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Scam. They only re-upped their O-3 program when Reduce-It was positive.
See this thread for a good primer on the uphill battle in front of them w/ DPA.
STRENGTH fail problem for O3. Adcoms for sure. CVOTs required. I'm concerned for future $MTNB patients. "Unexpectedly, DPA shows direct correlation w/ischemic infarcts"-Afib pt study. Is that why afib disallowed in new MAT9001 P2 study? .@FDAMedWatch $AMRNhttps://t.co/0h7oQTlU3t pic.twitter.com/Hj4rsBdiju
— TerraPharma (@TerraPharma1) January 19, 2020
Agreed, and I think the point illustrated in the quote at the post below (h/t relocatedmetsfan) adds a knockout punch to the inducement argument:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=153368300
TTE - Excellent find, and I think when your post is combined with the testimony posted at the link below by metsfan, the inducement argument is (and probably always was) very strongly in our favor.
metsfan's post: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=153368300
bold/red my emphasis...
3 Q. The defendants' proposed labeling does not limit the duration of treatment with the ANDA product and leaves the duration of treatment up to the discretion of the prescriber as well, correct?
A. Correct.
Q. A prescriber would understand that if there were a safety or efficacy reason to limit the duration of treatment, the labeling would state that, correct?
MS. FUNDAKOWSKI: Objection; form.
THE WITNESS: I'm not sure what a prescriber would specifically understand. But certainly in the absence of a warning or limitation, the prescriber would assume that the duration of treatment would be within the prescriber's discretion.
BY MR. SIPES:
Q. And if you look to Paragraph 132 of your report, you quote FDA's regulations of 21 CFR Section 201.57(c)(3)(i)(F). Do you see that?
A. Yes.
Q. And FDA's regulations require that the Dosage and Administration section include, quote, "the usual duration of treatment when treatment duration should be limited." You quote that, correct?
A. Yes.
Q. And neither the Vascepa labeling nor defendants' proposed labeling includes the usual duration of treatment in the Dosage Administration section, correct?
A. That's correct.
Q. Nothing in the Vascepa labeling or the defendants' proposed labeling contains a limitation of use concerning the duration of treatment, correct?
A. Nothing in which section, indications and dosage?
Q. Nothing in the Vascepa labeling contains no -- scratch that. No section of the Vascepa labeling contains a limitation of use concerning the duration of treatment, correct?
A. I believe that's correct.
Q. And similarly, no section of defendants' proposed labeling contains a limitation of use concerning duration of treatment, correct?
A. That's correct.
Great post. To my layman's brain this is a very strong argument for the (generic) label promoting inducement, and corroborated by the defendant's witness. Especially where it says when treatment duration should be limited. HELLO. WINNER.
Half expected the last line to be a GIF of Gene Wilder:
OPW - "Prescribe this ONLY for <12 weeks"
From the deposition of Dr. Mathers, one of the expert witnesses for the generics...
Quote:
3 Q. The defendants' proposed labeling does not limit the duration of treatment with the ANDA product and leaves the duration of treatment up to the discretion of the prescriber as well, correct?
A. Correct.
Q. A prescriber would understand that if there were a safety or efficacy reason to limit the duration of treatment, the labeling would state that, correct?
MS. FUNDAKOWSKI: Objection; form.
THE WITNESS: I'm not sure what a prescriber would specifically understand. But certainly in the absence of a warning or limitation, the prescriber would assume that the duration of treatment would be within the prescriber's discretion.
BY MR. SIPES:
Q. And if you look to Paragraph 132 of your report, you quote FDA's regulations of 21 CFR Section 201.57(c)(3)(i)(F). Do you see that?
A. Yes.
Q. And FDA's regulations require that the Dosage and Administration section include, quote, "the usual duration of treatment when treatment duration should be limited." You quote that, correct?
A. Yes.
Q. And neither the Vascepa labeling nor defendants' proposed labeling includes the usual duration of treatment in the Dosage Administration section, correct?
A. That's correct.
Q. Nothing in the Vascepa labeling or the defendants' proposed labeling contains a limitation of use concerning the duration of treatment, correct?
