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Yes, indeed. Pfizer has a clear business plan unlike some other BP's I've been watching.
Yellow Bluff thanks for sharing and here's my take for what it's worth:
"Under the SPA for our ESPRIT study, we are able to submit an NDA for an indication for Epanova for the reduction of non-HDL-C and triglycerides in patients with high triglycerides in combination with statin therapy after we obtain approval for Epanova for patients with severe hypertriglyceridemia and are substantially underway with a cardiovascular outcomes study."
Omethera/AZN's designed path:
1) get approval for the Fatty Acid version of Lovaza, that increased DHA levels 250% higher than the A.fib warning drug Lovaza
A) convince GSK your not launching a generic
B) convince TEVA your not launching a generic (they WON dibs in court against Pronova)
C) convince Amarin, Pronova that your not infringing on their FA omega 3 patents...that's right Amarin and Pronova have FA patents
D) 2015 at the earliest, and TEVA will have a generic at this time, could be FA generic since Omthera has NO IP
2) After easly jumping the above hurdles, Design a similar REDUCE-IT study for your combo ( notice it's NOT mono therapy due to complete lack of efficacy in the high trig population with JUST Epanova.
A) Then find a partner, AZN, who is willing to front a $50 million dollar per year outcomes study for a drug that likely will have the same A.fib warnings, and has NO IP protection, and likely violates Amarin's IP protection. It'll wrap up in 2021 assuming approval in 2015 for severe trig., but they'll somehow get 8000 patients interested in a CV outcomes trial after Amarin already finished REDUCEIT. Assuming it takes them the same two years to be "substantially underway" they can apply for the NO IP protected combo in 2017 and approval in 2018 assuming everything went PERFECT with an inferior drug.
So, 2018 AZN will be ready to do battle with Vascepa/AMR102 with their non patented Epanova Combo violating multiple Amarin/Pfizer/Merck/TEVA patents???
AZN has clearly frick'n lost all it's marbles here!!! (For $5 million AZN, I'll find you a loophole to can that Omthera "deal".)
Pfizer is going to own your ass again AZN if you don't wake up!
Williams
Study, it does look like the volume is related to a very successful spin-off likely to generate $12 Billion in valuation.
Reuters) - Pfizer Inc said on Wednesday it will spin off its majority stake in animal health business Zoetis Inc to shareholders by allowing them to swap Pfizer stock for Zoetis shares at a 7 percent discount.
Pfizer, the largest U.S. drugmaker, sold Zoetis shares in an initial public offering in February that raised $2.2 billion. Pfizer retained an 80 percent stake in Zoetis after the IPO and now plans to unwind that, starting with this offer.
The move comes as Pfizer continues to unload its non-pharmaceuticals businesses to focus on its core prescription drugs business, which has far higher profit margins.
The offer would allow Pfizer shareholders to exchange $100 worth of company stock for $107.52 worth of Zoetis stock. The premium is meant to encourage Pfizer shareholders to acquire Zoetis shares.
Pfizer owns 400,985,000 shares of Zoetis Class B common stock that it will convert to Class A shares for the exchange. Pfizer shareholders must request at least 160.4 million shares of Zoetis common stock for the exchange to take effect.
Pfizer said that selling the rest of Zoetis will boost earnings starting in 2014. If it does not sell all of its stake through the exchange offer, Pfizer said it could turn to additional exchange offers or a special dividend.
Pfizer shares rose 3 percent to $29.65 on Wednesday while Zoetis shares fell 1.5 percent to $32.53, moving closer to their relative values under the estimated exchange ratio.
Zoetis shares were priced at $26 in the February IPO and closed their first day of trading at $31.01.
In April 2012 Pfizer sold its infant nutrition business to Nestle SA for $11.9 billion. The drugmaker has said it plans to use cash from asset sales to aggressively buy back its shares.
Last month Pfizer said it had repurchased $6.3 billion of stock this year and was authorized to spend another $5.5 billion on buybacks.
Meanwhile, the company is considering whether to sell off its wide array of generic prescription drugs, which it calls "established products." In that event, the company would keep its branded patent-protected medicines.
