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Please, somebody write down what is the middle ground which allows Amarin to market Vascepa in high TG population? I do not request any reference, proof, link, etc. just a simple wording.
And please, keep it in mind that they did not apply for labelled CVE reduction.
Yes, unfortunatelly the managment did not do a great job. If I balance it 10-20% of management and 80-90% of FDA fault.
Ajax: I really do not understand the difference between ANCHOR and "to market Vascepa for Trgs >200mg/dl. but to clearly state that there is no proof as yet that it lowers CVE's."
Do not judging what you say, just do not understand the difference between ANCHOR and "to market Vascepa for Trgs >200mg/dl. but to clearly state that there is no proof as yet that it lowers CVE's." as FDA - and not Amarin - said during the AdCom:
"Vascepa 4 grams per day is indicated as an adjunct to diet and in combination with a statin to reduce triglycerides, non-HDL, Apo B, LDL, total cholesterol, and VLDL in adult patients with mixed dyslipidemia and coronary heart disease or coronary heart disease risk-equivalent, as defined on the slide."
"Although the indication strictly speaks to reduction in lipoprotein levels and improvement in numbers, this indication for this population certainly implies that one should expect cardiovascular benefit from treatment."
For "All Agency wanted was a compromise," they did not have to rescind the SPA. Simple approve it with a label:
"VASCEPA is an ethyl ester of eicosapentaenoic acid (EPA) indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with high(= 200 mg/dL and and <500 mg/dL).
Limitations of Use:
•The effect of VASCEPA on cardiovascular mortality and morbidity and reduction of the risk for cardiovascular diseasehas not been determined."
I see one reason only to rescined the SPA: they do not have to decide on sNDA till the appeal is ongoing (and it was obvious that Amarin will appeal.)
I just want to understand what you are saying.
What will be released in Q2-4 2014?
Q2:
- weekly script number (however do not forget that since 01/01/2014 they recognized revenue on wholesale delivery quantity and based on retail sales)
Q3:
- weekly script number
- 10-Q for Q214 between 07-12 August
- refer to OND’s decision (uphold) in 10-Q or 8-K in case of reinstatement
Q3:
- weekly script number
- 10-Q for Q314 between 10-14 November
- refer to CDER’s decision (uphold) in 10-Q or 8-K in case of reinstatement
(I did not expect any ruling regarding legal cases)
Cash-Flow: It’s the primary priority!
They still forecasting “that during 2014, our net cash outflows will be less than $80 million”, so they will close 2014 at least with 111,8M cash. It could be achieved with increased revenue and decreased OPEX.
Revenue: if they could increase the script number by 50/week (average) and KOWA effort will be realized from beginning of July they could reach 19K script and 2,4M revenue / w by EOY. (I calculating KOWA effect as: current sales team scipt / 130 x 250 x efficiency x 0,9; efficiency is 2% for 1st week of July and added 2% for every week: 0,9 related to KOWA’s fee).
COR: increased the to 66% from the current 61,28%
OPEX: with linear decrease from the current level (11,7M R&D, 20,6M SGA) 25,5 M is an additional 21% reduction. For me it looks like realistic (Reduce-it cost was 7,5M and selling was 13,9M in Q1).
If they reach the revenue, the margin and the OPEX target the 122014 cash-flow (from operation) will be (2,4) M. Which means (28,8)M for 2015 without additional revenue increase.
SPA / PDUFA:
Based on BD, AdCom transcript:
Amarin indication: “Vascepa 4 grams per day is indicated as an adjunct to diet and in combination with a statin to reduce triglycerides, non-HDL, Apo B, LDL, total cholesterol, and VLDL in adult patients with mixed dyslipidemia and coronary heart disease or coronary heart disease risk-equivalent, as defined on the slide.
FDA statement: the only reason to treat these mid-range triglycerides is to prevent heart attack, stroke, and death. “ … companies wanting to target this lower range of TG, it was clearly with the goal of selling it to reduce the risk for cardiovascular disease”.