A. Nothing in which section, indications and dosage?
Q. Nothing in the Vascepa labeling contains no -- scratch that. No section of the Vascepa labeling contains a limitation of use concerning the duration of treatment, correct?
A. I believe that's correct.
Q. And similarly, no section of defendants' proposed labeling contains a limitation of use concerning duration of treatment, correct?
A. That's correct.
With all the potential upside here I have to think polarity flips (v2.0, 1.0 being 9/24/18) with the Jan '20 options expiration and a positive trial outcome in the rear view.
Not a perfect analogy by any means but AMRN here reminds me of TSLA early 2013, right before it really took off.
I know Joe Kennedy is a bulldog and seems pretty fearless, so it doesn't surprise me they've taken this route, even with it being open somewhat to "interpretation." That said, I also wonder if during negotiation talks, interested parties have expressed doubt w/r/t IP protection, and either directly or indirectly, encouraged a trial (win) to further de-risk their purchase.
Question for the patent pros: beyond the methods of use patents which are in play here, isn't their composition patent essentially bulletproof? Especially since the generic has to be identical? So why didn't Amarin assert that in their original complaint?
Last question, we know another element in the secret sauce is the method for manufacturing which prevents oxidation. Is this process specifically patented, or is it like a WD40 situation where they never patented to avoid divulging too much info? If it was, couldn't that also be asserted from a better position of strength than MoU?
TIA.
R - thanks.
Settlement = temporary bandaid
Win = permanent fix
Obviously, Win > Settlement
But the risk is losing.
IMO the only reason this is at trial because the ultra conservative JT is fairly certain that he will win, otherwise he wouldn't risk the entire company.
Yes, the counter argument is why would generics accept settlement if this was a winnable case for them? But Amarin's loss would mean a far far far greater loss for Amarin than a gain for generics. At least a 20:1 difference, probably greater.
My point is that if Amarin would stand a serious chance of losing, JT would find the right amount to settle, because of the above.
I can absolutely see there being SOME collusion between 2-4 parties, but industry-wide, the conspiracy theory breaks down. At the end of the day they're all in competition with each other and all it takes is one enterprising S.O.B. to have his team pull the trigger. Could be an outlier with lots of cash like GILD or JNJ, could be one of the Japanese pharmas that have a tendency (willingness) to overpay (though I think Takeda's hands are still full from the Shire deal).
I put more stock into the idea that MMs have had the largest vested interest in holding this back as sellers of call options, and they can have some influence through their iBankers, but again that's not a lid they can keep on it forever... Additionally, when they get wind of a real deal, the polarity will flip, and I think we'll see one of those phantom $10-15 runups for 1.5-3 weeks before the share price goes nuclear (in a good way) for the last time.
I’m in the camp that there is a big effort by either big companies or the supplement industry to hold the price down. Obviously they have been somewhat successful. However sales are going to take off. No question. When they do the stock price will too.
IIRC they bent over backwards to get a deal done for LOXO in something like 11 days to make a splash at last year’s JPM Conference.
That’s said I agree. Not enough cash to get the deal done and not the best fit.
I posted about this as well, echoing your points.
Agree with you that litigation does not rule out BO, but IMO it all depends on the amenability, urgency, and cooperation of the acquirer.
To me that workable scenario looks something like an agreement where both parties agree 1) the litigation is a nuisance AND 2) it will only affect the valuation at nominal (relatively in BP terms) dollars “X”.
In this possible but rather unlikely case I think the acquirer would just make it part of the deal and cover the cost of settlement to get it done.
If a settlement happens at an unusually high price could mean a buyer is in the wings and Amarin is effectively the straw man to avoid an even larger payout by the BP suitor.
Lars Ekman is Amarin’s Board Chairman.
JZ is a non-executive Director, and has not served as Chairman sincere 2013.
“Lars G. Ekman, M.D., Ph.D. joined Amarin as a non-executive director in November 2008, and was named Amarin’s lead independent director in October 2011 and Amarin’s Chairman of the Board effective January 2014.”
