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.
'598 aplication is '146 patent. Listed in the OB here:
http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=202057&Product_No=001&table1=OB_Rx
'146 claims: A pharmaceutical preparation comprising EPA in an appropriately assimilable form where of all the fatty acids present in the preparation at least 90%, and preferably at least 95%, is in the form of EPA and where less than 5%, and preferably less than 3%, is in the form of DHA is provided.
The invention claimed is:
1. A pharmaceutical composition comprising one or more fatty acids, at least 95% of which are in the form of ethyl-eicosapentaenoic acid, wherein the composition contains no docosahexaenoic acid and the composition is present in a capsule.
2. The composition of claim 1 wherein the composition contains less than 3% of any fatty acid other than eicosapentaenoic acid.
3. The composition of claim 2 wherein the capsule is a gelatin capsule.
4. The composition of any one of claim 1, 2, or 3 wherein the ethyl-eicosapentaenoic acid is present in the composition in an amount of 250 mg to 1000 mg.
5. A pharmaceutical composition comprising 250 mg to 1000 mg of fatty acids at least 95% of which are in the form of ethyl eicosapentaenoic acid, wherein the composition contains no docosahexaenoic acid, and the composition is present in a capsule.
6. A pharmaceutical composition comprising 250 mg to 1000 mg of fatty acids at least 95% of which are in the form of ethyl-eicosapentaenoic acid, wherein the composition contains (a) less than 5% in aggregate of arachidonic acid and n-3 docosapentaenoic acid, and (b) no docosahexaenoic acid; and wherein the composition is present in a capsule.
7. The pharmaceutical composition of claim 5 wherein the composition contains arachidonic acid in an amount less than 3%, by weight, of said fatty acids.
8. The pharmaceutical composition of claim 6 wherein the composition contains docosapentaenoic acid in an amount less than 3%, by weight, of said fatty acids.
9. The pharmaceutical composition of claim 6 wherein the composition contains arachidonic acid and docosapentaenoic acid in an aggregate amount of less than 3%, by weight, of said fatty acids.
10. The pharmaceutical composition of claim 6 wherein the capsule comprises about 1000 mg of said composition.
--------------------------
Very important points AZN:
1) Amarin has it in the OB, "Fatty Acid"
2) Claim #8 shoots your Omthera Patent app #13734846 DPA-ENRICHED COMPOSITIONS OF OMEGA-3 POLYUNSATURATED FATTY ACIDS IN FREE ACID FORM
I was slightly concerned you might have got that one through, until today. Epanova's got a snowballs-in-hell for getting IP or NCE. If it makes it beyond the 74 day letter, which I doubt due to Lovaza RLD.
What a waste of $260 Million!
Biobill
Lovaza petition due date:
-----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
___________________
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
Atlas, "One of the Innovative business segments ... will generally include products across multiple therapeutic areas that are expected to have market exclusivity beyond 2015. The therapeutic areas include Inflammation and Immunology, CV/Metabolic, Neuroscience and Pain, Rare Diseases and Women's/Men's Health" could very likely be taxed at the Irish level.
They could enjoy the great tax benefits.
Pure speculation, of course.
Yes, this patent app was directed at Epanova. Lists Epanova and it's phase 3 study Evolve in rejection as obvious,
It's possible this doesn't make it to the CC.
Stang
Occasional small truths are told on CafePharma...it's a rare event though:
"Rick is at PDI, never left, he was contracted by Amarin to set up sales force and merge SF into acquiring company. He's now working with the suitor to mesh sales force together when deal closes in October.
Wow the truth got out. I was at PDI as a RD on another contract, and set in on that meeting."
http://www.cafepharma.com/boards/showthread.php?t=535000
Rick works for both Amarin and PDI.
http://www.linkedin.com/profile/view?id=1337787&authType=name&authToken=iTMt&trk=skills&_mSplash=1
We should start a run from here, Monday.
BioBill
LM
Even worse for Epanova, Obviousness....pg 12 referenced Omthera's Evolve study.
Thanks for your read
Biobill
Stang...week know it's not his first choice, but it may be our only choice when the time comes.
