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FDA exclusivity move:
Patent use codes for two of the 16 patents are blank now, they both contained patent use code "U-1287" previously.
http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=202057&Product_No=001&table1=OB_Rx
8298554
8188146
http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=202057&Product_No=001&table1=OB_Rx
'554 is "capsule" patent http://patft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8298554.PN.&OS=PN/8298554&RS=PN/8298554
'146 is EPA composition patent
No need to remove the prior code unless the FDA has plans to add another use;)
Williams
One message I hope every rep is sharing: Vascepa doesn't raise LDL like Lovaza. Raising LDL fly's directly against ATP 3 guidelines.
ATP 4 guidelines should include Vascepa, no room for a product that increases LDL.
17 new sales positions posted at Amarin.
http://www.amarincorp.com/careers.html
Good to see expansion. I wished we diluted in November and launched in January with a 1000 reps though....
CP filed two weeks before MAPP 5021 posted, somewhat odd timing. Perhaps you'd like to explain MAPP 5021 to me? I guess John F just got lucky on submitting timing...
Please enlighten me with your DD.
The petition should be withdrawn based on the filer having knowledge of advancing FDA MAPPs. For all we know Fuson could have written MAPP 5021.
Williams
Anchor to be posted on Label
This application also contained a study report, but not the dataset, for the ANCHOR trial. This trial was not considered pivotal to the efficacy claims of Vascepa for this NDA. The ANCHOR trial investigated patients with TG between 200 mg/dL and 499 mg/dL despite statin therapy. The applicant was told prior to this NDA submission that data from the ANCHOR trial would not be mentioned in the Vascepa labeling until, at a minimum, 50% enrollment of a cardiovascular outcomes trial was reached.
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdf
I posted that Amarin could add Anchor to label months ago. It's in the public document at the FDA. Someone at the meeting may have asked the right question.
In 2008 the FDA requested a NCE toxicology program.
Medical Review of Marine pg 15
Page 10 Medical Review Document for Marine, Anchor data can be added at 50 % REDUCE-IT enrollment.
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdf
Addition of the Anchor data to the label was an agreement made with Marine approval. REDUCEIT was required to 50% enrolled...I'll see if I can find the document. As far as adding the JELIS study, that's news to me but would fall inline with the new Guidance document posted at the FDA.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
I posted this before but got no takers at the time. Vascepa would qualify under this guidance for early REDUCEIT approval before the outcome study is fininshed. It was posted 6-25.
Will
Interesting PR due out Friday or Monday about '699 Mail Notice of Allowance. I expect the PR will tie the patent into October Ad Com. We may if see some agressive Epanova wording:)
Will
BioWill
Good article, could have used some scientific transition to justify 10x Anchor though.
I suggest ATP 3 guidelines. I also hope Amarin brings physicians to the table that are working on the updated 4 guidelines due out "soon".
BioBill$
Did AZN set up a SPEC in conclusion with Omthera, only to buy them two months later? It looks like something the SEC should review. Especially if used as leverage to negotiate with Amarin. Certainly the FDA won't take kindly to the shame NDA filing infringing on BASF patents.
Is AZN as rotten as GSK's China dealings?
In the United States, the SPAC public offering structure is governed by the Securities and Exchange Commission (SEC). A public offering for a SPAC is typically filed with the SEC under an S-1 registration statement (or an F-1 for a foreign private issuer) and is classified by the SEC under SIC code 6770 - Blank Checks. Full disclosure of the SPAC structure, target industries or geographic regions, management team biographies, share ownership, potential conflicts of interest and risk factors are standard topics included in the S-1 registration statement. It is believed that the SEC has studied SPACs to determine whether they require special regulations to ensure that these vehicles are not abused like blind pool trusts and blank-check corporations have been over the years. Many believe that SPACs do have corporate governance mechanisms in place to protect shareholders. SPACs listed on the American Stock Exchange are required to be Sarbanes-Oxley compliant at the time of the offering including such mandatory requirements as a majority of the board of directors being independent and audit and compensation committees.
What's your thought on KAFA, the shell company AZN created, to aquire Omethera?
Provides AZN from direct litigation from BASF patent infringement?
Thoughts?
Agreed, but I doubt anyone expects it to get by BASF's patents. This is not up to the FDA's discretion.
Possible, still you should wear sunscreen;)
Still thinking...
AZN formed a shell company, KAFA, to purchase Omthera. Protecting AZN from being sued for breach of BASF's Lovaza's patents when the NDA was filed. What a bunch of D bags:)
Will
I believe AZN set up a triangular merger. Amarin's value is "to be determined" still. KAFA Acquisition company is the vehicle being used for both Omthera and Amarin. BAM!!
