatile working fluid to the mixture, where the volatile working fluid comprises at least one of a fatty acid ester, a fatty acid amide, a free fatty acid and a hydro-carbon, and subjecting the mixture with the added volatile working fluid to at least one stripping processing step, in which an amount of environmental pollutant present in the fat or oil, being edible or for use in cosmetics, is separated from the mixture together with the volatile working fluid. The present invention also relates to a volatile environmental pollutants decreasing working fluid, for use in decreasing an amount of environmental pollutants present in a fat or oil, being edible or for use in cosmetics. In addition, the present invention relates to a health supplement, a pharmaceutical and an animal feed product prepared according to the process mentioned above.
Inventor(s): Breivik; Harald (Porsgrunn, NO), Thorstad; Olav (Porsgrunn, NO)
Assignee: Pronova Biopharma Norge AS (Baerum, NO)
Application Number: 10/517,812
Patent Claims: 1. A pharmaceutical composition comprising a marine oil which comprises eicosapentaenoic acid ethyl ester and docosahexaenoic acid ethyl ester in a pharmaceutically effective concentration to therapeutically treat hypertriglyceridaemia, wherein the concentration of brominated flame retardants in the pharmaceutical composition is less than 0.2 .mu.g/kg as measured by the concentration of BDE 47, and wherein said pharmaceutical composition is not a health supplement.
2. A pharmaceutical composition according to claim 1, further wherein the sum of PCDDs and PCDFs in the marine oil is less than 4.65 pg/g.
3. A pharmaceutical composition according to claim 1, further wherein the sum of TE-PCBs in the marine oil is less than 22.6 pg/g.
4. A pharmaceutical composition comprising a marine oil which comprises eicosapentaenoic acid ethyl ester and docosahexaenoic acid ethyl ester in a pharmaceutically effective concentration to therapeutically treat hypertriglyceridaemia, wherein the sum of TE-PCB in the marine oil is less than 22.6 pg/g, and wherein said pharmaceutical composition is not a health supplement.
5. A pharmaceutical composition prepared from a marine oil, wherein the pharmaceutical composition is prepared by reducing the concentration of brominated flame retardants as measured by the concentration of BDE 47 in the marine oil, and increasing the concentration of eicosapentaenoic acid ethyl ester and docosahexaenoic acid ethyl ester in the marine oil to a pharmaceutically effective concentration to therapeutically treat hypertriglyceridaemia, and wherein said pharmaceutical composition is not a health supplement.
6. A pharmaceutical composition according to claim 5, wherein the concentration of brominated flame retardants in the pharmaceutical composition is less than 0.2 .mu.g/kg as measured by the concentration of BDE 47.
7. A pharmaceutical composition prepared from a marine oil, wherein the pharmaceutical composition is prepared by reducing the sum of TE-PCB as measured in the marine oil, and increasing the concentration of eicosapentaenoic acid ethyl ester and docosahexaenoic acid ethyl ester in the marine oil to a pharmaceutically effective concentration to therapeutically treat hypertriglyceridaemia, and wherein said pharmaceutical composition is not a health supplement.
8. A pharmaceutical composition according to claim 7, wherein the sum of TE-PCB in the marine oil is less than 22.6 pg/g.
9. A method of treating at least one cardiovascular disease comprising administering a pharmaceutical composition comprising a marine oil which comprises eicosapentaenoic acid ethyl ester and docosahexaenoic acid ethyl ester in a pharmaceutically effective concentration to therapeutically treat hypertriglyceridaemia, wherein the concentration of brominated flame retardants in the pharmaceutical composition is less than 0.2 .mu.g/kg as measured by the concentration of BDE 47, and wherein said pharmaceutical composition is not a health supplement.
10. A method according to claim 9, wherein the at least one cardiovascular disease is hypertriglyceridaemia.
11. A method according to claim 10, further wherein the sum of TE-PCB in the marine oil is less than 22.6 pg/g.
12. A pharmaceutical composition comprising a marine oil which comprises eicosapentaenoic acid ethyl ester and docosahexaenoic acid ethyl ester in a pharmaceutically effective concentration to therapeutically treat hypertriglyceridaemia, wherein the concentration of BDE 47 in the marine oil is less than 12.2 ng/g, and wherein said pharmaceutical composition is not a health supplement.
13. A pharmaceutical composition according to claim 4, wherein the concentration of BDE 47 in the marine oil is less than 12.2 ng/g.
14. A pharmaceutical composition according to claim 5, wherein the concentration of BDE 47 is less than 12.2 ng/g in the marine oil after reducing the concentration of brominated flame retardants as measured by the concentration of BDE 47 in the marine oil.
15. A pharmaceutical composition according to claim 1, further wherein the sum of PCDDs and PCDFs in the marine oil is 0.46 pg/g or between 0.46 pg/g and 4.65 pg/g.
16. A pharmaceutical composition according to claim 4, further wherein the sum of TE-PCB in the marine oil is 0.09 pg/g or between 0.09 pg/g and 22.6 pg/g.
17. A pharmaceutical composition according to claim 12, further wherein the concentration of BDE 47 in the marine oil is less than 5.3 .mu.g/kg.
Evidence has shown dialysis patients should all be taking Vascepa.
