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.
Partially, yes... With this out any decision the FDA makes on the Lovaza citizen petition would be questioned. John's citizen petition should be dismissed immediately and a decision rendered. The FDA's got another week to wake up. (Timing not a threat, based on Citizen Petition timing) My next step is to inform all Institutions with holdings. I've started this process with the largest holders with members on Amarin's Board.
If this is unsuccessful I will file a claim with the SEC for suspicion of securities manipulation via Citzens Petition and known conflicts of interest at FDA.
If this doesn't bear immediate fruit, I will contact a couple of Senators that will be vary interested in a FDA political scandle and they can investigate as they see fit.
Any retailation from the FDA will be met with heafty alligations of C-Path financial conflicts and Dr. Woodcock can explain this at a Senate Hearing. President Obama certainly doesn't want another IRS like scandle. This would likely dawf the IRS issues in my opinion.
The Sh!t will hit the fan, the FDA needs to move.
NME = 3 yrs exclusivity
NCE = 5 yrs exclusivity
Orphan status exclusivity = 7 yrs for Pediatric Hyperlipidemia (oral flavored Vascepa) break a cap put under your tongue very mild flavor easily "cherried"
The "next step", finances for Anchor launch, needs valuation JL....period...
IMO a Royality agreement would be the best option, Amarin would get the better deal with 5 yrs.
How do you see them "raising" finances for Anchor launch?
Will
The PPS sucks and is at a 3 year low because Amarin is impossible to value as an asset without NCE decision....period.
The current Market cap is based on 2014 "lowest" sales estimates.
John Fuson, former Associate Chief Counsel at the FDA as late as May 2012, was the partner from Crowell & Moring LLP that filed the citizen petition requesting an active ingredient change in the OB. That right, an ex FDA employee privy to confidential FDA material was hired by ??? to further delay a NCE decision.
This petition was filed two weeks before MAPP policy 5021.1.
MAPP 5021.00, "Naming of Drug Products Containing Salt Drug Substances" was posted and effective 2-20-2013. Referring to page 7 and the Active Moiety definition reference 17 at the bottom of page 7. "The USP has announced plans to revise the USP Salt Policy definition of an active moiety so that it will no longer include 'esters'." How lucky was that? Or did he get a tip?
MAPP 5021.11 appears to be directly relevant to Vascepa's exclusivity.
How much access did Mr. Fuson have of these matters before May 2012?
It looks suspicious that Crowell & Moring filed their citizen petition two weeks before MAPP 5021.11 was posted.
How much does Crowell & Moring know about the inside FDA discussions related to Vascepa exclusivity?
Has this petition delayed Vascepa exclusivity decision?
The stock price and options have been manipulate every FDA OB update. An intentional delay could be seen as Securities Manipulation.
The FDA can delay a 505b2 application at the request of a citizen petition if it believes a patient safety issue is involved.
No one at the FDA will discuss this. Crowell & Moring and whoever hires them, is privy to more information than the FDA has released.
Please contact the FDA and complain.
Open Letter to John Fuson, former Associate Chief Counsel at the FDA.
Law Clerk
The Hon. Marsh S Berzon, US Court of Appeals May 2000-June 2001
Associate
Covington & Burling Oct 2001 - Nov 2007
Associate Chief Counsel Nov 2007 - May 2012
Partner
Crowell & Moring LLP May 2012 - present
--Drafted "The Citizen Petition" to change the OB listing for Lovaza's active ingredients Feb 2013, shortly BEFORE MAPP policy 5021.1.
===========
Just a few questions:
Who hired Crowell & Moring to draft the petition?
Did you know about MAPP 5021.1 before it was posted at the FDA?
If yes, who told you?
How much did you know about Vascepa's exclusivity before May 2012?
===========
Congratulations on your new Partnership at Crowell & Moring,
Amarin investors
jfuson@crowell.com
It'll happen similar to how I called it. Trying to drop it lower than 5.35 will be difficult.
I got some nice FDA info I break later this week...rotten to the core.
