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James B. Lee Jr., a pioneering deal maker and among the most influential Wall Street investment bankers of his era, died on Wednesday. He was 62. Mr. Lee, a vice chairman of JPMorgan Chase, died of a heart attack after working out in his home. Vascepa might have prolonged his life.
Totally agree and a great first post.
FDA Responds to the Amarin Complaint – Did We Just Take Two Steps Back?
http://www.corporatecomplianceinsights.com/fda-responds-to-the-amarin-complaint-did-we-just-take-two-steps-back/
JL, totally agree about the market action and your explanation of it. There is not too many stock sellers yesterday and was only able to get few shares sitting on the bid. Today, I was getting hit at $2.4, $2.39, $2.38 so far. With the NCE in the bag, I see the upside far exceeds the downside.
Conflicts of Interest in Cardiovascular Guidelines,
http://cardiobrief.org/2011/03/29/conflicts-of-interest-in-cardiovascular-guidelines/
Can You Test A Drug And Also Say Negative Things About It?
http://cardiobrief.org/2015/06/15/can-you-test-a-drug-and-also-say-negative-things-about-it/
I particularly agree with what's posted in the comment section:
"If referees, umpires and game officials in professional sports admitted that they regularly take money from team owners (or anybody else with a clear stake in the results of a game), the financial conflicts of interest would immediately render those on the take permanently unemployable in their chosen fields. But in medicine, we call people who take cash from drug or medical device companies “thought leaders” or “key opinion leaders” or “experts” – and then quote them in the media. How does this make any sense?"
Steven Nissen, Conflicts Of Interest, And The New Cholesterol Drugs
http://cardiobrief.org/2015/06/12/steven-nissen-conflicts-of-interest-and-the-new-cholesterol-drugs/
Judge has to show understanding and flexibility so the FDA will have no more excuses. We are dealing with a very cunning and corrupt adversary here. I am glad of the Judge's steadfast insistence on the July 7th date. Thank god for the legal system. Otherwise, even a successful R-IT won't stop the FDA from screwing Amarin (i.e. mineral oil).
Background
In the U.S., there are two primary ways that drugs can be protected from generic competition: (1) patents; and (2) FDA market exclusivities. For small molecule drugs, the FDA typically grants, upon approval of a new drug application (NDA), either five-year new chemical entity (NCE) market exclusivity or three-year exclusivity for a new indication, dosage regimen or dosage form for a previously approved drug where clinical data is used as the primary basis for the approval.[2] Although the difference between three and five years seems small at first glance it is not.
If a drug is granted NCE exclusivity, an abbreviated new drug application (ANDA) for a generic version of the drug cannot be approved by the FDA — and therefore cannot be legally marketed — during the five-year exclusivity period.[3] In addition, absent a paragraph IV certification,[4] the FDA cannot even accept a generic drug manufacturer’s ANDA for review until the five-year NCE exclusivity period has expired. After an ANDA is filed, the average time to FDA approval is about 35 months.[5] Thus, even without any patents, a drug having five-year NCE exclusivity should enjoy about eight years of market exclusivity.
Conversely, for a drug that has been granted three-year market exclusivity, the FDA can accept an ANDA from a generic manufacturer anytime within the three-year exclusivity period. Thus, a generic drug manufacturer who submits its ANDA one day after the FDA grants three years of market exclusivity for the reference listed drug could potentially have its generic drug on the market the day after the three-year exclusivity expires.[6] Thus, in practice, the difference between three-year exclusivity and five-year NCE exclusivity can actually amount to a difference of five years of market exclusivity, not two years.
Amarin
Amarin initiated development of eicosapentaenoic acid ethyl ester ("EPAe") for the reduction of triglyceride levels in adults with severe hypertriglyceridemia. Amarin sought five-year NCE exclusivity for EPAe, notwithstanding that EPAe was a component in the FDA-approved drug Lovaza.