It's a Billion dollar Vascepa population...
http://clinicaltrials.gov/ct2/show/NCT00308295
http://medicalxpress.com/news/2013-02-fish-oil-dialysis-patients-sudden.html
Morbidity and Mortality is very high in the HD population, Vascepa can improve outcomes and reduce costs...insurance companies like that.
http://www.renalbusiness.com/news/2008/09/number-of-u-s-esrd-patients-exceeds-500-000.aspx
"In 2006, more than 500,000 patients received some form of end-stage renal disease therapy in the United States, and Medicare spent nearly $23 billion to care for them, according to the U.S. Renal Data System’s 2008 Annual Data Report.
Between 2005 and 2006, the number of new ESRD cases grew 3.4 percent, which is the first time the population has grown more than 2 percent in a year since 2000, according to the USRDS report. Of the new ESRD cases, the number of new dialysis patients grew nearly 4 percent.
In 2006, 110,854 new dialysis and transplant patients started ESRD therapy; 87,654 patients died. In all, more than 506,000 patients were receiving treatment by the end of 2006. Of that, nearly 355,000 were being treated by dialysis, a three-fold increase since 1988. Also in 2006, 151,502 patients had a functioning transplant."
The Lovaza patent game is really just starting.
Lovaza's last standing patent protects against a pharmaceutical grade Omega 3 Ethyl Esters that's free of dangerous chemicals.....U.S. Environmental Protection Agency pertaining to drug or dietary supplement products containng or derived from fish oiL. It does, however, include in its Appendix a guidance published by the U.S. Environmental Protection Agency that provides toxicological summaries and detailed information on risk assessment methods for 25 environmental contaminants and classes of contaminants potentially present in fish, including the contaminants mentioned in the petition, polychlorinated biphenyls (PCBs), dichlorodiphenyltrichloroethane (DDT), and dioxins.
Lovaza just has to play the contaminants card...then stand back until generics figure out if it's even worth it with Vascepa on the market.
I'm afraid Pronova's gonna have the last laugh;)
Do your DD.
Williams
"Step Therapy" is more of a Lovaza restriction. Very few Tier 2 require Vascepa step while many are pushing Lovaza to this requirement. Once Anchor is approved, step goes away, as V is the only in the class of high trigs.
The Street was selective in choosing an Insurance that requires steps for Vascepa...LOL...shady motives.
New Forbes Amarin/TEVA article:
http://www.forbes.com/sites/edsilverman/
Mr. Silverman seems to be a straight shooter.
Williams
Thanks JL...you save me some time with that post. Ultimately the Generic Lovaza decision means very little to Vascepa and Amarin.
I see it speeding up GSK "Plans", they could take Lovaza off the market due to LDL/afib concerns and make a grab for Amarin in the same day. Not sure they're ready to pay the $15 Billion though...so a deal might not get signed.
AZN is sh!t out of luck....Epanova is a dead fish rotting on the beach.
TEVA/PAR appear to be the first to file.
Another interesting twist will come when/if Amarin gets '281 ap through the patent office...this is a virtual high concentration generic omega 3 with Fatty Acid/Ethyl Ester 70:30 EPA/DHA mix. Not sure if the Lovaza ruling makes this easier?
Williams
I take the worse case senerio and work forward to "reality", but I don't rule anything out. After reviewing his personality I can see how you could influence him into thinking a generic is for the people's benefit....ignoring all science of course....
I get paid well to be paranoid;)
" We in Delaware say it is fine to consider those issues, as long as there is a rational basis and as long as you keep your eye on the real ball, which is taking care of the people to whom you owe the responsibility – your investors and the corporation. We do not sanction directors who consider societal interests where there are circumstances that benefit the corporate entity to do so"----Chief Justice Myron Steele...
http://whoswholegal.com/news/features/article/29240/an-interview-chief-justice-myron-steele-delaware-supreme-court/
The Lovaza generic case was very important to Cheif Justice Myron Steele, he had to get it on the docket before he retire "surprisingly early". Wonder if he just wanted to golf more with his AZN country club friends?
Delaware Chief Justice Myron T. Steele retiring
In surprise, judge leaving post in Nov.
Sep. 7, 2013
http://www.delawareonline.com/article/20130907/NEWS/309070027/Delaware-Chief-Justice-Myron-T-Steele-retiring?nclick_check=1
AstraZeneca
1800 Concord Pike
P.O. Box 15437
Wilmington, DE 19850-5437
Phone: (302) 886-3000
Fax: (302) 886-2952
Anybody know who Myron likes to hang with?
You worked as a litigation partner at Prickett Jones & Elliott for 18 years. How did that come about?
They recruited me from law school. Then they loaned me to the attorney general’s office. The Delaware culture at the time, before we had an attorney general’s office populated by tenured professionals, was for major law firms to lend their young associates — lend in the sense that they didn’t pay our salaries, left the firm, but was expected to return. In the UK you might say ‘seconded’ to the attorney general’s office. That was good for me and good for the firm because it gave me an opportunity to do more jury trials more quickly than I would ever have had an opportunity to do.
http://whoswholegal.com/news/features/article/29240/an-interview-chief-justice-myron-steele-delaware-supreme-court/
Williams
Amarin's Patent # 8524698 is so good the FDA put it in the OB twice!!!!
LOL
JL---
I haven't finished vetting him yet.