They said: “So back in 2007/2008, we weren't in a position to say there's no way you're going to get this approved without doing a cardiovascular outcomes trial and completing it and then coming back to see us.” – Yes, they reached this stage during they prepared the BD … Not immediately after the AIM-HIGH or ACCORD or HPS2-THRIVE result was available …
FDA interpretation: “Although the indication strictly speaks to reduction in lipoprotein levels and improvement in numbers, this indication for this population certainly implies that one should expect cardiovascular benefit from treatment.”
Since ANCHOR trial met all criteria FDA has only one choice to not approve it (immediately): “substantial scientific issue essential to determining the safety or efficacy of” VASCEPA
“New, substantial” science issue is based on different studies, which, “failed to demonstrate unequivocally additional cardiovascular benefit from non-statin lipid-modulating drugs” however in patients with borderline high (TG: R&P - 150, ACCORD-Lipid 162 and AIM-HIGH -161 mg/dL) and normal (Origin – 141 and HPS2-THRIVE TG 125 mg/dL) TG, but not with high TG. Furthermore the sub-group data (ACCORD-Lipid and AIM-HIGH) made stronger the hypothesis (not confirmed, but definitely not failed).
Summary: I do not say that the future is bright, but it is reasonable to running the company at least till Reduce-IT interim data (01/2016), result (Q3-Q4 2016) without additional fund and I am still believe that some level (maybe the court) will reinstate the SPA, which means that ANCHOR / sNDA will be approved.
The current PPS is so terrible (but this is the current WS sentiment), however it does not effect the company itself, till above $1 (NASDAQ regulation) or want to raise fund (which I think not necessary) - so funny when somebody say that PPS decrease will be resulted in bankruptcy of AMARIN.
My interpretation of ANCHOR (let’s say label):
VASCEPA is an ethyl ester of eicosapentaenoic acid (EPA) indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with high hypertriglyceridemia (>=200 and <500 mg/dL).
Limitations of Use:
•The effect of VASCEPA on the risk for pancreatitis in patients with high hypertriglyceridemia has not been determined.
•The effect of VASCEPA on cardiovascular mortality and morbidity in patients with high hypertriglyceridemia has not been determined.
•The effect of VASCEPA as an add-on to statin therapy, in reducing the first major cardiovascular event in high-risk patient population has not been determined.
As Dr. Colman said on 16 October: “Well, good morning. On behalf of the division, I'd like to welcome all of you to today's meeting. We are here because Amarin is seeking approval of Vascepa as an adjunct to diet and in combination with a statin to reduce triglycerides and other lipid and lipoprotein parameters in adult patients with mixed dyslipidemia and coronary heart disease or coronary heart disease risk equivalent.”
However in the BD and ADCOM presentation FDA said:
“the presumption has been that improving various lipid parameters will translate into a reduction in cardiovascular risk” and “Seeking approval for: As add-on to statin therapy in subjects with mixed dyslipidemia and residually high TG levels (200 – 500 mg/dl) Cardiovascular risk reduction“
http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm371761.pdf
Also from BD: “Several cardiovascular outcome trials of non-statin lipid-modulating therapy, …, which were designed to target residual cardiovascular risk by improving lipid parameters other than LDL-C (e.g., HDL-C and/or TG) in patients optimally treated with statin therapy, failed to demonstrate unequivocally additional cardiovascular benefit from non-statin lipid-modulating drugs”
As I understood, FDA does not want to approve ANCHOR since it does not have benefit for patients, and this is the main reason to approve any drug.
a.) Based on available information – and since Amarin doing R-IT – Amarin did not apply for “cardiovascular benefit” in ANCHOR. It’s the target of FDA.
b.) The citied studies, “failed to demonstrate unequivocally additional cardiovascular benefit from non-statin lipid-modulating drugs” in patients with borderline high (ACCORD-Lipid and AIM-HIGH - TG 162 and 161 mg/dL) and normal (HPS2-THRIVE TG 125 mg/dL) TG, but not with high TG …Furthermore the sub-group data made stronger the hypothesis (not confirmed, but definitely not failed)
This is the reason why I could not imagine the offer for ANCHOR’s SPA revision which allow Amarin to market Vascepa in high TG population.
Please let me/us know what the exact offer of FDA was. (I do not need a link or source just the wording of the offer).
R-IT enrollment: 2013/09: 6,000; 2013/12: 6,500; 2014/05: 6800;
Q42013 CC: “Right now, we would project, based upon the mix that we're seeing and the timing of enrollment, that enrollment would be completed somewhere in the first half of 2015.”
