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My last free Advice to AZN:
Epanova infringes on Amarins patent #? claim number 5. "Fatty Acid"
You can't get around it...period. Vascepa's RLD & Lovaza's RLD along with your 3 Epanova studies are all you need to see the futile attempt. Amarin raised $120 million to litigate while likely accepting an offer from someone else.
I'll raise my fee to $10 million to help you negotiate a BO:)
Will
The cancer risk will have to be dealt with for DHA products by the FDA. Something that should be brought up at the Ad Com in October.
Your Welcome!
STS
You underestimate my experience with beuracracy, resources, and resolve. Amarin has already started the process through the USPTO and it's attorney. Amarin's NCE decision will be made in 180 days either by the FDA or HUD Secretary. This is a FACT and the purpose of this "Letter", thank you to Amarin for traveling this route.
Dr. Margaret Hamburg, the Commissioner at the FDA, will not allow this decision to go above her head. She's very capable and cleaned CBER house after a scandalous letter was sent to President Obama. Dr. Hamburg is from Illinois, her household income was over $120,000,000 last year...you can't buy her. Dr. Woodcock is hanging on by a thread at CDER...Monday I'm getting the scissors.
Letter to FDA from USPTO:
"Since a determination has not been made whether the patent in question claims a product which has been subject to the Federal Food, Drug and Cosmetic Act, or a method of manufacturing or use of such a product, this communication is NOT to be considered as notice which may be made in the future pursuant to 35 USC 156(d)(2)(A)."
35 USC 156(d)(2)(A)
Within 60 days of the submittal of an application for extension of the term of a patent under paragraph (1), the Director shall notify—
(i) the Secretary of Agriculture if the patent claims a drug product or a method of using or manufacturing a drug product and the drug product is subject to the Virus-Serum-Toxin Act, and
(ii) the Secretary of Health and Human Services if the patent claims any other drug product, a medical device, or a food additive or color additive or a method of using or manufacturing such a product, device, or additive and if the product, device, and additive are subject to the Federal Food, Drug, and Cosmetic Act,
of the extension application and shall submit to the Secretary who is so notified a copy of the application. Not later than 30 days after the receipt of an application from the Director, the Secretary receiving the application shall review the dates contained in the application pursuant to paragraph (1)(C) and determine the applicable regulatory review period, shall notify the Director of the determination, and shall publish in the Federal Register a notice of such determination.
(B)
(i) If a petition is submitted to the Secretary making the determination under subparagraph (A), not later than 180 days after the publication of the determination under subparagraph (A), upon which it may reasonably be determined that the applicant did not act with due diligence during the applicable regulatory review period, the Secretary making the determination shall, in accordance with regulations promulgated by such Secretary, determine if the applicant acted with due diligence during the applicable regulatory review period. The Secretary making the determination shall make such determination not later than 90 days after the receipt of such a petition. For a drug product, device, or additive subject to the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act, the Secretary may not delegate the authority to make the determination prescribed by this clause to an office below the Office of the Director [1] of Food and Drugs. For a product subject to the Virus-Serum-Toxin Act, the Secretary of Agriculture may not delegate the authority to make the determination prescribed by this clause to an office below the Office of the Assistant Secretary for Marketing and Inspection Services.
(ii) The Secretary making a determination under clause (i) shall notify the Director of the determination and shall publish in the Federal Register a notice of such determination together with the factual and legal basis for such determination. Any interested person may request, within the 60-day period beginning on the publication of a determination, the Secretary making the determination to hold an informal hearing on the determination. If such a request is made within such period, such Secretary shall hold such hearing not later than 30 days after the date of the request, or at the request of the person making the request, not later than 60 days after such date. The Secretary who is holding the hearing shall provide notice of the hearing to the owner of the patent involved and to any interested person and provide the owner and any interested person an opportunity to participate in the hearing. Within 30 days after the completion of the hearing, such Secretary shall affirm or revise the determination which was the subject of the hearing and shall notify the Director of any revision of the determination and shall publish any such revision in the Federal Register."
Someone cut and paste this all over web...YMB and Stocktwits...please. I'm gonna make a drink and eat a steak.
Williams/Biobill
"The transaction is expected to close by the third quarter of 2013 subject to regulatory approvals"
Why this is AZN not knowing how to negotiate an Amarin deal:
The NDA will be denied because of Lovaza's RDL & incomplete Patent information for a 505b2 or 505b1. Great that AZN was smart enough to wait for the application to get denied, but 3rd quarter is only within the 74 day communication period and NOT approval. They never intended to buy Omethera, only to use the press releases in negioations.