Chief Executive Ian Read in April said Pfizer would need three years to evaluate whether to spin off the generic medicines.
JPMorgan Chase, Bank of America, Goldman Sachs & Co and Morgan Stanley are managing the exchange offer. Skadden, Arps, Slate, Meagher & Flom is advising Pfizer.
(Reporting by Caroline Humer and Ransdell Pierson; Editing by Gerald E. McCormick and John Wallace)
If you having trouble sleeping read this:
http://www.sec.gov/Archives/edgar/data/1555280/000119312513230781/d533019ds4.htm
I'm out, too.
Will
Study, it could be related, but this is literally the most volume Pfizer's seen in 3 years. If you read there message board and look at the articles written...many feel something big is in the works. $7 Billion plus CVR combo and REDUCEIT another 5$ Billion gets it done for me;)
They may have learned with the Lipitor FU?
Williams
You have to go back to April 2010 to see Pfizer volume anywhere close to the the last 12 trading days.
Pfizer is sitting on $34.4 Billion in cash.
Bravo, I'm not sure how the Zoetis deal factors the increase in volume.
Average volume is 38.9 M, for 7 days over the last few weeks it has more than doubled average volume to the tune of about $9 Billion extra traded...
Something big is cooking, I've only gone back a year, and Pfizer never had an increase like this in that time period.
What do you think?
Will
On 7-20-2012 PFE won a patent suit on Lyrica, so that explains the 300 million shares in 3 days, also cancer drug approval in Europe.
Over 450,000,000 shares traded the past 6 days....odd.
Has anyone noticed the Pfizer volume the past 7 trading days, ie since AZN Omethera grab?
Average volume 38 million
1)May 31st, 89.7 M
2) 6-3, 57 M
3) 6-4, 69.9 M
4) 6-5, 71.2 M
5) 6-6, 82.4 M
6) 6-7, 83.9 M
Today over $50 M
Hasn't had this volume since 7-19, 20, & 23rd
Something's up with Pfizer!
Options play for NCE week? Look at the weekly 7 calls.
http://finance.yahoo.com/q/op?s=AMRN+Options
What do we have here?
Thanks
Will
New Administrative Document(s) & Correspondence under Lovaza/Omacor review. It appears the FDA granted 5 yrs of NCE without an exclusivity request. Interesting?!
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-654_Omacor.cfm
Part one
Lovaza 465 mg EPA per cap, Cmax about 60 mcg/ml after 4 grams of Lovaza or 1860 mg of EPA
(0.032 mcg/ml increase in blood plasma levels per mg of Lovaza)
Vascepa 4000 mg EPA, Cmax 360 mcg/ml. (0.09 mcg/ml increase in blood plasma EPA levels per mg of Vascepa)
Assuming PlusEPA and Lovaza have similar bioavailability (?) you'd need about 3 times the dose to achieve the same EPA blood plasma levels. 12 grams of PlusEPA would run you about $444 per month and you likely would be in the bathroom changing your underwear.
To be sure you need to check blood levels after dosing for the same time periods as Vascepa.
Is that what you wanted?
Williams
I was waiting for that response...thanks.
DRRC--I have not come across any PlusEPA blood levels. The contents of PlusEPA are oxidized...they smell like fish. Vascepa is not oxidized, due to patent capsule design and content. The oxidation of PlusEPA likely will effect the pharmaceutical potency.
PlusEPA 4 Gm / Day = $147.96 per month unknown pharmaceutical properties
Vascepa 4 Gm / Day = use the coupon or your insurance (worse case out of pocket) $200 per month
Williams
DHA blood levels for Epanova and Lovaza
Pg. 4
http://omthera.com/pdf/ECLIPSE_Slides.pdf
That should be a serious FDA A.fib concern.
Epanova's DHA blood concentration is 250% higher than Lovaza's DHA levels...
With the recurrent A Fib warning, for Lovaza, it's going to be problematic to get Epanova approved without a safety study.
A. Fib warning with Epanova is all but guaranteed. It likely will cause A.fib at a higher rate than Lovaza with the increase in DHA blood levels. AZN didn't consider this in the basic risk/benefit approval. It possible it's not even a generic to Lovaza.
