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John
Great job & thank you!
Williams
Friday A.M. if Vascepa posts sales growth greater than last weeks 13%, manipulation stops and investors pile in. Soon it's going to be all about sales. Money talks and Bull Shit walks.
Severe Trig Ad Com...should be concerning since Vascepa got a pass. They'll need safety data with those DHA levels much higher than Lovaza. LDL? & Afib warning?
Grant, to be fair to those shame OTC sups, we should look at the harmful drugs the FDA has approved because they got their pocks stuffed with perks from the Merck's.
Lets start with Viox, FDA warning: 2001 Viox pulled from market 2004
"Sept 30, 2004 -- Merck & Co announced today that it was pulling its popular arthritis and pain drug Vioxx (rofecoxib) from the worldwide market after a clinical trial showed that the drug carried an increased risk for heart attacks and strokes."
http://www.medicinenet.com/script/main/art.asp?articlekey=39463
The FDA warning letter to Merck CEO in 2001:
"You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for Vioxx. Specifically, your promotional campaign discounts the fact that in the VIGOR study, patients on Vioxx were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator non-steroidal antiinflarnmatory drug (NSAID), Naprosyn (naproxen)."
http://www.pharmcast.com/WarningLetters/Yr2001/Sept2001/Merck0901.htm
Vascepa is EPA blood levels...EPA is essential to good health...EPA has been reduced in the western diets by greater than 30 fold since 1900...AA bad fatty acids has replaced EPA...this causes inflamation and disease...Vascepa will sell over $100 billion in it's lifetime...you already know this;)
JL Looks like Amarin will have full enrollment early 2014 if the current enrollment pace continues.
It's hard not to notice Astra's "news":
9-24-2013
"The acquisition of Omthera Pharma added Epanova to AstraZeneca’s pipeline. The candidate has been developed for the treatment of patients with severe hypertriglyceridaemia (triglyceride levels greater than or equal to 500mg/dL). The U.S. Food and Drug Administration (:FDA) accepted the marketing application for Epanova and is expected to render a final decision on the candidate by May 5, 2014."
"AstraZeneca also intends to get Epanova approved as a fixed dose combination with its cardiovascular drug, Crestor, for mixed dyslipidemia patients who are at a high risk of cardiovascular events. Moreover, AstraZeneca is planning to conduct a large scale cardiovascular outcomes trial to assess Epanova in combination with statins."
http://finance.yahoo.com/news/astrazenecas-stage-pipeline-154008313.html
AZN'S STARTING TO SOUND DOWNRIGHT DELUSIONAL. CAN EPANOVA BE APPROVED FOR SEVERE TRIGS?...A BIG MAYBE!!! AMARIN'S VASCEPA NEVER NEEDED AN AD COM FOR TRIGS >500 BECAUSE IT HAD NO SAFETY SIGNALS THAT WHERE APPARENT. FROM A PHASE 3 TRIAL WITH EPANOVA THEY SHOWED BLOOD LEVELS OF DHA MULTIPLES HIGHER THAN LOVAZA, THIS IS CONCERNING SINCE LOVAZA'S RAISES LDL AND COMES WITH AN A-FIB WARNING. BEFORE APPROVAL FOR SEVERE TRIGS, AZN'S GOING TO HAVE TO PROVE, AT THIS AD COM, THAT IT DOESN'T HAVE THE SAME CONCERNS LOVAZA HAS. (IF I HAVE TO PERSONALLY GO MYSELF TO RAISE THIS ISSUE, SO BE IT) BOTH OMTHERA'S PHASE 3 STUDIES ARE SPA DESIGNED, YET THEY ARE CALLED IN FRONT OF AN AD COM FOR THE MERE SEVERE TRIG INDICATION.
YET, AZN IS LOOKING PAST EPANOVA'S SEVERE TRIG APPROVAL AND ONTO COMBO EPANOVA/CRESTOR FOR THE TREATMENT OF HIGH TRIGS, SOMETHING THE FDA HAS REQUIRED AMARIN TO DO A CARDIOVASCULAR STUDY TO APPLY FOR THIS INDICATION. THE PATENT WILL EXPIRE ON CRESTOR BEFORE THEY GET THEIR FIRST PATIENT ENROLLED IN THIS "large scale cardiovascular outcomes trial to assess Epanova in combination with statins".
