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BBI, let me add my thanks for your excellent summary.
dogn
johnhancoque, I looked into the GILD NASH trial back in the Spring and posted comments in #376051. Study was completed Dec. 17, 2020, last update March 16, 2022. Not much to see.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168709983
-dogn
MrM, always love your # of similar rally days posts! But decided to understand the math & found it’s actually slightly better!
If n is counting how many more days like today & calculated from today’s closing price ($1.23), it’s 29 days like today starting from prior close ($1.14), but just 28 “more days like today” (as you put it) to reach double digits (& 23 “more days” to reach your $7+ exit target)!
1.23*(1.23/1.14)^28=10.326
n=log(10/1.23)/log(1.23/1.14)=27.578
Aside from the unknown of whether Adam Berger is a Denner nominee or not, I do think he looks like a solid new board director with his stated experience of advising/working on 180+ M&A in predominantly healthcare (and his recent selection as a top 25 healthcare banking investment executive in 2022). It would be interesting to know more details about these 180+ transactions valued at >$400 Billion, but I don’t have any reason to view this as fluff. I hope he contributes to making all of us long-suffering AMRN investors whole.
Now long 28K shares.
dogn
Lizzy, doing a date limited search from Jan. 1 through yesterday turns up nothing on Three Peaks Partners so I presume it was founded/cofounded by Adam Berger ("Managing Partner") when he left Wells Fargo Securities after 11 years in Aug. 2022 as a private consulting firm and (as yet) has no website or publicity (other than the mention in today's Amarin PR).
The good news in that may be that he has a lot of free time on his hands to help facilitate Amarin's sale.
I did find 2 news pieces from when he started at Wells Fargo:
https://www.businesswire.com/news/home/20111006006134/en/Wells-Fargo-Securities-Hires-Two-New-MA-Industry-Leaders
https://www.efinancialcareers.com/news/2011/10/wells-fargo-securities-expands-investment-banking-unit
Comparing Amarin's PR to these 2011 releases it appears he closed more than 40 M&A transactions in 11 years, but the total value has been updated only from the prior "worth nearly $400 billion" to "totalling more than $400 billion." Perhaps Wells Fargo will not permit such a disclosure, or the value of these 40 new M&A deals is negligible (which seems unlikely).
Amarin PR today:
Mr. Berger has more than three decades of experience with investment banking focused on mergers and acquisitions. He has advised on over 180 announced M&A transactions predominantly in the healthcare industry totaling more than $400 billion in value...
In his more than 22 years as an M&A banker, Berger has worked on 140 announced transactions worth nearly $400 billion.
Mr. Berger has a fairly impressive background
Managing Partner
Three Peaks Partners
Aug 2022 - Present · 3 mos
Managing Director, M&A; Chairman of Investment Banking Opinion Committee; Head of Healthcare M&A
Wells Fargo Securities
Sep 2011 - Aug 2022 · 11 yrs
Managing Director, Head of M&A
Leerink
Jun 2008 - Aug 2011 · 3 yrs 3 mos
Managing Director, Head of Healthcare M&A
Citigroup
Jul 1991 - Jun 2008 · 17 yrs
Managing Director, Mergers & Acquisitions
Salomon Brothers
Jul 1991 - Dec 1999 · 8 yrs 6 mos
Analyst
Janney Montgomery Scott
Jul 1989 - Jun 1991 · 2 yrs
New director Geraldine Murphy
Founded Evolution Partners: https://www.evolution-partners.ie/about/
From Linked In:
https://www.linkedin.com/in/geraldine-murphy-37592222/
27 yrs 2 mos at LEO Pharma
From https://amarincorp.com/board-of-directors.html, retiring director Patrick O'Sullivan bio:
...30 years as Chief Executive Officer and board member of the LEO Pharma companies in Ireland and more than 10 years as a board member of the parent company of the LEO Pharma Group in Denmark
Geraldine Murphy would thus appear to be hand-picked successor of Patrick O'Sullivan rather than Denner pick.
dogn
RMB, thanks much for sharing that joke. As an Electrical Engineer it gives me quite a chuckle and I am surprised that I had never heard it anywhere!
dogn
Almost 60
Amarin arrives in Spain and focuses on cardiovascular residual risk
Via Google translate… still awaiting reimbursement decision it appears.
dogn
DAILYPHARMA | 09.29.2022 - 14:01
The North American company Amarin has landed in Spain and brings with it significant knowledge in the cardiovascular field backed by more than 10 years of accumulated investment in R&D and manufacturing in this area.