1) Don't like his AZN connection with Brilinta trial
2) Agree, he doesn't seem to get EPA
3) Seems to back agressive LDL and trig management though
At the very least his involvement with AZN should be documented via e-mail to Stephanie L. Begansky, PharmD...Agree?
http://www.prevention.com/health/health-concerns/protect-yourself
Protect Yourself
Prevention is your best bet when it comes to PAD
By Hugh O'Neill
When the blood vessels in the legs are narrowed and choked with cholesterol and other fatty materials (the disease process known as atherosclerosis), you have a condition called peripheral arterial disease (PAD).
Health Concerns
¦8 Delicious Low-Salt Recipes
¦Problem Solved: Tinnitus
¦The Ultimate Owner's Guide To Menopause
Heart Health
Quick fixes for chronic conditions and common ailments. Learn more.Because your calf muscles can't get enough oxygen, they start to hurt whenever you try to walk much farther than a block or two. You get a cramplike, aching sensation that can stop you in your tracks. It might let up after a couple of minutes of rest, but when you start walking again, the pain returns.
Five million Americans, most of them 50+, are burdened with this circulatory ball-and-chain. And the most likely reason is tobacco. "Smoking is a more malignant risk factor for intermittent claudication than it is for heart disease," says William Hiatt, MD, professor of medicine in the section of vascular medicine at the University of Colorado Health Sciences Center and executive director of the Colorado Prevention Center, both in Denver.
The entire body gets suffocated as carbon monoxide from cigarettes shoves aside the oxygen in red blood cells. Exactly why smoking hits blood vessels harder below than above the belt isn't clearly understood, says Hiatt. But studies have shown that 90 to 95 percent of people with the disease are smokers. "The best way to prevent this disease is to not smoke or to quit smoking," he concludes.But a few other cautions are in order, too. Here is what Hiatt advises.
Consider folate.
High levels of the body chemical homocysteine are a risk factor in intermittent claudication. And when you increase the level of the B vitamin folate in your diet, you can lower homocysteine levels. Good food sources of folate include beans, broccoli, spinach, orange juice, and fortified cereals.
Cut cholesterol and triglycerides.
"Try to raise high-density lipoprotein (HDL) cholesterol and lower triglycerides," says Hiatt. HDL cholesterol is the "good" kind that helps usher artery-clogging low-density lipoprotein (LDL) cholesterol out of the body. And triglycerides are a blood fat with the same mean streak as LDL.
The best way to affect both of these blood fats at once is to lose weight if you are overweight. "Even losing as little as 5 to 10 pounds will significantly lower triglycerides and LDL cholesterol," says Hiatt.
William R. Hiatt, MD, is Professor of Medicine, Division of Cardiology, University of Colorado School of Medicine. Dr. Hiatt serves as President of CPC Clinical Research, a nonprofit, university-affiliated clinical trials research center. CPC manages clinical trials in PAD. Dr. Hiatt provides grant-supported research support for the following sponsors relevant to this discussion: Aastrom, AstraZeneca, CSA, DNAVEC, Juventas, Kowa, Pluristem. He may be reached at (303) 860-9900; will.hiatt@ucdenver.edu.
AZN?
Display Settings:AbstractSend to:
Cochrane Database Syst Rev. 2013 Jul 4;7:CD003833. doi: 10.1002/14651858.CD003833.pub4.
Omega-3 fatty acids for intermittent claudication.
Campbell A, Price J, Hiatt WR.
Source
College of Medicine and Veterinary Medicine, University of Edinburgh, Edinburgh, UK, EH16 4TJ.
Abstract
BACKGROUND:
Omega-3 fatty acids have been used in the treatment and prevention of coronary artery disease although current evidence suggests they may be of limited benefit. Peripheral arterial disease and coronary artery disease share a similar pathogenesis so omega-3 fatty acids may have a similar effect on both conditions. This is an update of a review first published in 2004 and updated in 2007.
OBJECTIVES:
To determine the clinical and haematological effects of omega-3 supplementation in people with intermittent claudication.
SEARCH METHODS:
For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched September 2012) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2012, Issue 9).
SELECTION CRITERIA:
Randomised controlled trials of omega-3 fatty acids versus placebo or non-omega-3 fatty acids in people with intermittent claudication.
DATA COLLECTION AND ANALYSIS:
One review author identified potential trials. Two review authors independently assessed trial quality and extracted data. We contacted study authors for additional information if necessary.
MAIN RESULTS:
Nine studies were included representing 425 participants. All studies compared omega-3 fatty acid supplementation with placebo lasting from four weeks to two years. Three studies with long treatment periods administered additional substances, making any observed effects impossible to attribute to omega-3 fatty acids and were excluded from the statistical analyses. One study did not express any mean values and, therefore, could not be included in statistical analyses.No significant differences between intervention and control groups were observed in pain-free walking distance (mean difference (MD) 11.62 m, 95% confidence interval (CI) -67.74 to 90.98), maximal walking distance (MD 16.99 m, 95% CI -72.14 to 106.11), ankle brachial pressure index (MD -0.02, 95% CI -0.09 to 0.05), total cholesterol levels (MD 0.27 mmol/L, 95% CI -0.48 to 1.01), high-density lipoprotein cholesterol levels (MD 0.00 mmol/L, 95% CI -0.16 to 0.15), low-density lipoprotein cholesterol levels (MD 0.44 mmol/L, 95% CI -0.31 to 1.19), triglyceride levels (MD -0.39 mmol/L, 95% CI -1.10 to 0.33), systolic blood pressure (MD 5.00 mmHg, 95% CI -11.59 to 21.59) or plasma viscosity (MD 0.03 mPa/s, 95% CI -0.02 to 0.08).There was some limited evidence that blood but not plasma viscosity levels decreased with treatment and gastrointestinal side effects such as nausea, diarrhoea and flatulence were observed in two studies.