BioChica: It’s true R-IT SPA was amended to TG = 200 to <500 from TG = 150 to <500 mg/dL around June-July, 2013.
"Ajax, thanks for the info. While you are here, would you please describe, once and for all, what did the FDA offer to Amarin as a compromise during the MLK weekend negotiation. TIA."
I am interested also, since I could not imagine any acceptable version/offer ...
With 65% gross margin (after KOWA fee) and 25,5M OPEX they need 24,337 weekly script for +/-0 Operating Income or Loss.
Vascepa (unfortunatelly) is not available in Hungary ...
You have right regarding BioC and me however it's not a comparison. According to all accounting standard, you have to show the net (real) revenue, so in every 10-Q the revenue is after discount to wsalers, coupon, etc. (btw: BioC check your calculation ie.: 7/4/2014 12018 $4,136,496.00 should be $2,019,024.00)
1.) Yes, agree and u were conservative. My current guess for script is 8,364 (end of Q2), 14,009 (Q3 w KOWA), 20,084 (Q4 w KOWA).
2.) Yes. I guess (hope) that the current level (11,7 R&D, 20,6 SGA) could be decreased to 8-8,5 R&D, 16-17 SGA), so additional 6,8-8,3M decrease on quaterly basis.
3.) If mission 1 & 2 completed they do not need a partner, they will have enough cash to see the interim result by end of 2016 (data vill be available Q12016).
Wholesale price = gross price. Net price (before COGS): "our gross to net price adjustments include certain launch year-related factors, which resulted in a lower net price per capsule than the approximately $1.25 net price per capsule that we anticipate achieving over time." which is $150 and it's not include "higher costs for our intense co-pay card program"
One week number is not a number, so we have to see at least additional 2 weeks script number to see the trend and prepare some forecast for Q2. (My current expectation is: 95-100k script, 12,5M rev, 63% GP, 30M OPEX, (22,3)M OIL, (0,13) EPS)
Legal cases (for long-term prospective): NCE is not important, it's more PR/marketing IF (!) at least one relevant patent will exist. (Which I think is realistic). However we will not see any final ruling in any legal issue in the near future.
SPA / PDUFA: I still believe that FDA basis is not strong / not valid. The type of other drugs is not really relevant, however the characteristic of the population is that and the sub-group data prove the Vascepa’s science. If Hamburg does not want to deal with this issue, so maybe we get positive answer from Woodcock by October. (if Woodcock has the same attitude, iDr. Jenkins level will be reinstate the SPA by end of July) After SPA reinstatement ANCHOR will be approve since met all requirement and the department does not have choice.
I just wondering why we did not hear anything about label change: include ANCHOR trial data. I do not see any reason to refuse it by FDA since it is not approval. (Just like in case of Lovaza)
PPS: 1,50 is not good, however till it's above $1 it does not have any effect on the company itself.
It will not happan:
a.) wsc is not $168, it's app. $126. The real sales was around 9,6M in Q1 since 10,9M inc. the deferred revenue from previous Q.
b.) KOWA will start end of May / begining of June. "Kowa team should be before the end of this month be fully trained out and promoting Vascepa"
c.) It takes time to them to reach at least the same script level / sales person as the current sales team. "So we anticipate that it will take Kowa multiple calls before they have a major impact relative to prescription writing and maybe a little bit different than normal on the sense that some of these doc have been called on by Amarin in the past, albeit, multiple months back at this juncture. We're not prepared to quantify the extent of their impact. But we would anticipate that, that impact will be increasing throughout the second half of this year and then accelerating beyond that in years going forward"
"telling us they are not going to have enough money for Reduce-It." - it's not a new info, app.6 months old.
btw: they do not have to complete R-IT. If it at least 25% effective - I think yes - they could stop it based on positive interim data / analysis
Assumptions / facts:
- R-IT SPA will not modified, so interim analysis will be done at 967 events.