As I stated market cap of $805M, $5.37 PPS. This is based on lowest 2014 estimate. So far Vascepa sales have tracked higher than low range.
$264M average 2014 estimate $1.34B / $8.93
$605M high 2014 estimate $3.024B / $20
Anchor not included in those estimates, once funds get some skin in the game Anchor estimates will start to roll in.
This is the game.
WILL
The stock price will be driven as low as possible. Our lows today take us to 2010. Our support will be based on 2014 low estimate earnings of $160 M for 2014. With a PE of 5, looking at a market cap of $805 Million.
http://finance.yahoo.com/q/bc?s=AMRN&t=5y&l=on&z=l&q=l&c=
This is the Ad Com game. Drive it as low as possible, manipulate & accumulate long, and sell when the sheep jump aboard before Ad Com.
Watch for the August results of the citizen petition. A "NO" for changing Lovaza's OB would be a big win for Vascepa politically at the FDA.
Good Luck and let the games begin;) WILL
New FDA combo guidance doesn't look good for AZN if they planned to seek an Epanova/Crestor combo as an initial application.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM236669.pdf
AZN's combo runs into more than one wall in this guidance. It was posted 6-19-2013, same date the Ad Com was announced.
What a joke!
http://www.fiercepharma.com/story/genzymes-176k-kynamro-price-undercuts-its-250k-plus-rival/2013-01-31
BRIG do you have $175,000 to spend on Isis Rx? LOL!!! 1/3 of the treatment group had flu like symptoms
KYNAMROâ„¢ Long-term Data at ISA
KYNAMROâ„¢ (mipomersen sodium) Data Presented
at XVI International Symposium on Atherosclerosis
Phase 3 Extension Study Highlights Long-term Safety and Efficacy in Patients with Familial Hypercholesterolemia (FH)
Genzyme and Isis announced today that new two-year data from a phase 3 long-term extension study of KYNAMROTM (mipomersen sodium) were presented at the XVI International Symposium on Atherosclerosis in Sydney, Australia. In the study, patients treated with KYNAMROTM for two years maintained robust reductions in LDL-C and all other Apo B containing atherogenic lipoproteins measured with a safety profile consistent with the phase 3 studies of KYNAMROTM.
ISIS treatment is a complex biological with COGs that would be extreamly high. Toxicity and long term safety is not vetted.
http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=44564107#x299
I recommend strong DD before I would consider falling for this DNDN like senerio.
Potential Vascepa market is $1.1 Trillion, with a T. Page 11
http://www.milkeninstitute.org/pdf/chronic_disease_report.pdf
The Milken Institute has access to the top of all our Government branches.
http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/PastMeetingsWithFDAOfficials/ucm351139.htm
A smart R&D team could build an armada of block busters NCE/combo Vascepa's in a short time period. Many of these drugs could achieve orphan status exclusivity.
Example:
Orphan status for Sepsis Treatment:
IV Tylenol + EPA (has been given IV for CV studies)
http://www.ccmtutorials.com/infection/sepsis/page4.htm
Amarin should expand R&D and start the ball rolling.
Williams
In the last two weeks it became apparent to me that the pharmaceutical value of Vascepa is FAR greater than the $34 Billion dollar per year statin market.
Vascepa is Icosapent Ethyl, the API
Icosapent Ethyl's active moiety is EPA
(http://www.fda.gov/ohrms/dockets/ac/99/slides/3506s2/tsld013.htm)
Draft Icosapent Ethyl guidance
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM347002.pdf
EPA metabolites produce the mechanisms of actions, reducing triglycerides, and reducing inflamation by increasing the concentrations of Resolivins (RvE1 & RvE2). This is the cellular level mechanism of actions of "fish oil" not under stood by Wall Street last week.
"Potential mechanisms of action include increased ß-oxidation; inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT); decreased lipogenesis in the liver; and increased plasma lipoprotein lipase activity."