As a result of this knowledge, Amarin has developed an innovative drug that "provides new hope for heart disease to stop being the main cause of death in Spain", explains the company. Vazkepa (ethyl icosapent) has obtained the support of the European Medicines Agency (EMA) and the European Commission for its commercialization of Vazkepa has obtained authorization for the treatment of residual cardiovascular risk, which until now current treatments did not address and represent a serious health and economic burden with 8% of health spending.
The efficacy and safety of the new drug have been evaluated in a complete clinical development, in which studies such as Reduce-it, designed to evaluate the cardioprotective efficacy and safety of Vazkepa, and where significant data were shown in the reduction of these events with a good tolerance profile . Thus, in December 2019, this drug was approved as the first and only drug to reduce cardiovascular risk beyond cholesterol-lowering treatment in high-risk adults taking maximum-tolerance statins with more than 150 mg/dL of triglycerides and established cardiovascular disease or diabetes and two or more risk factors for cardiovascular events.
Residual risk in treated patients
Intervention studies on LDL-C with statins and more recently with PCSK9i support aggressive LDL-C lowering to reduce cardiovascular events. However, in many patients , achieving the LDL-C levels recommended by international treatment guidelines also requires the implementation of other necessary strategies to adequately reduce residual CV risk. These would be to lower the systemic inflammation that leads to the development of atherosclerotic plaque; treat hypertriglyceridemia and triglyceride-rich lipoproteins or reduce thrombotic processes.
The Reduce-it study has provided evidence that targeting such residual CV risk pathways among high-risk patients on statin therapy and hypertriglyceridemia can significantly reduce cardiovascular events beyond LDL-C treatment alone.
For Salvador López, general director and CEO of Amarin Spain, the arrival of Vazkepa "comes to improve the life of the patient" since, as has been seen with the pandemic, the most efficient way to address these situations is "by approaching the prevention ”. For this reason, he considers that in order to fight against the deadliest pandemic of the 21st century, such as cardio-metabolic disease and cardiovascular death, “preventive measures must be implemented, such as heart-healthy habits and the introduction of drugs that reduce the risk of the appearance of cardiovascular diseases. , like a heart attack or a stroke ”.
In addition, López explains that with the launch of Vazkepa in Spain, Amarin will make available to Spanish citizens its pharmaceutical innovation that "has more than 10 years of experience in the North American market" and that has obtained the endorsement of the EMA, which “recognizes that this new active substance reduces residual cardiovascular risk”underlying patients who are well controlled on statins. In this sense, the CEO of the company explains that "science has shown that approaches other than cholesterol control are necessary to avoid the negative consequences of atherosclerosis".
Killing the Culprit: Pharmacological Solutions to Get Rid of Cholesterol Crystals
From Current Problems in Cardiology
Volume 47, Issue 9, September 2022, 101274
https://www.sciencedirect.com/science/article/pii/S0146280622001712
Abstract
Cholesterol crystals (CCs) play a key role in the pathophysiology of cardiovascular diseases (CVD) via triggering inflammation, plaque formation and subsequently plaque rupture. Although statins can stabilize plaques via calcification and alteration of the lipid composition within plaques, there is still a high residual risk of CVD events among statins users. Several studies have tried to blunt the detrimental effects of cholesterol crystals by pharmacological interventions. Cyclodexterins (CDs) and other nanoformulations, including polymers of CDs and liposomes, have the ability to dissolve CCs in vitro and in vivo. CDs were the first in their class that entered clinical trials and showed promising results, though their ototoxicity outweighed their benefits. Moreover, small molecules with structural similarity to cholesterol may also perturb cholesterol-cholesterol interactions and prevent from expansion of 2D crystalline domains to large 3D CCs. The results from ethyl eicosapentaenoic acid and ursodeoxycholic acid were encouraging and worth further consideration. In this review, the significance of CCs in pathogenesis of CVD is discussed and pharmacological agents with the ability to dissolve CCs or prevent from CCs formation are introduced.