“Mr. Zakrzewski is currently the Chairman of Onxeo and serves on the board of directors of Onxeo, Acceleron Pharma, and Sangamo Therapeutics as well as a number of privately held companies.”
Agree with you that litigation does not rule out BO, but IMO it all depends on the amenability, urgency, and cooperation of the acquirer.
To me that workable scenario looks something like an agreement where both parties agree 1) the litigation is a nuisance AND 2) it will only affect the valuation at nominal (relatively in BP terms) dollars “X”.
In this possible but rather unlikely case I think the acquirer would just make it part of the deal and cover the cost of settlement to get it done.
If a settlement happens an unusually high price could mean a buyer is in the wings.
Meaningless spec, but still interesting.
https://www.leagle.com/decision/infdco20190412b01
Amarin Pharma, Inc. & Amarin Pharmaceuticals Ireland Limited, Plaintiffs, represented by Jordan Laird Moran , Covington & Burling LLP, pro hac vice, Megan Patricia Keane , Covington & Burling LLP, Michael Kennedy , Covington & Burling LLP, pro hac vice, Alaina Marie Whitt , Covington & Burling LLP, pro hac vice, Christopher Neil Sipes , Covington & Burling LLP, Einar Stole , Covington & Burling, LLP, pro hac vice, Eric Ritland Sonnenschein , Covington & Buling LLP, Han Park , Covington & Buling LLP, pro hac vice, Jason D. Smith , Santoro Whitmire & Nicholas J. Santoro , Santoro Whitmire.
Can someone fill me in on this “sales meeting” scheduled around the time of the JPM presentation? I can only find bits and pieces and can’t figure out how to search on mobile. Thanks in advance.
For momentum's sake, it would be truly great for them to PR the terms of a settlement Tuesday AM. Would imply the company may be in late stage negotiations, especially if they are willing to pony up more $. Would also create some near to mid term FOMO, especially heading into JPM. Should keep share price buoyed for next 6-8 weeks at minimum.
Full disclosure - I'm in the camp hoping they sell the Co. Give me $50-55 cash + a $10-15 CVR for BRAVE. Acquirer needs to move quickly to make hay before patent sunset and I think JT should move quickly given general risks of GIA, 2020 election, and so on.
That and he thinks his only way to stay relevant is to stir the pot. It doesn’t need to be that way, but it’s less work for him to drive page views/subscribers to his articles through mostly half-baked contrarian views than thorough unbiased research. Same becoming true for Herper, who even this weekend tweeted things indicating he’s still 5-7 years behind most of us here w/r/t knowledge of EPA.
Excellent question. I don't know. I want to believe there's something there, I just have no evidence other than the same abstracts we all have access to w/r/t EPA and liver function. But even if R-IT data didn't show a clear path for V (alone) in the NASH space, it makes terrific sense for V to be paired with a drug that is known to elevate trigs, and for one Co (to try) to own them both. The addition of V to the GILD trial may very well be part of their DD, but given they just started who knows how quickly they can get a look at that data...
I like this, don't get me wrong, but could simply be a known side effect of NASH drugs is elevated trigs, which V would of course offset, and they want to compare that arm using both treatments. If trial data have shown additional synergistic effects, well then, you could very well be on to something.
Either way NASH market will be huge and for whichever Co has the biggest share, they can add revs with incremental cost if the same rep is pushing both drugs together.
GILD / NASH
A reminder that REDUCE-IT contained a NAFLD/NASH subgroup.
Has this data been publically released? NO.
Has this data been shared with GILD under NDA?Well, GILD are using VASCEPA in their trial, so use your imagination.
Additionally, a ton of outside research shows benefit of EPA for NAFLD/NASH.
If that was the case they would just PR it. No need to wait for benefit of open market.
I meant the contingency would be in place of a discount, ie we both agree (now) this will be the price after the litigation is settled or won.
Also wondering if anyone might swoop in with a BO offer contingent on settlement/trial win, to be first in line.
Label on the other hand obviously required for accurate valuation but I gather (based on hive mind here and elsewhere) litigation >95% in the bag.
