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$MDCO Novartis Nears Deal to acquire $MDCO For $85/share per WSJ https://wsj.com/articles/novartis-nears-deal-to-buy-cholesterol-drug-maker-medicines-co-11574535418…
Oh no, MRC is short $MDCO.
Why do you think the gap will be filled? The gap was associated with material news.
There should be a nice Milestone payment from HLS to Amarin associated with Canadian approval. If approval does occur in December as we anticipate, they could throw Amarin into positive territory for the 4th Quarter. I don't think the amount has been disclosed but it should be a good one.
" Terms of the agreement include up-front and milestone payments to Amarin of up to US$65.0 million. These payments include a non-refundable upfront payment of US$5.0 million, as well as development, regulatory and sale-based milestones totaling up to an additional US$60.0 million. The agreement also provides for HLS to pay Amarin tiered double digit royalties on net sales of Vascepa in Canada. Amarin is obligated to supply finished product to HLS under negotiated supply terms. The agreement for supply and commercialization is for Canada only and includes all Canadian provinces."
NOV 19 • HLS Therapeutics Inc (HLS). Canaccord Genuity initiates coverage with buy rating and a target price of C$22.50, saying the company’s drug Vascepa is expected to improve net sales and EBITDA.
Current price C$17.92
Not sure if this got posted this week. The more exposure HLS gets the better.
I am also seeing Baker Bros owning 1,984,965 shares of MTNB. $1.2M which is like pennies to them.
There is no reason to hire someone and then pay for them to be off over the holidays. Bring everyone in on 1/1 and have them trained during January.
My understanding is Neptune is no longer associated with Acasti.
I've got 11 on my TDAmeritrade feed. Amazing.
HLS last guidance during their quarterly conference call said December. I have seen discussion that the clock stopped for a brief time while the company provided Health Canada more information.
Instead of using a generic statin as an example, think about a new cancer drug that is a first of its kind. It would clearly not be generic but it would be essential. Think pancreatic cancer where many patients die today. If someone came out with a new drug for pancreatic cancer it would become an essential drug.
However they write up this label, it is going to be the only drug available for this indication trigs < 500 . I realize I do tend to think outside the box but I think you can make a case that it should be there. There has not been a new lipid target in years. There is clearly residual risk because people are still dying. Call it trig lowering or call it EPA raising either way IMO, it is a class by itself and clearly the evidence only supports Vascepa and it is essential. They need to come at this from many angles, this is just one of them.
Typically individual companies go through lobbyist groups such as the AHA and ADA and potentially hire their own lobbyist on top of that. There are regulations that need to be changed to to Affordable Care Act plans, high deductible plans and to commercial plans. You know how many right now you can get a statin for $4. That is because it is considered an essential medicine. Vascepa, after the label change, should be included on this list. I have brought that up a few times to Amarin since last September. This stuff will not happen overnight.
Many Medicare Part D plans do not have Vascepa in their formulary because they are not required by regulation to have it there. Lobbyist need to get the regulations changed in conjunction with the new label.
You and others might consider contacting AARP with what is going on. They should know specifically what needs to be changed. In addition to the AHA, ADA etc, I believe the AARP could take this on, on behalf of Medicare patients. It will be the only drug with CVOT outcomes trial for an indication and Medicare patients should have reasonable access to this safe effective drug. Once we have the real label indication in December it will be easier but if they are not working on it now they should be.
They are going through criteria for inclusion right now
Joel Beatty
Got it. So in the near-term, it sounds like manufacturing capacity is increasing quite a bit already. So what’s realistic in the longer term for Vascepa revenues? I think occasionally some of the highest estimates reach as high as let’s say $10 billion in revenue for Vascepa. Is that something that’s realistic? Is there a path to get there?
John Thero
We do hear those numbers and I have done or had various quantitative analysis done that have a range of scenarios that would include numbers in that ballpark. At this point in time, that’s not our guidance. We’ve only given guidance for this year. We don’t even have a label yet for cardiovascular risk reduction. We do think that’s the opportunity here is in multiple billions of dollars as to whether it’s, $10 billion or not. I think it’s a little premature to be providing guidance there. But this is a very large opportunity and we are positioning ourselves that if the demand is that high that we’ll get there.
