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good point Raf!!
IMO, Amarin will be sold within 18 months - max. The bigger question will be at what price. $30 to $50 Billion? The presentation Nov 10th will be fun to watch.
You could hear it in JT's voice on the CC yesterday. He knows he has a real winner, best in class!!! My other guess is the secondary endpoints are even better (by a lot).
Every CEO says they won't sell but there is always a price!! It is going to be ALOT MORE FUN to watch Amarin moving forward than the pain we all have felt the last 5 years. Congrats again to all!!!
south of SF, I know it well. I worked for a medical company based there
I love hearing the excitement in JT's voice!!! He knows AMRN is in the driver's seat moving forward
BB, I too think big pharma will come calling soon. 25% RRR is better than anything on the market and Amarin has all of the patents. I think $15 Billion offer could be low?
Congrats again to all!!!
new slides out for the CC
http://investor.amarincorp.com/static-files/bdb4dda0-edcc-4a94-87bd-6fa245482ad0
CONGRATS TO ALL!!!!!!
Nice find!
Good call and straight to the point!!
100% agree!!
Dude, I agree 100%
Thx for the article Chris! Here are the details on the ASCEND study. 1g is way to low of a dose to be therapeutic.
ASCEND is a randomized trial assessing whether 100 mg daily aspirin safely prevents CVD and cancer in patients with diabetes without known arterial disease. It is also assessing whether supplementation with 1 g omega-3 FA daily prevents CVD. This paper describes the methods and baseline characteristics of the randomized participants.
Maz, I am excited too!! I hope to see the job openings triple in the next 60 days. Apologies if you took my post in a negative way. I just wanted to explain the general pharma sales rep comp plan with most larger companies. Good luck to all moving forward.!
Marzan,I think your very low on the comp plans for sales reps. My guess is total comp closer to $120-$140k plus car (gas and insurance $7-$10k), computer and monthly expenses ($500-$1k monthly). Normally, reps make larger amount salary and smaller amount commission rates.
Also, Amarin is not going to hire reps without cardiology call point experience.
JL, we all want the same thing, a postive ending to the study. I don’t think Amarin’s management will leak info. But, it seems to happen with this stock from somewhere on big events. Sorry you disagree
IMO it will leak before the official announcement. Amarin unfortunately has along history of this happening with big news. You will see it in options/stock price.
O, I saw this but I was hoping for a list with more detail? Sorry for not being specific.
Good morning everyone!!!, Like most here I have been holding this stock since 2012. I do not post a lot but I thought a breakdown of the Reduce-IT trial might help re-focus us all.
I understand the primary endpoints, but does anyone know where to find a FULL copy of the "more than 30 pre-specified secondary and tertiary endpoints designed to capture multiple potential drug effects in multiple additional sub-populations." as stated in the Aug 4, 2016 press release?
Also, I will be interested to see the over-all drop out rate of both groups.
Here is a copy of the study.
https://onlinelibrary.wiley.com/doi/full/10.1002/clc.22692
Great read BB!! This would be dangerous and deadly policy for patients with a wide range of diseases (not just our area).
I like these parts:
Natural sources EPA, such as common fish or krill oil, on their face, are much less potent. A consumer would have to consume a likely intolerable amount of common fish oil or common krill oil in an effort to even get the same dosage ofE-EP A in Vascepa®. For example, a 350 mg capsule of MegaRed Omega-3 Krill Oil contains approximately 50 mg of natural EP A in eachcapsule,29 whereas a 1 gram capsule of Vascepa contains 1000 mg of EPA. Given that the FDA-approved dose of Vascepa® to reduce triglyceride levels in adult patients with severe hypertriglyceridemia is 4000 mg per day (e.g., two, l gram capsules twice a day), consumers
would have to take approximately 80 capsules of MegaRed® Omega-3 Krill Oil daily to get a similar dose of EPA from that product as they would get from four, 1 gram capsules of Vascepa. And, significantly, even if patients were willing to take 80 capsules of MegaRed Omega-3 Krill Oil, or another common fish oil, per day (and it is unlikely that they would bewilling to do so), there would be no assurance that it would either have the same effect as Vascepa® or that such a large volume of common krill oil is safe.
AND
Finally, even when dietary supplements and drugs both contain simi/err components, they may have wholly different active moieties (i.e.. the functional part ofa drug molecule), which may make them have different risk/benefit profiles. For example, FDA has explicitly determined that Lovaza®, an FDA-approved drug that contains a mixture of omega-3 fatty acids in the ethyl ester form, has a different "active ingredient, and a different "active moiety'' than Vascepa®, which is almost 100% E-EPA. Thus, common fish or krill oil dietary supplements, which unlike Vascepa®, contain multiple fatty acids - have a wholly different active moiety than V ascepa®.
