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Lovaza's script numb this week is the lowest since xmas 2009 and that was when scripts were still ramping higher for them.
The best thing about today's trading is notching off one more day before Adcom. At least with Adcom, our floor should rise.
given the amount of time the stock has sat at .33 and .34 today, it feels like another guy is getting out. always another one that loses patience..
as am i.
but just as a data point - i know a few fund managers that were in the stock for the anchor p3 data, then held it through the initial IP scare and lack of NCE. they finally punted. they still love the story but have yet to pull the trigger again.
a lot of guys like that out there. it will all happen in a week, when it happens.
I cant disagree Ajax. If someone has some piece of illegal insider info on the short side, then they do.
AMRNs language in the 6k Reduce IT PR was quite cut and dry in its confidence, especially around the SPA language.
Also, dont forget, that we are all too close to this story, and a 40 cent move seems epic. Most of WS doesnt care.
Perhaps Ajax. We are all so bullish and its always good to be skeptical. Lets not also forget that there is unfortunately a shitload of stock out there. Anyone who wanted to own AMRN cheap could have and gotten more than his fill of shares. Those who bought in the latest offering have made a decent little profit in a relatively short time and they could be sellers if they dont know the story that well.
Thus the only true incremental buyer of AMRN is one who wants a story that has less uncertainty to it. Or we just get a naturally upward bid to the stock as value creating events unfold.
At this point, I fully expect the stock to yawn at Adcom and mildly smile at PDUFA. Unfortunately, the reality here is that Vascepa is bucketed as fish oil. Its great but that is what it is. This is not a cancer cure that every oncologist will know about before P3 data is out. The path to solid sales for V is inevitable, but WS wont pay up too early. Maybe JZ via GIA can ramp better than WS thinks, but at this point, they are watching and waiting and will buy later rather than sooner. There are sellers on the way up now without a value creating catalyst.
I think we overestimate the real short interest here, ex the hedge in place for the convert. Perhaps Im wrong. Fundamental short is making less and less sense here but new, slow moving, long only money is still far away from AMRN.
Ajax
I think the simple answer is WS only cares a tiny bit about the Adcom decision. AF doesnt have that much influence. The street pretty much knows that Adcom is a no brainer.
Net net, AMRN will start to work when there is either a partnership or under GIA scripts begin to ramp materially.
We may all believe that even under GIA the script ramp due to Anchor + denial of Lovaza for off label will be low hanging fruit to ramp scripts but WS will wait.
We had a very fragile run up starting last week. But too fragile given govt shutdown uncertainty. WS wants a buyout or a real partnership. Remember downdraft of 8pct the day after Marine was approved?
WS wants a BO, partnership or scripts ramping like a Saturn V leaving the launchpad. The only thing JZ did wrong was to say he had more parties interested in buying him than he had employees. Everyone piled in then and they all got burned. Compelling greed will have to exist for some to return to this name.
The story seems intact, at least to me. We will just have to wait.
On average Vascepa gains 50-60basis points of market share gain v Lovaza in prescription omega 3s per week...
Good stuff Ajax. May there be more balls hit and more tacks done in the future and less time on the message board, if you know what I mean.
I will be doing a bit of sailing on SF bay now that there will be some room to do some tacks and gybes out there...
For me it seems too coincidental that exactly when Boehner lost control of his votes that the stock faded...
the facts are that if there is no new funding by oct 1, parts of the govt will shut down. new fy starts oct 1.
oct 17th is the day US begins to default on debt if debt ceiling not raised. they are two different issues.
about the same time the stock started to fade today, it became clear that Boehner's did not have this party in a place to be able to vote to keep the govt from shutting. This will play out all weekend and into Monday. The govts new fiscal year starts on Tues.