MY POINT? AZN'S TALKING SHIT! AT THIS STAGE IN THE GAME THEY ARE S.O.L. WITH THE EPANOVA PLAN. I EXPECT THEM TO BE THE FIRST "OFFER"...AND THE TIMING BEFORE OCT 16 TO PUT PRESSURE ON AMARIN STOCK HOLDERS TO SETTLE WITH LESS BEFORE ANCHOR PDUFA.
MOST ON THIS BOARD WOULD SETTLE FOR $20-30... I WILL NOT AND DOUBT THAT AZN CAN COME TO AN AGREEMENT WITH THE BOARD.
AMARIN SHOULD CONTINUE GIA, AS BREAKEVEN SALES ARE FAST APPROACHING, AND MANAGEMENT HAD THE BRAINS TO RAISE CASH FOR DIRECT ANCHOR MARKETING.
I'M IN THIS TO SEE REDUCE-IT GET IT'S JELIS OFF:)
WILLIAMS
Guessing November 2013 to February 2014;)
Has Tier 2 follow through kicked in?
The nail in AstraZeneca's coffin ap # 13540319. Mailed NOA 9-19-2013, Perkins Coie new Law firm handling Amarin's patents,
On 6-19 Amarin received Reasons for Allowance, for combining EPA and statin for treatment of Mixed Dyslipidemia and inflamation markers. It's very broad, but is the first of many AMR 102 patents. It protects against any statin/EPA combo. Any statin any combo....Broad. It will be shored up further with specific claims. As of today, it doesn't have an issue date...but should be posted soon...next couple months.
Perkins Coie LLP - Amarin Corporation PLC
Address: 1201 Third Avenue
Suite 4900
Seattle WA 98101
The low ball BO bid, good chance before ad com.
$20 to $30...rejected.
JMO
The Anchor Ad Com isn't about treatment of just high Trigs, and patient population 10 times Marine.
It's about treating CV risk factors for those most at risk, Metobolic Syndrome. Treating High Trig > 200, high non HDL C, Apo B, LDL, total cholesterol, VLDL-C for those with CHD or risk factors for CHD.
This population is closer to 100 million patients...not 40 million.
1% market penetration is a million patients and $2 Billion in sales. This is bigger than any investment banks are giving credit for. In 3 weeks from Wedsday, the Bull shit stops.
Ad Com Agenda:
The committee will discuss the supplemental new drug application, NDA 202057/S-005, Vascepa (icosapent ethyl) Capsules, submitted by Amarin Pharmaceuticals Ireland Ltd. Vascepa is currently approved as monotherapy for the treatment of severe hypertriglyceridemia. This supplemental application proposes concomitant use with an inhibitor of HMG-CoA reductase (statin) to reduce triglycerides (TG), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (Apo B), low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and very-low-density lipoprotein cholesterol (VLDL-C) in adults with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent.
The should put it on the Lovaza label.
BP's gonna get so Warner- Lambert it's funny!
In 1993, Warner-Lambert acquired Wilkinson Sword, combining it with Schick ® to create the world's second largest wet-shave business. However, a far greater expansion of the company came in 1996, when Warner-Lambert entered into a co-marketing agreement with Pfizer on Lipitor ® (atorvastatin calcium) , a new entry into the statin class of lipid-lowering agents. Discovered by Parke-Davis Research and introduced in 1997, Lipitor ® is the largest-selling pharmaceutical of any kind worldwide.
After three months of wrangling, Pfizer announced Monday that it will acquire Warner-Lambert in an all-stock deal the companies have valued at $90 billion.
LOL!!!! BP is screwed!!!
Because the FDA hates Amarin.
13768906 WOW!!!! This is more than Anchor!
This patent has no trig range of 200-500 or 500+, likely a reflection of ATP 4 guidelines recommending treatment of trig as low as 150 with those at risk patients with metabolic syndrome. This increases Vascepa treatment population for Anchor to around 100,000,000 patients.
http://www.medscape.com/viewarticle/496190_8
Objective—The purpose of this study was to examine the prevalence of individual risk factors for metabolic syndrome as well as the prevalence of metabolic syndrome in the National Health and Nutrition Examination Survey (NHANES) 2003–2006.