Just a thought. Not a lawyer nor have I served on a BOD.
I have zero concrete info so take this with a grain of salt, but I’d shortlist this Vin Kutty guy (scroll down): https://omegavia.com/about-us/
Digestion/absorption vs metabolism.
Agree with this especially after the summary judgement dramatically increased likelihood of settlement pre-trial.
And even if not, AMGN is sometimes called the legal firm with a pharma department (or thereabouts) who could squash the aNDA filers like the cockroaches that they are.
No one will want to miss an opportunity of this size.
Scooe of label likely remains as the final variable in any talks, and as you say an announcement could certainly follow very closely behind.
My spreadsheet has always had $55/share highlighted as my guesstimate, but a broad label could obviously see that go even higher.
Interesting idea. Is it just me or do MRC’s posts read a lot like this OV co-founder’s blog?
“Vin is a nutritionist, writer and Omega-3 evangelist. He’s OmegaVia’s co-founder and has worked in the health care industry for over 20 years. When he is not ranting about fish oil, he is scouring scientific journals for the latest research on Omega-3. Vin is an avid traveler and lover of nature and is the owner of a non-profit rainforest preserve in Bolivia’s Amazon region. He does not know when to shut up about Omega-3. Seriously!”
https://omegavia.com/about-us/
https://omegavia.com/fish-oil-incidents/
“This is what I had to say about it in 2013:
‘The media circus around this study plays along with this researcher’s irresponsibility and personal bias. I think the authors are aware that their data does not support these statements. It’s not ignorance. It’s just career advancement. This kind of media attention brings funding and ensures job promotions, tenureship and all-around back-slapping.
And the media? Well, fear-mongering sells. And in a facts-be-damned media circus, it’s always the supplement that gets taken out back and shot.’”
I think the label will be TG >135, only because it was mentioned in paragraph 2 of their ICER letter, which to me implies that's the line they aim to defend. Could be wrong of course, but I think a more broad application might be considered a straying from the SPA and R-IT guidelines, increasing the need for an AdCom (which hasn't happened, thus I'd wager they maintained a relatively conservative application).
I am also in the camp that approval comes early, guessing mid August, in part due to the SPA and reasons stated above.
As far as PPS post-approval, the market is all about known vs unknown, and approval is largely expected, as is eventual acquisition (i.e. it's on everyone's M&A list). I do not think approval is priced in yet, but I do expect it to be priced in as part of a run-up over the next 4-6 weeks. May also see a couple extra bucks thrown in for takeover FOMO.
I am not a legal eagle by any means, but I am not particularly concerned about the ANDA litigation, as I think they will be even happier to settle with BP overlords who will build out a nice big market for generics 10+ years out.
Biggest wild card for me is EVAPORATE. I presume it will follow CHERRY to success, but if anyone has insight on why things have been silent on this, I'd love to hear your thoughts.
Guessing ~ $30 by approval, +/- $10%. Would be surprised if we're still independent 60 days post approval.
Completely agree, but that said, this was directed at all agencies, so until another admin takes office they are steering the ship.
Knowing that, and given the known efficacy, safety profile, and sNDA nature of this indication, I think they skip an AdCom, despite the enormity of the new patient pop. (I also think we get early approval, but that's just my guess.)
Can't help but think this news significantly decreases likelihood of AdCom for Vascepa sNDA. From over a week ago, and figured someone else might post here, but doesn't look like it has been. Apologies if missed in my topic searches.
Trump directs agencies to cut advisory boards by 'at least' one-third
https://thehill.com/regulation/energy-environment/448678-trump-directs-agencies-to-cut-advisory-boards-by-at-least-one
Ha, same. Fingers crossed we get something on EVAPORATE as well. Combined with the way that chart has been coiling, an efficacy halt in an additional trial demonstrating MoA ought to ignite the powderkeg.
A reminder that either tomorrow or Wednesday, Amarin will announce next week's earnings / CC.
I personally like to know of an upcoming email, to avoid that painful feelings when I see an email alert from Amarin and having 100s of thoughts on what it could be, before I open it.