…
Ethyl Eicosapentaenoic Acid
Ethyl eicosapentaenoic acid (EPA) is a polyunsaturated omega-3 fatty acid with the most potent antioxidant activity followed by the other members of its family. Highly purified EPA has been used for the reduction of plasma level of triglycerides (TG) and possesses numerous beneficial effects for cardiovascular and nervous systems.47 In combination with statins, EPA, but not omega-3 fatty acid mixtures (such as EPA/DHA), significantly reduced cardiovascular risk in addition to the protection afforded by statins.48 This finding proposes the idea that cardioprotective mechanism of EPA should be more complicated than simple reduction in TG levels and antioxidant properties since many other triglyceride-lowering agents failed to show any positive effects in combination with statins in large clinical trials.49
Recent studies revealed that EPA has the most efficient chemical structure in comparison with the other omega-3 fatty acids for the stabilization of the membrane (Fig 2) and the prevention of cholesterol crystal domains formation.50 In cholesterol-enriched model membranes, EPA prevented from glucose-induced cholesterol domain formation while other triglyceride-lowering agents including fenofibrate, niacin and gemfibrozil were inactive. Primary studies suggested that the protective activity was related to the antioxidant activity of EPA. However, further study revealed that the protection is independent of the antioxidant activity and is mainly mediated through direct physicochemical effect of EPA on membrane lipid organization. Interestingly, combination of EPA and DHA slightly reduced the inhibitory activity in the model. These finding proved that EPA has the most optimal chain length and degree of unsaturation related to the observed effects. In fact, unlike DHA, EPA preserves membrane structure and also prevents from lipid oxidation and CC formation.51, 52, 53
FIG 2. Different mechanisms for the prevention or dissolving of CCs.
https://ars.els-cdn.com/content/image/1-s2.0-S0146280622001712-gr2.jpg
Future studies should aim to determine the significance of the inhibitory activity of EPA against CCs formation in the overall biological activities which were observed for this fatty acid in in vivo studies.
48 D.L Bhatt, P.G Steg, M Miller, et al.
Effects of icosapent ethyl on total ischemic events: from REDUCE-IT
J Am Coll Cardiol, 73 (2019), pp. 2791-2802
49 R.D Bhatt, P Libby, S Verma, et al.
The role of eicosapentaenoic acid in reducing important cardiovascular events, including coronary revascularization
Progress Cardiovasc Dis (2021)
50 SCR Sherratt, RA Juliano, RP Mason
Eicosapentaenoic acid (EPA) has optimal chain length and degree of unsaturation to inhibit oxidation of small dense LDL and membrane cholesterol domains as compared to related fatty acids in vitro Biochim et Biophys Acta Biomembr, 1862 (2020), Article 183254
51 RP Mason, RF Jacob
Eicosapentaenoic acid inhibits glucose-induced membrane cholesterol crystalline domain formation through a potent antioxidant mechanism