Methods—The analytic sample consisted of 3,423 adults, 20 years of age and over, from NHANES 2003–2006. The National Cholesterol Education Program’s Adult Treatment Panel III (NCEP/ATP III) guidelines were used to identify adults who met their criteria for metabolic syndrome. Prevalence estimates were calculated for each risk factor for metabolic syndrome in addition to the prevalence of metabolic syndrome. Prevalence estimates and odds ratios were analyzed by sex and by age group, race and ethnicity, and body mass index (BMI) stratified by sex.
Results—Approximately 34% of adults met the criteria for metabolic syndrome. Males and females 40–59 years of age were about three times as likely as those 20–39 years of age to meet the criteria for metabolic syndrome. Males 60 years of age and over were more than four times as likely and females 60 years of age and over were more than six times as likely as the youngest age group to meet the criteria. Non-Hispanic black males were about one-half as likely as non-Hispanic white males to meet the criteria for metabolic syndrome, while non-Hispanic black and Mexican-American females were about 1.5 times as likely as non-Hispanic white females to meet the criteria. Overweight males were about six times as likely and obese males were about 32 times as likely as normal weight males to meet the criteria. Overweight females were more than five times as likely and obese females were more than 17 times as likely as normal weight females to meet the criteria.
Conclusions—These results demonstrate that metabolic syndrome is prevalent and that it increases with age and with BMI. The prevalence varied by race and ethnicity but the pattern was different for males and females.
Keywords: National Health and Nutrition Examination Survey (NHANES) c metabolic syndrome c BMI c abdominal obesity
JL...Are you feeling OK? Crazy speculation is best left to me.... I do agree with your math, though.
Easier yet, look at Crestor/generic Liptor sales. AMR 102 should top those within 5 yrs. AHA is pushing combo's, ATP 4 will support AMR 102 use.
Williams
Zum, Thanks...so I need to "tell" them again;). I had a PHD/MD look at the Resolvin patents Harvard has through Women's Hospital. He said they locked it up. Still trying to convince him to do an Asthma trial with Vascepa.
Williams
When did Amarin get them? I had an exchange months ago, with Amarin, to grab these Resolvin and Neuro patents.
Zum, when was this aquired out of curiosity? I had an exchange with Stuart Sedlack, Amarin SVP, about grabbing some of these patents.
I'll take the cataract to grabing my chest and pushing up daisy's. The real test, I would like to see Vascepa head to head with Statins...I think Vascepa might surprise.
Take these concerns to your physician as the Valtrex might really be helping your EBV infection. EBV can cause increased liver enzymes. It sounds like your EBV might be given you the hard time...? Good Luck...had mono as a teenager...really kicks your ass!
STS, it's possible if your docs started you on Valtrex to treat your chronic EBV, it may be "severe" enough to bump your inflamation markers. Chronic fatigue syndrome?
Akanz
You and your PA wife are doing a great thing! After she gets this going, I hope she writes it up.
Williams
STS, do you have any active infections, or had an infection at the time of lab draw?
-do you have clotting disorders? Factor V Leiden, history of DVT's, history of Pulmonary Embolism? (Or a blood relative with DVT's or PE)
Williams
No, in addition, if AZN attempts to discredit Amarin's IP...they are only hurting themselves.
Statins & Pancreatis
http://www.spacedoc.com/pancreatitis_statins.html
That's the gamble AZN will have to take. Buy Amarin, or shot themselves in the foot by "maybe" defeating a patent they could have owned. Bring it!
Williams
My opinion was it couldn't be accepted with Lovaza's last Patent standing, that's not an issue now. By default, Epanova lucks out and gets to enter first with Fatty Acid twist compared to ethyl ester. Lovaza's last patent covered FA's thus blocking an Epanova 505 B 1 or 2 app. Whether or not the FDA is prepared to give Epanova 5 yrs for FA vs. Ethyl Ester is unclear. What is clear, if Amarin gets ap'281 AZN will be paying Amarin royalties for Epanova;)
Epanova still has to prove full safety, remember DHA levels are multiples higher than Lovaza, this may give an uncomfortably high LDL considering Vascepa's on the market already with no LDL bump. Epanova approval is a true 50:50.