In the Hatch-Waxman Act, Congress provided that drugs with new active ingredients would be entitled to receive five-year NCE exclusivity. In 2004, the FDA approved Lovaza, whose active ingredient was a mixture of omega-3 esters, including EPAe. Although “portions of Lovaza’s label refer to the specific components of the mixture, there is no dispute that its sole ‘active ingredient’ is the mixture as a whole.”[7] Supporting the proposition that Lovaza’s mixture-equals-active-ingredient, the FDA, in a recent citizen petition response, “explained that because the Lovaza mixture has not been ‘fully characterized,' the FDA has identified the ‘entire fish oil mixture as the active ingredient of Lovaza.’”[8] The FDA also explained that “when naturally derived mixtures are not sufficiently characterized to precisely identify every molecule that meaningfully contributes to the activity of the mixture it is difficult to define the active ingredient in terms of the specific components of [the] mixture.”[9]
Based on its reading of the statute and the FDA’s regulations, Amarin contended that EPAe had never been previously approved by the FDA as an active ingredient. Amarin argued that Lovaza’s mixture-as-active-ingredient was different from EPAe as a sole active ingredient for purposes of determining exclusivity. Amarin concluded that if EPAe received approval from the FDA, it should be entitled to five-year NCE exclusivity.
Months after Amarin’s EPAe was approved as the drug Vascepa, the FDA denied NCE exclusivity based on a new ‘one-to-many’ framework analysis.[10] This one-to-many framework, used without previous notice and comment rule-making or guidance, did not perform the ‘active ingredient’ to ‘active ingredient’ comparison as required by statute. Instead:
Under that [one-to-many] framework, the FDA “generally” considers component molecules of a mixture to be previously approved “active moieties for purposes of determining a subsequent drug’s eligibility for five-year exclusivity where[:] (1) specific molecules in the mixture have been identified; (2) those specific molecules are “consistently present in the mixture”; and (3) those molecules are “responsible at least in part for the physiological or pharmacological action of the mixture, based on a finding that they make a meaningful contribution to the activity of the mixture.” The determination of whether a particular molecular component of a previously approved mixture meets these criteria is based on “technological tools and scientific concepts available” at the time the FDA evaluates the exclusivity of a new drug — not the understanding that the FDA had when it approved the mixture in the first place.[11]
Chevron and APA Analysis
Amarin appealed the FDA’s administrative decision. On appeal, the district court analyzed the FDA’s regulations under two well-known tests: the (1) Chevron standard[12] and (2) Administrative Procedure Act’s “arbitrary, capricious, abuse of discretion or otherwise not in accordance with the law” standard.[13]
The district court found that the FDA’s one-to-many interpretation failed both tests for a variety of reasons, including three violations of basic rules for interpreting statutes and because the FDA’s actions were not reasonable (e.g., they were arbitrary and capricious). Quoting the district court: The “problems with the FDA’s decision are characterized as failures under Chevron step one, step two or the APA’s requirement of reasoned decision-making, [and] the [a]gency’s decision must be set aside.”[14]
Recommendations
With patents being challenged earlier and more often, including in inter partes review proceedings at the U.S. Patent and Trademark Office, exclusivities, which are distinct from the protection provided by patents, are increasingly important to innovating pharmaceutical companies. Five-year NCE exclusivity is significantly more advantageous than three-year exclusivity. Thus, innovators developing single molecule drugs which contain, as their sole active ingredient, a single component of a previously approved active ingredient multicomponent mixture should attempt to gain five-year NCE exclusivity, especially in situations where the multicomponent mixture is uncharacterized or poorly characterized. Steps toward achieving this goal include requesting five-year NCE exclusivity from the FDA, engaging often with the FDA to ensure its thinking on exclusivity is aligned with the innovator’s thinking and the law, and being prepared to challenge the FDA both before, and if necessary after, NDA approval, if five years of NCE exclusivity is not granted.
Finally, innovators should make certain that, upon NDA approval, relevant patents are timely listed in the Orange Book so that innovators will be able to take full advantage of the protections afforded by Hatch-Waxman and five-year NCE exclusivity.
Conclusion
In light of Amarin, innovators developing single compounds that are components of previously approved mixtures or combination products should proactively seek, where appropriate, five-year NCE exclusivity. In doing so, innovators should be prepared to challenge any contrary position taken by the FDA based on how a multicomponent drug mixture has been previously characterized and approved by the law.
Amarin Decision Opens Door To Longer Exclusivity Periods.
http://www.law360.com/articles/665186/amarin-decision-opens-door-to-longer-exclusivity-periods
If TG is not a valid bio-market, why the FDA allow the ANCHOR SPA to be created?
To be selfish, I hope the stock will stay around the current level until I establish a full position.
HD, I totally disagree. The prevailing medical theory is that TG is a valid bio-marker to treat residual risk of CVD. Otherwise, the FDA won't even create the ANCHOR SPA in the first place. To rescind the SPA, FDA needs substantial scientific evidence to refute TG as a valid bio-marker. The 3 failed outcome studies are not "scientific evidence". In fact on the contrary, they further validate TG as a valid bio-marker.