From the Vascepa Label---http://www.vascepa.com/full-prescribing-information.pdf
In addition to beta-oxidation & inhibition of Acyl-CoA, EPA is metabolized by the cytochrome P 450 system. This is one of the natural pathways to Resolvins, and the cellular mechanism of action of systemic inflamation reduction.
EPA metabolism can be manipulated by drugs at multiple levels in the above mechanism to produce MASSIVE amounts of tissue specific Resolvins to treat Cancer, rheumatoid arthritis, Insulin resistance, obesity, CVD, Crohns Dz. on and on.... It's through these mechanism and manipulations that have GREATLY increased the value of EPA beyond the World statin sales number of $34 billion.
NCE and old generics can be combined with Vascepa (EPA) to target these systems. Aspirin, Tylenol, & Indometacin are available now to use off label. Vascepa 2 gms + Excedrine in the AM, Vascepa 2gms + 81 mg ASA in the PM... Has greatly reduced the pain in one Fibromyalgia patient in a weeks time.
The true value of this asset is only starting to be recognized and is likely the reason for the slow exclusivity decisions at the FDA level;)$$$
Williams
The recent IRS scandal will make this issue easy to catapult politically. Like one email to one source easy...
We should stop discussing this topic further. The FDA just needs to ethically do their job.
Vascepa is moving in the right direction, the speed is governed by FDA legal. If the FDA put's water in the gas tank they'll be exposed. I'm done discussing this back to the science.
Naivety, when you deal with the FDA you must understand that they make the latest IRS government abuse look like child's play.
.".. many other FDA managers who have failed to protect the American public, who have violated laws, rules, and regulations, who have suppressed or altered scientific or technological findings and conclusions, who have abused their power and authority, and who have engaged in illegal retaliation against those who speak out, have not been held accountable and remain in place"
This is an excerpt written to the Obama administration in 2009.
I will expose the corruption and drag their sorry asses in front of a Senate Committee, their own colleagues will testify and they will be prosecuted to the fullest extent of the law. It's likely that witnesses are due whistleblower settlements if BP/FDA involvement can be proven. I speculate it would be the largest settle ever.
Ad Coms are needed only if the FDA needs an outside opinion on safety and efficacy. It's the job of the ATP 4 committee to decide if 200-500 levels warrants agressive treatment.
The FDA needs to be cleaned.
Some will cop pleas, other will go to jail.
FDA "Corruption" Letter Authenticated: Lawyers, Start Your Engines!
Lawyers who want to sue drug companies will be drooling over the news that the FDA has "certified" a 2009 letter sent anonymously by FDA staff to President Obama describing "systemic corruption and wrongdoing that permeates all levels of FDA."
The FDA's official recognition of the letter means that lawyers who want to use it to demonstrate that the FDA isn't perfect won't have to go through weeks of tedious discovery demands to find someone at the FDA who can officially say, "Yup, we sent that." That's going to be a headache for drug companies who often defend their drugs in court by saying, "Hey, the FDA said this product was fine and we did everything they asked -- so it's not fair to hold us responsible."
Plaintiffs' lawyers can now hold up the letter in court and argue that drug companies have been on notice that the FDA is riddled with politics, conflicts of interest and outright corruption, and is, as the letter says, "fundamentally broken."
The letter made headlines when it was sent last year to John Podesta of Obama's transition team. Written by a group of scientists on FDA letter head -- but with their names blacked out for fear of retaliation -- the letter describes a nightmare of bungling and self-dealing among higher-ups at the drug safety agency. It begs Obama to step in and reform the shop:
... many other FDA managers who have failed to protect the American public, who have violated laws, rules, and regulations, who have suppressed or altered scientific or technological findings and conclusions, who have abused their power and authority, and who have engaged in illegal retaliation against those who speak out, have not been held accountable and remain in place.
The letter cites three dark chapters in FDA history:
Former chief Andrew von Eschenbach's interference with the approval of a knee device.
The approval of a breast cancer detection device by director of the Office of Device Evaluation Donna-Bea Tillman even though all FDA experts voted against it, following a phone call from Connecticut congressman Christopher Shays.