AZN has no combo patents and no hope of ever getting one with Amarin's issued patents and obviousness hurtles. That's FACT!
If they would like to protect Crestor they might be able to cut some deal with Amarin for Patent rights...unlikely though with the Liptor/Vascepa combo being more potent than the Crestor combo. Sounds like AZN's CEO knows jack about Amarin's IP...LOL.
For $5 million I offered to help them...oh well.
They waste $260 million if they don't aquire Amarin...Impossible to get around that...even more so with Generic Entry.
I see NCE timetable moving forward with generic overhang and Epanova over.
Epanova is not an Anchor competitor. Epanova will never happen if '281 materializes.
'281 is very likely to happen. Affidavits signed 8-8, forwarded to examiner 9-10, track one (priority filed in August also) Hopefully NOA before December.
Amarin's Epanova patent forwarded to examiner after affidavit's signed 9-10.
13/685,281
Should get NOA before Epanova's PDUFA
Let the games begin!!!
Here: 1. A method of lowering triglycerides in a subject with triglycerides of at least 500 mg/dl comprising, administering to the subject daily a pharmaceutical composition comprising an amount of eicosapentaenoic acid selected from the group consisting of about 1100 mg, about 1650 mg and about 2200 mg, and not more than about 30%, by weight of total fatty acids, docosahexaenoic acid, for a period effective to reduce triglycerides in the subject.
2. The method of claim 1 comprising, administering to the subject the pharmaceutical composition daily for a period effective to reduce triglycerides by at least 10% in the subject.
3. The method of claim 1 comprising, administering to the subject the pharmaceutical composition daily for a period effective to reduce triglycerides by at least 20% in the subject.
4. The method of claim 1 comprising, administering to the subject the pharmaceutical composition daily for a period effective to reduce non-HDL-C in the subject.
5. The method of claim 1 comprising, administering to the subject the pharmaceutical composition daily for a period effective to reduce non-HDL-C by 5% in the subject.
6. The method of claim 1 comprising, administering to the subject the pharmaceutical composition daily for a period effective to increase HDL-C in the subject.
7. The method of claim 1 comprising, administering to the subject the pharmaceutical composition daily for a period effective to increase HDL-C by 5% in the subject.
8. The method of claim 1 wherein the effective amount of eicosapentaenoic acid is about 1100 mg.
9. The method of claim 8 wherein administration of about 1100 mg of eicosapentaenoic acid per day results in an increase in plasma eicosapentaenoic acid levels of at least 200% in the subject.
10. The method of claim 1 wherein the effective amount of eicosapentaenoic acid is about 1650 mg.
11. The method of claim 10 wherein administration of about 1650 mg of eicosapentaenoic acid per day results in an increase in plasma eicosapentaenoic acid levels of at least 200% in the subject.
12. The method of claim 11 wherein the effective amount of eicosapentaenoic acid is about 2200 mg.
13. The method of claim 12 wherein administration of about 2200 mg of eicosapentaenoic acid per day results in an increase in plasma eicosapentaenoic acid levels of at least 400% in the subject.
14. The method of claim 13 wherein the pharmaceutical composition comprises not more than about 20%, by weight of total fatty acids, docosahexaenoic acid.
They don't have combo drug. They have Epanova, monotherapy for very high trigs >500. Amarin has patent for Crestor combo. No way to refute this patent.
If Amarin pulls off pat. Ap '281 then Epanova is dead...again.
The court ruling opened the way for Epanova. AZN still has no patent. They still have dreams of AMR 102.
I see this exceptance as decision finally being made. Sounds like May PDUFA.
AstraZeneca looks for new heart drug approval by next May
Reuters 3 hours ago
LONDON (Reuters) - U.S. regulators have accepted an experimental fish oil-based heart drug from AstraZeneca for review and will make a decision on whether to approve it by next May.