AZN hire me to negotiate a buyout, I'll charge you a $5 million flat fee (plus negotiated bonus) and cash out my shares at 5 year high.
Williams
Citi and Jeffery's placed these shares PDQ:)
Why "Kay's letter" is a BFD:
Under 35 USC 156(g) Vascepa meets the guidelines for a patent extension. In the USPTO's scientific eye, Icosapent Ethyl (Vascepa) has never been approved before by the FDA. This is a NCE definition. After the USPTO reviewed both Vascepa's and Lovaza's label they are willing to grant an extension.
This is a legally admissible document as is Amarin's dilution prospectus admitting material harm with lack of FDA exclusivity decision. Both these documents together provide more than circumstantial evidence to put CDER in front of a Senate Committee trying to explain many issues I've already posted, some of which may lead to individual criminal prosecution and Civil liability. If BP involvement can be proven this will lead to more than just Amarin seeking monetary retribution. (Who hired an Ex FDA attorney to file a citizen petition? How could the FDA even except a petition form someone with likely first hand knowledge into Vascepa's confidential review information?
I have given them enough time and "communication". Monday I will start this process if the OB is now anything but NCE for Vascepa. Prior to today I would except NME, but not after the USPTO letter. Ms. Behr, the neutral CDER Ombudsman, could persuade me to wait if she ever returned my phone calls.
Williams
Crystal clear the USPTO considers Vascepa / Icosapent Ethyl never approved before. They are willing to grant a patent extension regardless of Lovaza's Label including EPA...because Lovaza is a MIX. This will go great with my complaint I will file with DOJ and SEC next week.
Tick tock....
This is the closest you will get to the USPTO calling Vascepa a NCE. This is an example of going the other way :
http://www.hpm.com/pdf/blog/PRILOSEC%20OTC%20-%20Reconsid%20Req%20-%206-2011.pdf
Kay
That's the best dig I've seen into NCE reasoning and timing so far. Thanks for sharing!
Williams
Dancing in the Dark, another nail in the coffin to this theory is a NDA for Epanova would have to contain all BASF's Lovaza patents and BASF's permition to step all over them:
Review this:
Filing errors
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm074994.pdf
Will
Dancing in the Dark, another nail in the coffin to this theory is a NDA for Epanova would have to contain all BASF's Lovaza patents and BASF's permition to step all over them:
Review this:
Filing errors
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm074994.pdf
Will
Epanova is a generic Lovaza;). Check it out:
Links to all three Phase 3 Epanova studies:
http://www.omthera.com/clinical_trials.html
Exclusion criteria for ESPRIT:
"Allergy or intolerance to omega-3 fatty acids and omega-3-acid ethyl esters", should read " allergy or intolerance to omega-3 fatty acid (Epanova) "OR" omega-3- ethyl ester, if the weren't the same end compound.
Also, "Use of any eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA) products" would not be needed if the two drugs Epanova and Lovaza where two separate NCE. EPA and DHA are the active moieties in each and both could be assessed by Lovaza's RLD.
Lovaza's RLD:
"Analytes to measure (in appropriate biological fluid):
(1) EPA total lipids in plasma
(2) Baseline-adjusted EPA total lipids in plasma
(3) DHA total lipids in plasma
(4) Baseline-adjusted DHA total lipids in plasma
(5) EPA free fatty acids in plasma
(6) Baseline-adjusted EPA free fatty acids in plasma (7) DHA free fatty acids in plasma
(8) Baseline-adjusted DHA free fatty acids"
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM320011.pdf
The above EPA and DHA levels are used in ESPRIT because the two drugs have the exact active moieties. Just because Epanova is a fatty acid and is absorbed at a higher level doesn't change the fact it has the same active ingrediates already approved and patented.
These are issues AZN has to hammer out to get the value of Vacsepa.
Will
STS
Email this link. http://www.aetna.com/cpb/medical/data/300_399/0381.html
I copied and pasted wrong link sorry:)
Call the person you email, and asks what's going on...at the first sign of stonewall ask to speak to their manager. Remain polite...I know at this point it's hard. Let me know.
Will
Dew
Omethera filed a NDA for Epanova 7-9 or 7-8, this is why Amarin diluted...nothing else makes sense. AZN was so pumped about the NDA filing they DIDN'T PR it. Epanova is a better absorbing generic of Lovaza with the same mix of active Moeities, in fact one of their phase 3's directly compairs it to Lovaza. Epanova's NDA will be rejected, but Amarin certainly couldn't sit back and wait for the FDA to F this up in the next 74 days they have to reject the ap.
