Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Pharmacydude, when I saw these inventory details in Lizzy's post 387972 earlier today (thanks, Lizzy!), I thought the same thing.
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
"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
On June 12, 2018 AMARIN AND MOCHIDA ANNOUNCE COLLABORATION ON FUTURE DEVELOPMENT OF EPA-BASED DRUG PRODUCTS AND INDICATIONS
https://investor.amarincorp.com/news-releases/news-release-details/amarin-and-mochida-announce-collaboration-future-development-epa
Mochida simultaneously issued a PR also dated June 12, 2018 that contained more detail. I translated and posted it previously (posts 385734, 373771). I first found it in March at the following website,
https://www.mochida.co.jp/english/news/#anchor-2018
but Mochida has since removed it.
I have added to my long position at these levels.
dogn
“Mochida Pharmaceutical Co., Ltd. announced on June 12 [2018] that it has signed a license agreement to license the right to develop and commercialize a new high-purity EPA formulation to Amarin, Ireland. Amarin has acquired the rights to "the United States and other regions," but at least Japan is not included in this, and Mochida retains Japan's rights. Mochida will receive a lump-sum contract payment, a milestone fee according to development progress, and a royalties according to the sales amount **after the product is launched.**”
Looks like a US launch of Vascepa 2 has been in the works >4 years.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169630832
dogn
The point of the emulsifiers is to improve absorption of the active ingredient. Less is then needed to reach same blood serum EPA levels. The June 2022 paper reporting trial results showed this.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169654085
More on exclusive license pertaining to MND-2119 in https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169630832
Interesting that the simultaneous June 2018 PR by Mochida that I posted no longer appears under their 2018 news releases.
Something’s cooking.
dogn
AMRN collaboration with Mochida (PR’d by both companies in 2018) was to develop MND-2119 (revealed in Mochida PR as noted in my prior posts), so quite sure they have exclusive license.
Seems FDA has recently approved several self-emulsified drugs
https://www.google.com/search?q=fda+approved+self-emulsified
It’s the same drug, just adds surfactant emulsifiers. Details are in the June 2022 paper on MND-2119 trial posted here previously. Seems the FDA could approve based on Japanese trials.
dogn
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
Info on BRAVE trial from piggybacking TBI study
Came across poster P03- VETERANS IN AD PREVENTION CLINICAL TRIALS: AN EVALUATION OF THE ASSOCIATION OF TBI ON MEMORY AND GLOBAL COGNITION from 14th Conference Clinical Trials on Alzheimer's Disease, Therapeutic Trials in AD: A New Hope for 2022?
Held Nov. 9-12, 2021 Boston
TBI=Traumatic Brain Injury
https://www.ctad-alzheimer.com/files/files/CTAD21%20Posters.pdf
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8589634/
“AstraZeneca is also looking for bolt-on acquisitions, including small and mid-sized companies specialising in oncology and cardiovascular treatments, Soriot added. "We always look for external opportunities," he said.
https://www.reuters.com/business/healthcare-pharmaceuticals/astrazeneca-hunt-oncology-cardiovascular-acquisitions-2022-08-23/
Published 18 August 18: https://www.astrazeneca.com/media-centre/articles/2022/why-we-need-innovation-in-heart-failure-care-now.html
“As heart failure prevalence increases globally, there is a growing need for new innovative solutions. At AstraZeneca, we remain steadfast in our commitment to advancing patient centric science, while highlighting the importance of early intervention and delivering life-changing medicines for the millions living with heart failure and other cardiorenal
diseases.
Elisabeth Bjork,
Senior Vice President, Late-Stage Development, Cardiovascular, Renal & Metabolism (CVRM), AstraZeneca”
REDUCE-IT HF analysis presented by Deepak Bhatt at ACC21:
REDUCTION IN HEART FAILURE WITH ICOSAPENT ETHYL: INSIGHTS FROM REDUCE-IT HF
https://www.jacc.org/doi/abs/10.1016/S0735-1097(21)01935-5
Amarin PR: https://www.globenewswire.com/en/news-release/2021/05/15/2230263/18362/en/REDUCE-IT-Heart-Failure-Analyses-by-VASCEPA-Icosapent-Ethyl-Driven-Serum-Eicosapentaenoic-Acid-EPA-Levels-Suggest-Potential-Benefit-in-New-Heart-Failure-in-Studied-At-Risk-Patients.html
dogn
Alm- nice post. Thanks.
dogn
Thanks for sharing this. Here’s the link:
https://www.reuters.com/business/healthcare-pharmaceuticals/astrazeneca-hunt-oncology-cardiovascular-acquisitions-2022-08-23/
“AstraZeneca is also looking for bolt-on acquisitions, including small and mid-sized companies specialising in oncology and cardiovascular treatments, Soriot added. "We always look for external opportunities," he said.