AUTHORS' CONCLUSIONS:
Omega-3 fatty acids appear to have little haematological benefit in people with intermittent claudication and there is no evidence of consistently improved clinical outcomes (quality of life, walking distance, ankle brachial pressure index or angiographic findings). Supplementation may also cause adverse effects such as nausea, diarrhoea and flatulence. Further research is needed to evaluate fully short- and long-term effects of omega-3 fatty acids on the most clinically relevant outcomes in people with intermittent claudication before they can be recommended for routine use.
PMID: 23824785 [PubMed - in process]
LinkOut - more resources
----------------------
Keep a close eye on Dr. Hiatt's bias for Brillinta and AZN....
William R. Hiatt, MD, a professor of medicine in the division of cardiology at the University of Colorado School of Medicine in Denver, is the principal investigator for the EUCLID study. It is being conducted in partnership with the Duke Clinical Research Institute, an academic research organization affiliated with the Duke University School of Medicine, and CPC Clinical Research, an academic research organization affiliate of the University of Colorado.
His involvement should be withdrawn as AZN is a primary competitor to Vascepa.
Dr. Elan Seely is a colleague of Dr. Bruce Levy
Bruce Levy's Resolivin Patents:
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=Resolvins.TI.&OS=TTL/Resolvins&RS=TTL/Resolvins
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=2&f=G&l=50&co1=AND&d=PTXT&s1=Resolvins.TI.&OS=TTL/Resolvins&RS=TTL/Resolvins
-----------
These two patents are intimately linked to EPA blood levels and are worth $$BILLIONS$$.
I'll be keeping a very close eye on her at the Ad Com.
Guess I should have specifically stated the goal of Improving CV outcomes. We know of course the only outcomes study to show a significant difference in improving CV outcomes was with EPA in the JELIS study.
Funny JL, I was just going to post something similar.
I'm certain FOOL's didn't go into the science for a few reasons.
1) Well they are fool's
2) WS would like to make Amarin "controversial", but it's pretty straight forward science. Fish oil doesn't work because high enough blood levels of EPA are not achieved. You don't even need to know about eciosanoids or Resolvins.....
3)They still need to buy shares
Bottom line: Fish oils fail to prove beneficial because blood EPA levels are less than 10 mcg/ml after 1000 mg of OTC supplements. With 4 Grams of Vascepa blood levels are about 350 mcg/ml of EPA, 35 times higher than OTC supplements.
If you take 1/35 of any dose of prescription drug, the therapeutic effect will be negated because of inferior levels of drug.
I hope this is simple enough for the fools to understand.
Williams
Should we dumb it down more for them?
Agreed, must have changed a few hours ago as I checked it earlier in the day. This is the dagger in AZN's heart pill dream. Thanks Study
Will
The FDA needs to define Omega 3 into 3 categories:
1) Mixed Omega's like Lovaza and Epanova
2) Isolated single agents Vascepa or other pure Omega concentrates
3) The ability to define combinations of concentrated agents like 50:50 EPA:DHA
The Lovaza CP I believe was requested to subvert Pronova patents. It could have been a Private generic company or Omthera. As I've previously stated Epanova treads on Lovaza patents and CP mentioned Lovaza's patents in last C&M comment. AZN and Omthera's 74 day letter is due at the end of next week. It's my opinion, it's not fileable due to patent infringements and the inability to get a patent. This might be the next binary Amarin event.
A refuse will have to be announced by AZN, as it's material.
(3) If FDA refuses to file the application, the agency will notify the applicant in writing and state the reason under paragraph (d) or (e) of this section for the refusal. If FDA refuses to file the application under paragraph (d) of this section, the applicant may request in writing within 30 days of the date of the agency's notification an informal conference with the agency about whether the agency should file the application. If, following the informal conference, the applicant requests that FDA file the application (with or without amendments to correct the deficiencies), the agency will file the application over protest under paragraph (a)(2) of this section, notify the applicant in writing, and review it as filed. If the application is filed over protest, the date of filing will be the date 60 days after the date the applicant requested the informal conference. The applicant need not resubmit a copy of an application that is filed over protest. If FDA refuses to file the application under paragraph (e) of this section, the applicant may amend the application and resubmit it, and the agency will make a determination under this section whether it may be filed.
Yesterday's Press release: Why? I don't get the timing...are they just waiting until they get three to annouce? Are they only gonna PR multiples of 10's? Was Joe Z & Joe B just board?
September 9, 2013
Amarin Announces 30th Patent for Vascepa(R)
BEDMINSTER, N.J., and DUBLIN, Sept. 9, 2013 (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 now has 30 patents issued or allowed by the United States Patent and Trademark Office (USPTO) related to its flagship product, Vascepa® (icosapent ethyl) capsules.
Amarin recently received Notices of Allowance for U.S. Patent Application Serial Numbers 13/777,398, 13/768,897, and 13/768,869, each titled "Stable Pharmaceutical Composition and Methods of Using Same." The scope of coverage related to Vascepa represented by these applications is the broadest allowed to date.