Please also see AMarin's Q&A take on supply.
https://amarincorp.gcs-web.com/static-files/415bd347-0579-4897-bec9-a0e82d4f0380
I actually worked for the hospital at the time that the Abiocor was first implanted at. Jewish Hospital, Louisville Ky.
I don't know a great deal about abiomed anymore and how much of their revenue is related to Impella.
Here is a short blurb about today's study results. http://www.firstwordmedtech.com/node/1025084?tsid=28®ion_id=6
Just go to twitter and search for Impella or search for #AHA19 and Impella and see what some are saying. I do see where there may be bias in the study results because impella patients may have been the sicker patients to begin with.
Good luck.
Did you look at the data that came out on the impella trial today? I don't think it was very good.
Yes, you can definitely specify each lot.
Yes, in your case it can be both. You could probably also ask your doctor for a written prescription and take it in somewhere else where they will fill it self pay w/the coupon.
Here is the next tweet
https://twitter.com/GPUWorld/status/1196089178942894080
Yes, I am also excited about Evaporate. It probably means another nite of waking up before 5am. It has been quite a week.
Dr Bhatt Day one highlights from AHA. https://www.acc.org/latest-in-cardiology/articles/2019/11/09/08/45/video-interview-sat-day-1-highlights-aha-2019#.XdEpNrEQoMo.twitter
A drug plan doesn't fill a script, a pharmacy does. A physician can appeal the decision which is happening now and will continue to happen or you can pay out of pocket. We are just widening the goalpost of what is on label and what is off label.
I was never a king or a CEO as most kings and CEO's do not come out of Finance. I have done well enough in the market and in my job that I retired in my 40s.
Twitter feed #AHA19 and ISCHEMIA yesterday was in an uproar about these trial results. Interventionists are worried patients will not want to have stents because of these results. The only people who were enrolled in the trial were patients that had milder symptoms. If a patient was in bad shape they were not enrolled in the trial and were stented or had surgery. It is good news though, it will help us on the Medical Management front for sure.
I worked in Healthcare Finance and am well versed in how the insurance industry operates. I am not saying that the label could not limit access as it could.
Vascepa is Tier 4 currently for CVS Silver scripts whether you are on label or not. The Tier for a Medicare Part D plan will not change until CMS changes how it treats this drug. It is a separate government agency from the FDA. Coverage for it and it will move to a different Tier at some time in the future. It will not be in two different tiers as you suggest. We are going to need lobbyist to get the changes made for the Part D plans, that is why the AHA is working on it. Just the change in indication from the FDA is not going to help with the Medicare plans.
I personally have gone through 3 insurance changes while taking Vascepa so I understand personally and professionally.
I stopped reading at bookeeper, not spelled correctly.
Typically phase 1 only occurs for a 1st indication, once you know it is safe you can move onto phase 2 after you have some justification (usually pre-clinical) for proceeding forward.
This study already underway seems to be along the lines of what you are referring to as far as cancer.
https://www.clinicaltrials.gov/ct2/show/NCT03661047?term=colon+cancer+icosapent+ethyl&draw=2&rank=1
i have never seen a drug company have more than one tier for a drug based on whether it is on or off label. What they will do if they choose to, but will be a major pain for them is to have prior authorizations in place and try and deny coverage if the patient is not on label. Just like today, many patients get it off label, that will still be the case in the future, it is just that the label will be much bigger.
Different tax rates in the U.S. for short vs long term so you need to consider that as well.
I have never mentioned this before but I had a parathyroid tumor. The parathyroid is suppose to regulate calcium in the body. Well mine wasn't working and I had calcium everywhere. Before I knew what was going on I had an x-ray of my foot as I had so much foot pain. Two radiologist put me in a room and told me that he had never seen anything like it before. This was at a major teaching hospital. I had a layer of "something" on top of my bone and they could not see my bone. Well anyway, come to find out i had calcium everywhere and I was very sick. There are both mental and physical symptoms that I won't get into. If anyone is interested they can look them up. So it took a few years to be diagnosed with the parathyroid. It took changing primary care physicians to figure it out. Once diagnosed I had one (out of four) parathyroid glands removed, the one with the tumor. Yes, I felt better afterwards but still felt like a sludge. I have never had a calcium scan so I don't have evidence of how bad it was.
I have been on Vascepa since 2013 (with one break in the middle after my physician quit practicing. Over the years I have felt better and better.