Will
No volume, this dilution was a response to AZN's Epanova "generic" filing that WILL be rejected on the basis of Lovaza's RLD active moieties. All the cards are on the table...lets dance;)
Will
Negotiations are hotter than ever IMO and will likely be settle after the acceptance or rejection of Epanova's NDA. AZN, GSK, Merck, Pfizer, TEVA, BASF, Elan, Mochida are all on my radar.
AZN was so excited about Epanova NDA read about it here:
http://www.astrazeneca.com/Media
NOT!
Amarin had dilute now if on the miraculous outside chance the FDA wanted to piss off GSK, BASF and generic Lovaza filers....
No way in hell the FDA can except this application.
That would be poor form and perhaps the "offer" was not material enough to be disclosed...in which case we'll never know.
The fact remains on or around 7-9 Epanova filed a NDA, Amarin diluted....
http://www.theflyonthewall.com/permalinks/entry.php/?symbol=AZN
Epanova's active moeities are EPA and DHA and this falls under Lovaza's RLD...BASF will NOT tolerate the filing. It should be outright rejected. Gamesmanship by AZN and part of the negotiations.
Will
My quote I use to teach at work "always suspect sabotage".
Something behind the scenes trigger the untimely offering. Negotiations with AZN have heated up to the point of Amarin pulling the dilution trigger.
http://www.theflyonthewall.com/permalinks/entry.php/?symbol=AZN
No PR from AZN on this event is a "tell", Epanova falls under RLD of Lovaza and generics are out until late 2015. BASF will not lose that battle.
Good Movie clip!
Will
AZN is f'n with Amarin and GSK
From flyonthewall
06:05 EDT AZN Omthera announces NDA submission for Epanova
Something big is going on behind the scene. I going to throughout the idea that Amarin rejected an offer from AZN flat out, was prepared to reject an offer with an "dilution" deal in place with Jefferies and Citi. Since a formal rejection is material we should hear the offer in the next 4 days. 9, 10, 11, 12
Generics can not enter the market for Lovaza until late 2015. BASF owns these patents and collects revenues through Pronova....LOL.
AZN just picked one hell of a fight with the Germans;)
Will
STS
Email them this:
"High-sensitivity C-reactive protein (hs-CRP):
Aetna considers high-sensitivity C-reactive protein (hs-CRP) testing medically necessary for members who meet all of the following criteria: (i) member has 2 or more coronary heart disease (CHD) major risk factors*, and (ii) member has low-density lipoprotein (LDL) cholesterol levels between 100 to 130 mg/dL; and (iii) member has been judged to be at an intermediate-risk of cardiovascular disease by global risk assessment (i.e., 10 to 20 % risk of CHD per 10 years using Framingham point scoring**).
*Major risk factors include the following:
Age (men aged 45 years or older; women aged 55 years or older)
Current cigarette smoking
Family history of premature CHD (CHD in male first-degree relative less than 55 years of age; CHD in female first-degree relative less than 65 years of age)
Hypertension (blood pressure [BP] of 140 mm Hg or higher, or on anti-hypertensive medication)
Low high-density lipoprotein (HDL) cholesterol (less than 40 mg/dL).
**Note: Framingham risk scoring for men and women is presented in the Appendix below.
Aetna considers hs-CRP testing experimental and investigational for all other indications, including use as a screening test for the general population and for monitoring response to therapy, because its clinical value for these uses has not been established."
Call the person you emailed, and ask them why they're discriminating against you?
If that doesn't work let me know.
Thank You for the analysis.
Bottom line. Amarin has to build war chest to fight BP and FDA. The prospectus clearly laid out material damage by NCE indecision. Amarin attempted to communicate this before dilution and I certainly communicated it in multiple emails in September, October, November, December, January, February, March, April, May, June and July. It's time for follow through. This is CDERs last week to avoid serious allegations they will have to publicly deal with.
I'm not backing down!
Agreed. In addition I would like to see combo and an attempt at an EARLY REDUCEIT filing through new guidance document. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
An Early REDUCEIT filing is a true possibility.
I guess you didn't read the document.
Bottom line, without NCE Amarin needs to build up the war chest to fight BP and the FDA. I wish they would have diluted before GIA, but hindsights 20/20.
If this dosn't spark a major event by the end of the month then this really sucks. No point in dilution when the PPS is likely to run before Ad com.