Jefferies June meeting transcript: "We've no plan to hire a primary care sales force but we're looking for the results and feedback from our early results of our launch here to better appraise the size of salesforce needed and approach for a launch in the product relative to the second indication and this part of that also considering how best to launch it with the alone or with others and in what form I don't have any announcement today regarding that and it's too early for us to have to make that announcement." ---JT
If a BO's not finalized by December IMO...our direct 306+ and PDI team...launch Anchor with Rick at the helm.
It was:
"Amarin attempted to patent an Epanova like free fatty acid, 13685281. It received a final rejection 7-22 and mailed final rejection today.
It was rejected on the basis of double patenting, it conflicted and was obvious to Amarins current patents. Epanova can NEVER get IP protection.
Congrats Amarin, your IP got stronger today. "
Look up 13685281 at PAIRs and read the 14 page final rejection. Amarin's prior IP and applied for IP protects it, even themselves from being able to file IP protection for Epanova. This is a HUGE deal and reason why Roth Capital is meeting with Amarin this Wednesday...
Also Amarin has a total of 306 reps now and ads for 17 new positions, and suspected plans with PDI to rapid expand sales force.
I suspect AZN will receive a very disappointing 74 day letter soon.
The Lovaza CP is due to be ruled on this week.
Williams
Yes they are, but the 306 are Amarin's hired by Rick. Rick would/could be point for both contract sales and Amarin's 306. Amarin could up the sales force to 1000 overnight with 700 being PDI contract. All run by Amarin/PDI VP, Rick Shalaby. Brilliant. FYI as far as Amarin sales force (reps), Rick has been MIA the past three weeks. I'm guessing he's training Amarin's PDI crew. Been holding this theory until today.
Sales Force at 306 and able to expand out quickly with PDI. That's right, Rick Shalaby is VP of sales at Amarin and also VP of Dedicated sales at PDI.
http://www.linkedin.com/profile/view?id=1337787&authType=name&authToken=iTMt&trk=skills
Atlas, I like the timing...it sends a message. 7-22 Amarin's mixed EPA/DHA Fatty Acid patent gets notice of rejection...Abingworth moves. 7-26 Amarin is Mailed Rejection documents 14 pages that lists Double Patents (7 patents & 8 patent apps) conflicted...3 Amarin F 4's filed. It's the thought that counts IMO.
Williams
Why?.. I'm on iggy and JL's got no clue that Amarin kicked ass at the USPTO today...3 officers exercised options,..and high EPA concentration in the skin prevent DNA damage...
Ak...why the heck you still go to those Cards at Kaiser/UCSF is beyond my comprehension, anybody that has to wait for an outcomes to REDUCE morbidity and mortality with a compound that has little to no side effects is just plain stupid. If a body of knowledge points to a potential benefit with no harm their pompous asses not to concede.
Williams
Akanz
I'm strictly here for your entertainment, the 75,000 shares I own is just fluff.
Williams
JL
Your constipated again, take your fiber and prune juice.
Williams
No blood no foul, I'm a big boy. There's some big sh!t going down and it's going to happen fast. After Hour SEC Amarin forms....http://www.sec.gov/cgi-bin/browse-edgar?company=Amarin&CIK=&type=&owner=include&count=40&action=getcurrent
That's not a mere coincidence. If you ever want to co-author a SA let me know...
They don't...get it.
Amarin attempted to patent an Epanova like free fatty acid, 13685281. It received a final rejection 7-22 and mailed final rejection today.
It was rejected on the basis of double patenting, it conflicted and was obvious to Amarins current patents. Epanova can NEVER get IP protection.
Congrats Amarin, your IP got stronger today.
Williams
Dude....thanks
Big stuff at the USPTO today...
13685281
I think AZN and Amarin are getting closer to a deal.
Chuck
"New Molecular Entity (NME)
A New Molecular Entity is an active ingredient that has never before been marketed in the United States in any form."
http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm#NewMolecularEntity
At minimun Vascepa will be granted 3 years of Waxman-Hatch. Sometimes known as 3 yrs NME (Business definition)...often confused with the NME (New Molecular Entity never approved before drug definition).
"A 505(b)(2) application may itself be granted 3 years of Waxman-Hatch exclusivity if one or
more of the clinical investigations, other than BA/BE studies, was essential to approval of the
application and was conducted or sponsored by the applicant (21 CFR 314.50(j);"
The 2012 Congressional Report references Vascepa as a "NO" for NME (New Molecular Entity never approved before). Amarin should claify this with the FDA. Some argue the "NO" is a nondecision...maybe...maybe not.