"With 30 patents issued and allowed and over 30 additional applications pending in the United States, Amarin now has one of the most extensive, and expanding, patent portfolios covering a product in the industry," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "Amarin is pleased that the USPTO continues to recognize the novel characteristics of Vascepa. The continued issuance of a variety of patents covering Vascepa is emblematic of the success achieved at Amarin toward its goal of protecting the commercial potential of Vascepa to beyond 2030 through patent protection. In addition, Amarin's Vascepa is also protected by trade secrets and existing manufacturing barriers to entry, along with anticipated three- or five-year regulatory exclusivity in the United States."
Amarin is also making significant progress with its patent applications related to Vascepa in multiple jurisdictions outside the United States, including the May 2013 patent grant by the European Patent Office covering the use of Vascepa based on the results from the MARINE trial.
===========
With 30 patents issued and allowed and over 30 additional applications pending in the United States, Amarin now has one of the most extensive, and expanding, patent portfolios covering a product in the industry
Amarin is pleased that the USPTO continues to recognize the novel characteristics of Vascepa. The continued issuance of a variety of patents covering Vascepa is emblematic of the success achieved at Amarin toward its goal of protecting the commercial potential of Vascepa to beyond 2030 through patent protection.
In addition, Amarin's Vascepa is also protected by trade secrets and existing manufacturing barriers to entry, along with anticipated three- or five-year regulatory exclusivity in the United States
I don't understand the timing of Amarin's NOA patent PR today. Two of the 3 happened almost a month ago and the third a week ago. Has the FDA communicated an exclusivity decision will be made this week? Odd PR for Amarin.
Lovaza CP comments are still open, when that closes the FDA has figured "it" out.
Williams
Great article JL, also the Author, Petter Libby is chief of cardiovascular medicine at Brigham and Women's Hospital, Mallinckrodt Professor of Medicine at Harvard Medical School, and co-editor of the sixth edition of Heart Disease, a classic cardiology textbook.
Brigham and Women's Hospital jointly own the patents for Resovins with the NIH.
Thanks for posting
Williams
$15 Billion Amarin Market Cap Jan 2016 without partner
With Anchor and New ATP 4 guidelines Vascepa will rapidly gain market share.
"The global statin market had already been on a downward slide, dropping from $23.7 billion in 2004 to $20.5 billion in 2011, thanks in part to patent expiries for Merck’s simvastatin (Zocor) and Bristol Myers Squibb’s pravastatin (Pravachol). The compound annual growth rate (CAGR) is expected to further decline 7.2 percent by 2018."
http://www.cardiovascularbusiness.com/topics/healthcare-economics/slides-generics-push-statin-revenues-down-7b
2015 Vascepa sales > $5 Billion with ATP 4 Lowest LDL & Inflamatory treatment guidelines.
PDI sales force expansion at will....Without BP or partner...available NOW!
No competition...Lovaza (massive LDL), Epanova (will never be approved for Trigs >200), OTC (No evidence and heavy medal contamination potential)
Don't underestimate ATP 4 as a MASSIVE BINARY event.
Williams
Why $15 Billion or more for BO?
ATP 3 guidelines to treat cholesterol are so old they don't include Crestor. Posted 2002 and updated 2004...ATP 4 guidelines are complete and only need to be review by HHS then will be posted.
Review the ATP 3 guidelines here: http://www.nhlbi.nih.gov/guidelines/cholesterol/atglance.htm
ATP 4 guidelines will focus on getting LDL as low as possible and treating inflamation markers. ATP 4 guidelines are not posted yet, but to gain insight into recommendations this is the best presentation I've found. Review presentation here: https://www.acli.com/Events/Documents/Tue22812%20-%20Lipidology%20-%20Pamela%20Morris.pdf
6/80 Obtain lowest LDL with drugs combinations
8/80 Hyperlipidemia (They might get as agressive as Trigs as low as 150)
10/80 "Focus on LDL-C"
11/80 Sorry Arena and Vivus by at this time your drugs will not be recommended
17/80 "Trigs less than 200"
24/80 hs-CRP, Apo-B, LDL-P, Trigs ? (big Vascepa slide)
25/80 "alternative treatment targets". ? Ie Trigs and inflamation markers (Vascepa)
45/80 newer algorithms including hs-CRP (Vascepa)
49/80 high risk women: Metabolic syndrome, high Trigs (Vascepa)
55/80 lipids, diabetes, inflamation (Vascepa)
56/80
!!!58/80!!! Inflammatory markers
59/80 Biomarkers...they should look familiar it's what Anchors Ad Com is about!!!
60/80 Vascepa will be treating theses labs and not just Trigs
Conclusion: Vascepa will play a huge role in the ATP 4 guidelines!
The buyout crowd has no say at what price JZ and Amarin's board is willing to except. A buyout will not happen until BP's willing to pay close to $15 Billion. It might not happen until Amarin's selling $5 B per year.
ATP 4 guidelines will focus on reduction of LDL and inflammation markers, the goal is to get them as low as possible. To achieve this, Statin & Vascepa is the best combo. Vascepa sales, under the above ATP 4 model, should come close to equalling Statin sales.
Statins Drugs Market Forecast to Reach $12.2 Billion by 2018 in New Research Report at ReportsnReports.com
http://www.prweb.com/releases/statins-drugs-market/analysis-forecast-2018/prweb10367278.htm
AMR 102 ;) & ATP 4
JZ & the board are not parting with Amarin at a ridiculous price.