And the approval by Daniel Schultz of a medical device that prevents tissue scarring against the unanimous opinion of his scientific staff.
According to Doug Kreis, who sues drug companies, "Consumers have been given a slight fighting chance now against [the] 'FDA Defense,' based on this certification."
Still unanswered: Who wrote the thing.
Image by Flickr user mlcastle, CC 2.0 Related:
John Stossel's Plan to Abolish the FDA Should Be Laughed Out of Town
Why the Maalox Stomach-Bleeding Mixup Is the FDA's Fault
FDA Has Only 2 Inspectors Watching Drug Factories in China
I'm not comfortable with a partner in a private equity firm having the keys to the FDA. He was vetted in 2002 and passed on. 2005 C-Path is formed on the Vioxx fear... And Dr. Wood is on the Board with two CDER members. Why is his Symphony relationship not posted on his C-Path bio? C- Path is far from neutral, Symphony is not neutral, what the hell was congress thinking? Who approved of this "neutral relationship?
Symphony Capital
"Symphony Capital is a private equity firm dedicated to collaborating with leading innovative biopharmaceutical companies, helping them capture more of the value in their most important clinical development programs."
"Symphony’s unique investment strategy brings a combination of dedicated capital, deep industry expertise and tailored investment structures to biopharmaceutical companies with compelling pipelines of products in all stages of clinical development."
http://www.regulations.gov/contentStreamer?objectId=09000064811ed8a0&disposition=attachment&contentType=pdf
Check out the partners.
Symphony collaborates with leading innovative biopharmaceutical companies to invest in their strategically important clinical development programs, enabling companies to fully fund robust clinical trials, accelerate the development of their product pipelines and create more value for their shareholders.
We form Symphony Collaborations with companies that have significant internally developed clinical programs or attractive in-licensed or acquired products. Each Symphony Collaboration is a distinct portfolio company in which the capitalization, clinical development design and management resources are tailored to accelerate the development of 2-4 pipeline candidates of a single biopharmaceutical company.
The Symphony Capital team brings more than two decades of strategic, financial, clinical and regulatory experience within the biopharmaceutical industry to our portfolio companies’ pipelines. Our experience in financing and advising many of the world’s leading biotechnology companies extends back to the earliest days of the industry. When companies collaborate with Symphony, they are able to retain more of the value in their most important products, maintain substantial flexibility in downstream commercialization options and avoid premature out-licensing that ultimately erodes shareholder value. In Symphony, biopharmaceutical companies have a trusted, collaborative partner.
When needed, Symphony brings world-class clinical design and management capabilities to our collaborations to enable biopharmaceutical companies to maximize the development opportunity of each pipeline program. Our exclusive alliance with RRD International provides an unparalleled breadth and depth of clinical development and regulatory resources to a biopharmaceutical company’s pipeline. Through their careers at FDA, leading biopharmaceutical companies and CROs, RRD’s executives have decades of industry expertise. RRD manages and designs global and domestic clinical development programs in collaboration with biopharmaceutical companies with an eye towards regulatory approval. As needed, they can manage all aspects of biopharmaceutical product development including clinical, preclinical, regulatory/quality systems and manufacturing. RRD's far-reaching networks of clinical, technical and regulatory experts allow them to have broad expertise across all therapeutic areas and classes of drugs.
It's a real joke, companies can pay to get in the club of special treatment though. Amarin should have probably made a donation this year. 2% of fall non profit members of the board are unpaid. I requested the boards salary's from HR ... FDA grants are used.
No, it approved to reduce triglycerides. Lowering numbers for treating triglycerides isn't for the FDA to decide. Safety & Efficasy.
http://www.regulations.gov/contentStreamer?objectId=09000064811ed8a0&disposition=attachment&contentType=pdf
Last paragraph: EPA 465 mg & DHA 375 mg
Icosapent ethyl is a prodrug, the body converts it to EPA the active product of the metabolism of Vascepa.