- Vascepa efficacy is at least 25%, so 967 would happen in March 2016 as earliest with results expected to be available by end of 2016
- they will close 2014 around 115M cash ("We continue to estimate that during 2014, our net cash outflows will be less than $80 million", they already "used" 27,5M, so less than 52,5M during Q2-Q4 2014)
- w same cash burn it will be enough till end of Q2 2016
Conclusion: they need additional 40-60M till end of 2016 and it's not impossible.
and it's w/o Anchhor.
Definitely not (that time) - 10-Q: "The Company believes its cash and cash equivalents will be sufficient to fund its projected operations for at least the next twelve months"
Is it from .. ?
I think we will get answer from the current level (OND / Dr. Jenkins ) at end of July only. (Based og ODE II timeframe).
From CC: "We would get a response from Dr. Jenkins and if to that we have a negative response and we have the ability to appeal to next level, which is Janet Woodcock and then up to the Commissioner from there"
So if each level will give a negative response will will know the final decision from Hamburg by end of January 2015 (if no delay).
(I guessed OMPT / Leona Brenner-Gatih level based on FDA org. chart.)
FORM 10-Q
Based on the last 3 script data (6,9 - 6,8 - 7,4) I have a feeling that data is 2 weeks "old". So this number is for 21-25/ 04 and not for last week.
Everyone, including Jenkins at current level (OND), each of them the next level so exc. the current, 3 level remains before court.
With current revenue level it's true, but the real answer will be come with Q314 report (without reinstatment).
Nothing (but I could not listen the whole)
OMD' decision will be last week of July. (It looks like every level takes 90 days)
Additional level:
- CDER / Janet Woodcock
- OMPT / Leona Brenner-Gatih
- OC / Margaret A. Hamburg
Not Woodcock, it's OFFICE OF NEW DRUGS (OND), John Jenkins, M.D. (Director)
New appeal was submitted on Thursday.
Kowa will start near to the end of the month and it will "realized" inthe second half of the year.
"We appealed to the next level within the FDA and were informed in late April 2014 that that level determined to uphold the rescission determination. Our plan is to appeal the rescission decision to the next level within the FDA in accordance with FDA dispute resolution guidance. ... Based on our communications with the FDA, we currently expect that final positive results from the REDUCE-IT outcomes study will be required for label expansion for Vascepa." - so it is at Woodcock now.
You have right, however tha ADCOM's member not (fully) guilty. They answered the question (set-up by FDA): Treating TG in this range, does not reduce the risk of CVE's, so before RIT result should we approved or not?"
FDA does not have a poor sciense. They do not have a sciense!
Other studies prove that if sbody healty (TG below 150) it does not need to treat ...
1. the NCE suit - "we're in that process right now"
2. the SPA appeal - "So we're in that process right now. .. We're not going to get into on this call exactly where we are within the process. But it does take some time to prepare appeals from each additional level that we hear back from FDA, for the FDA to respond."
2. the partnership with KOWA - great opportunity, will increase our sales, no real details
3. any negotiations with the FDA - we're in that process right now.
4. the sales and revenue reports - 10,9 M rev, 6,9 M GP, (23,1)M OP, (0,13) EPS
5. the cash situation - Cash and Cash Equivalents: 167M
6. the legal expenses - no details
7. the strength of our patents - OK
8. progress with R-IT - same as last call
9. up to date results from other CV event studies - not mentioned
10.news about the CP - not mentioned
short term: SPA appeal is the most important thing (the one and only). This could generates significant - 5-8$ - increase in pps
I hope you have right, but:
- what's the source of "362 MACE events would already have happened"
- as I know interim analysis will be done at 60% of total events, so if they can reneg (20% & 80%), instead of 967 (will be reached 01/2006) we need 822 (will be reached 08/2015)
Feel frre to correct me if I wrong
a.) if R-IT will be success they will get wider label than A
b.) timing:
http://seekingalpha.com/article/1901351-amarin-todays-market-is-underestimating-the-probable-success-of-reduce-it
"gained $ Billions in new share price value, what should they spend the money on?" - AZN did not gained any money on share price increase, shareholders gained
Appeal to higher levels will reach the commish within these 60 days - I do not think. It's still on ODE II level.