Biochim Biophys Acta, 1848 (2015), pp. 502-509
52 R.P Mason, R.F Jacob, S Shrivastava, et al.
Eicosapentaenoic acid reduces membrane fluidity, inhibits cholesterol domain formation, and normalizes bilayer width in atherosclerotic-like model membranes
Biochim Biophys Acta, 1858 (2016), pp. 3131-3140
53 RP Mason, P Libby, DL Bhatt
Emerging Mechanisms of cardiovascular protection for the Omega-3 fatty acid eicosapentaenoic acid
Arterioscler Thromb Vasc Biol, 40 (2020), pp. 1135-1147
From Healthcare Institute Netherlands
GVS advice icosapent-ethyl (Vazkepa®) in the treatment of adults at high risk of cardiovascular disease
The National Health Care Institute has tested whether icosapent-ethyl (Vazkepa®) can be included in the drug reimbursement system (GVS). A medicine is eligible for reimbursement as soon as it is included in the GVS. The Zorginstituut advises the Minister of Health, Welfare and Sport (VWS) to include icosapent-ethyl (Vazkepa®) in the GVS on Appendix 1B under certain conditions. Appendix 1B contains the list of medicines in the GVS that are not mutually replaceable.
Download 'GVS advice icosapent-ethyl (Vazkepa®) in the treatment of adults at high risk of cardiovascular disease'
PDF document | 131 pages | 16.4MB
Advice | 16-09-2022
Condition in which the product can be applied
The active ingredient icosapent ethyl is available as a medicine under the brand name Vazkepa. This is a highly purified form of the omega-3 fatty acid eicosapentaenoic acid (EPA). The drug is licensed to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides and established cardiovascular disease or diabetes with at least one cardiovascular risk factor. This means that they have an increased risk of cardiovascular disease.
Advice from the Healthcare Institute
The Zorginstituut advises the Minister of Health, Welfare and Sport to include icosapent-ethyl in appendix 1B of the GVS. For the full registered indication, icosapent-ethyl has added value compared to standard treatment. With regard to cost-effectiveness, there is a big difference between the subgroups 'primary prevention' and 'secondary prevention'. Primary prevention involves preventing disease. Secondary prevention means early detection of diseases or abnormalities in people who are ill, at increased risk or who have a certain genetic predisposition. The disease can therefore be treated earlier, so that it heals sooner or does not get worse.
Due to the large difference in cost-effectiveness, the Zorginstituut recommends that icosapent-ethyl be reimbursed only in the context of 'secondary prevention'. These include statin-treated patients at high cardiovascular risk with elevated triglycerides and established cardiovascular disease. Since icosapent-ethyl is not cost-effective at the current price for the treatment of these patients, the Zorginstituut recommends negotiating a discount of 30%. If the application of icosapent-ethyl is included in the package after successful price negotiations, the Zorginstituut recommends a reimbursement condition for the drug. the Zorginstituut advises to negotiate a discount of 30%.
If the application of icosapent-ethyl is included in the package after successful price negotiations, the Zorginstituut recommends a reimbursement condition for the drug. the Zorginstituut advises to negotiate a discount of 30%. If the application of icosapent-ethyl is included in the package after successful price negotiations, the Zorginstituut recommends a reimbursement condition for the drug.
Conditions for reimbursement of icosapent-ethyl
Only for an insured person with an established cardiovascular condition:
being treated with a statin;
have a high cardiovascular risk;
with elevated triglycerides (at least 1.7 and at most 5.6 mmol/l).
Drug Reimbursement System (GVS)
Icosapent-ethyl is an outpatient drug. Extramural medicines are medicines for home use, which are available at the pharmacy with a prescription from a doctor. They are only reimbursed from the basic health insurance package if they are listed in the GVS. The amount of the compensation depends on the list on which they appear. Mutually replaceable medicines are clustered on Appendix 1A. A reimbursement limit may apply for this. Unique medicines are listed in Appendix 1B. There is no reimbursement limit for this. Additional conditions may also apply to reimbursement. Then a medicine will also be added to Appendix 2.
The Scientific Advisory Council (WAR) and the Package Advisory Committee (ACP) advise the Zorginstituut in the assessment. Based on the assessment, the Zorginstituut sends a recommendation to the Minister of Health, Welfare and Sport. The minister makes the final decision whether or not to reimburse the medicine from the basic health insurance package.
Attachments
ACP advice icosapent ethyl (Vazkepa®) for the treatment of adults at high risk of cardiovascular disease
ACP advice to the Board of Directors of the National Health Care Institute on icosapent ethyl (Vazkepa®) for reducing the risk of ...