AZN’s Crestor statin was not that long ago the top selling cardiovascular drug.
It seems to me plausible that AMRN could quickly become the subject of a BP bidding war (AZN, PFE, NVS, BMY) driven by the strong potential in the CV space for a “megablockbuster” statin-IPE combo pill.
dogn
https://www.fiercepharma.com/special-report/top-10-cardiovascular-drugs-world
1. Crestor
1. Crestor/Provisacor
AstraZeneca/Shionogi/Chiesi
2016 sales: $3.87 billion
AstraZeneca’s Crestor stands at the top of the cardiovascular drugs heap for 2016, but 2017 will be a different story. Generic versions of the med hit the U.S. market last year after a last-ditch court fight against the FDA, and the brand immediately lost share to the cheaper copycats.
Crestor had a great run while its patent life lasted. It was considered a more powerful choice than other statins, which is one reason why its sales weathered competition from all the generic statins it faced, including copies of Pfizer’s megablockbuster Lipitor. The drug’s sales peaked in 2011, EvaluatePharma says, and over its lifetime, it generated a whopping $62.8 billion in sales.
AstraZeneca, of course, anticipated its quick decline, because multiple generic versions were ready to hit the market as soon as exclusivity lifted. Rather than facing one first-to-file generic, a competitive situation that limits pricing pressure, Crestor would immediately battle an onslaught of copycat drugmakers ready to do what it took to grab their share of the market. So the U.K.-based pharma giant moved to capture as much branded revenue as possible in the waning days of Crestor’s monopoly.
How? By the usual method drugmakers use in similar situations: price increases. AstraZeneca posted street-beating first-quarter sales for the product last year—$1.16 billion—thanks in part to those price hikes.”
Another news review of EPA MOA for relieving chronic pain publication
https://newsazi.com/elucidating-the-molecular-targets-of-eicosapentaenoic-acid-a-natural-remedy-for-chronic-pain-study-finds-that-epa-inhibits-an-important-signaling-molecule-thereby-reducing-chronic-pain/
67,890
rdhitchcock, thanks for sharing these further connections between neuropathic pain and CVD. These are new & interesting concepts to me.
dogn
Interesting quote from paper: “Here, we demonstrated that a low concentration of EPA and its metabolites, but not docosahexaenoic acid (DHA), are potent and selective physiological inhibitors of vesicular ATP release via the blockade of purinergic chemical transmission, which improved neuropathic and inflammatory pain and insulin resistance. Furthermore, EPA is more effective for neuropathic and inflammatory pain and has fewer side effects than existing drugs.”
Further puts nail in coffin of failed STRENGTH trial & EPANOVA & should be further ammo against continued RX use of generic Lovaza, and any OTC fish oil supplements containing mixed EPA/DHA.
https://www.astrazeneca.com/media-centre/press-releases/2020/update-on-phase-iii-strength-trial-for-epanova-in-mixed-dyslipidaemia-13012020.html
This is first time I have seen EPA proposed for chronic pain and as partial solution to opioid crisis. Just yesterday, NYT reported “A federal judge on Wednesday ordered three of the nation’s largest pharmacy chains — CVS, Walgreens and Walmart — to pay $650.5 million to two Ohio counties, ruling that the companies must be held accountable for their part in fueling the opioid epidemic.”
https://www.nytimes.com/2022/08/17/health/opioids-cvs-walmart-walgreens.html?smid=nytcore-ios-share&referringSource=articleShare
Seems this could provide a big boost to acceptance of Vascepa.
dogn
Researchers unravel a novel molecular target of eicosapentaenoic acid
https://www.news-medical.net/news/20220809/Researchers-unravel-a-novel-molecular-target-of-eicosapentaenoic-acid.aspx
Quite technical, but very encouraging new work which looks like important progress elucidating the mechanism of action of Vascepa=Icosapent Ethyl=Ethyl Eicosapentaenoic Acid (e-EPA) and its unique benefits over DHA.
dogn
“Explaining the rationale behind their study, Research Professor Miyaji, the corresponding author of this paper, says, "Conventional molecular targets such as COX-2 inhibitors can explain the anti-inflammatory and analgesic effects for inflammatory pain, but not neuropathic pain, of EPA. However, since EPA significantly attenuates both inflammatory and neuropathic pain, there is a strong possibility that there exists another important molecular target of EPA related to neuropathy." Diving deeper, the team, thus, sought to understand the mechanism of action of EPA in alleviating both inflammatory and neuropathic pain.”