Will
I have had some discussions with Amarin r/t other uses...not sure if they are following up. I was assured my idea was passed along...my communication was with management and not IR.
Amarin has clearly stated they are not hiring a primary sales force to launch Anchor. (Elan royality funding) They have a defined plan and timetable.
Just read the hydrox-lipitor patent arguements...again...No way AZN has delusions of a combo product without Vascepa. No F'n way!!! I believe Pascal showed his hand to early, Amarin's got months to let them stew. The only play Pascal has is to file a NDA for Omthera...
Pascal Soriot, Chief Executive Officer of AstraZeneca said: "The number of people with elevated triglyceride levels is rising
rapidly across the world, due in part to the increasing prevalence of obesity and diabetes. There is a clear need for effective
and convenient alternatives to some of the existing treatments. Epanova offers real potential both as a distinctive monotherapy
for the treatment of hypertriglyceridemia and in combination with Crestor for patients at high risk of adverse cardiovascular
events. This is an exciting acquisition that clearly complements our existing portfolio in cardiovascular and metabolic disease,
one of our core therapy areas."
Gerald L. Wisler President & CEO, Board Member, and Co-Founder of Omthera, commented: "We are delighted to be joining
AstraZeneca, a leading pharmaceutical company with a proven track record in the development and commercialization of global
brands in the area of cardiovascular disease. We believe strongly that AstraZeneca can maximize the value of Epanova not
only as a monotherapy treatment for dyslipidemia but also as a treatment for cardiovascular disease in combination with
Crestor."
Dr. Nissen is bitter his former Cleveland Clinic colleague is running the REDUCEIT trial.
Akanz, go get your off label Vascepa....pay out of pocket it's cheaper than your 4 grams of PlusEPA.
Williams
I'm not a fan of Matt Herper's spin, but he call this one low enough for retail investors to get in AMRN low, very low.
"But Amarin has an agreement with the FDA, called a special protocol assessment, saying the data it has produced should be sufficient for the expanded approval. It has funded the first ever clinical trial to show whether a fish oil product prevents heart attacks, strokes, chest pain, and stent procedures. Given this, I think it’s likely that the FDA will grant Amarin the wider indication without waiting for that trial to finish."
Williams/Biobillionair
At this point it means next to nothing with the 23 patents Amarin has under it's belt. Two of the 23 are Crestor/Vascepa combo;)
I agree the FDA really f?cked the dog on NCE.
Endocrine Board met today, I'm sure this was discussed...
I would like an Ad Com, great trading event.
Generally Ad Coms are held for risk benefits...the side effects are placebo like and lower Trigs, LDL, & inflamation is definitely beneficial.
Could the Lovaza Citizen petition filed by Crowell-Moring be holding up NCE?
IMO, yes.
My FDA email:
-------------
The decision on this petition should be done sometime in August.
The time frame to respond to this petition is 180 days. Therefore, it should be sometime in August.
Gloria Ortega
Administrative Proceedings Officer
FDA/Office of the Executive Secretariat (OES)
5630 Fishers Lane
Rockville, MD 20852
-----Original Message-----
From: Williams
Sent: Wednesday, June 05, 2013 4:03 PM
To: Ortega, Gloria M
Subject: Lovaza Citizen Petition FDA-2013-P-0148/CP1
Ms. Ortega,
When can we expect a response from CDER regarding the 2-6-2013 Citizen Petition filed by Crowell-Moring?
Thank you,
Williams
Hey Adam, Enocrine and Metabolic Drugs Ad Com, met yesterday and today. Maybe they approve tomorrow;)?
I'm 95% confident REDUCE-IT achieves the primary endpoint
Page 19
CI % = 95% N = 957
http://files.shareholder.com/downloads/AMRN/2186131830x0x651653/CC47C992-CAF5-4A08-8DC6-F1DBF0AD5DB7/Amarin_Investor_Presentation_April_2013.pdf
Akanz
30 DHA/70 EPA or 20:80 or 10:90 doesn't matter, it's OBVIOUS it all works, just not as good as a >96% EPA with no DHA. Prior art and Amarin's 2 Phase 3 studies and 20 Patents.....