Advice | 19-08-2022
https://www.zorginstituutnederland.nl/publicaties/adviezen/2022/09/16/gvs-advies-icosapent-ethyl-vazkepa
Vazkepa arrives in Spain for the treatment of coronary diseases through Amarin Corp.
9/23/2022
Categories: CARDIOVASCULAR
https://www.pmfarma.es/noticias/34943-vazkepa-llega-a-espaya-para-el-tratamiento-de-las-enfermedades-coronarias-a-travys-de-amarin-corp..html
Translated in Google Chrome:
Amarin Corporation, after more than 10 years of accumulated investments in R&D and manufacturing in the cardiovascular area, has achieved with the drug Vazkepa an important scientific innovation to reduce cardiovascular risk. The drug is positioned in the sector to successfully address cardiovascular risk, which affects millions of patients around the world. In addition, the pharmaceutical company is presented as a key healthcare partner in Spain.
An innovative drug developed by the Amarin pharmaceutical company that contains the active ingredient icosapent ethyl, which represents new hope for heart disease to stop being the main cause of death in Spain.
The clinical benefits of Vazkepa also provide tangible economic and social benefits for residual cardiovascular risk, which until now has not been addressed by current treatments and represents a serious health and economic burden with 8% of health spending. Reducing Cardiovascular Risk is a priority objective according to the CVD Report of the Spanish Heart Foundation, 2015.
The efficacy and safety profile of Vazkepa is supported by REDUCE-IT, a study of cardiovascular events, designed to evaluate the cardioprotective efficacy and safety of Vazkepa, which showed significant data in the reduction of these events with a good tolerance profile and in December In 2019, after more than a decade of development and testing, Vazkepa was approved as the first and only medicine to reduce cardiovascular risk beyond cholesterol-lowering therapy in high-risk adults taking maximally tolerated statins with TG ≥150 mg/dL and established CVD or diabetes and ≥2 CVD risk factors.
Intervention studies on LDL-C with statins and more recently with iPCSK9 support aggressive LDL-C lowering to reduce cardiovascular events (CVs). However, in many patients, despite achieving the LDL-C levels recommended by international treatment guidelines, other necessary strategies can be implemented to adequately reduce residual CV risk.
Efforts aimed at reducing this residual CV risk have focused on addressing the following pathways:
1) Lower the systemic inflammation that leads to the development of atherosclerotic plaque.
2) Treat hypertriglyceridemia and triglyceride-rich lipoproteins.
3) Decrease thrombotic processes.
Recently, the REDUCE-IT study has provided evidence that targeting such residual CV risk pathways among high-risk patients on statin therapy and hypertriglyceridemia can significantly reduce CV events beyond LDL-C treatment alone.
Salvador López, General Director and CEO of Amarin Spain adds the following: " Amarin and Vazkepa come to improve the life of the patient, we want to improve the life of each one of them. We have recently witnessed that the most efficient way to deal with pandemics is through a prevention approach, which is why, in order to fight against the deadliest pandemic of the 21st century, that is cardiometabolic disease and cardiovascular death, preventive measures must be implemented, such as heart-healthy habits and the introduction of drugs that reduce the risk of onset of cardiovascular diseases, such as heart attack or stroke ".
With the launch of Vazkepa in Spain, Amarin makes available to Spanish citizens its pharmaceutical innovation that has more than 10 years of experience in the North American market. The European drug agency recognizes that this new active substance reduces residual cardiovascular risk, the one that underlies in patients who are well controlled with statins. Science has shown that approaches other than cholesterol control are necessary to avoid the negative consequences of atherosclerosis.
In March 2021, the European Commission (EC) approved the marketing authorization application for the drug, to reduce the risk of cardiovascular events in high-risk adult patients treated with statins who have elevated triglycerides (≥150 mg/dL) and disease. established cardiovascular disease or diabetes and at least one additional cardiovascular risk factor, under the brand name Vazkepa.
sí, Vale, Por supuesto, Cierto, Ya, Claro!