It was renewed govt shutdown fear
someone could have just as easily shorted the pop after it was clear it wasnt going higher than 7. market fade added more confidence on the trade. while someone may have some sort of info out there, it seems more like a trading call today versus some new nugget of info being played out by someone.
just my opinion.
agreed. we are close but until we are really there, WS will continue to ignore AMRN. Right now the lemmings love anything cancer.
someone wanted out and there was volume today. end of month is monday.
just a lot of loose stock out there after all the volatility and offerings. no one said filling the gap back up would be easy until adcom re values the company. sellers today could easily have been the guys that bought on the lovaza generic break. 6.60 close remains elusive technically.
6019
Lets also not forget they are enrolling patients in places like Ukraine where CAEs are insanely high. Ukraine was not chosen as an enrollment site by chance.
I wonder... If in a post Anchor approval world, will AMRN reps be able to pitch the value prop that using Vascepa allows patients to be on a reduced dose of statin, which obviously has bad side effects?
yep. think of getting double the lovaza into your system in half the time! that is epanova!
Second point first - Esprit was a six week trial:
http://www.prnewswire.com/news-releases/omthera-pharmaceuticals-presents-successful-phase-3-results-from-evolve-and-esprit-clinical-studies-for-epanova-both-trials-meet-primary-and-secondary-endpoints-177243171.html
First point - as you can see in the Esprit side effects, they talk about mild GI issues. None of those w Vascepa. Other than those facts, its just my opinion that over time, people may get sick of mild GI issues persisting for the rest of their lives. What else would cause the mild GI issues for Epanova v Lovaza as they are basically the same drug, w Epanova uptaken faster by the the body than L?
Look at the side effect profile from Omthera. It is definitely slightly worse than Lovaza or Amarin in GI issues. This is my opinion, but the once a day formula means rapid absorption which in turn means more GI issues. Also, the six week trial seemed to be timed perfectly to get beneficial omega 3 effect but not long enough for GI issues to get build... Again, my opinion, but why else would you only do a six week trial v a twelve week one?
I dont know why they wouldnt want to be involved. Its likely a price/economics issue. One or both sides will have to budge somewhat. Adcom and PDUFA and even NCE should help budge the positions somewhat.
In the meantime its GIA until someone blinks...
Epanova gives one the trots pretty good after one has taken it for a while, I think. Why else would they limit the duration of their Anchor study to only 6 weeks. I think the drug may have a tough time receiving widespread durable adoption. Maybe one script and one refill but the burps and fishy runny stuff in the toilet are major turnoffs for long term use. No reason for an omega three to be uptaken into the body that fast... Would you want to be burping up fishy for the rest of your life?
When do we get full enrollment in Reduce IT? I think very soon.
Trial enrollment began Dec 11; Substantially underway occurred Jan 13. Assuming sites are still full run rate and it took a few months to get ramped at the beginning of enrollment, we should be close.
If the company announces this, it should be a positive catalyst as we are one step closer to outcomes data. Given the sick nature of many patients in Reduce IT, I think the company is being conservative in its target end date.
If docs pay attention to the Adcom, we could see acceleration in scripts before approval.
Based on this week's 5830 script number, Vascepa only needs steady 2.4pct weekly growth to get to 20k scripts in a year.
Perhaps this cant be done in the Marine only population but who knows exactly where off label is going with Vascepa. With Anchor this seems like a very very low bar to breakeven. assuming 20k scripts is breakeven.
Combine this with the fact that Amarin has already hit up a lot of the docs that are high omega three subscribers so sell into Anchor should be easy w these docs and that Lovaza wont be covered by insurance if Anchor is approved.
This is why GIA is making a lot of sense whether you like it or not.
Yes and this is off a bigger base, but offset somewhat by the slower summer season...
If the Adcom is comprised of practicing doctors and not experts on chemistry, how could they actually have a say on NCE?
Seems like one of two things is going on
1) Since they have not already assigned NME, then they are waiting for Anchor approval to assign NCE given that the new indication supports NCE
2)They are waiting on NCE post Adcom as the Adcom may really matter relative to near term approval or post Reduce IT approval.
Seems to me the former is the much more likely possibility given everything that continues to be discussed here re SPA, clean day 74 letter, FDA's desire to get outcome data, etc...
OB updated. Vascepa status unchanged.
For JL and his scleroderma research:
Amazing device and approach that CYTX has to using regenerative cells; multiple applications for the device; but a bear to get out into the market.
Cytori Therapeutics posts preliminary data from Scleroderma study
Friday, September 20, 2013 02:05:12 PM (GMT)
CYTX posted preliminary results on its website:
CYTX announces positive early data from a study evaluating Cytori’s cell therapy as a potential treatment for scleroderma, a rare autoimmune disorder.
The results will be presented today by the principal investigator of the study at H?pital de la Conception, AP-HM Marseille, France, at the 3rd Annual Cell Society Meeting.
As part of the study, 12 patients received injection of Cytori’s cell therapy into their fingers. The primary endpoints are safety, and the improvement in function of the hands, as measured by the Cochin hand functional scale at six months. At two month follow-up, the following outcomes were observed:
Primary
No reports of infection, ischemic complications or serious adverse events;
Significant improvement in the Cochin hand function disability scale (48.5±10.8 to 25.5±16.5, p<0.001)
Secondary
Significant improvement in hand pain, as measured by the visual analog pain scale (from 59.4±17.2 to 21.6±17.5, p<0.001);
Significant improvement in scleroderma health assessment questionnaire score (p<0.001);
Significant improvement in Raynaud’s Severity Score (p<0.001).
Industries: Medical Equipment & Supplies
Primary Company: CYTX-US
Related Identifiers: CYTX-US
Reference Links: ir.cytori.com
Related Stories:
Cytori Therapeutics announces initiation of cell therapy trial in France
Teva announces launch of generic equivalent to NIASPAN in US
Friday, September 20, 2013 01:52:17 PM (GMT)
Teva Pharmaceutical Industries announces launch of the generic equivalent to NIASPAN (niacin extended-release) tablets, 500, 700, and 1000Mg in the US
Teva was first to file, making the product eligible for 180 days of marketing exclusivity
StreetAccount notes NIASPAN is marketed by AbbVie (ABBV) and used with diet to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia
Industries: Biotechnology & Drugs, Major Drugs
Primary Company: TEVA-IL
Related Identifiers: TEVA-IL, ABBV-US, ABT-US
Subjects: Drugs (FDA, CHMP, etc.), Regulatory
Tnx Akanz, but if they don't get Anchor approval, will FDA let them market s combo pill, as most statin use is in Anchor population and statin exacerbate pancreatitis in Marine?
Not clear to me how AZN can market a combo pill of Crestor and Epanova....
For very high trigs, statins aren't always used as they raise risk for pancreatitis, which these pts are already at risk for. Thus, without their own Anchor, they must rely on a massive off label combo strategy or stick w pipsqueak addressable market size w increased pancreatitis risk.
Am I missing something here?
If FDA was focused on Outcomes at the ADcom, wouldn't they be convening a cardio panel instead of endocrinology and metabolism. I mean do the endo metabo guys even have the credentials to talk about cardio outcomes????
Message board fatigue has kicked in.
We are close boys and girls. The chips are on the table and the the flop is coming in a month.
Also no mention of risk of Anchor approval. All risk is a function rollout and commercialization..
Adcom expanded to CHD in addition to mixed trigs. Can someone confirm the below?
FDA panel to review Amarin's sNDA Vascepa for the indication in adults with mixed dyslipidemia and CHD
Friday, August 16, 2013 01:01:52 PM (GMT)
On October 16, 2013, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee will discuss the supplemental new drug application 202057/S-005, VASCEPA (icosapent ethyl) capsules, submitted by Amarin Pharmaceuticals Ireland Ltd.
VASCEPA is currently approved as monotherapy for the treatment of severe hypertriglyceridemia.
This supplemental application proposes concomitant use with an inhibitor of HMG-CoA reductase (statin) to reduce triglycerides, non-high density lipoprotein cholesterol, apolipoprotein B, low-density lipoprotein cholesterol, total cholesterol, and very low density lipoprotein cholesterol in adults with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent.
StreetAccount notes the estimated PDUFA date in this indication is 20-Dec-13