…
“They found that EPA competes with chlorine ions that normally activate VNUT and inhibits VNUT-mediated release of ATP. Moreover, they observed this effect with EPA and its metabolites only, and not with docosahexaenoic acid, another omega-3 fatty acid, thus, suggesting that the structure of omega-3 fatty acids with side chains is necessary for VNUT inhibition.”
…
“We found that low concentrations of EPA completely and reversibly inhibited the release of ATP from neurons, without inhibiting the release of other neurotransmitters. Compared with other drugs, EPA demonstrated a higher analgesic effect and fewer side effects.”
“Besides, neuropathic pain and associated insulin resistance, the analgesic effects of EPA can be further extended to chronic pain associated with several other conditions like chemotherapy, diabetes, rheumatism, gout, sciatic nerve ligation, and inflammation. Additionally, purinergic chemical transmission is also associated with a variety of conditions including Alzheimer's disease and depression, for which EPA can be explored as a therapeutic strategy.
Moreover, opioids and other pain-relief medications can have long-term side effects and result in addictions. In the absence of optimal drug treatments with fewer side effects, chronic pain leads to a decreased quality of life, besides increasing the economic burden of treatment. With this discovery, 'nutrient-based EPA' and its metabolites can be indicated in the management of chronic pain, while also keeping potential side effects at bay.
Elaborating the long-term implications of their research, Research Professor Miyaji adds, "Our results can help develop novel nutrient-based treatment and prevention strategies by targeting purinergic chemical transmission for inflammatory, neurological, and metabolic diseases, without the adverse side-effects of conventional pain-relieving medications."
A very Happy Birthday, Kiwi!
dogn
See my earlier post I just replied to. June 2022 MND-2119 study paper
Folks are missing that the mean increase in serum EPA levels with the lower 2g/day dose was greater than achieved with 4g/day of Vascepa.
dogn
Never mind
dogn
if V2 is so much as $1 more expensive than gV they will simply refuse to cover it.
So price V2 $1 less than V1.
Lizzy, hopefully something's brewing whether it's related to a new formulation launch or not! Largely following XBI (up 14.4% last month vs. 16.3% for AMRN), but notable divergence seen today (XBI down 3.2%), and more high volume days this month. Not sure it isn't just technical... short trade finally exhausted, leading to a strong momentum reversal. Could also be related to perhaps an expanded Pfizer marketing partnership...but if something is brewing, progress on launching MND-2119 in USA would certainly have more impact. Looking forward to NEWS.
And thanks for removing me from your red flag list
dogn
I agree, thinking the case study fails to mention the subject also perhaps went on a diet, took up swimming and high-intensity training, lost 200 lbs, ...
I wonder to what extent there are inconsistencies in LDL and TG lowering with V vs Lovaza in the trial data vs anectdotal or case studies due to differences in the patient population risk factors. I haven't looked at the data you refer to, but imagine the outcome described in this case study must be replicable in the right group.
Very interesting, thanks sstyles. I do think a new once-daily formulation may be ready to launch before the oft-mentioned fixed dose combination IPE+statin combo pill, and may be the key to life-cycle management as applied to recovering from a tragic DUsaster of the VHTG patents loss. I have to believe Amarin has been working towards this for quite a while (Mochida collaboration and MND-2119 patent date to 2019), and we could see something on this front sooner rather than later.
dogn
Thanks for this info. I am also looking specifically for FDA guidance on bioequivalence for icosapent ethyl, mentioned to exist in the BE paper I cited in an earlier post today, if you would know where to find it!
dogn
Lovaza vs. Vascepa
This is old (2015) but it turned up (again?) in my searching today:
Case Reports Postgrad Med. 2015;127(8):869-73.
doi: 10.1080/00325481.2015.1100086. Epub 2015 Oct 9.
https://pubmed.ncbi.nlm.nih.gov/26453247/
Effects of switching from omega-3-acid ethyl esters to icosapent ethyl in a statin-treated patient with elevated triglycerides
Just 1 case study here, but switch from Lovaza to Vascepa "resulted in beneficial and substantial changes in the lipid profile with a notable reduction of TG levels along with additional reductions in LDL-C levels in a statin-treated obese patient with persistently high TG levels."
Weekly scripts have recently appeared headed towards TRx Vascepa dropping below TRx G. Lovaza.
In contrast, the European Medicines Agency (EMA) has approved Vazkepa but with regard to Lovaza/Omacor "has confirmed that omega-3 fatty acid medicines containing a combination of an ethyl ester of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) at a dose of 1 g per day are not effective in preventing further problems with the heart and blood vessels in patients who have had a heart attack. ... This means that these medicines should no longer be used in this way. However, they can still be used to reduce levels of certain types of blood fat called triglycerides.