Oui!
How To Say 'Yes' In Spanish (Formal And Informal)
https://www.mezzoguild.com/learn/spanish/phrases/yes/
26 new job postings in Spain in past 2 days on LinkedIn (search Amarin Spain Jobs)
https://www.google.com/search?q=amarin+jobs+spain
Here’s one: Check out this job at Amarin Corporation: Cardio Metabolism Specialist
https://www.linkedin.com/jobs/view/3283103278
One needs a LinkedIn account to view
On list of 6 MOST READ articles in European Heart Journal Cardiovascular Pharmacotherapy:
"LIPIDS RESEARCH ARTICLE
Potential effects of icosapent ethyl on cardiovascular outcomes in cigarette smokers: REDUCE-IT smoking"
https://academic.oup.com/ehjcvp
This stood out to me as possibly new info: “…with Abuaf sharing news of an impending positive recommendation from Spain.”
dogn
Amarin makes moves towards global expansion of Vazkepa
September 22, 2022
The company has its eye on being included in China’s National Reimbursement Drug List. Abuaf explains, “This would be a massive milestone because cardiovascular disease is also touching a massive number of patients in big geographies like China.”
In reference to the company’s hopes for the future and its current plans for Vazkepa, Abuaf says, “We’re trying to make the most of the environment in a smart way, putting together what we know and what we understand. Most of the time, it works. Sometimes we hit a wall, like in Germany, but overall, it’s overwhelmingly progressing well.”
https://www.pharmaceutical-technology.com/news/amarin-makes-moves-towards-global-expansion-of-vazkepa/
Kiwi, RESPECT-EPA is being presented by Hiroyuki Daida (presenting author in bold; 10 minutes)
Taub follows as “discussant”, 3 minutes
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169973509
Omega 3 Market Size to Surpass USD 4.76 Billion with CAGR of 9.40% by 2029
“North America dominates the omega 3 market due to the increasing occurrences of chronic diseases, as well as the prevalence of improved medication and better health supplements. In contrast, Europe is expected to grow from 2022 to 2029 due to the growing geriatric population, as well as rising usage in treating obesity.”
https://www.globenewswire.com/news-release/2022/09/19/2518283/0/en/Omega-3-Market-Size-to-Surpass-USD-4-76-Billion-with-CAGR-of-9-40-by-2029-Share-Demand-Top-Players-Industry-Size-Future-Growth-Outlook.html
NS, in the past I posted something I had found from a journal paper reviewing FDA draft guidance on determining bioequivalence of omega 3 ethyl esters, and recall it noted different guidance for EPA+DHA and EPA only formulations. It was apparently related to approving generic Lovaza but seems similar criteria could apply here at least for judging efficacy if not safety. What was interesting is that bioequivalence seemed to be based entirely on blood serum levels achieved. I did find the following googling “draft FDA EPA blood serum” which seems to be for the mixed EPA+DHA and while it dates to 2012 states it was revised as recently as Aug. 2020. I do not know how to find such things on the FDA website nor when such draft guidance showing dates from 2012-2020 actually becomes “finalized.”
https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021654.pdf
“Bioequivalence based on (90% CI):
1) EPA ethyl esters in plasma 2) DHA ethyl esters in plasma”
dogn
North, the data is in the J. Clinical Lipidology paper posted here Monday (#388650) by rdhitchcock:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169930117
https://www.lipidjournal.com/article/S1933-2874(22)00246-X/pdf
Unfortunately it’s not open access, but one can pay for one time (24 hour) online access.
dogn
Nice summary, Captain. It would be useful to add a plot where the x axis instead of % change is absolute EPA serum levels. You could start the bar at baseline and extend it to end of trial values. This way it would be easier to visualize the differences in baseline between trials as well as more clearly show that the MND-2119 end of trial values exceed those of Reduce-It. It’s these absolute EPA serum levels that correlate to MACE risk reduction so the % change from baseline is less important and as plotted it can be misleading if one only looks at size of % increase.