AND FINALLY:
As referenced above, pursuant to the FDCA and its implementing regulations, a dietary supplement cannot be marketed with a "disease claim" (i.e., a claim that the product is intended to treat, prevent, cure, or mitigate a disease) without invoking unlawful "drug" status. Moreover, FDA regulations specifically provide that "disease claims" include claims that a purported dietary supplement is a substitute for a "product that is a therapy for a disease. If this were not the case - if products marketed as dietary supplements could be marketed with ''disease claims" or as substitutes for drugs- then a large number of products could evade FDA's drug approval process and manufacturers would have no incentive to invest in the scientific research that would otherwise be necessary for drug approval. Given that these products cannot be marketed with disease claims, it follows that Part D plans should not be using these products to treat disease.
Congress and FDA clearly do not intend for dietary supplements to be widely used to treat disease or widely used as substitutes for drugs. Any CMS policy that explicitly or even implicitly could be interpreted (and would be understood) to encourage dietary supplements to be substituted for drugs, therefore, would stand as an obstacle to Congress' and FDA's objectives, ultimately undermining the provisions in the FDCA intended to drive scientific investigation and undermining the drug approval requirement.
BB, FYI, My old partner worked for ICPT for the past 2 years and just left the organization. Their management is a total wreck, losing ALL of their top reps across the country. Their NASH study is delayed and Ocaliva has over 65 deaths since launched (keep in mind this is a sick patient population).
My point, I don't think this is the company AMRN would want to partner with at this time.
Sam, Whal is not taking seriously that this IS the time period when most physicians (and everyone else) are out on vacations. Not just some, most all. I have been in medical sales for 17 years and July - August is always flat or down slightly. The fact that the numbers have held steady is impressive. We should see the numbers continue to improve.
Thanks to Sam and FF for these updates and graphs. FF I still think we need to be watching the call options closely in the next few months.
Thanks Sam. Thinking back on a past post, I believe there were 5 fewer sales days in this earnings report? Great numbers and CC today.
Pyrr - my thought is that JT is covering AMRN's butt by adding secondary endpoints so there are NO questions of data within any sub-groups of patients at the next SPA. Its a high goal, but IMO if successful it locks the competition out. I think they learned their lessons after the ANCHOR SPA.
WOW, thanks FF!! That makes sense!!! So, IF this plays out like the options show (I am a novice with options, bare with me) the open PUTS are saying the stock pulls back under $3 after the CC before going long on CALLS into Sept $4 and $5?
Guys, has anybody been watching the options in the past few days? The $4 (2008 contracts) and $5 ($2952 contracts) Sept calls are going crazy!! Something has leaked. We will most likely find out on the CC in 24hrs. Good luck to all!!
Nice find Fish!! Interesting someone made almost a million share long bet with 26 TRADING days left on the contracts with a strike price we have not see since Oct 2013. Hell, we haven't seen $2.5 since March 2015. This looks like more than just a Hedge. Thats a big bet. Seems like someone has been tipped off again.
Guys and girls, are we missing some binary event?
I agree. Good news to move forward.
Apollo, great summary. IMO we are days away from finding out the fate of GALE. IMO The FDA move early this month was a great signal of the good things to come. Im wondering if BP buys after the BLA is filed? You would think the longer they wait the higher the price will be for GALE.
Wow, now JAMA is printing opinion articles? This is one of the worst takes I have heard yet. Misleading to say the least
BB - These models (or similar plans) have been talked about for years. I believe Hillarycare proposed these single payer or tier pricing for pharma in the mid 1990's.
BB, once again we are all on the team here!! But you are comparing apples to the WHOLE FARM!! Gilead has a cure to eliminate Hep C (my sales partner worked for Vertex so I know the details) that's why the treatment is $82,000 to $92,500. Congress can have all the hearings they want but it will have very little effect on pricing.
With all due respect, I have been in medical sales for over 15 yrs and never seen that type of change come out of these hearings. This Congress won't do anything other than push sub-par treatments and generic drugs. V will have to over come these challenges with superior study results. I believe (like you) that we have, are and will be seeing this more in the future.
BB, FYI, any effect on reimbursement rates would be for 2017 and beyond. 2016 is set.
AstraZeneca Wields Amarin Win In FDA Exclusivity Fight
Share us on: By Jeff Overley
Law360, New York (November 4, 2015, 5:03 PM ET) -- AstraZeneca is wielding a recent court victory by Amarin Pharma in hopes of securing longer exclusivity for triglyceride-reducing drug Epanova, a sign that the ruling carries significant implications for new products with older components.