Merger Subsidiary
Resource type: Glossary Item
Status: Maintained
Jurisdiction: USA
A subsidiary formed by a party for purposes of effecting a form of indirect merger, such as a forward triangular merger or reverse triangular merger. In a forward triangular merger, the target company is merged with and into the acquiror’s merger subsidiary. In a reverse triangular merger, the merger subsidiary is merged with and into the target company.
http://uslf.practicallaw.com/9-382-3627
AZN "made" an "affiliate" company, KAFA Acquisition Corp to BO Omthera.
http://www.bizapedia.com/de/KAFA-ACQUISITION-CORP.html
Why?
"The Company's stockholders approved the proposal to adopt the Agreement and Plan of Merger, dated as of May 27, 2013, as it may be amended from time to time (the "Merger Agreement"), among the Company, Zeneca, Inc., a Delaware corporation ("Parent"), and KAFA Acquisition Corp., a Delaware corporation and a wholly owned subsidiary of Parent. The following are the final voting results for this proposal: "
http://biz.yahoo.com/e/130716/omth8-k.html
Disagree, BASF owns the patents r/t Lovaza's and Epanova's method of use for high trigs. The FDA can't accept an application for a product that infringes on Patents. All patents related to use must be on Epanova's application. Epanova only has IP related to capsule composition and not treatment of high trigs.
Will
No crazier than that
Amarin may be looking to buy Omethra.
PRINCETON, N.J., July 16, 2013 /PRNewswire via COMTEX/ -- The stockholders of Omthera Pharmaceuticals, Inc. OMTH +0.08% (the "Company") voted today at a special meeting of stockholders to adopt the previously announced merger agreement providing for the acquisition of the Company by an affiliate of AstraZeneca PLC.
"Affiliate" not AZN as prior PR's state.
The votes cast by the Company's stockholders in favor of the proposal to adopt the merger agreement represented approximately 88.3 percent of the Company's issued and outstanding common stock entitled to vote as of June 13, 2013, the record date for the special meeting.
http://www.marketwatch.com/story/omthera-stockholders-approve-acquisition-by-astrazeneca-2013-07-16
Orginal PR has no mention of "affiliate".
http://www.reuters.com/article/2013/05/28/us-astrazeneca-omthera-idUSBRE94R04L20130528
To even get more speculative. Amarin announced share offering one day before Epanova's NDA. Share offering netted $120 million which also happens to be the CVR with AZN's purchase agreement made on June 13 th. Timing and amounts raise my suspicion that Amarin and AZN are in advanced negotiations with only the need to value Vascepa's over hang.
The over hang includes Anchor, REDUCEIT, and exclusivity. This may all get obvious if Epnova's application gets an earliy denial of 74 day letter is negative.
My personal opinion is Epanova is a superior bioavailable Lovaza generic and doesn't qualify to file a NDA.
Amarin's JPM meeting could be related to the purchase of Omthera and an "Afiliate" of AZN.
Crazy...maybe
Will
Crazy thought...
Omethera's last PR
"PRINCETON, N.J., July 16, 2013 /PRNewswire/ -- The stockholders of Omthera Pharmaceuticals, Inc. (NASDAQ: OMTH) (the "Company") voted today at a special meeting of stockholders to adopt the previously announced merger agreement providing for the acquisition of the Company by an affiliate of AstraZeneca PLC. The votes cast by the Company's stockholders in favor of the proposal to adopt the merger agreement represented approximately 88.3 percent of the Company's issued and outstanding common stock entitled to vote as of June 13, 2013, the record date for the special meeting."
By an AFFILIATE! Could it be Amarin? Elan? Amarin/Elan?
Agreed, something in the neighborhood of $15 Billion with REDUCEIT.
YB
Under SEC rules Omethra has 4 business days to disclose a rejection.
This Friday or next Monday, just a possibility I'm sharing. Oddly Omethera makes no mention of the NDA is last PR related to AZN BO offer.
Will
I'm under the impression Lovaza's CP has held the exclusivity decision for Vascepa. This decision is due in August.
Another timeline to be aware of is the 74 day letter Omthera will receive. I expect the application has been rejected already. No mention of the NDA in latest PR.
http://www.marketwatch.com/story/omthera-stockholders-approve-acquisition-by-astrazeneca-2013-07-16
AZN may make offer in this time frame
Williams
JL Please comment:
JL? Vascepa new indication for the prevention of skin cancer?
http://www.ncbi.nlm.nih.gov/pubmed/12771037
Market size is as big as REDUCE-IT.