Thanks,
dogn
Michael Miller, ESC 2022: Icosapent ethyl for smoking, the REDUCE-IT study
Published Online: September 9th 2022
https://www.touchcardio.com/cardiovascular-risk/conference-hub/michael-miller-esc-2022-icosapent-ethyl-for-smoking-the-reduce-it-study/
“It is extremely unfortunate that REDUCE-IT did not measure EPA/AA.”
I believe the Riker bio markers paper was based on new analysis of cryogenically stored blood serum samples from Reduce-it trial. I see no reason why these stored samples couldn’t be further analyzed if investigators believe something new, such as EPA/AA, is worth studying.
dogn
PD, good post & I agree Amarin is doing the right thing by playing hardball and not giving their lifesaving drug away at unreasonably low pricing. The excellent find attributed to me was found I believe by Number Sleven:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169872055
dogn
Zip, yes see post 385979
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169654085
“In the current study, although the baseline values of plasma EPA concentrations were higher than ANCHOR and REDUCE-IT, post-dose EPA concentrations and increases from baseline were higher than that of ANCHOR in both MND-2119 doses, and higher than the results of REDUCE-IT at 1 year for MND-2119 at the 4 g/day dose.”
https://pace-cme.org/2022/09/06/slides-a-continuum-of-multifactorial-benefits-of-icosapent-ethyl/
No need to register… just tap or click on thumbnail of slides to open & view!
dogn
Ziploc, yes… I hope Amarin discusses or even announces their plans!
dogn
Epadel EM reimbursement
Capsules, 2 g
Prescription, on list of “Drugs to be added to NHI price list on August 18, 2022”
NHI Price (yen): 113
Pricing Method: Inter-strength Price Adjustment
Indication: Hyperlipidemia (Additional
formulation)
“No Premium for Once-Daily Epadel
Elsewhere, Chuikyo also supported the listing of a new formulation of Mochida Pharmaceutical’s hyperlipidemia drug Epadel (ethyl icosapentate). This is an upgraded once-daily soft capsule version of the current formulation, which requires a twice- to thrice-daily regimen. It was priced at 113 yen based on inter-strengths adjustments with one of the existing versions, with peak sales put at 4 billion yen in the sixth year with 96,000 patients. Although Mochida claimed a 5% utility premium for the less frequent dosing required for the new product, this was rejected by the Drug Pricing Organization, which determined that the upgraded version does not have a higher medical usefulness versus the comparator that warrants the granting of the premium.”
https://pj.jiho.jp/article/247268
Epadel EM Once-Daily
https://pj.jiho.jp/article/247307
Mochida to Roll Out Once-Daily Epadel on Sept. 12
August 19, 2022
Mochida Pharmaceutical said on August 18 that a new once-daily soft capsule version of its hyperlipidemia drug Epadel (ethyl icosapentate) listed the same day will be available on September 12.
The new product, Epadel EM Capsules 2 g, is a self-emulsifying high-purity ethyl icosapentate (EPA) preparation designed to improve gastrointestinal absorption. Compared to the current Epadel products, which require twice- to thrice-daily dosing, the new version is expected to boost patient’s convenience and adherence to its once-daily administration.
Peak sales are projected at 4 billion yen in the sixth year on the market, according to a document submitted to the Central Social Insurance Medical Council (Chuikyo).
Japan Healthcare Market Access Update
Reimbursement in Japan
Introduction
Reimbursement fees in Japan are effectively established by the Central Social Insurance Medical Council (Chuikyo), a separate body designated by the Ministry of Health, Labor, and Welfare (MHLW). The Chuikyo consists of 20 members including 7 payer members (e.g. insurance union representatives), 7 providers (e.g. physicians and dentists), and 6 public representatives (e.g. members of the academia). The Chuikyo also has several subcommittees and designated organizations that support with the review of new reimbursement requests and establishment of reimbursement policy.