As the OB reads today, at no other time has Icosapent Ethyl been approved, however, a citizen petition file by a Washington law firm is requesting to change Lovaza's OB to include the active ingrediate in Vascepa. This ruling should be out soon. In my opinion the FDA legal council is waiting for this ruling to determine Vascepa status.
It appears to me there's foul play, the motivation is to minimize the exsistance of Vascepa and it's active metabolites. The active metabolites of EPA are currently being targeted by numerous C-Path back organizations, either directly or through effiliations through C-Path board members.
-Pediatric orphan treatment for hypertriglycemia for one
-Resovins for dry eyes
....the list is long and runs through two Board members of C-Path. Both these board members either RUN or are very involved in private equity firms (Hedge Fund?).
It's been made crystal clear to Amarin to shut up and take it, hence the Anchor Ad Com.
I personally believe that Vascepa is almost impossible to value if you consider it a NCE and it's active metabolites.
I'm outing this so the FDA hopefully can make an ethical and correct decision. I expect them not to, though...the OIG will not be surprised.
Akanz
The current FDA is set to torpedo Anchor and NCE. The citizen petition is locked and loaded. When the decision to retro Lovaza's OB active ingredient is made the decisions will come down. There's no legitimate reason to have an Ad Com with Vascepa safety and Anchor results. Amarin as a company is refusing to fight out of fear of FDA retailation. C-Path needs Amarin to fail.
Non-Retaliation Policy
At the FDA, our mission is to protect, promote, and enhance the public health. We also have important responsibilities to the industries we regulate, including working to bring new products to the market and minimizing regulatory burdens.
In carrying out this mission, FDA employees are required to make many decisions and take many actions involving complex clinical, scientific, legal, and factual issues. In this context, questions can be, and have been, raised about the fairness of agency proceedings and retaliatory actions-against companies which challenge or criticize the agency.
We take such concerns and allegations very seriously. Without question, companies are free to vigorously challenge agency positions and requirements, and to freely voice their views to the agency, the press, the public, and the Congress. One of our fundamental duties is to be scrupulously fair, even-handed and objective. We can accept no less. Fear of retaliation among those we regulate may chill scientific, legal and policy discourse, depriving the agency of information crucial to sound judgments and decisions. Given our special responsibilities, all FDA employees must make every effort to avoid even the appearance of unfairness or retaliatory action.
Because of the critical importance of these issues, any allegation of retaliation should be reported immediately to the Office of the Ombudsman. In addition, anyone with concerns about retaliation or related issues should contact that office. Such matters will be treated in confidence, and the office will work with other agency offices to address all relevant issues.
http://www.fda.gov/AboutFDA/ContactFDA/ResolveaDispute/HowtoContactanOmbudsman/Non-RetaliationPolicy/default.htm
The CDER Ombudsman has put me touch with a CDER tow the line Pharm D, it was also great to see the Director of Marketing for GSK on her Linkedin page. I will keep the saved picture of this private. I'm sure her job is to just string me along until the Citizen Petition is answered. I now suspect the petition came through C-Path but this should all come out in the Senate Hearing if the FDA want to persist down this road.
I have enough circumstantial evidence to level some serious accusations.
Open letter to the legal counsel at the FDA. Your being taken for a ride by your delay of exclusivity for Vascepa.
I suggest you directly talk to Dr. Wood and Dr. Woodcock. Investigate their interests in, Omega 3's, Inflamation, Pediactric rheumatoid treatments, Pediactric Hypertriglycermia.
Also investigate the money flow between the FDA, Symphony capital, and the personal accounts and family members of the above. Please coordinate this investigation with the SEC.