Skin Cancer Statistics
Skin cancer is the most common form of cancer in the United States. The following statistics refer to melanomas of the skin. Non-epithelial skin cancers, which are not reflected below, represent 7% of skin cancers that are tracked by central cancer registries. These statistics also do not include data for basal cell and squamous cell carcinomas, which are not tracked by central cancer registries.
In 2009 (the most recent year numbers are available)—
•61,646 people in the United States were diagnosed with melanomas of the skin, including 35,436 men and 26,210 women.*†
•9,199 people in the United States died from melanomas of the skin, including 5,992 men and 3,207 women.*†
*Incidence counts cover approximately 90% of the U.S. population; death counts cover approximately 100% of the U.S. population. Use caution when comparing incidence and death counts.
http://www.cdc.gov/cancer/skin/statistics/
================
61,646 per year dx for just Melanomas, the most deadly of the skin cancers.
NDA 505b2 could be applied for using NEW "Epideted Programs for Serious Conditions" guidance.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
Williams
JL
Skin Cancer? Have you read the research (4 grams EPA increasing skin EPA concentrations by 6 fold) preventing DNA damage secondary to UV radiation?
Will
And no formula with less than 4% DHA can compete with Vascepa's prior patents for pure EPA.
Very crafty lawyering;)
Williams
"4 % DHA, or it's Esters, by weight of all fatty acids present."
That change is directly pointed at Epanova.
FDA travels back in time
Instead of updating May OB to June, they post April:)
LOL!
http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM086233.pdf
IT'S "GO TIME"!!!
----------------
Next stop Sentor Chuck Grassley
-----------------
Virginia (CDER's Ombudsmen)
Is 11 AM going to work for us to discuss four public documents?
Lovaza's Citizen Petition filed 2-6-2013
Letter from the USPTO to Office of Regulatory Policy FDA dated 6-11-2013
http://www.regulations.gov/contentStreamer?objectId=0900006481348650&disposition=attachment&contentType=pdf
Documents received by USPTO on 9-21-2012
http://www.regulations.gov/contentStreamer?objectId=0900006481348650&disposition=attachment&contentType=pdf
Letter from "FDA scientists" to President Obama
http://www.whistleblowers.org/storage/whistleblowers/documents/FDAwhistleblowers/letter2presidentobama.pdf
http://truth-out.org/news/item/10524-former-fda-reviewer-speaks-out-about-intimidation-retaliation-and-marginalizing-of-safety
Thank You for your time,
Williams
----------------
Yes, Wednesday meeting that will determine how I start my journey.
I'm not a fan of law suits. I have specific information r/t Lovaza's review. It's not relavant to Vascepa at this time, so I'm done discussing it. ($$unless paid$$)
Will
A long term study should be done with extension of life and metastatic disease with Vascepa & Melanoma.
EPA/Mechanisms for treating Cancer
http://www.sciencedirect.com/science/article/pii/0006291X89924698
Recent studies have shown that the cyclooxygenase and the 5-lipoxygenase pathways of arachidonic acid, are required for the invasive and metastatic activity of certain tumor cells. We show here that malignant murine melanoma and human fibrosarcoma cells cultured in media supplemented with eicosapentaenoic acid show a dose and time dependent decrease in invasiveness, in collagenase IV production and in the case of the murine cells, a reduced ability to metastasize to the lung after intravenous injection. It was also shown that a metabolite of eicosapentaenoic acid was less potent than the comparable arachidonic acid metabolite in restoring collagenase IV production and invasiveness after inhibition of the lipoxygenase pathway. These studies indicate that such supplements have the potential to reduce the metastasis of certain tumor cells, converting them to benign status.
JL? Vascepa new indication for the prevention of skin cancer?
http://www.ncbi.nlm.nih.gov/pubmed/12771037
Market size is as big as REDUCE-IT.
Skin Cancer Statistics
Skin cancer is the most common form of cancer in the United States. The following statistics refer to melanomas of the skin. Non-epithelial skin cancers, which are not reflected below, represent 7% of skin cancers that are tracked by central cancer registries. These statistics also do not include data for basal cell and squamous cell carcinomas, which are not tracked by central cancer registries.