My hunch is, the FDA with grant 3 yrs of W-H at Anchor approval and the FDA leaked the info by mistake, certainly woundn't be the first time.
It's telling Amarin has remained this quiet, I'm guessing Partnership/BO are as hot as ever.
What the FDA should do:
1) Cancel the Anchor Adcom...your wasting time
2) Approve Anchor now
3) Apologize to Amarin and shareholders for not communicating
4) Wait for REDUCEIT to come in
The minimum exclusivity Vascepa will be granted is 3 years at the point of Anchor approval. The Exclusivity designation is NME 3 yrs, awarded to a compound that's been approved for a new indication completing a clinical trial. The designation used in the Performance report NME has a separate definition given on page 67. "NME – New Molecular Entity" it's definition is a chemical compound never approved before. It has NO reference to NME 3 yrs, In this document. The FDA appears to have ruled Vascepa is NOT novel, despite USP considering Lovaza as a mix of seven Omega 3's, separate CAS numbers, and numerous PubChem references.
Should you panic? No
NME Exclusivity will be awarded because of Anchor Trial (new clinical trial and indication) in fact no exclusivity for Marine is telling that the FDA will approve Anchor. December 2013, 2014, 2015....January 2016 generic competition if they can get by the MASSIVE IP.
NME Exclusivity might not be awarded for a combo product considering it would still be the same indication. NME 3 yrs Exclusivity can be awarded for REDUCE-IT though...
Why am I so pissed?
1) The FDA harmed Amarin and shareholder with their horrible communication.
2) Amarin should have been allowed to combine Marine/Anchor into one approval cycle, what a waste of resources.
3) Amarin's review raises many red flags of FDA indiscretions.
----3 yrs NME at Anchor approval---I disagree, but this document leaks the decision IMO.
Williams
The document clearly states No for NME for Vascepa. Page 75
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/PDUFA/UCM359106.pdf
It appears some sort of decisions been made for them to update Congress and the President.
"Goal Met"...really? Who's goal was met?
This should have been either left blank or the FDA's digging a huge ass hole.
Is this document accurate? Yes...well they should be talking to Amarin then.
No, then the FDA sent an inaccurate document to Congress and the President. I want to know who filled it out.
The document clearly states No for NME for Vascepa. Page 75
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/PDUFA/UCM359106.pdf
It appears some sort of decisions been made for them to update Congress and the President.
"Goal Met"...really? Who's goal was met?
This should have been either left blank or the FDA's digging a huge ass hole.
Is this document accurate? Yes...well they should be talking to Amarin then.
No, then the FDA sent an inaccurate document to Congress and the President. I want to know who filled it out.
The FDA is lying to someone.
Is a decision made?
Why does this document say No for NME?
If it's not true and should be blank, then did the FDA lie in the document?
http://www.democraticunderground.com/discuss/duboard.php?az=view_all&address=389x492578
5 years in jail? Who's going first? Janet...?
The document states Vascepa is NOT a NME. If this is true, it's news and should be communicated to Amarin.
If false, it's a lie... in a federal document and given to Congress and the President....heck that might even be criminal.
Williams
"Face to Face" was fun...for me. I did get the impression the Lovaza petition was holding up Vascepa's exclusivity. She spoke to CDER/legal and said "informally" saw no conflict of interest with John Fuson filing the petition...LOL. She emphasized the informal. She was "uncomfortable" and "felt like she was on the witness stand"...so I do believe I got my point driven home. Formally, I'll wait until the Anchor dust settles before moving forward...If I'm too busy picking out a new sports car...I might forget this ever happened.
I pointed out the document today so investors could see the lies taken to Congress and the President.
A NME is not a NCE, but can NO NME ever be a NCE?...I guess we'll wait...........and see.
I'm waiting for comment from the FDA, I'll share the excuse.
No thoughts just questions?
Has the agency made a decision?
Why does this document say Vascepa is NOT a NME?
Is this an error? If yes, will you update Congress and the President?:)
How many other errors are there?
I'm trying to get an answer, but in the mean time investors should be aware this document is out. If no decision have been made this should have been left blank.