Epanova, for treating people with very high levels of fatty triglycerides in their blood, was developed by Omthera Pharmaceuticals, which AstraZeneca acquired earlier this year.
AstraZeneca said on Wednesday that the U.S. Food and Drug Administration had set a date of May 5, 2014 to act on the Epanova submission.
Buying Omthera forms part of a drive by Chief Executive Pascal Soriot to revive AstraZeneca's fortunes through a series of bolt-on deals in core areas, including cardiovascular medicine.
The acquisition pitches AstraZeneca into competition with rivals including GlaxoSmithKline and Amarin that already have similar heart-friendly fish oil drugs approved.
AstraZeneca's sales and profits are falling as older medicines lose patent protection and the company badly needs new products to replace former big sellers like the antipsychotic Seroquel, which lost exclusivity last year.
Cardiovascular medicine is a key area for AstraZeneca, whose top-selling drug is the cholesterol fighter Crestor. The British-based group is working on a fixed-dose combination of Crestor and Epanova that, if successful, would extend the Crestor franchise beyond 2016, when the drug's U.S. patent ends.
Grant
That's the main mechanism of action.
"Eicosanoids are derived from either omega-3 (?-3) or omega-6 (?-6) fatty acids. The ?-6 eicosanoids are generally pro-inflammatory; ?-3s are much less so. The amounts and balance of these fats in a person's diet will affect the body's eicosanoid-controlled functions, with effects on cardiovascular disease, triglycerides, blood pressure, and arthritis. Anti-inflammatory drugs such as aspirin and other NSAIDs act by downregulating eicosanoid synthesis."
EPA is the building block for the anti-Inflamatory eciosanoids. Omega 6's the Inflamatory eciosanoids.
"The biological effects of the omega-6 fatty acids are largely mediated by their conversion to omega-6 eicosanoids that bind to diverse receptors found in every tissue of the body. The conversion of tissue arachidonic acid (20:4n-6) to omega-6 prostaglandin and omega-6 leukotriene hormones provides many targets for pharmaceutical drug development and treatment to diminish excessive omega-6 actions in atherosclerosis,[2] asthma, arthritis, vascular disease, thrombosis, immune-inflammatory processes, and tumor proliferation. Competitive interactions with the omega-3 fatty acids affect the relative storage, mobilization, conversion and action of the omega-3 and omega-6 eicosanoid precursors (see Essential fatty acid interactions)."
Vascepa is important because it can increase EPA blood levels 30 times higher than a gram for gram OTC fish oil. This is why it works, and fish oil just gives you the fish burps. It's impossible to get the same EPA blood levels with OTC.. you'd shit yourself.
DHA lowers trigs better than EPA but has proven to also raise LDL ( bad cholesterol) this is historically connected to poor CV outcomes.
Your body doesn't need the extra DHA, it regulates the amount needed and can easily produce it from EPA. The reverse is not true, your body doesn't normally convert DHA to EPA .
Your likely correct, thanks for the help digging. There's still that one John Mulhern with the two Pfizer links...more probable the Coie Employee though. Oh well...maybe we'll get NCE this week...LOL.
The FDA still has patent 8524698 listed twice...ya think they would fix that after a week of daily updates.
http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=202057&Product_No=001&table1=OB_Rx
Study
IMO, Pfizer is supervising patent so it suits their needs when the time comes to get the checkbook out. Just pointing out an interesting tidbit;) BO after Anchor and NCE firm up. Bidding war...that could happen anyday.
The other attorney on the document has an impressive IP background. Omega 3 & Statin derivitives...likely "neutral" Lawfirm.
Perhaps,
Also Attorney John Mulhern who's a partner at NY law firm 2 miles away from Pfizer Manhattan HQ. Lawfirm's clients BASF, Merck, & Pfizer.
Search "John Mulhern + attorney" & "John Mulhern + Pfizer"
Your John Mulhern is from New York, this patent update was filed by a Chicago Lawfirm, I don't think he commutes to Chicago to help file paperwork.
This is our guy, I believe:
http://www.martindale.com/John-P-Mulhern/1107648-lawyer.htm His office is 2 miles from Pfizer HQ in Manhattan.