We just tripled the sized of our sales force today - We do not know the exact date within May, but if it's today we could see the first resuly by May 16
Courts still have Amarin's request for NCE - I do not expext any decision within the next 12 months
From the CC Feb 27: "As reported in January, we anticipate that it won't be until sometime in Q2 or Q3 before we reach the level within the FDA that we initially targeted in our appeal in early November. While it is always possible that the FDA responds favorably before that time frame, we cannot now predict whether the FDA will act in a timely manner, and we do not have visibility into the FDA's internal deliberations. We do not plan to provide further updates on this matter until such time as there is a substantial change in the status."
Is it means that they will submit 8-K in case of positive decision only? They can do it?
Agree w u, that script is important, but reinstatment is also (my view: if the SPA will be reinstated by any level, the DMEP has to approve the ANCHOR - they do not have a choice)
The last PR was on 21 Jan (87 days ago). Based on the appeal process 27 days for Amarin's new appeal submission and FDA's answer. (27 = 87 - 30 (to inform AMRN about action) - 30 (give an answer after the action completed).
Unfortunatelly we don't know whan AMRN submitted the appeal to ODE-II, but let assume 7 days was enough for them.
It is also hard the estimate the time for FDA's action but if we assume that 30 days should be enough for any of them we "have to" see (within the next 10-14 days)
a.) decision
b.) explain the reasons for the delay
(btw: AMRN already had to received the interim response from FDA)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM343101.pdf
shortly: It's more expensive than Vascepa: 140$ / 30 days (for 4 g / day)
http://seekingalpha.com/article/1901351-amarin-todays-market-is-underestimating-the-probable-success-of-reduce-it
Yes it's morbid, but we need higher event rate per year in placebo group to see the interim result earlier.
Maybe, but not as a result of this agreement. It's a co-promotion, so KOWA is a sales agent: "target audience of primary care physicians and cardiologists".
Current appeal "will (?) be released" during the next 14 days
Amarin submitted the 8-K regarding CDER's deciosion on 21/01 and assuming that they submitted the new appeal on 24/01 as the latest (btw: the submission is never confirmed, they never replied my simple question - sent to IR department: what is the date of the new appeal to ODEII) we are at 74 days, so:
It's not:
- delayed
- simple no
- no A-Type meeting (30 days should be enough to keep it 30 = 74-14-30)
- additional clarifying information from the sponsor (14 days should be enough for Amarin to submit the requested info 14 = 74-30-30)
- limited discussion with one or more members of an advisory committee or internal or external experts (maybe yes, but doesn't seems real as Amarin had a ADCOM)
It should be "FDA decides a meeting with the sponsor" and I guess it takes 3-4 weeks (21-28 days): we will see the 8-K during the next 14 days (30+30+21/28=81/88-74=7/14
AMRN is in the 1,7-1,0 range since 23 January. I don't see real possibility to go below 1,7 and two "option" to go over 2,0 significantly:
1.) increased script number - not expected before KOWA SF start their work
2.) SPA reinstatement (which is equal w ANCHOR approval, since CDER doesn't have a choice: all end point met, R-IT is significantly enrolled, so they have to approve it). I hope, but do not expect it from ODE II, however one level (or finally the court) has to reinstate it, since all real sciense / practice, other studies - sub-groups' data for the same target group (TG above 150/200), FDA's own reply (21 Jan) suggest that the theory (TG treating above 150/200 will reduce CVD) is good / promising.
FDA's statement - based on the 3 studies - that healty people (TG below 150) should not be treated is true, but ANCHOR is not targeting healty people.
"the trial results are being monitored every three months. If the results show an unanticipated large percentage of reduction in events, the monitors have the option to stop the study"
In this case, yes it could be within 12 / 18 months, however we never got a positive "answer" for any open issue (SPA, NCE, etc.)
During the last 6 months I go through again and again on all info, docs, etc. and I still could not find out how the FDA's division set-up the new sciense. I could not find any person, organisation, recommendation who/ which said: TG below 500 is OK (except E.T, pardon E.C.).
Based on facts, current practise, based on the 2 (out of 3) citied study (maybe the 3rd also, but post-an is not available yet) I could (not) imagine other final conlusion than: yes, ANCHOR is OK, since TG above 200 should be treated and Vascepa is safe, met all end-point.
(Much cheaper for any BP to BO Amarin for $15-30 than corrupt every FDA' employee :))
Agreed. Maybe in 2018 only