STS, is it better just AMRN Vs FDA and not all Pharma Vs FDA? The former shows the Judge that the FDA is not being fair only to Amarin while the later indicates to the Judge that the whole industry is rebellious VS the FDA.
ANCHOR-like data was on Lovaza label up until recently. ANCHOR data on Vascepa label shouldn't be a problem for the FDA to giver up, much better than than losing a 1st Amendment lawsuit. If I were JT, I'll also ask for a R-IT guarantee, i.e., able to communicate to doctors as soon as R-IT results are available, to prevent any FDA traps such as the mineral oil BS (see bottom of page 6 in the June 5th letter).
"The three studies have higher than normal TG level"? This statement is not true. Please check.
HD, thanks for the nice summary. I remember your cash flow breakeven estimate was closer to 30K scripts per week instead of 20K scripts per week, what has changed? My breakeven estimate has always been 20K per week.
There is no seller of the stock today. Try to buy it all morning and get zero share. Yesterday was the complete opposite. Not complaining though.
If Amarin win the 1st amendment suit, it can spread the good news of R-IT success to doctors and patients as soon as interim results are available instead of waiting for the FDA to drag its feet. That's very important, IMO.
With the letter, FDA tries to convey an illusion to the judge and the public that it has compromised and Amarin is not being reasonable in its request. It certainly fools some lazy journalist from WSJ, Forbes, etc. I hope Judge Engelmayer is as clear minded as the Honorable Judge Moss and see thru FDA's various lies.
BP lobbyists should be for the 1st amendment lawsuit, right? Those who were interviewed sounded pro FDA and Vs the lawsuit.
Stock_risk, you can treat every down day as buying opportunity.
"Suntrust will provide guidance to their clients (Baker, Stonepine)"? I am pretty sure the Baker Brothers don't need any quidance from Suntrust. I think you sold too eaely with plenty of catalysts ahead.
LOL JL, very good catch.
You are right. See p.22,
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ContactCDER/UCM070722.pdf
HD, what's mean by "in the basement" in the NCE context? TIA.
Is Epanova a NCE based on Judge Moss ruling of Vascepa NCE status? Should I say unintended consequence?
Dude, you should be a movie script writer for Hollywood studios. If there were any suitors for Amarin, it would be AZN and not GSK. I think you give too much credit for the FDA in your theory. FDA is not that smart. IMO, FDA is in the same class as FIFA. The only thing I agree with you is "the interim results will show 25% or above benefit".
Raf, are you aware of any "unapproved indication" that meets all endpoints of a FDA sponsored trial? If not, what you suggested is a moot point. ANCHOR sNDA approval has as good a chance as NCE clock starts upon Jude Moss's ruling. Remember FDA will never make it easy for Amarin.
Freak, do you mean $5 by year end?
Proof That Lower Is Better — LDL Cholesterol and IMPROVE-IT,
my best Kiwi imitation,
http://www.nejm.org/doi/full/10.1056/NEJMe1507041?query=featured_home&
Welcome back BB. There is a typo in your briefing. Vascepa was approved on 7/26/2012, not 2014.
BC, it's 60 days.
Louie, did this just come out? If yes that explains the high volume run up of the stock in last few minutes.
JL, I hope JT's confidence is not just based on qualitative evidence like you so eloquently said here but quantitative as well. They have the event number to date and they should be able to estimate Vascepa efficacy based on methods you described few months ago.
"the FDA if they have a lick of common sense"? They have none. FDA think it is above the law. It is just using its delay tactic now.
"restore the SPA and grant the sNDA." I hope you are right but I think it is a very low probability event. FDA is all about saving face and restoring the SPA and granting the sNDA slap its face very hard.
Depends on his confidence on the success of R-IT. JT should negotiate for full ANCHOR and more (150-499 TG) as soon as R-IT interim proves successful. On the other hand, if he's not that confident about R-IT success (he knows the progress of the trial based on the event number to date), he should offer no compromise to the FDA.
Buying 50 @ 2.38 post market.
I know one guy that fits your profile, Joe Z. Do you want him back?
Focus on the upside Vs the downside. Estimate the probability of the upside Vs. the probability of the downside. JT's confidence on the success of R-IT increases the probability of the upside, IMO, as he knows more about the progress and status of R-IT than anybody.
Robin, JT choice of words is perfectly fine with me. It definitely makes me more confident in the success of R-IT. In fact, JT's reaffirmation of his confidence convinces me to buy more shares today.