Any statin "fish oil" combo is OBVIOUSLY Amarin's PRIOR ART;). Amarin has built an amazing IP fence in one year!
Williams
Who has Crestor Patents?
1)United States Patent 8,455,472 Amarin yesterday
Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
2) United States Patent 8,410,086 Amarin 4-2-2013
In various embodiments, the present invention provides compositions and methods for treating and/or preventing cardiovascular-related diseases in subject in need thereof.
Amarin has currently two composition patents related to treatment of Trigs/LDL and various inflamation markers. Any AZN "Crestor" fish oil combo would be litigated...any patent application would be obvious.
Bottom line, Amarin has AZN by the balls if they want a combo. End of story.
Williams
Akanz
Epadel has a couple of US patents. Most relate to stroke and one is an EPA/Pitavastatin combo. Amarin doesn't list Pitavastatin. If AZN does apply for a Crestor/ "fish oil" patent it will be an uphill battle.
AZN current in the works patents:
http://assignments.uspto.gov/assignments/q?db=pat&qt=asne&reel=&frame=&pat=&pub=&asnr=&asnri=&asne=AstraZeneca&asnei=&asns=
WILL
Hi Akanz,
How would AZN get around prior art. Regardless of the EPA ingested form, free fatty acid or Ethyl ester the EPA blood level is the active moiety. This is both factual in Lovaza and Vascepa thearpeutic equivalent documents at the FDA.
Anything increasing blood levels of EPA to "high" levels r/t "fish oils" and Crestor/statin is obviously going to reduce trigs and LDL (?) depending on DHA levels. Otherwise known as prior art. Trigylcerides form means jack as far as Active Moiety vs API. NCE is also based on Active Moiety. AZN bought a decent pill patent with Omthera, that's it.
JMO
Will
I don't see an easy/any way around Amarin's Patent, there's no inventive step to claim. I'm not a lawyer though.
The inventive step and non-obviousness reflect a same general patentability requirement present in most patent laws, according to which an invention should be sufficiently inventive — i.e., non-obvious — in order to be patented.[1] In other words, "[the] nonobviousness principle asks whether the invention is an adequate distance beyond or above the state of the art."[2]
The expression "inventive step" is predominantly used in Europe, while the expression "non-obviousness" is predominantly used in United States patent law.[1] Although the basic principle is roughly the same, the assessment of the inventive step and non-obviousness varies from one country to another. For instance, the practice of the European Patent Office (EPO) differs from the practice in the United Kingdom.
The new patent 8455472 claims looks to cut AZN from combo patent.
Read 18 & 19
Can anyone post to stocktwits? Thanks
1. A method of lowering triglycerides in a subject on stable statin therapy having baseline fasting triglycerides of about 200 mg/dl to about 500 mg/dl, the method comprising administering to the subject about 4 capsules per day, each capsule comprising about 900 mg to about 1 g of ethyl eicosapentaenoate and not more than about 3% docosahexaenoic acid or its esters, by weight of all fatty acids present, for a period of at least about 12 weeks.
2. The method of claim 1 wherein the subject has a baseline LDL-C level of about 40 mg/dl to about 115 mg/dl.
3. The method of claim 2 wherein the step of administering said 4 capsules to the subject daily for the period effects a reduction in serum LDL-C.
4. The method of claim 3 wherein the step of administering said 4 capsules to the subject daily for the period effects at least a 5% reduction in fasting triglycerides and a reduction in LDL-C in the subject.
5. The method of claim 3 wherein the step of administering said 4 capsules daily for the period effects at least a 5% reduction in LDL-C in the subject.
6. The method of claim 3 wherein the step of administering said 4 capsules to the subject daily for the period effects at least a 10% reduction in triglycerides in the subject.
7. The method of claim 3 wherein the step of administering said 4 capsules to the subject daily for the period effects at least a 15% reduction in triglycerides in the subject.
8. The method of claim 7 wherein the step of administering said 4 capsules to the subject daily for the period effects a reduction in Apolipoprotein B, total cholesterol, and lipoprotein associated phospholipase A2 in the subject.