Pfizer could purchase all 25 million shares at $30 tomorrow AM before the market even opens.
On 6-25 the FDA released a guidance document that would cover the approval of Vascepa for REDUCEIT before study finished. In February, Amarin was invited to a meeting discussing this possibility. Just connected the two events. This could have sparked the premium Amarin deserves.
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM340568.pdf
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
It gonna get interesting tomorrow.
Will
I needed a few deep breaths to come to the conclusion. No other reason to dilute at 2 year low. They want to break up....
Full offer raises $148,731,800
BIOPHARMA SECURED DEBT FUND II HOLDINGS CAYMAN LP
WALKER HOUSE, 87 MARY STREET
C/O WALKERS CORPORATE SERVICES LIMITED
GEORGE TOWN, GRAND CAYMAN, CAYMAN ISLAND
You just got issued your walking papers by JZ for some reason....that's my read...
Williams
Going to read through the documents before I comment...initially really pissed off Amarin didn't dilute before $140 million loan.
Yes, a 505b2 should have been rejected flat out if the two have the same active ingrediate. Obviously at one point the two where considered two separate NCE;). The FDA is still defining Lovaza 6 years after approval....as we wait for the CP. I argue at this point it's an active delay for the FDA and abuse of power.
The FDA regulation would go against an ANDA or 502b2 until we get an exclusivity designation. Tons of FDA guidance links, do an ANDA search and read for hours.
The only reason Amarin filed a 505b2 was one right to reference document, so they did discuss changing to a 505b1 even after the 505b2 was excepted.
Amarin needs this out of the way to move along.
YB
Filed 2-6-2013 two weeks before the release of MAPP 5021 excluding Esters and Lovaza in USP naming.
Odd timing, but of course the Attorney who filed the petition work at the FDA a year prior to his new partnership and filing.
The petition requesting a name change in the OB for Lovaza, could have potentially delayed exclusivity further until a ruling due this August.
I will request an investigation by the Justice Department via James M. Cole, Deputy Attorney General Monday. If GSK hired Crowell and Moring LLP to file the Citizen Petition it points to using inside FDA information to influence a decision delay likely to provide an unfair market advantage. Of course this would be the first in the can of worms this would open with CDER.
If GSK hired Crowell and Moring & then used an ex-FDA Attorney to file the petition serious Sh!t will hit the fan.
Will
Has the FDA changed the Avandia label to reflect how safe they feel the drug is now?
No!
WARNING: CONGESTIVE HEART FAILURE AND MYOCARDIAL INFARCTION
•
Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1)]. After initiation of Avandia, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to current standards of care. Furthermore, discontinuation or dose reduction of Avandia must be considered.
•
Avandia is not recommended in patients with symptomatic heart failure. Initiation of Avandia in patients with established NYHA Class III or IV heart failure is contraindicated. [See Contraindications (4) and Warnings and Precautions (5.1).]
•
?A meta-analysis of 52 clinical trials (mean duration 6 months; 16,995 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with a statistically significant increased risk of myocardial infarction. Three other trials (mean duration 46 months; 14,067 total patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, showed a statistically non-significant increased risk of myocardial infarction, and a statistically non-significant decreased risk of death. There have been no clinical trials directly comparing cardiovascular risk of Avandia and ACTOS® (pioglitazone, another thiazolidinedione), but in a separate trial, pioglitazone (when compared to placebo) did not show an increased risk of myocardial infarction or death. [See Warnings and Precautions (5.2).]
•
?Because of the potential increased risk of myocardial infarction, Avandia is available only through a restricted distribution program called the Avandia-Rosiglitazone Medicines Access Program. Both prescribers and patients need to enroll in the program. To enroll, call 1-800-Avandia or visit www.Avandia.com. [See Warnings and Precautions (5.3).]
--------
But a drug like Vascepa should perform $250 million dollar outcomes trial to expand it's label....LOL
Vascepa safety profile similar to placebo, Avandia safety profile similar to ....?
One example of continued corruption:
Is Avandia a dangerous drug?
http://www.gsk.com/media/press-releases/2013/gsk-statement-in-response-to-fda-advisory-committees-vote-on-ava.html
"Concerns about rosiglitazone's adverse effects has reduced its use despite the benefits it offers in treating diabetes.[2] Adverse effects caused by rosiglitazone are currently the subject of over 13,000 lawsuits against GSK.[3] As of July 2010, GSK has agreed to settlements on more than 11,500 of these suits.