FDA defining NME:
"Certain drugs are classified as new molecular entities (“NMEs”) for purposes of FDA review. Many of these products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but nonetheless contain active moieties that are closely related to active moieties in products that have previously been approved by FDA. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act."
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm336115.htm
2012 Performance Report to Congress and the President pg 75
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/PDUFA/UCM359106.pdf
Established name Applicant NME(Y/N)
Vascepa Amarin N
-------------
In the report to Congress and the President the FDA does not have Amarin listed as a NME. Shouldn't this have been left blank with an asterisk explaining the reason???! F#$@%
New evidence the FDA ruled Vascepa is not a NME. I'm trying to get FDA confirmation on documents accuracy before I post the source.
Will
Amarin lays out NCE argument 6-10-2013 responding to Icosapent Ethyl Ester RLD guidance.
Page 5, 3 paragraphs
Read:
http://www.regulations.gov/contentStreamer?objectId=0900006481310a2c&disposition=attachment&contentType=pdf
Comments?
Will
To the FDA from Steven Ketchum Amarin President Research and Development
Pg 5, I enjoyed the Lovaza comment...Thanks Steven:)
This is new stuff:
http://www.regulations.gov/#!documentDetail;D=FDA-2007-D-0369-0187
Bio
9-23-2013, Lovaza petition 180 days up 8-2-2013
AZN doesn't have IP for their "future product".
Grant
Do you know when AZN's Epanova 74 day letter is due?
Williams
The trend has followed the FDA's incompetence of no exclusivity. The PPS is completely disconnected from the likely REDUCEIT value which none of the money mangers has a clue about. There's nothing suspicious about the JELIS study and the results are ONLY 4 yrs out. I wouldn't hold this if I didn't believe in JELIS.
http://files.shareholder.com/downloads/AMRN/2186131830x0x674598/2E9D6AF3-D8CC-4953-ACF9-F90B9F11BFB0/2013_Annual_Shareholder_Meeting.pdf
Pg 14
53% reduction in subgroup with mixed hyperlipidemia, the patients in REDUCEIT are WAY sicker than this cohort and weren't taking 4 grams of EPADEL. EPADEL and VASCEPA's blood generating EPA levels have been referenced in Rat studies requested by the FDA for Marine approval.
Vascepa's EPA blood levels are 2570 % than 4 grams of "Fish oil "/ Lovaza, and 900% higher than 2 Grams doses of Epanova (AZN drug hopeful). In addition to massively inferior EPA levels the DHA raises LDL levels in both "fish oils" & Epanova. WS is clueless to the science, they'll understand after the results are in;).
My note on JPM note;)
Amarin sales:
Q1 10,484 reported IMS scripts
sales $2.34 million
$5.2M total sales with stocking
12,857 actual using $182
18.4% under reported IMS data
----------
Using above:
Q2 47,000 IMS totals reported or 55,648 with 18.4% under reported
$10.2 Million projected sales Q2
$20.4 total with stocking
JPM is working with forces looking to acquire or partner.
Williams
Really, what about the jobs posted for new territories? I'd call that an expansion of sales force.
http://www.amarincorp.com/careers.html
75,000,000 target population with Anchor approval and REDUCE-IT study on Label in December would also be "expansion".
10% penetration of this market is $15,000,000,000 in sales, now that's "expansion". The JELIS effect is the reason JZ's GIA...why in the Hell would you sell for less...
Other EPA indications:
> 75,000,000
World Omega 3 sales:
>$ 30 Billion per year
Vascepa vs. "fish oil"
EPA blood levels after 4 Grams of Vascepa 360 mcg/ml
EPA blood levels after 4 Grams of "fish oil" <20 mcg/ml...pathetic!
EPA is the active moeity to focus on period.
Competition? None
Slide 5
http://www.omthera.com/pdf/ECLIPSE_Slides.pdf
Great post JL. I trade bio for the same reason...only 17 years into though. Amarin has been my longest holding and I have no intension of selling soon, unless I see a break in the science, IP, or significant competition.
Williams
Sell cause Amarin's not selling for under $15B! Why would they with a >50% reduction in CV outcomes? You should by Omthera they just applied for a NDA.
"One more dilution" doubtful...clarity before October. Someone will have to pry this asset out of my cold dead hand.
Williams