Williams
I have used it probable more than 100 times on patients with PCN allergies and haven't seen any cross reactions...
Teebone,
My name is listed in the C&M comment to GSK and BASF...apparently Mr. Fuson thought this would intimidate me into not responding to his ridiculous request of redefining Lovaza in the OB. He was wrong.
I do occasionally check Steve's Blog...but he's way off on his price prediction. If he understood the science of EPA and Eicosanoids his timing might improve.
Amarin understands what they have, JZ's not giving it up for $30-35.
Williams/BioBillion/Williams 4076
JL
Well said...I like to simplify complex topics down before I study them. My Omega 3 "simple thoughts":
1) "Fish Oil" doesn't appear to be effective at reducing CV complications at the doses taken or studied
2) "Fish Oil" taken at higher levels may be dangerous due to heavy metal contamination, and not tollerated at a thearaputic 8 to 25 Gms per day to achieve Vascepa EPA blood levels
3) EPA levels are the key, science has proven this
4) Vascepa is EPA
5) World Omega 3 sales are $30 to 33 Billion per year
6) Vascepa will eventually dominate #5 because of 1,2,3,&4.
I have faith BP's figured this out...we should see by end of the year. I'll hold my shares until the Patents expire in 2030.
Have a great weekend JL
Williams
I doubt it will be just GSK. They are phasing out Lovaza and setting up a generic Omega 3 to fail.
Second generation PCN likes do not transfer over.
First yes...Cefazolin yes
Cefoxitin No cross rxn with PCN...
Yes, Vascepa is safer than all the above....
LOL...but if PCN was never discovered molding around 100 plus years ago Millions would have died. Now day we have 2nd and 3rd generation cephalosporins, however, PCN was their " daddy". PCN is arguably the biggest drug discovery of all time. Vascepa's history has yet to be written...but it will be a PCN like history in my opinion.
Williams
JL
My knowledge of Science and Trading are fractional when compared to you. I'm weak on options and overall you have more experience in both trading and science. But... I'm not some pimpled faced kid trading out of his Mom's basement;). I've had success and failures....
Vascepa potential is absolutely mind blowing, I know you get this. Do you think no buyout because BP is unwilling to put down the $15 Billion plus now?
Vascepa World target market in the next 5 years is 200,000,000 patients with a drug side effect profile equal to placebo. The Medical risk reward benefit of Vascepa has NEVER been achieved by any drug ever, except PCN. If 200,000,000 people where taking PCN everyday for the rest of their lives...WoW!!! Vascepa has a very real potential to be a record selling drug...this value is not missed by BP. Offers will likely be made before approval of Anchor, but not excepted until they pay for the potential.
Williams
GSK will aquire Amarin. They have been setting this up for over a year with the shut down of their website. They've now rebooted it with the TRUTH, increase LDL and A.fib warnings. This helps sheild them from Antitrust suits....oh I know what your thinking....here goes Williams with Antitrust BS again, but here's my angle:
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May 31, 2006
Antitrust Case Against Abbott Moves Forward: Were TriCor Formulation Changes Illegal?
In an opinion released last Friday, Judge Kent A. Jordan of the U.S. District Court for the District of Delaware denied Abbott's motion to dismiss numerous antitrust claims in Abbott Labs et al. v. Teva Pharms. et al., No. 02-1512.
The antitrust claims were originally brought by Teva and Impax as counterclaims in patent infringement litigation concerning Abbott's TriCor (fenofibrate) drug product, a treatment for high cholesterol and triglycerides. Later, various pharmacies and third-party payors filed related antitrust claims against Abbott, and those cases were consolidated with the patent infringement cases. The antitrust plaintiffs are seeking treble damages from Abbott.
Teva and the other antitrust plaintiffs allege that Abbott responded to the threat of generic entry by changing the formulation of TriCor, not to improve the product but simply to prevent generic formulations from becoming AB-rated for substitution with TriCor. Pharmacists may substitute a generic equivalent for a branded drug only if the generic drug has been AB-rated by the FDA, which means not only that the generic drug is bioequivalent to the branded drug, but also that the generic has the same form, dosage, and strength.
If true, Teva's allegations reveal how Abbott employed some very creative "life-cycle management" strategies for TriCor:
1998: Abbott receives FDA approval for TriCor capsules;
1999: Teva files ANDA for TriCor capsules, with Paragraph IV certification to U.S. Pat. No. 4,895,726, covering the TriCor capsule formulation;
2000: Abbott sues Teva for patent infringement, initiating a 30-month stay;
early 2001: Abbott files a new NDA for 54 mg and 160 mg TriCor tablets, submitting capsule safety and efficacy data as support;
Sep. 2001: FDA approves Abbott's TriCor tablets NDA; Abbot withdraws capsules from market and changes the code for TriCor capsules in the National Drug Data File ("NDDF") to "obsolete," meaning pharmacies can no longer fill TriCor prescriptions with a generic capsule formulation;
Mar. 2002: N.D. Ill. grants summary judgment of non-infringement to Teva in the capsule litigation;
Apr. 2002: FDA approves Teva's ANDA for TriCor capsules;
Jun. 2002: Teva files ANDA for 54 mg and 160 mg TriCor tablets, with Paragraph IV certification;
Oct. 2002: Abbott sues Teva for infringing its patents on TriCor 54 mg and 160 mg tablets, initiating another 30-month stay; Teva files counterclaims for antitrust violations;
Mar. 2003: Fed. Cir. affirms summary judgment in capsule litigation;
2003-2005: Abbott files a new NDA, for 48 mg and 145 mg TriCor tablets, seeking a label change stating that the new tablets need not be taken with food (the "no food effect label");
May 2005: D. Del. grants partial summary judgment of non-infringement to Teva in the tablets litigation; FDA then grants final approval to Teva's ANDA for 54 mg and 160 mg TriCor tablets; Abbott voluntarily dismisses remaining patent infringement claims.