Guessing Pfizer hired outside attorney to handle this but new Chicago Lawfirm F-d up by putting his name on document. Remember, patent attorney's changed hand on this patent 3-2013.
Study... Go to 1)Public PAIRs
2) pat app 13266085
3) Image File Wrapper
4) Fee Worksheet
5) Filer: Randy R Micheletti/John Mulhem
Randy Micheletti Attorney specializes in Omega 3 & statin derivatives
John Mulhem, listed on two job sites as a Pfizer "manager", also New York Attorney law firm that represents BASF, Merck, & Pfizer.
Will
It appears patent app 13/266,085 is directly linked to Pfizer.
Mr. Founier is the attorney at K&L Gates that's handled Amarin's Patents. He change positions 3-2013 and is now a partner at Perkins & Cole, Chicago. Attorney Micheletti, at Perkins Cole, filed the Extension 9-13-2013. On the Electonic Patent App Transmittal extension form, John Mulhern's name is next to Attorney Micheletti. John Mulhern is listed as a "Pfizer Manager", also happens to be an attorney for a NY lawfirm that represents BASF, Merck and Pfizer.
Pfizer/Merck Amarin grab:)
Good luck covering.
Williams
Annac---first I welcome your "voice"...understand that this is only an investment for most on this board, some lie in hopes of creating price volatility.
Vascepa...EPA may be the biggest drug ever. The only other "investor" on this board that may agree with me on this opinion is JL. (Although I hate to put this opinion out there without him actually saying it)...sorry JL;). It's safe to say if the World changed it's AA:EPA ratio it would reduce chronic diseases and save thousands of lives and $Billions of healthcare dollars.
Dr. Sears is no joke:
"A turning point in his research occurred in 1982. That year, the Nobel Prize in Medicine was awarded for discoveries of the role that specialized hormones, known as eicosanoids, play in the development of cardiovascular disease, diabetes, auto-immune diseases, and cancer. Since eicosanoids are only generated from dietary fat, Dr. Sears reasoned that one could apply drug delivery principles to nutrition in order to control these exceptionally powerful hormonal responses with laser-like precision. In essence, this theory treats food as if it were a drug"
http://www.cbn.com/health/naturalhealth/drsears_bio.aspx
So yes, Vascepa, in my opinion, will dawf Lipitor life sales which have exceeded $120 Billion life time sales...so far.
Conspiracy's happen to be my speciality. Many BP's have positioned themselves around Amarin, some legally, some questionable that could go as far as Antitrust violations. At this time I currently believe the FDA is committed to get this right. The NCE delay, Lovaza Citizen Petition delay are proof they are in no hurry to get this wrong...which I take as a good sign.
My absolute worse case senerios:
Vascepa is approve for Anchor (the science of approvability is a no brainer efficasy:safety leaves no other possibility)...but the FDA concludes Vascepa is only due 3 years of NME. NME provides 3 years of exclusivity from the date of approval, December 20 th PDUFA. This gives Amarin 2014, 2015, and 2016...at which point a generic EPA could enter the market...IF they could defeat the OB's patents. In December, if Amarin is given "only 3 NME" the FDA will see the largest number of generic applications ever for a drug...EVER.
This leaves us with the following questions:
Can Amarin protect exclusivity with the 40 patents they likely have booked by December 2013? ( as of today Amarin has 20 patents OB'd for Marine...with the approval of Anchor 11 sitting on the sidelines will go in the OB at Anchor approval). Worse case some slimy attorney finds a way around all the patents...December 2016.
Amarin legally will get a 30 month stay....2017, 2018, 2019.
At worse case...Amarin gets the EPA market until 2019, at which time a Generic could enter after defeating patents. 2014, 2015, 2016, 2017, 2018, 2018. 6 years of solid Anchor marketing and sales.
At bare minimum Amarin is worth $5 Billion worse case.
At best case...Lipitor life time sales >>$100 Billion.
Thanks for sharing your story,
Williams/BioBillion
Better yet, BASF can supply Generic Lovaza and Vascepa....should be a no brainer for GSK once Anchor and NCE are firmed up.