9. The method of claim 1 wherein each capsule comprises at least about 95% ethyl eicosapentaenoate by weight of all fatty acids.
10. The method of claim 9 wherein each capsule comprises about 0.22% to about 0.4% ethyl octadecatetraenoate by weight of all fatty acids, about 0.075% to about 0.2% by weight ethyl nonaecapentaenoate by weight of all fatty acids, about 0.25% to about 0.40% ethyl arachidonate by weight of all fatty acids, about 0.3% to about 0.4% ethyl eicosatetraenoate by weight of all fatty acids, and about 0.075% to about 0.25% ethyl heneicosapentaenoate by weight of all fatty acids.
11. The method of claim 1 wherein the capsules have a shell.
12. The method of claim 11 wherein the shell comprises gelatin.
13. The method of claim 1 wherein the statin is selected from the group consisting of atorvastatin, rosuvastatin and simvastatin.
14. The method of claim 1 wherein the subject has a baseline body mass index not greater than 45 kg/m.sup.2.
15. The method of claim 1 comprising administering said 4 capsules to the subject daily for the period of 12 weeks to effect at least a 15% reduction in triglycerides and a reduction in LDL-C levels compared to a placebo controlled subject.
16. The method of claim 15 comprising administering said 4 capsules to the subject daily for the period to effect at least a 5% reduction in LDL-C compared to a placebo controlled subject.
17. The method of claim 16 comprising administering said 4 capsules to the subject daily for the period to effect at least a 5% reduction in apolipoprotein B compared to a placebo controlled subject.
18. The method of claim 13 wherein the statin comprises rosuvastatin.
19. The method of claim 18 comprising administering said 4 capsules to the subject daily for the period to effect at least a 15% reduction in triglycerides and at least a 5% reduction in LDL-C compared to a subject on the stable statin therapy for said period who has not received said 4 capsules each comprising a fill material comprising about 900 mg to about 1 g of ethyl eicosapentaenoate and not more than about 3% docosahexaenoic acid or its esters, by weight of all fatty acids present.
Not Marine indication Anchor so not OB's. Read the claims all... I wouldn't rule out AZN...
Combo OB tomorrow?
Title:
COMPOSITIONS AND METHODS FOR LOWERING TRIGLYCERIDES WITHOUT RAISING LDL-C LEVELS IN A SUBJECT ON CONCOMITANT STATIN THERAPY
http://assignments.uspto.gov/assignments/q?db=pat&pat=8455472
Congrats Amarin
Time frame r/t launch plans, just like last November & December.
Elan's Jefferies presentation is tomorrow. You should short more today above 7...K;)
30 May 2013
Elan to Present at the Jefferies 2013 Global Healthcare Conference
DUBLIN--(BUSINESS WIRE)--May. 30, 2013-- Elan Corporation, plc (NYSE: ELN) today announced that it will present at the Jefferies 2013 Global Healthcare Conference on Wednesday, June 5, 2013 at 9:30 a.m. Eastern Time (ET), 2:30 p.m. British Summer Time (BST).
Interested parties may access a live audio webcast of the presentation by visiting the Investor Relations section of the Elan website at http://www.elan.com, then clicking on the event icon. Following the live webcast, an archived version of the presentation will be available at the same URL.
About Elan
Elan is a biotechnology company, headquartered in Ireland, committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. For additional information about Elan, please visit http://www.elan.com.
###
Source: Elan Corporation, plc
Investor Relations
Chris Burns
Ph: + 1-800-252-3526
David Marshall
Ph:+ 353-1-709-4444
or
Media Relations
Emer Reynolds
Ph: + 353-1-709-4022
Jonathan Birt/FTI Consulting
Ph: +44-751-559-7858
Jamie Tully/Sard Verbinnen & Co
Ph: +1-212-687-8080
Finance
1) This has always been Amarin's plan 1) Marine (2012-2013) 2) Anchor late (2013) 3) Combo (late 2014) 4) REDUCE-IT (earliest 2015 to latest 2017) 5) rule the world statin market with combo > $10 Billion sales per year 2018 until 2030
2) Each statin would be a different filing. They'll go with the most potent combo, which is generic Lipitor. Crestor is the most potent statin, but the most potent combo has been Atorvastatin.