Teva is pursuing ten separate antitrust claims against Abbott, including Sherman Action monopolization and sham litigation violations, Walker Process violations, and state law tortious interference with valid business expectations. In opposition to Teva's motion to dismiss, Abbott unsuccessfully argued that changing its TriCor formulation did not violate federal antitrust law; that any actions taken in its patent infringement litigation are immune under the Noerr-Pennington doctrine because Teva did not adequately plead the litigation was a sham; and that the state law allegations failed to state a claim.
While acknowledging that "[o]ne of the benefits of competition is the introduction of new, improved products," the court relied on the Microsoft case, 253 F.3d 34 (D.C. Cir. 2001) and the "nature of the pharmaceutical drug market," to determine that Teva's antitrust counterclaims should proceed and be analyzed under the "rule of reason." According to Judge Jordan's opinion, "The per se standard proposed by Defendants presupposes an open market where the merits of any new product can be tested by unfettered consumer choice. But here, consumers were not presented with a choice between fenofibrate formulations. Instead, [Abbott] allegedly prevented such a choice by removing the old formulations from the market while introducing new formulations.
As the antitrust case moves forward, "Plaintiffs [will] not [be] required to prove that the new formulations were absolutely no better than the prior version or that the only purpose of the innovation was to eliminate the complementary product of a rival. Rather, as in Microsoft, if Plaintiffs show anticompetitive harm from the formulation changes, that harm will be weighed against any benefits presented by Defendants."
http://www.orangebookblog.com/2006/05/antitrust_case_.html
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GSK by shutting down Lovaza website in the Fall of 2012, then rebooting it in the Summer of 2013 with LDL and Afib warnings galore have clearly indicated superior clinical and safety profiles driving them to withdraw Lovaza and replace it with Vascepa.
This is definitely going down...When, How much, and with what other BP ire the questions....
AZN didn't get invited to the Omega party, did Merck, Pfizer, Abbott, TEVA....get invited?
After Anchor Vascepa target population is 50 million patients in the US, 200 million world wide. This is a World wide drug, REDUCE-IT is in many European, Asia, and North American countries.
REDUCEIT success doubles the above to: 100,000,000 target in US and 600,000,000 World.
Japan has Epadel OTC, one of the first Pharmaceuticals in Japan to change from prescription to OTO.
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Lovaza will be withdrawn, generics Omega prescriptions will never happen, Omthera might get it done...but they will have no patents and have a clinically inferior drug, GSK leads a consortium of BP's that aquire Amarin for more than any have predicted....$15 Billion plus.
BP's have purchased Hep C bios with no products, Amarin has a drug that will out sell Lipitor records by multiples.
Good luck
Williams/Biobillion
Zumantu
'412 intermixed a composition of ethyl esters and fatty acids,
Omthera's application: '643 Title:
DPA-ENRICHED COMPOSITIONS OF OMEGA-3 POLYUNSATURATED FATTY ACIDS IN FREE ACID FORM
Omthera tried an end around with the DPA spin....Amarin's claim #24 beat Omthera to the "idea" .
Williams
With Amarin there might not be a tomorrow;). I think it's pretty clear GSK is going to make a move.
1) Reduction in Lovaza supply with shortages
2) Dropped two capsulators, kept the US capsulator Amarin used
3) No reduction in Lovaza sales force
4) positive Vascepa remarks supporting NCE in CP comments
5) Updated Lovaza website clearly putting a grave stone on generic Lovaza.
Process of elimination C&M client file under "private" code. Rules out all public BP and Generics. So it's an educated guess.
Generic Lovaza won't happen.
1) Clinically "unsafe" with LDL bump & A.fib warning(see the new Lovaza web site)
2) API can not be obtained at a cheap enough cost to under cut Vascepa. (Last C&M comment mentions BASF)
Who wants to pay more for less?
Not insurance company's!
Williams
This just destroyed any hope of any current Epanova Patent applications.
Why is the largest private generic pharmaceutical company trying to change the definition of Lovaza with a CP?
Did they use the inside information of an ex FDA attorney to hamper Amarin's exclusivity to buy time for a generic Lovaza launch?
Could this violate US Antitrust laws?
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Apotex:
Pronova BioPharma reaches agreement with Apotex regarding Lovaza(TM) U.S. patent litigation
Oslo, 30 March 2011: Pronova BioPharma announced today that it has entered into an agreement with Apotex Corp. and Apotex Inc. (collectively "Apotex") to settle patent litigation regarding Apotex's proposed generic version of Lovaza(TM) (omega-3-acid ethyl esters) yesterday.
The settlement grants Apotex a license to enter the US market with a generic version of Lovaza(TM) in the first quarter of 2015, or earlier depending on certain circumstances.
The US District Court of Delaware will enter the Stipulation of Dismissal without Prejudice and the corresponding patent litigation will be dismissed. Other terms of the settlement are confidential.