The U.K. drugmaker’s action came Monday in a supplement to a citizen petition it lodged last year with the U.S. Food and Drug Administration. The supplement focused on a May court ruling that vacated the FDA’s denial of five-year exclusivity for Amarin Pharmaceuticals Ireland Ltd.'s omega-3 drug Vascepa.
According to AstraZeneca LP, the ruling "firmly supports" its request that the FDA grant five-year exclusivity to Epanova. The omega-3 product was approved last year but has not received a decision on whether it deserves five years of exclusivity as a new chemical entity.
Vascepa was initially denied five-year exclusivity because its so-called active moiety, EPA, is one component of GlaxoSmithKline PLC's Lovaza, an omega-3 mixture. Active moieties are molecular components that determine exclusivity. Under federal regulations, a product can be deemed a new chemical entity so long as it “contains no active moiety that has been approved by FDA.”
The May ruling found that EPA had not been approved previously in isolation and that it was therefore eligible for five-year exclusivity.
AstraZeneca says the court's logic applies to Epanova, which is a new mixture of older components, including the fatty acids EPA and DHA, but has only one active ingredient — the mixture as a whole. According to AstraZeneca, the court ruling means that a mixture approved as a single active ingredient cannot be broken down into separate active moieties for the purposes of exclusivity.
“The Amarin decision has established an important precedent for evaluating five-year exclusivity when naturally derived mixtures are involved,” AstraZeneca wrote. “Specifically, when FDA approves a naturally derived mixture as a single active ingredient product, the agency cannot later treat its components as individual active moieties for exclusivity purposes.”
The FDA has not acted publicly on the May ruling, which included a remand for further proceedings. Adding more uncertainty is the fact that Allergan PLC unit Watson Laboratories Inc. is trying to intervene in the case and overturn the ruling.
Regardless, even if the FDA were to somehow ultimately stick to its original approach, it would need to engage in formal rule-making, AstraZeneca said on Monday.
A spokesman for the FDA on Wednesday declined to comment, saying that the agency will respond directly to AstraZeneca.
AstraZeneca is represented by Robert F. Church and David M. Fox of Hogan Lovells US LLP.
--Editing by Christine Chun.
Anybody have thoughts about the 8 am EST earnings C.C. tomorrow?
I enjoy reading all post, and the good and bad discussions. Everyone is entitled to their opinions and here is mine after today's update.
IMO I think we need to take a closer look at the past events and the studies argued. Mainly, the time frame from the PUFDA date to the update today on the talks with the FDA. At this point AMRN has a pseudo Anchor label (1st amendment case). AMRN can and will market their product in that way under the current judgement (even if it is temp judgement, it is still a positive judgement for AMRN). The FDA knows this and is in a very bad spot with the overall industry. If the FDA does not appeal they are dealing with 1 company now (just speaking of our case, others are making claims but have not won in court). Appeal it and lose, then you have opened Pandora's box not only for pharma companies but for every medical device maker claiming 1st amendment rights on ANY study.
With that said, the FDA isn't going to lay down and roll over. This is why we are at this point today with another delay. These decisions take time with both parties to weight the outcomes. IMO this delay has more to due with getting Anchor labeling on the product in some way and some how. Maybe not having the FDA saying it was wrong to pull the SPA agreement but close to it.
R-IT will be finished out. IMO R-IT will stand on its own after peer reviews and the full data is released. If the interim look is as positive as people on this board think (I am in this side of thinking and that is why I am invested in it) then we could have a possibility of a cross over from the blinded side after the interim. The study would be modified,the stock price will rise and the AMRN will be sold to the highest bidder.
NCE is another issue that I am still trying to figure out why Watson currently has any standing (I know the argument Watson is currently making and I think Judge Moss knows it will get tossed out on merits in the Appeals Court). This looks like it could be an open issue for some time (I hope over the 5 yr mark) and be a muted point.
I have been in Med sales for 15 years and IMO (and only mine) I can't imagine the FDA allowing R-IT on the labeling at an interim look no matter how positive the results without going thru some type of PUFDA process.
FDA Removes Pacira Warning Letter Amid Free Speech Suit
Share us on: By Jeff Overley
Law360, New York (October 16, 2015, 8:40 PM ET) -- The U.S. Food and Drug Administration has quietly unpublished a warning letter objecting to the promotional practices of Pacira Pharmaceuticals Inc., an unusual step that follows the drugmaker’s constitutional challenge to restrictions on its commercial speech.
A spokeswoman for the FDA declined to comment on why the warning letter was removed from the agency’s website, citing ongoing litigation that Pacira launched last month. The agency is scheduled to formally respond to Pacira’s lawsuit in New York federal court by Oct. 26.