How much better, just this week I golfed 18 on Monday and went to the gym Tuesday Wednesday and Friday., got the grass cut and did other work around the house. It is not just physical improvement is is mental as well. Also memory issues have resolved. I credit Vascepa with removing the residual calcium that was all over my body after the surgery. I literally feel great.
I feel like I owe Vascepa and Amarin my life. If anyone has high Calcium scores in your blood, make sure to get a PTH (parathyroid) test. Only way to fix it is to have the offending parathyroid removed.
You are missing the point, read AMRN's frequently asked questions about their source.
Thanks Sam, I know you were frustrated yesterday with the broadcast cutting in and out but I am glad you got to listen to the important part at the end. Thank you for your continued dedication and all you do. I appreciate it.
Read the thread. He was telling me I was wrong, when I stated that it wouldn't open tonight.
It is my understanding that if you do not tell the Nasdaq to open it back up by 4, it stays closed overnight.
There was only one vote. No vote on primary or secondary. Nothing was in the briefing documents for additional questions. They will leave it up to the FDA.
If you get back in, do not reboot or close out if it closes down, Just wait and it will eventually come back up.
Still speakers, all positive. Budoff presented MO data from Evaporate which showed similar outcomes to other placebo. Take some deep breaths everybody. It is all good.
You might close out of some other stuff on your laptop.
Thanks to RobCOS - IV Board Jefferies just out -Amarin Corporation (AMRN, BUY): Going into Half-Time Show...Continues to Look Fine Based on FDA Presentation
Key Takeaway
FDA presented their review and handled Q&A from committee. FDA presented a rigorous analysis on mineral oil (5-10 slides) and other sensitivity factors (dropouts, etc.) and concluded results of REDUCE-IT are robust and mineral oil would have at worst, a small impact (3%). We remain positive on approval and also believe the "wording" of the label population to be another investor debate but overall not a big impact to consensus, in our view.
Insights
Finishing the first half of the Adcom Panel, the presentation by FDA suggests positive conclusions and we remain confident on approval of label expansion for AMRN. And while one committee doc kept asking/pushing on mineral oil impact on LDL and even blood pressure, FDA continued to suggest it had minimal impact. Interestingly, the committee questions are all aimed at FDA and few - if any - were to AMRN.
The FDA stated: (1) data shows stat sig efficacy results, (2) this is confirmed by multiple sensitivity analyses, (3) mineral oil placebo is unlikely to invalidate the study conclusion, (4) the proposed indication is broader than trial population, and (5) on safety there is higher A-Fib and bleeding but despite this the benefit risk profile remains favorable.
There is at least one doc who keeps asking on mineral oil and on all the other biomarker impacts (e.g., increase in hsCRP, 1mmHg increase in blood pressure, etc.) and FDA essentially said you could look at every little signal and marker and maybe it's an outstanding question, but it's not likely to impact the overall conclusion. And CRP and LDL may or not be independent from each other, so you cannot just take each and add up all the biomarkers and say it's due to mineral oil. And 1mmHG blood pressure doesn't portend anything whereas 20mmHG increase could double relative risk, but FDA said can't scrutinize 1mmHG as significant. Doc then said he feels challenged by the conclusion that none of this has an effect.
To address another investor debate around broadness of label (primary vs secondary): we want to clarify for the Street this is not a label for broad "primary" vs "secondary" patients but a request by AMRN for a labeled population that reflects a "high risk primary" population as well as obviously secondary prevention for pts with existing CV disease. The total could be at least 5-15M pts in the US. But even hitting just 1M pts on drug is a $2.5B drug in USA.
The "high-risk" primary population is a request for pts with high trigs, existing diabetes, and one other factor (one of many are listed out). We believe the label could reflect a "high-risk" primary population and we'll await final discussion by committee during the vote later today - but the secondary prevention is the vast majority of what is likely to be using Vascepa anyway, and frankly it's not clear that the exact wording of the label would even materially impact prescriptions, utilization, or reimbursement (and we note payor access even right now w/o a label has minimal restrictions, and it doesn't even have a formal CVOT label yet). So we think it's a good debate to have around wording of the label, but will not dramatically impact the stock either way or consensus numbers.
No one has even asked for Amarin's explanation for anything.