The drug is controversial and is estimated to have caused 83,000 heart attacks in the United States alone. Some reviewers have recommended rosiglitazone be taken off the market, but a Food and Drug Administration panel disagreed, and it remains available in the U.S., subject to significant restrictions.[4] From November 18, 2011, the federal government will not allow Avandia to be sold without a prescription from certified doctors. Patients will be required to be informed of the risks associated with its use, and the drug will be required to be purchased by mail order through specified pharmacies.[5]"
Any idea home much money is spent by the US tax payers to treat 83,000 heart attacks?
http://en.wikipedia.org/wiki/Rosiglitazone
CEDER's not big on history, Vioxx history....
Pretty much correct IMO, however, Amarin filed a 505b2 for Marine & applied for 5 yr NCE. Partly what set the confusion in motion.
See these documents:
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000AdminCorres.pdf
It certainly doesn't excuse the no decision after a YEAR.
The problems:
1) Amarin changed application forms 505b1 to 505b2
2) The FDA had never defined Lovaza's active moeity or mechanism of action
3) Lovaza had no RLD until after Vascepa Approval
4)The FDA is corrupt, CDER is the by far the most corrupt of any government agency of any world government ever!
5) delay became intentially prolonged after the FALL due to ?? ... Prolonged further in February with the Citizens petition filed by one of CDER's former Attorneys who likely had details on Vascepa/Lovaza exclusivity issues. I wonder who hired him? The FDA should have never excepted a petition filed by a former colleague with inside information.
No f'n brainier...on 7-26-2012 the FDA approved Icosapent Ethyl, Vascepa for the treatment of Very high triglycerides. No other active ingredient, moeity, drug period was listed in the OB at this time of approval. By definition this is a NCE.
After approval the FDA had to retroactive Lovaza's history to define Vasecepa. They have harmed Amarin, Vascepa and Amarin shareholders in this process.
They need to wake the F'k up this week!
Williams
Capsule "design" patent...unlikely to work around the method of use Amarin already has, It would compliment Amarins IP though. Note none of the claims treat trigs or cholesterol...
Claims
1.-5. (canceled)
6. A compound preparation comprising at least one selected from the group consisting of ?3 polyunsaturated fatty acids and pharmaceutically acceptable salts and esters thereof and at least one selected from the group consisting of water-soluble statin compounds, wherein the compound preparation is in a form of a soft capsule having a capsule coating with a pH adjusted to 7.0 to 9.5.
7. The compound preparation according to claim 6, wherein the at least one selected from the group consisting of the ?3 polyunsaturated fatty acids and the pharmaceutically acceptable salts and esters thereof is contained in a capsule content and the at least one selected from the group consisting of the water-soluble statin compounds is contained in the capsule coating.
8. The compound preparation according to claim 6, wherein the capsule coating contains a carbonate and/or magnesium metasilicate aluminate.
9. The compound preparation according to claim 6, wherein the capsule coating contains gelatin and at least one selected from the group consisting of succinylated gelatin, tartaric acid, hydrolyzed gelatin and trehalose.
10. The compound preparation according to claim 6, wherein the water-soluble statin compounds comprise at least one selected from the group consisting of pravastatin and rosuvastatin, and salts and hydrates thereof.
11. The compound preparation according to claim 7, wherein the capsule coating contains a carbonate and/or magnesium metasilicate aluminate.
12. The compound preparation according to claim 7, wherein the capsule coating contains gelatin and at least one selected from the group consisting of succinylated gelatin, tartaric acid, hydrolyzed gelatin and trehalose.
13. The compound preparation according to claim 8, wherein the capsule coating contains gelatin and at least one selected from the group consisting of succinylated gelatin, tartaric acid, hydrolyzed gelatin and trehalose.
14. The compound preparation according to claim 11, wherein the capsule coating contains gelatin and at least one selected from the group consisting of succinylated gelatin, tartaric acid, hydrolyzed gelatin and trehalose.
15. The compound preparation according to claim 8, wherein the water-soluble statin compounds comprise at least one selected from the group consisting of pravastatin and rosuvastatin, and salts and hydrates thereof.
16. The compound preparation according to claim 9, wherein the water-soluble statin compounds comprise at least one selected from the group consisting of pravastatin and rosuvastatin, and salts and hydrates thereof.
17. The compound preparation according to claim 12, wherein the water-soluble statin compounds comprise at least one selected from the group consisting of pravastatin and rosuvastatin, and salts and hydrates thereof.
United Health has prior authorization on Lovaza...none for Vascepa...both Tier three Amarin's making significant headway with payers.
United Health is the largest health insurance group in US.