Here's his Bio at the C-path web site:
Alastair J.J. Wood, MB, ChB
Dr. Wood received his medical degree from St Andrew's University and Dundee Medical School in Scotland. He joined the Faculty at Vanderbilt University School of Medicine in 1978 where he became tenured Professor of both Medicine and Pharmacology, and Attending Physician at Vanderbilt Medical School. He was Assistant Vice Chancellor for Clinical Research (1999-2004), and Associate Dean, Vanderbilt Medical School (2004-2006) before being appointed Emeritus Professor of Medicine and Emeritus Professor of Pharmacology in 2006. His current academic appointments are Professor of Medicine and Professor of Pharmacology at Weill Cornell Medical College, New York. Dr. Wood has served on a number of Editorial Boards. He was a member of The New England Journal of Medicine Editorial Board (2004-2006); he was the Drug Therapy Editor of The New England Journal of Medicine from 1985 to 2004, and is currently on the Editorial Board of The British Journal of Clinical Pharmacology and The Scientist. He has previously served on the Editorial Boards of Clinical Pharmacology and Therapeutics and Biopharmaceutics and Drug Disposition. He authored the Chapter in Harrison's Principles of Internal Medicine on Adverse Drug Reactions from the 9th through the 15th edition.
Why did C-Path leave out his JOB at Symphony Capital? It' s lucrative and relivant.
http://www.symphonycapital.com/
http://www.symphonycapital.com/team/investmentteam.htm
Not finished yet....just my ruff draft that goes out to OIJ, & DOJ...Tuesday. The following week it will be released to the media.
Williams
Akanz...the use of Crestor was a pure negotiation tactic in my opinion. First it puts Pfizer on notice that Amarin has intensions of getting the highest dollar for their assests. Then in the PR JZ makes it crystal clear of the IP protection Amarin's has secured with all patents.
My advise to Amarin is apply for orphan status in the Anchor application. Dr. Wood wrote a great article on pediactric Trigylceremia and it's likely orphan status. Vascepa's taste is very mild and could be compounded easily with flavoring.
I suspect he's actually the one running the FDA via Dr. Janet Woodcock and C-Path.
http://www.mc.vanderbilt.edu/reporter/index.html?ID=2118
Hedge Funds have full access to the FDA through C-Path.
Well, then Tuesday I'll be talking to the OIG & Eric.
I'd say your in the top 98%
"Studies suggest that EPA reduces hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and/or secretion and enhances TG clearance from circulating VLDL particles. Potential mechanisms of action include increased ß-oxidation; inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT); decreased lipogenesis in the liver; and increased plasma lipoprotein lipase activity."--from the Vascepa label
DGAT-1 inhibitors have potential for the treatment of obesity[6][7] and a number of DGAT-1 inhibitors are in clinical trials for this indication.[8]
http://en.wikipedia.org/wiki/Diglyceride_acyltransferase
Possible pediatric indication for prevention of obesity with at risk children? Also prevention of type 2 DM, DGAT mechanism and insulin resistance. p450 metabolism of EPA producing RvE1 & RvE2
http://jimmunol.org/cgi/content/meeting_abstract/190/1_MeetingAbstracts/130.13
-------------------
I have a TON of circumstantial evidence that the FDA is intentially delaying Amarin's process due to the anti inflammatory metabolites of EPA. The money flows through C-Path, a non profit organization financed by donations and grants from the FDA. It was "think tanked" on the Vioxx disaster. Dr. Janet Woodcock, CDER director, happens to be on the board of directors. Critical Path institute or C-Path used my tax dollars in the form of grants to pay 52 employees $6,661,380 in salarys for 2012.
The real interesting players: Dr. Alastair Wood, he's a partner in Symphony Capital, "a leader in bio pharmaceutical structured investing". On top of his board of director job at C-Path he's busy with chairing Ad Com committees, FDA non-prescription and COX-2 inhibitors. Vioxx, is his great success story, as under his leadership the FDA saw fit to allow Merck to continue to sell their product. Including a vote from Amarin's friendly cardiologist Dr. Steven Nissen. For those that don't know much about Vioxx, the FDA approved it and kept it on the market, giving people two times the MI risks as OTC COX-2 drugs. At least the mind set for C-Path was cemented and Dr. Woodcock and Dr. Wood could get whatever stupid Azz politicians approval for C-Path.