Pronova BioPharma is currently still involved in lawsuits with Teva Pharmaceuticals USA, Inc. ("Teva") and Par Pharmaceutical, Inc. ("Par"), regarding infringement of the company's patents relating to Lovaza(TM).
- ends -
About Lovaza(TM)
Omacor®/Lovaza(TM) is the first commercialised product developed from Pronova BioPharma's active pharmaceutical ingredient (API). It is also the first and only EU and U.S. FDA-approved Omega 3-derived prescription drug. Blockbuster status was achieved in the fourth quarter of 2009 as the global end-user sales were USD 1 063 million. Pronova BioPharma estimates that more than one million patients are currently on a prescription for one of the branded products containing its API.
About Pronova BioPharma
Pronova BioPharma is a global leader in research, development and manufacture of lipid therapies derived from nature.
The group's first commercialised product is branded in a number of countries throughout Europe, Asia and in the USA. End-user sales are growing rapidly in all international markets and the reached annual run rate at 31 December 2010 was USD 1 260 million, according to IMS Health. The product is the first and only EU- and FDA-approved Omega 3-derived prescription drug. Marketing and distribution of Pronova BioPharma's key product is currently licensed to both local and global pharmaceutical companies.
Pronova BioPharma's headquarters are located at Lysaker in Norway, while production takes place in manufacturing facilities at Sandefjord in Norway and in Kalundborg, Denmark. The company's shares are listed on Oslo Børs with the ticker code PRON.
For further information contact
Hamed Prodersen VP Investor Relations Tel: +47 40 46 81 10 +47 40 46 81 10
This information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
http://www.herkulescapital.no/index.php?visID=131
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Apotex lost Pronova as an API supplier when BASF bought Pronova they lost API source now need to redefine Lovaza to obtain API.
REDUCEIT study could make label for Anchor. Amarin "should"/may have requested JELIS to be included, this opens the discussion with clinicians.
Hey Akanz...likely when Amarin starts to launch World Wide...Mochida will be a partner.
Mochida could be the first to file a generic claim, but with the distance they have to ship wouldn't be able to out price Amarin's Canadian API sources. To launch a generic they would have to defeat Amarin's now 19 OB'd patents with many more that will be immediately added after Anchor is approved on or before December 20.
Japan's Health Care is equal to or ahead of the US, their drug agency sought to OTC to improve the health of their citizens...the FDA shouldn't wait for REDUCEIT.
Taisho Pharmaceutical Co., Ltd. (“Taisho Pharmaceutical”) [Head Office: Toshima-ku, Tokyo; President: Shigeru Uehara] has announced that it will launch “Epadel T” (Category 1 medicines), a treatment for improving abnormal triglyceride levels, on April 15. The drug marketing approval for “Epadel T” has been obtained by Mochida Pharmaceutical Co., Ltd. (“Mochida Pharmaceutical”) [Head Office: Shinjuku-ku, Tokyo; President: Naoyuki Mochida].
“Epadel T” was developed by converting the ethical drugs “Epadel” into an OTC drug, making it Japan’s first switch-OTC drug for lifestyle-related diseases. “Epadel” is a prescription pharmaceutical treatment for hyperlipidemia and arteriosclerosis obliterans that is manufactured and sold by Mochida Pharmaceutical. The active ingredient is EPA-E (Generic name: ethyl icosapentate). “Epadel T” contains 600 mg of EPA-E per packet, and is indicated for “the treatment of triglyceride levels that are in the borderline region, identified through health check-ups and other means.”
In the run-up to the nationwide launch of “Epadel T,” Taisho Pharmaceutical will conduct a survey on proper use in accordance with the instructions of the Ministry of Health, Labour and Welfare. This survey is designed to confirm whether or not pharmacists are able to determine customers suitable for taking this drug, and to provide proper guidance on drug administration, recommendations to see a doctor, and other services. During the survey period, “Epadel T” will be sold only at drugstores implementing the survey. Furthermore, Taisho Pharmaceutical will provide customers with the information they need to properly take “Epadel T.”
Mochida Pharmaceutical will continue to market the prescription pharmaceuticals “Epadel” for medical use.
[Product descriptions]
-Japan’s first switch-OTC drug for lifestyle-related diseases
-Administered to treat triglyceride levels that are in the borderline region, identified through health check-ups and other means.
[Product overview]
Product name: Epadel T
Category: Category 1 medicines
Suggested retail price: 42 packets ¥5,800 (Product ¥5,524 + Tax ¥276)
Ingredients: Each packet contains
Ethyl icosapentate·················600 mg
Indication: Treatment of triglyceride levels that are in the borderline region,* identified through health check-ups and other means.
*Borderline region: Refers to slightly elevated triglyceride levels (from 150 mg/dL to no more than 300 mg/dL) relative to the normal range, identified through health check-ups and other means.
Administration and dosage: Adminster the following dosage immediately after meals.
Age 20 and above Under 20
Single dose 1 packet Do not use
Daily dosage Three times a day
Date of launch: April 15, 2013
http://www.taisho.co.jp/en/company/release/2013/2013041501-e.html
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Williams
Snuggles
Did I mention the Lovaza CP and how C&M hasn't responded to my most recent comment?
They have to come up with some BS quick or the FDA's gonna close the comments...
I hope they spell my name right.
Williams/Bio