With this update, for comparison's sake, I find it interesting that the COMPASS trial page maintains its "Active, Not recruiting" status despite being halted over a year ago.
I don't think the update to Phase 4 means anything other than to attach proper labels, along with removal of site contact info as enrollment has ceased... but I want to read into the editing of other miscellaneous details, which gives the impression of a final page cleanup vs. a simple status update... I can hope right?
Also note the anticipated completion date was not pushed back, it remains Sept 2019.
I gather the DSMB has very recently reviewed, and we should find out near-term if it has halted, or in the absence of news, runs to completion.
EVAPORATE and Phase IV status
This is bizarre to me. Characterization of this trial as a post-registrational trial. Not sure what exactly to make of that.
I do think the update signals the trial is not stopping at the interim. But there may indeed be more going on behind the scenes.
Perhaps the FDA wants this trial to go the full 18 months because demonstrating MOA is important to them. Ideally that would be a quid pro quo conceded by AMRN in exchange for faster approval of the expanded label?
I'm talking out my butt here. Where is AVII? Why hasn't he anticipated and answered all of our questions on this already? So disappointing.
Of course.
If the PFE rumor was stage 1 of the astroturfing groundwork as PE has speculated, perhaps a 13D/G is stage 2, obviously throwing real gas on the fire.
Then with things in the mid-upper 20s it’s a 100% walk to where I think we are eventually sold around $23B plus a CVR worth up to another $8-10B. I believe that puts us at ~ 60/sh + CVR fully diluted.
Ha as much as I would love one I am not going that far. But today’s action coupled with yesterday’s green in a sea of deep red felt different. Even Twitter sentiment was very positive today from all the randoms. How do we trade 66k AH as simple follow through from morning news on data in ~ 7 weeks, and only move 1%? Just doesn’t line up. Here’s to being a little wealthier this weekend.
Bit late to the party here but today was one weeeeeiiirrrdddd day of trading. Between the boat load of lotto calls, the dip, and the 66k in AH vol, it sure felt like a party with an existing and sizable position was sitting on the bid somewhat, even AH.
I’m terrible with predictions but after that PFE rumor and the Big Boy levels of volume that followed, maybe they are betting on a 13D/G filing before week’s end?
Heck maybe the call buyer is the filer themselves knowing it will spur on higher prices?
Time will tell...
I agree with most of the quotes below, but I think the biggest question (obviously) is how much now, ie cash/stock, vs how much later, ie CVR. The CVR can be a great tool for a deal like this, but it also puts a lot of success into the hands of others. I liken it to a NFL contract, which can look great on the surface, but are not guaranteed and can go up in smoke with an injury. Not a perfect analogy but you get my drift. In our case, of course the buyer would be are incentivized to do the best they can with it, but as a control freak, it still makes me uncomfortable. I'd be willing to trim some long term payouts off the CVR for more cash up front.
As PE/TTE has also explained, we may need several more days/weeks of astroturfing to get that price into a range that closes the premium gap to a reasonable jump.
If our board is willing to accept a deal at 40 + CVR we'll know about it very soon, because 18 is close enough to justify slightly over 100%.
I personally don't see them taking less than $45-50 + CVR. But even if that offer were proposed, the share price will jump to that range, making the next bid's need for a CVR less necessary. Strategically then, it stands to reason we should see a very rosy cash offer and any CVR will be icing on the cake.
For that reason, I don't think pps is high enough yet. Further, I doubt we see anything Monday AM that puts an end to speculation. If this is real, we'll see additional confirmation of rumors, further driving up price, until the gap is small enough to jump.
Since December I've been pointing to the TSRO deal as a model. Rumor, followed by a 2 week climb, and a final price roughly 3x pre-rumor.
Time will tell!
VuBru -
Why is a serious BO offer likely? Just look at all the good reasons posted here for why a BP would want to make an offer - this is the same information that BP is considering:
1) Already an FDA-approved approved drug, with no legitimate reasons not to get expanded FDA indication (only a matter of time). V approval of expanded indication is derisked, which is NOT the common situation in many BOs.