Another notable VIP board member with Dr. Woodcock is Peter B. Corr, he happens to be the Chairman of the Board for Auven Therapeutics. Auven leading drug candidate Kiactar was "lucky" enough to get orphan status. I'm sure it's just chance that the mechanism of action blocks AA and GAG interaction. That might sound familiar if you've heard of an AA:EPA ratio. Auven Thearpeutics also happens be a major partner in Resolvyx, their lead drug candidate is RvE1, Resolvin.....
It also great to know all of the above is supported by the NIH, they happen to hold the most solid patents on Resolivins. Resolvins, for a refresher...is the last active metabolite produced for EPA & DHA.
You'd think that was enough, right! ShaAuhree Buckman is also on the Board of C-Path, she's the boss at CDER biostatistics....
http://c-path.org/
http://www.symphonycapital.com/
http://c-path.org/project-pipeline.cfm
The active metabolites of Amarin's Vascepa, cut's many pipeline drugs out of the loop. The "FDA" is just talking to their friends first before they make a decision. You tax payers and investors will just have to wait for the politician to get rich first.
Just my opinion
Williams
Unless AZN would like to launch AMR102 late next year and cut Actavis and Egis's generic launch in 2016.
Or perhaps Pfizer would like to be first in the combo market?
Or maybe TEVA would like to sign Royality aggrement for Vascepa/lipitor and Amarin launches this first?
Or perhaps Mylan Pharmaceuticals signs a Royality agreement tomorrow to launch the Vascepa/Crestor combo ASAP, since it's generic already in Canada.
Or Merck, decides they don't want any of the above and they buy Amarin over the weekend.
Or GSK, knowing that the lose the Lovaza market after the Anchor indication is approved, decides to step in before Merck.
But I'm pretty sure Pfizer has been working the math out and is likely to make a play before any of the above transpires....?
At this point if BP doesn't want Amarin to start signing AMR102 Royality agreements they better pull the trigger, soon.
I would like Amarin to do none of the above and develop the EPA market for all inflammatory diseases through biologics, perhaps something Biogen Idec would be interested in. Biogen is extremely successful in the MS market and Resolvins have a huge role to play;)---just dropped them an email on some cool NIH studies.
Designing a drug that interacts with COX & EPA is likely one of the reasons the FDA is politically and bureaucraticly dragging ass on an exclusivity decision. (Looking into Woodcock's Rhuematology connections)
Williams
JL
One of the NIH funded studies also reference Tylenol as a substitute for ASA.
Will
At this time I have no further comment.
There's a huge sh!t storm brewing at the FDA. I expect an exclusivity decision before Monday.
Williams
Vascepa or Icosapent Ethyl is an EPA Prodrug and EPA is a Prodrug for Resolvins of E class (RvE1,2,&3) the science is new and HUGE. The RvE's work at the vascular structures because this is where EPA interacts with the COX-2 enzyme. The DHA Neuroprotective "resolvins" RvD's work at the neurologic structures, eyes, brain, nerves where DHA normally interacts with the COX-2.
The EPA active metabolite Resolvins are produced by natural enzymatic reactions in the body, thus making EPA their "prodrug" by definition. It's now obvious and prior art since a dumb-ass like me found and posted this information. Amarin's IP should provide a nice base to build Resolvin RvE's off of.
The future market for Resolvins is as easy and as valuable as trying to put a price tag on the Hiawian Islands. Resolvins are the future of 21st treatments of Cancer, CVD, PVD, chronic pain, and Crohn's disease...this list is NOT all inclusive. EPA provides the base to build this science, Amarin has EPA IP until 2030.