In 2009 (the most recent year numbers are available)—
•61,646 people in the United States were diagnosed with melanomas of the skin, including 35,436 men and 26,210 women.*†
•9,199 people in the United States died from melanomas of the skin, including 5,992 men and 3,207 women.*†
*Incidence counts cover approximately 90% of the U.S. population; death counts cover approximately 100% of the U.S. population. Use caution when comparing incidence and death counts.
http://www.cdc.gov/cancer/skin/statistics/
================
61,646 per year dx for just Melanomas, the most deadly of the skin cancers.
NDA 505b2 could be applied for using NEW "Epideted Programs for Serious Conditions" guidance.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
Williams
Vascepa and Pediactric Orphan status
Vascepa and Amarin have enough information to apply for a very impressive exclusivity status.
In July 2008, the AAP released updates to their lipid screening and cardiovascular health recommendations.[3] The more recent guidelines agree with most of the NCEP guidelines but are more specific, recommending precise ages and more aggressive repeat testing in high-risk patients. The guidelines state that pediatric patients with a family history of dyslipidemia or premature cardiovascular disease (defined the same as NCEP), those with an unknown family history, or those with risk factors including lifestyle (smoking, physical inactivity), metabolic disorders (eg, low HDL-C, diabetes mellitus), and hypertension should be screened with a fasting lipid profile. Initial screening should take place between age 2 and 10 years; if levels are within normal limits for age, repeat testing does not need to be obtained for 3-5 years.
-------------------
This market is more lucrative than "Marine", and if embraced would have extreme Marketing potential.
Williams
Lovaza/FDA approval/Cancer/lawsuits
Any Attorneys that want the heat on the above info contact me, GSK's gonna be writing some checks in the future and the FDA's documents can help.
Williams/Bio
Amarins looking clear and has been well vetted, in fact I found a new indication in the prevention of skin cancer. EPA in your skins phospholipid layer helps prevent DNA mutation and cancer formation after sun burns. I'll post the studies later.
Zoo
"Mr. Market DOES hate uncertainty and that factor is abundantly present." Very accurate and describes pre approval 15's to the 5's we have today. Share offering was due to "overhangs" and we all know what that is.
I have been in touch with ZBD via personal email, his credentials are impressive. We are blessed to have ZBD and JL and their close to a centuries worth of Medical knowledge. You can't teach experience.
Thanks to both of you!
Williams/BioB$
STS
LOL..."The couple controls assets worth between $21 million and $40 million, according to disclosure forms Dr. Hamburg gave the White House. The forms don't reveal exact figures, just ranges."
"Controls".... Her husband made over $120 million from the hedge fund that he helps control. He also developed high frequency trading.
"Mr. Brown, an expert in artificial intelligence, is vice president and director at Renaissance Technologies. The fund company said recently its total assets were about $18 billion. Mr. Simons was the top-paid hedge-fund manager in 2008, receiving $2.5 billion, according to Alpha magazine."
A director of a $18 Billion dollar hedge fund, and inventor of High Frequency Trading...$10 million may be an accurate number for 2008...but not 2012.
"As far as your FDA - USPTO post, too much legalese for me - when was it sent, as in when did the deadlines start? And what does patent extension have to do with NCE?"
Amarin made the request last fall to file the extension. The deadlines have passed. If you read all the documents related to the USPTO and review the law they sited, you would see the clock is up from when the HUD secretary could make a NCE status decision. The USPTO needs the exclusivity determination to extend the patent by the laws they sited. They can circumvent the FDA to do this. The letter is a great document for the Sentate Commitee meeting reviewing CDER's indiscretions. A process I start on Monday.
I have a meeting with CDER next week.
Will
The body naturally coverts EPA to DHA...it's a feed back mechanism closely regulated. If your body has no need for more DHA it won't convert EPA to DHA. Conversely if you have an excess of DHA your body has limited mechanism to use or covert it to a useful product. As JL stated, EPA is closely related to AA and the excess produces the good ecosinoids.
"EFFECTS OF EPA SUPPLEMENTATION ON PLASMA FATTY ACIDS
Supplementation of adults with ˜4 g/d of pure EPA ethyl ester results in significant increases in EPA concentrations in whole plasma and plasma or serum phospholipids, but no increase in DHA concentrations, which is consistent with the poor enzymatic conversion of EPA to DHA (64, 68, 72, 73). A meta-regression dose-response analysis of pure EPA supplementation could not be performed because a sufficient number of studies across a range of EPA doses were not available."
http://ajcn.nutrition.org/content/83/6/S1467.full
-----------
There very well may be a carcinogenic level of chronic DHA, but you won't achieve it with taking pure EPA...
The FDA should look into this when the consider Lovaza like Epnova's very VERY high DHA levels.
Will