Representatives of Pacira did not respond to multiple requests for comment.
Scott S. Liebman, a Loeb & Loeb LLP partner who is not involved in the case, described removal of a warning letter as an extremely rare occurrence.
“It is unusual for FDA to take a letter down after posting it,” Liebman told Law360. “FDA began posting letters in 1997, and I'm not aware of any others that have been unpublished after the fact.”
It is not clear when the letter was taken down or if the removal is connected to any unpublicized development in Pacira’s case, such as possible settlement talks. Last month, in requesting more time to reply to Pacira's complaint, the FDA said that it would "use the additional time requested to explore whether the parties can amicably resolve or narrow the issues raised by [the lawsuit]."
In the September 2014 warning letter, FDA officials accused Pacira of promoting the anesthetic Exparel for unapproved uses and overstating the drug’s effectiveness. In doing so, the FDA warned of criminal liability if the alleged misconduct continued.
Pacira initially acquiesced and sent out corrective statements. But it eventually filed suit, asserting that the FDA had silenced its speech in violation of the First Amendment; enforced vague policies in violation of the Fifth Amendment; and abruptly changed Exparel’s approved labeling in violation of the Administrative Procedure Act.
According to Pacira, the FDA initially approved Exparel in 2011 for general use, only to backtrack three years later in the warning letter by asserting that Exparel was approved only for two specific surgeries that were studied in clinical trials.
Pacira’s lawsuit followed Amarin Pharma Inc.’s victory over the FDA in a First Amendment case this year involving off-label promotion of omega-3 drug Vascepa. In addition, Amarin’s triumph followed a pharmaceutical salesman’s victory over the FDA in U.S. v. Caronia, a First Amendment case in 2012 involving off-label promotion of narcolepsy drug Xyrem.
All three cases involved communications that purported to be truthful and nonmisleading. And with the FDA already reeling from the Amarin and Caronia defeats, the Pacira case has threatened to remove any doubt that the agency’s authority is rapidly being diminished.
In an amicus brief on Thursday, a drugmaker coalition called the Medical Information Working Group suggested that the FDA was poised for another defeat, writing that Pacira’s case “is at least as compelling as that presented in Caronia and Amarin.”
Trade group Pharmaceutical Research and Manufacturers of America also filed an amicus brief Thursday in support of Pacira, writing that the FDA's warning letter "raises serious constitutional concerns."
--Editing by John Quinn.
Am I reading this right? Basically the Waston's motion is a non-issue unless the FDA appeals?
King & Spalding Lures Off-Label Expert From FDA
Law360, New York (September 10, 2015, 4:30 PM ET) --
Lisa Dwyer
King & Spalding LLP has snapped up a U.S. Food and Drug Administration senior adviser who guided policymaking on off-label marketing, laboratory-developed tests and other areas of intense recent interest, the firm announced this week.
The hiring of Lisa Dwyer, who left the FDA at the end of July, gives King & Spalding a partner with firsthand information about the agency’s thinking on a variety of closely watched topics. Perhaps most prominently, Dwyer served as lead adviser in the FDA’s Office of Policy during development of guidance on acceptable off-label communications by drugmakers.
At King & Spalding, that experience will benefit drugmaker clients on “policy development with regard to what their sales forces can say” about unapproved uses, Dwyer said in an interview.
In a separate arena, Dwyer also supplied strategic advice to FDA leadership as the agency created and introduced plans to begin regulating laboratory-developed tests, or LDTS, as medical devices. That policy change has touched off an epic lobbying battle and is likely to result in litigation if finalized.
Dwyer declined to comment on any specific actions the FDA is planning with respect to off-label marketing and LDTs, including the possible timing of any announcements in those areas. She also declined to discuss agency thinking with respect to a lawsuit brought by Amarin Pharma Inc., which recently won the right to engage in truthful off-label marketing.
During more than five years at the FDA, Dwyer also presided over regulatory efforts involving the White House’s Precision Medicine Initiative, restaurant menu labeling, implementation of anti-smoking legislation and abuse of narcotic painkillers. She also served as deputy chief of staff to former FDA Commissioner Margaret Hamburg.
Prior to the FDA, Dwyer practiced law at Patton Boggs LLP, now Squire Patton Boggs, as well as Sonnenschein Nath & Rosenthal LLP, now Dentons.
“I’ve really been a jack of all trades,” Dwyer said.
King & Spalding was attractive, she said, because of its “vast international reach” and “incredibly deep food and drug law bench.” In addition, King & Spalding’s team includes two lawyers who Dwyer worked alongside during her days at Patton Boggs.
“It felt like a homecoming to a certain extent,” she said.