2) V has already to some degree penetrated the market, and this is slowly growing with much room for expansion. Market expansion after FDA label expansion will be exponential.
3) V has best in class efficacy data, with low side effects, and is already covered by multiple insurors
4) It is currently cheap, and prices could be raised if BP wanted to raise additional revenues
5)Even though specific numbers can be argued, the potential target population in the US alone is huge: anyone with CVD and all diabetics at increased risk of CVD, assuming they have at least minimally elevated TG levels.
6) The potentially large European market is totally untapped, with the competition there recently removed
7) Given V's MOA, it has high potential to get other inflammatory related indications (DES, etc) and extended patent life with only relatively short, lower cost trials needed to support an FDA application
8) The company that gets V will have the same market cachet as BPs initially selling statins ("we own the best and most widely used drug")
While I do not know if an offer would be high enough for Amarin to accept, there are certainly many reasons a BP would want to make a serious offer, sooner rather than later. I don't think waiting until FDA expansion happens to offer makes any sense at all. While people experiencing the ADCOM here are gun shy, there is no risk of them not getting an expanded label given the R-It data available, and BP knows this and how the system works (and recall that the FDA were the ones asking for exactly the trial Amarin has provided, as a condition for the expanded indication). Waiting only increases their cost of BO. Given everything above, any BP making an offer will also want to beat the competitors to the punch, and multiple offers will almost surely be out there. I totally agree with HDG that a serious BO offer before end of Q1 is probable, and my bet is that it is high enough (maybe via a CVR) that Amarin will take it.
JMHO
The issue here isn’t value, it’s corporate governance. Big companies boards don’t spend $20bn up front to pay 200% premia with big contingencies out there.
If a deal is coming soon, it’s coming in the $35 to $45 range, with significantly CVRs attached, or it’s not coming now.
Big Pharma boards would rather pay $100 per share with a 40% day-of premium than pay $50 with a 150% day-of premium. They are that myopic. And so are their shareholders.
#'s 5-8, are why there will be competing offers.
different acquirers willing to accept higher levels of risk and outbidding the competing acquirers.
I am all for a bidding war to high heaven, but I am not sure it'd be feasible to disclose confidential offers (or their existence) in the face of an (unknowingly) competing offer, to that competitor. That is to say, other than a wink or whatever the M&A equivalent of that is beyond "sorry we cannot accept your offer."
I think it would have to be public info, ie AMRN would accept an offer, make it public, and THEN the next bid comes in. Right?
Unrelated, but I have to speculate on the tweet on Tuesday night (right before JT's talk) saying very specifically to watch for Amarin "News" in his talk. There was no news. So, maybe they had a BO deal tentatively in place with another company that was to be announced in his talk, but PFE came in at last minute and offered more and stopping the announcement. For all we know, there could be a bidding war going on behind the scenes right now and we would never know.
Obviously a clue the company is about to be abducted by Commander Bourla of the spaceship Lipistar from the planet Pfizer in the Bee Pee Nebula.
Last commercial was aired 1/6/19 on ancient aliens!!
Link:
https://www.ispot.tv/ad/dQeA/vascepa-lowers-high-triglycerides
If this was a legit rumor it would be in the 10,20+ pps increase
North - thanks for the great insights.
If I recall correctly someone here with access to a Bloomie posted a screenshot not too long ago of top BPs with “Cash & Cash Equivalents” on hand — JnJ was top 2 or 3. (I have it saved on my laptop but currently on mobile.)
Also w/r/t Janssen - am I correct in my quick consult of the Google Machine that Janssen is JnJ’s cardio-focused subsidiary? I see JnJ also has a Cardio and Specialty Devices unit, but they seem centered around devices rather than Pharma.
Also according PMLive, here’s their 2018 forecast for top BP cardio sales:
https://www.flickr.com/gp/48406656@N00/7vMXBf
Agreed!
I don't know, someone apparently let the cat out, perhaps an attempt to start a run.
They're an Irish Co, but US HQ is Bedminster NJ.
https://goo.gl/maps/ifSyC7YiSXt