3) Guessing they couldn't file a combo until off patent without AZN's approval
4) Considerably more valuable than Anchor, it would garner the majority of all US statin sales due to convience and potency with less side effects than a statin and Omega 3. (Especially an Omega 3 not on formulary to treat > 200 trig levels). The Barriers that go up for Lovaza, with Anchor approval, will make 2014 an auto $1 Billion in Vascepa sales) The "market" has put no valuation currently on Anchor, Combo or REDUDEIT because 90% of bio's that self lauch fail.
5) Only time will tell.
6) Who's to say Pfizer isn't all over it, but at what price? This asset is extremely hard to value 5 yrs out at this time. Sales could be $2 Billion to a Lipitor dominating $12 Billion in 5 yrs. Amarin knows what they have, most holding AMRN stock don't understand the science, the EPA molecule in your blood stream is one of the essential needs of your body. The vast majory of the world is lacking this molecule in their diets, it causes diseases, one of which is CV disease.
7) I was concerned about this too. Then Elan statement brought on the idea of Royality agreements. Stuart Sedlack, SVP Amarin, is responsible for making such arrangements. How many knew he use to work for Elan?
http://www.amarincorp.com/partnering.html
I believe Elan and Amarin have always planned on a Royality partnership if Amarin needed to launch Anchor and combo. Elan and Amarin's history go back http://www.sec.gov/Archives/edgar/data/897448/000115955403000002/amarinjanuary2820032.txt
Despite past "arguments" I believe they consider themselves brothers.
Williams
Later this week: Amarin to Present at the Jefferies 2013 Global Healthcare Conference
1) I expect we get combo dosing data, perhapse with more Anchor data PR Thursday AM.
2) Depending on how aggressive Amarin feels like being, we may get an AZN quote: Pascal Soriot, Chief Executive Officer of AstraZeneca said: “The number of people with elevated triglyceride levels is rising rapidly across the world, due in part to the increasing prevalence of obesity and diabetes. There is a clear need for effective and convenient alternatives to some of the existing treatments. Epanova offers real potential both as a distinctive monotherapy for the treatment of hypertriglyceridemia and in combination with Crestor for patients at high risk of adverse cardiovascular events. This is an exciting acquisition that clearly complements our existing portfolio in cardiovascular and metabolic disease, one of our core therapy areas.”
http://www.astrazeneca.com/Media/Press-releases/Article/20130528-omthera
Also note, AF's silence since the AZN intial comment;). He doesn't bash the big boys, typical bully mentality.
3) And then perhapse a gental reminder of Amarin's IP statin protection. Those that know a small amount about patent law should know that an Epanova/Statin combo would violate Amarin's exciting patents and a new granted patent would be too obvious to be granted.
4) We should also hear a time frame for an Anchor launch, AZN improved our Royality Partnership possibilities with Pascal's statement.
5) Elan has always been an Amarin financial partner, these are well documented in Amarin's early days. An Amarin contract could be pushed up with Royalty Pharma and Elan hostIlities escalating.
----Good Luck All! Even to those who thought shorting at this point was a good idea, I expect you will need the most luck. At some time this summer Amarin is due for a 20-50 million shares traded day and a new price range.
Williams
Jefferies Conference starts today, Amarin presentation is Thursday, the last day.
Jefferies 2013 Global Healthcare Conference
June 3 - 6, 2013
New York City
We are pleased to announce the Jefferies 2013 Global Healthcare Conference taking place June 3-6 in New York City.
Following the success of last year’s conference, with over 300 presenting companies and 2,000 attendees, the 2013 conference will again feature an extensive range of public & private healthcare companies across the biopharmaceuticals, life sciences, healthcare services, healthcare IT and medical technology sectors.
The four day event will be comprised of concurrent tracks of company presentations as well as Q&A breakout sessions, investor meetings, business-to-business meetings and thematic panel discussions. This global gathering of institutional investors, private equity investors, VCs and leading executives will address near- and long-term investment opportunities and discuss the mechanisms driving healthcare in the U.S. and internationally.