Reimbursement fees are reviewed every two years with the fees of existing drugs, for example, typically undergoing a 5-10% reduction, on average. The general aim of the reimbursement fee cuts is to bring the reimbursement fees down closer to the wholesale price level thus limiting the margin that hospitals and wholesalers may receive from negotiating with wholesalers and manufacturers, respectively. Reimbursement revisions for some good and services may be reviewed annually starting in 2020.
Once a new drug or device is approved for marketing it is normally listed for reimbursement within a few months and marketed immediately thereafter. However, employment at facilities is not always immediate. Large hospital facilities as a policy often wait as long as 6 months before employing a new drug - especially if there already an alternative treatment available. The reasons for this delay include concerns about clinical safety as well as internal logistics when it comes to scheduling meetings to review products and ensuring the necessary space to stock the new products.
You can get 24 hour online access for $24.95 if you don’t have research library access. Check your email for details
dogn
It’s in the full paper, CB.
dogn
Efficacy and safety of self-emulsifying formulation of highly purified eicosapentaenoic acid ethyl ester (MND-2119) versus highly purified eicosapentaenoic acid ethyl ester in patients with hypertriglyceridemia: Results from a 12-week randomized, double-blind, active-controlled, phase 3 study
Takuya Mori
Kagari Murasaki, MD, PhD
Koichi Hayashi
Yuichi Yokoyama
Published:June 24, 2022
DOI:https://doi.org/10.1016/j.jacl.2022.06.007
JOURNAL OF CLINICAL
LIPIDOLOGY
https://www.lipidjournal.com/article/S1933-2874(22)00181-7/fulltext
It’s in the June 2022 paper reporting MND-2119 trial results. Did you find it?
No idea. If Amarin just even announces that they have submitted Vascepa 2 for FDA approval, I can see the SP rallying at least 13.565% to $1.3287, raising the market cap $64M… hence, yours is the classic 64 million dollar question.
dogn
Pharmacydude, when I saw these inventory details in Lizzy's post 387972 earlier today (thanks, Lizzy!), I thought the same thing.
Short-term investments of $85.2 million, Accounts receivable, net, of $143.9 million and Inventory of $225.8 million. In addition, as of June 30, 2022, the Company had Long-term investments of $11.4 million and Long-term inventory of $210.3 million.
Thank you, STS. I appreciate your many contributions here as well.
I think based on Mochida's 2 successful MND-2119 trials, Japanese approval, and now Mochida's Sept. 12 launch of "Epadel EM" (reported by Pharma Japan), it will be possible to launch "Vascepa 2" much earlier than the IPE+ statin combo pill, which needs further research to develop. I agree that the combo pill will likely use the once-daily formulation, but we may not have to wait for a combo pill to begin regaining significant lost US market share... Vascepa 2 technology is ready to launch pending FDA approval. FDA has approved numerous other drugs "self-emulsified" drugs. Following the [url]
https://www.google.com/search?q=fda+approved+self-emulsified [/url][tag]google search link[/tag] from post 387879, one seemingly relevant result is "Review and analysis of FDA approved drugs using lipid-based formulations" from 2017:
https://www.tandfonline.com/doi/full/10.1080/03639045.2017.1342654
Lipid-based drug delivery systems (LBDDS) are one of the most studied bioavailability enhancement technologies and are utilized in a number of U.S. Food and Drug Administration (FDA) approved drugs.
"My question is are they going to?"
I think yes, and assume it's in the works.
Mochida launches once-daily Epadel on Sept. 12
From Pharma Japan: Mochida to Roll Out Once-Daily Epadel on Sept. 12
Mochida Pharmaceutical said on August 18 that a new once-daily soft capsule version of its hyperlipidemia drug Epadel (ethyl icosapentate) listed the same day will be available on September 12. https://pj.jiho.jp/article/247307
Amarin Corporation plc (NASDAQ:AMRN) today announced that Karim Mikhail, Amarin’s president and chief executive officer, is scheduled to participate at the H.C. Wainwright 24th Annual Global Investment Conference on September 12, 2022.
Date/Time: September 12, 2022, 9:00 a.m. ET/ 1:00 p.m. GMT+1