The NIH has spent(guessing)Billions of dollars in grants advancing Resolvin science. Read:
http://www.ncbi.nlm.nih.gov/pubmed/21963090
http://www.ncbi.nlm.nih.gov/pubmed/22844113
http://www.ncbi.nlm.nih.gov/pubmed/23438748
http://www.ncbi.nlm.nih.gov/pubmed/23484005
http://www.ncbi.nlm.nih.gov/pubmed/23709617
http://www.ncbi.nlm.nih.gov/pubmed/23438740
http://www.ncbi.nlm.nih.gov/pubmed/23510485
http://www.ncbi.nlm.nih.gov/pubmed/23500003
http://www.ncbi.nlm.nih.gov/pubmed/18437155
http://www.ncbi.nlm.nih.gov/pubmed/23528855
http://www.ncbi.nlm.nih.gov/pubmed/22450811
http://www.ncbi.nlm.nih.gov/pubmed/21418190
http://www.ncbi.nlm.nih.gov/pubmed/23241890
http://www.ncbi.nlm.nih.gov/pubmed/23186989
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2785519/
http://www.nidcr.nih.gov/Research/ResearchResults/ScienceBriefs/Archive/SNIB2009/November/Resolvin.htm
http://www.ncbi.nlm.nih.gov/pubmed/22449948
http://www.ncbi.nlm.nih.gov/pubmed/17114001
http://www.ncbi.nlm.nih.gov/pubmed/23430978
http://www.ncbi.nlm.nih.gov/pubmed/21255928
http://www.ncbi.nlm.nih.gov/pubmed?cmd=Link&dbFrom=PubMed&from_uid=18480426
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3590122/
http://www.ncbi.nlm.nih.gov/pubmed/22013115
http://www.ncbi.nlm.nih.gov/pubmed/21206090
http://www.ncbi.nlm.nih.gov/pubmed/23462912
Any BP not watering at the mouth to own Amarin's IP would be greatly uninformed.
This is HUGE. Please link to ST, Twitter, and YMB.
Williams
JL, The chemerin receptor is the target of RvE1. Check this out:
http://www.iuphar-db.org/DATABASE/LigandDisplayForward?tab=biology&ligandId=3333
EPA is step 1 in the production of RvE.
EPA -->(ASA/COX2)-->18-R-hydro(per)oxy-EPA -->(5-LOX)-->5 S-hydroperoxy, 18R-hydroxy-EPA-->(reduction rxn)--> RvE2......different branched rxn from 5S-hydroperoxy, 18R-hydroxy-EPA-->5,6-epoxy, 18 R-hydroy-EPA--> (LTA4H)--> RvE1
Think of the ASA as a catalyst...Maybe?
All the molecules following EPA in the above reaction are small variations of the EPA molecule and would be considered active metabolites of EPA, I suggest Amarin Patent these using their original EPA patent.
The reason Amarin has a lock on the metabolites: obviously any layman could figure out the metabolites are active and considered prior art as they are posted here on an IHUB Amarin investor website. (Someone save that for legal;)
Williams
RvE1 (Resolvin) ligand from than natural metabolism of EPA search with Pfizer:
First result turns up a page sponcered by Pfizer, AZN and GSK....LOL!!!
http://www.iuphar-db.org/DATABASE/LigandDisplayForward?ligandId=2901
Propofol was the drug a cardiologist used, without the skill set to manage the effects, to sedate/kill MJ.
Why Pfizer might be interested in Resolvins?
Celecoxib and Black Box Warnings
http://en.wikipedia.org/wiki/Celecoxib
COX-1 & COX-2 101 lecture:
http://www.albany.edu/faculty/cs812/bio366/Cyclooxygenase_ppt.pdf
This is going to get very interesting as Investers learn about Resolvins, COX1&2, and the EPA molecule.
Good stuff JL, D1,2,&3 Resolvins are produce from DHA and are more neuroactive while E1,2,&3 are produced from EPA and are more Vascular like in targeting.
I hope Amarin's R&D is up to speed on Resolvins.
Williams
Let the Ad Com games begin. Yesterday it became clear to me that the NIH has been spending Billions in the research of Resolvins, not many paths for ANY company to get there except through the EPA molecule. Amarin has the IP and the NIH doesn't. I might have to schedule trip to Washington in the fall.
http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=52921890&loc=ec_rcs#x281
Ms. Behr, we'll be talking today.
Williams