"Omega-3 fatty acid medicines have been authorised for use after a heart attack, in combination with other medicines, in several EU countries since 2000, at a dose of 1 g per day. At the time of their authorisation, available data showed some benefits in reducing serious problems with the heart and blood vessels.
"EMA’s committee for human medicines, CHMP, re-assessed the evidence accumulated over the years on these medicines for this specific use and consulted additional experts in the field. It concluded that, although there are no new safety concerns, the effectiveness of these medicines in preventing recurrence of problems with the heart and blood vessels has not been confirmed.
"EMA concluded that the marketing authorisations of these medicines should be updated to remove this use."
https://www.ema.europa.eu/en/medicines/human/referrals/omega-3-acid-ethyl-esters-containing-medicinal-products-oral-use-secondary-prevention-after
It's really surprising generic Lovaza is still so widely prescribed. BPs eyeing Vascepa likely believe some heavy marketing education could swing much of the Lovaza market to Vascepa. It would be nice if the FDA would proactively address ineffectiveness of Lovaza so that instead of saving consumers money they would instead be saving consumers lives.
Yes, it will be interesting to see how this all unfolds, particularly how it impacts generics’ infringement & Amarin’s US market share.
Also from the MND-2119 study: No AFIB observed.
https://www.sciencedirect.com/science/article/pii/S1933287422001817
Thoughts on future FDA approval of self-emulsifying ethyl-EPA (Mochida MND-2119)
With MND-2119, licensed by Amarin, apparently now approved in Japan, what is path to approval by FDA?
The paper "Bioequivalence [BE] Demonstration for O-3 Acid Ethyl Ester Formulations: Rationale for Modification of Current Guidance" suggests the FDA guidance "established for icosapent ethyl (EPA ethyl esters) [has] the primary measure of BE [as] baseline-adjusted total EPA in plasma lipids for both the fasting and fed states."
From the recent June 24, 2022 Journal of Clinical Lipidology paper "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":
PDude, thanks for the explanation!
dogn
I had seen that, Lizzy! Yet I have never determined what the meaning of an “ethical drug” is.
Sleven,
I'm not an expert on Epadel or it's indications in Japan, but what I found is:
https://www.thepharmaletter.com/drug/epadel-epa
Description of MND-2119 from https://www.sciencedirect.com/science/article/pii/S1933287422001817
North, what I understand about MND-2119 is that it's the same API (active pharmaceutical ingredient) in a new formulation that adds something (a surfactant?) to render it "self-emulsifying," perhaps as described in this paper "Self-emulsifying drug delivery systems (SEDDS): formulation development, characterization, and applications"
https://pubmed.ncbi.nlm.nih.gov/20136631/#:~:text=Self-emulsifying%20drug%20delivery%20systems%20%28SEDDS%29%20possess%20unparalleled%20potential,yielding%20micro-%20or%20nanoemulsions%20containing%20the%20solubilized%20drug.
See translated Mochida PR I posted at
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168325803
as it more clearly describes collaboration than Amarin's PR:
Lizzy, yes I believe so. From June 18, 2018 press release announcing collaboration:
https://investor.amarincorp.com/news-releases/news-release-details/amarin-and-mochida-announce-collaboration-future-development-epa
Update on Mochida MND-2119 new formulation approval
Today I noticed "Stage = Approved" for MND-2119 on Mochida Pharmaceutical Co., Ltd.'s Research & Development Pipeline page "As of August 1, 2022"
https://www.mochida.co.jp/english/business/rd.html
Have not seen any press release, and to my best recollection, last time I checked it was just listed as "filed".
https://pj.jiho.jp/article/244669
"Mochida Pharmaceutical said on June 22, [2021] that it has filed for the Japan approval of MND-2119, a once-daily soft capsule version of its high-purity ethyl icosapentate (EPA) agent Epadel (ethyl icosapentate).This is an upgraded formulation of Epadel that is intended…
From May 13, 2022 document The Mochida Pharmaceutical Group's "22=24 Medium-Term Management Plan", p. 6: "2.3. Business Strategies... ii) Development ...- To obtain approval during the 22-24 Medium-term Management Plan period for MND-2119, a
new highly purified EPA drug" and p. 7 ...iii) Marketing ... "- In the cardiovascular area, to promote propagation of the value of Urece, a treatment for
hyperuricemia in gout; Also, to focus on early maximization of sales of MND-2119, a highly purified EPA drug, by leveraging our experience as a leading manufacturer of highly purified EPA drug;"
Recall recent publication (June 24, 2022): "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"
https://pubmed.ncbi.nlm.nih.gov/35871058/
https://www.sciencedirect.com/science/article/pii/S1933287422001817?via%3Dihub
concluding from trial: