The Sarissa Capital 13D notes they “reserve the right to, from time to time and at any time: (i) acquire additional Shares and/or other equity, debt, notes, instruments or other securities (collectively, “Securities”) of the Issuer in the open market or otherwise; (ii) dispose of any or all of their Securities in the open market or otherwise; or (iii) engage in any hedging or similar transactions with respect to the Securities.”

No one here is discussing (iii), which may include short selling, as a means for Denner to reduce his effective cost basis. If trades closed with <1% net change of ownership, no requirement to report.

Kiwi,

Having added more shares already "too soon" in the low 3s, high 2s, I did add a few more last week also too soon at 1.37-1.55, but am now out of dry powder and topped out at 17000. Many in inherited accounts I can't add new funds to.

I would agree it seems like a wonderful buying opportunity now with what my DD and this iHub board has taught me about AMRN following closely since starting a position just before the Reduce-it pop. Continuing to add after that, I sold ~1/2 just before the DU-saster which fortunately allowed me to average down the past 2 years.

Fortunately, most of my investments are in a 403B that doesn't allow individual stock holdings, or managed inherited accounts I can't wreck with my own mediocre stock picking skills. My dad picked stocks well, but I never acquired his prowess. I now only manage about 7-8% of my investments (which has dropped to 2-3% currently). Advisors recommend not putting more than 5% (some say 10%) into 1 stock, so I feel I'm already quite overweight AMRN.

I hope to get out of stock trading altogether after recovering a remaining ~$20K of realized losses (not going so well at moment ;-o) with a "buy low, sell higher" and "it's not a loss unless you sell" philosophy, and do truly believe AMRN is deeply undervalued and I'll make it out OK, just waiting much longer than hoped. For me it's a time savings to just follow 1 stock compared to what I was doing in the past, hence my more detailed DD here.

I did recently put ~1% of portfolio into positions in ETF XBI to "diversify" a bit, but also too soon - down ~16%. Assuming that recovers before AMRN, I may take on more AMRN for part of expected ride back up to allow myself an earlier exit.

dogn

Amendment Requirements for 13D Filers
From https://ibkr.info/node/2654

I think the large volume accompanying the huge post-earnings haircut is just a lot of churn (institutional holders buying/selling around core positions without changing net beneficial ownership), and do not find anything that would prevent even Denner from lowering his effective cost-basis by "day trading", selling options, and even short-selling. If short amount is less than 1% and covered, rinse and repeat, profiting from volatility. No expert here, but I don't see anywhere in regulations that any closed position realized gains need to be reported by 13D holders. I saw in Denner's 13D here the following:
Everyone has been focused on (i) or (ii) above triggering an amendment, but what about (iii)?

From this SEC Regulations 13D-13G document item 16: I am unable to decipher whether or not the above provides a mechanism for Sarissa Capital to avoid reporting "hedging activities" that may be capitalizing on huge volume and volatility to effectively reduce their reported cost basis. It seems that is the modus operandus of any hedge fund.

Perhaps the SEC's proposed new short disclosure/sale requirements (e.g. "buy to cover" order marking) will address these loopholes that currently may allow stock price manipulation to go undetected.
https://corpgov.law.harvard.edu/2022/04/02/the-secs-proposed-new-short-disclosure-sale-requirements/

I think this recent large drop represents temporary share price movements enabled by the poor earnings report. I may be wrong, but couldn't Denner simply maintain his long position without selling or adding, using "churn" to lower "effective" cost basis in ways not resulting in any net change in shares and thus not requiring reporting?

I personally haven't sold a share and don't engage in hedging (short selling, options), but can imagine others who do have professional know-how taking advantage of this window of opportunity Amarin gave them to do so. Just hoping SP can still get above my own break even point ($5.04) in due time.

71117

Gilead NASH combo drug trial Vascepa arm

I was wondering after re-reading the Nov. 2019 $20B buyout hype article [https://www.fiercepharma.com/pharma/amarin-for-20b-novartis-medco-deal-drives-fresh-buyout-rumors-for-fish-oil-derivative] when Amarin was at ~$21/share if results were ever reported or discussed here for the mentioned Gilead NASH combo drug trial that included Vascepa in Cohort 12 (FIR 20 mg + CILO 30 mg + VAS 2g).

https://clinicaltrials.gov/ct2/show/results/NCT02781584

Results 1st posted Feb. 2, 2022; Last update March 16, 2022

I guess it’s over and nothing spectacular or disastrous involving the IPE arm occurred.

Anyone follow this?

From Results tab: 30 participants on Vascepa completed. Lowest non-serious adverse event rate among all cohorts. 1 discontinued with adverse event (non/cardiac chest pain).

But otherwise cannot determined outcome of trial. There’s a June 2021 poster listed as last report (and miscellaneous 2019 and earlier reports I guess preceded the trial completion):

Lawitz E, Bhandari BR, Ruane P, Kohli A, Harting E, Jia C, et al. Fenofibrate is Safe and Mitigates Increases in Serum Triglycerides in NASH Patients Treated with the Combination of the ACC Inhibitor Firsocostat and the FXR Agonist Cilofexor: A Randomized Trial. Poster presented at: The European Association for the Study of the Liver (EASL): International Liver Congress; June 23-26, 2021; Virtual Meeting.

Granowitz left last summer… a surprisingly long spell for a pharmaceutical company to be without a CMO!

https://www.globenewswire.com/news-release/2021/07/30/2272047/0/en/Craig-Granowitz-M-D-Ph-D-Joins-Lexicon-as-Senior-Vice-President-and-Chief-Medical-Officer.html

Ziploc,

“Amarin holds the patent for treating CVD...It doesn't matter whether Amarin calls their EPA product ICPE or brand X...any EPA product issued by a generic company and prescribed to treat CVD is infringing on Amarin's CVD patent.”

I am asking how an authorized generic from a brand product manufacturer works in practice. Would/could it also be limited on it’s approved label to prescriptions for the MARINE very high triglycerides indication?

I assume an AG would only be for the carved out skinny label uses, so Amarin can still charge more for the Reduce-it label uses to get the ROI they deserve for paying for that expensive trial.

In the case then where an Amarin generic version of Vascepa fills a prescription not for CVD indication, who is held responsible for the infringement?

Perhaps this is the bind and argument against issuing an AG… it shines a light on the possibility that the manufacturer of the product is not responsible for infringement of the CVD patents?

It may be they should wait to see the outcome of the Healthnet case… if insurers and their formulary practices are the infringing parties, an AG is lower risk but perhaps then unnecessary as GV market share is reduced significantly.

Pharmacy Dude, thank you for this additional clarification.

Question regarding authorized generic

If Amarin did issue an AG, would it be authorized only for the Marine very high triglycerides indication?

Currently, GV is not authorized for the Reduce-it CVD indication. Would this be true for an AG from Amarin, too?

That is, prescriptions for the patented method of use for CVD (that Amarin spent millions to demonstrate and subsequently received the FDA-approved label for) would still be for brand Vascepa at a higher cost?

Then, any prescriptions filled with the Amarin generic not strictly prescribed for the VHG indication would still be subject to infringement by the insurers?

Is this not a solution to preserve the higher margin Reduce-it indication CVD label market while also competing against and undercutting obvious infringement (now crazily allowed by Hatch Waxman skinny label) of Reduce-it label prescriptions auto-switched to DRL, Himka, Apotex?

Then in parallel continue to tackle the infringement the autoswitching and formulary issues are inducing?

Is that better, Kiwi?

Question regarding authorized generic

If Amarin did issue an AG, would it be authorized only for the Marine very high triglycerides indication that current Generics have ANDA for selling without infringement, and not authorized for the Reduce-it CVD indication. That is, prescriptions for the patented method of use for CVD that Amarin spent millions to demonstrate and subsequently received the FDA-approved label for would still be for brand Vascepa at a higher cost, and any prescriptions filled for this indication with the Amarin generic would still be subject to infringement by the insurers? Is this not a solution to preserve the higher margin Reduce-it indication CVD label market while also competing against and undercutting obvious infringement now crazily allowed by Hatch Waxman skinny label with prescriptions auto-switched to DRL, Himka, Apotex? Then in parallel continue to tackle the infringement the autoswitching and formulary issues are inducing?

53% reduced risk of type II diabetes!
Thanks for sharing, Iryokabu.
Seems this could be huge if confirmed…

Findings

IPE, as proxied via increased FADS1 expression, was predicted to lower triglycerides and was associated with a 53% reduced risk of T2D. Statins and PCSK-9i, as proxied by reduced HMGCR and PCSK9 expression, respectively, were predicted to lower LDL-C levels but were not associated with T2D susceptibility.

Interpretation

Triglyceride lowering via IPE may reduce the risk of developing T2D in populations of European ancestry. However, experimental validation using animal models is needed to substantiate our results and to motivate randomized control trials (RCTs) for IPE as putative treatment for T2D prevention.

71117

https://bbbprograms.org/media-center/newsroom/innovix-pharma-omegavia-claims

https://www.prnewswire.com/news-releases/national-advertising-division-finds-innovix-pharma-qualified-claims-supported-recommends-certain-omegavia-performance-claims-be-discontinued-301533269.html

https://podcasts.apple.com/us/podcast/prevention-of-ischemic-events-and-mortality/id932118437?i=1000558646685

https://www.nutraingredients-usa.com/Article/2022/04/26/Amarin-makes-bid-to-force-fish-oil-supplements-firm-to-drop-claims

Class Action Lawyers Target ‘Ethyl Esters’ in Fish Oil Products – Natural Products INSIDER
21/04/2022 09:49:24

https://oltnews.com/class-action-lawyers-target-ethyl-esters-in-fish-oil-products-natural-products-insider

Unclear to me what the goal of the plaintiffs is here and how this might impact the prescription omega 3 market

71117

Long article on hedge funds with Oligarch money. Should we be concerned about how this might be affecting Amarin’s largest shareholder Sarissa Capital Management? A major distraction in the least, with potential future sanction impacts.

Bill Browder Warned Westerners Not to Take Russian Oligarch Money.
They Should Have Listened.

More than 100 hedge funds and private-
equity funds have been forced to freeze
sanctioned money — but what happens next?

https://www.institutionalinvestor.com/article/b1xl56hsvs2qv7/Bill-Browder-Warned-Westerners-Not-to-Take-Russian-Oligarch-Money-They-Should-Have-Listened
Select quotes:

“Abramovich’s money managers are a veritable who’s who of alternative investment managers. According to media reports, they include …Sarissa Capital Management, a relative newcomer launched by former Carl Icahn protégé Alex Denner in 2013 …”

“You don’t want to take [the oligarchs’] money because if you lose it, they’ll kill you,” is the message Browder relayed to his fellow financiers.”

“While their lives may not be in jeopardy, investment managers now find themselves in a tough spot between Western governments’ clamping down on Russian money on the one hand, and their Russian oligarch investors on the other. Firms have been forced to freeze the assets of sanctioned oligarchs but say they have been given no guidance on how to manage the money — and they now have to worry about future litigation from the oligarchs if and when sanctions are lifted.”

“…there are legislative efforts underway to allow Western authorities to simply seize sanctioned Russian money to help rebuild Ukraine after the war is over.”

“It’s just going to be a total nightmare, an expensive nightmare for every hedge fund that has Russian money, because it’s like 2 percent of their investor base and they’re going to probably be spending 25 percent of their time with lawyers, regulatory specialists, and staying up at night wondering how they’re going to get out of this mess,” says Browder.

“The funds, however, have been given little direction about what to do next.”

“Cayman lawyers are advising that the oligarch’s hedge-fund managers “don’t do anything; penalties for violating sanctions are criminal,” says the aforementioned hedge-fund executive, adding that “those who would like to get him out of the fund because he’s associated with a war criminal have no freedom to do it.”

70007

Sleven, currently with limited free docket access can see:

SO ORDERED that the pro has vice admission of Andrew J. Vaden is withdrawn.
Hon. Rukhsanah L. Singh, U.S.M.J.
April 11, 2022

jasbg, thanks for sharing your BVF Lampert research. Looking a bit more deeply myself, I found it interesting that Mark Lampert grew up in Ann Arbor, MI (home of University of Michigan), and also that the UM Regents on Dec. 9, 2021 approved an initial investment of up to $35M investment in BVF from their Long Term Portfolio:

https://regents.umich.edu/files/meetings/12-21/2021-12-IX-5.pdf

AMRN is BVF's 17th largest of 52 holdings (2.01% of their portfolio) according to your Hedgefollow link https://hedgefollow.com/funds/BVF+Partners

Not sure if there is difference between what Hedgefollow lists under "BVF" and the "Biotechnology Value Fund II, L.P.", or if they group all the BVF funds under one listing?

70707

swg_tdr. Glad to hear Vascepa has provided you many more years of improved health! Scary!

Yes, our Bhattman continues to watch over Gotham City

Could Gotham City be Bridgewater, NJ, home of Amarin's US company office?

ggwpq, thanks for confirming it's the same video. Still good to see it getting additional coverage.

Recent ACC.22 poster summary published in JACC

JACC Journals › JACC › Archives › Vol. 79 No. 9_Supplement
https://www.jacc.org/doi/10.1016/S0735-1097%2822%2902547-5

ICOSAPENT ETHYL REDUCES CARDIOVASCULAR RISK SUBSTANTIALLY AND CONSISTENTLY REGARDLESS OF WAIST CIRCUMFERENCE
Prevention And Health Promotion

Deepak L. Bhatt, Eliot A. Brinton, Michael Miller, Philippe Gabriel Steg, Terry A. Jacobson, Steven Ketchum, Lixia Jiao, Ralph T. Doyle, Jean Claude Tardif, Christie M. Ballantyne, and on behalf of the REDUCE-IT Investigators

J Am Coll Cardiol. 2022 Mar, 79 (9_Supplement) 1556

Background
REDUCE-IT randomized 8179 statin-treated patients with elevated triglycerides to icosapent ethyl (IPE) vs placebo and demonstrated a large reduction in ischemic events. Whether that benefit was modified by the degree of baseline abdominal obesity is unknown.

Methods
Analyses of the effect of IPE vs placebo were conducted for the primary (cardiovascular death, MI, stroke, coronary revascularization, hospitalization for unstable angina) and key secondary (cardiovascular death, MI, stroke) endpoints by baseline waist circumference tertiles (≤100 cm, >100 to ≤111 cm, >111 cm).

Results
Event rates increased with higher degrees of elevation in waist circumference. Both the primary and key secondary endpoints were statistically significantly reduced by IPE vs placebo in each waist circumference tertile (by 22% to 26% and 22% to 28%, respectively). No significant treatment interactions by waist circumference tertile were observed (interaction P = 0.94 and 0.88 for primary and key secondary endpoints, respectively) (Figure).

Conclusion
IPE significantly reduced CV events in patients regardless of baseline waist circumference. These data suggest that the benefits of IPE in patients with elevated triglycerides are independent of the degree of baseline abdominal obesity.

Download Figure
Download PowerPoint
Footnotes
Poster Contributions

For exact presentation time, refer to the online ACC.22 Program Planner at https://www.abstractsonline.com/pp8/#!/10461

Session Title: Prevention and Health Promotion Flatboard Poster Selections: Lipids

Abstract Category: 38. Prevention and Health Promotion: Lipids

Prof. Deepak Bhatt interactive webinar posted April 4 on YouTube
Lipoprotein-a and Cardiovascular Disease: Reduction of Cardiovascular Events with Icosapent Ethyl

[Not sure if this is same ~hr long Bhatt video posted recently, recycled from another source? Had not viewed it yet and can't quickly locate earlier post.]

"Prof. Deepak Bhatt, Principal Investigator of the REDUCE-IT trials will discuss the recently published REDUCE-IT data. This interactive webinar is designed for health care professionals (cardiologists, endocrinologists, lipidogists, diabetes specialists, neurologists) who are interested in learning more on the latest research, treatment, and clinical management of patients with a history and risk of Atherosclerotic Cardiovascular Disease ASCVD."

Impact of Icosapent Ethyl on Cardiovascular Risk Reduction in Patients With Heart Failure in REDUCE-IT

Senthil Selvaraj, MD, MS, MA, Deepak L. Bhatt, MD, MPH, Ph. Gabriel Steg, MD, Michael Miller, MD, Eliot A. Brinton, MD, Terry A. Jacobson, MD, Rebecca A. Juliano, PhD, Lixia Jiao, PhD, Jean-Claude Tardif, MD, Christie M. Ballantyne, MD and the REDUCE-IT Investigators

Originally published 4 Apr 2022
https://doi.org/10.1161/JAHA.121.024999 Journal of the American Heart Association. 2022;11:e024999

Abstract
Background
Patients with heart failure (HF) are at high risk for atherosclerotic cardiovascular disease. Studies of atherothrombotic treatments in this population have been disappointing to date. Icosapent ethyl reduced the risk of atherosclerotic cardiovascular disease among a broad array of statin-treated patients at elevated risk for atherosclerotic cardiovascular disease. Whether the treatment benefits of icosapent ethyl are consistent among those with HF is unknown.

Methods and Results
REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl–Intervention Trial) randomized 8179 participants, including 1446 (17.7%) patients with a history of HF (icosapent ethyl, N=703; and placebo, N=743). The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina. We used Cox regression to estimate the risk of outcomes of participants with and without HF. We estimated the placebo-controlled change in triglycerides and hs-CRP (high-sensitivity C-reactive protein) from baseline to 2 years. Among 1446 patients with HF, median age was 63.0 years, median body mass index was 31.0 kg/m2, and more were men (69.3%). Icosapent ethyl reduced triglycerides (median reduction, 33.5 mg/dL, or 15.4%; P<0.0001) and hs-CRP (35.1%; P<0.0001) compared with placebo, similar to patients without HF (P-interaction>0.90). The treatment effect on the primary end point in patients with HF history (hazard ratio [HR], 0.87; 95% CI, 0.70–1.08) was consistent with the effects observed in patients without HF history (HR, 0.73; 95% CI, 0.65–0.81) (P-interaction=0.13).

Conclusions
In REDUCE-IT, icosapent ethyl provided similar improvements in triglyceride levels and hs-CRP as well as similar cardiovascular risk reduction in patients with and without HF.

Dukesking, thanks for this great DD. Very encouraging. I have imagined with the Healthnet case moving forward Amarin has much leverage to negotiate favorable coverage as they can “offer” insurers the alternative option of being added to the infringement case and facing litigation and damages. Not worth their risk.

75432

Yes, but not in session planner detail if you click the “learn more” link or search for it

Amarin at ACC.22 Expo booth 711
Lots of opportunities for educating & networking (& negotiating?)

The Global Marketplace for Cardiovascular Innovation!

https://accscientificsession.acc.org/Meeting-Destinations/Expo

The ACC.22 Expo is the largest gathering of innovative cardiovascular products and services shown under one roof. Attendees will have dedicated time to visit 250+ companies and organizations to see the latest advances in pharmaceuticals, imaging, devices, health IT and the services you need to provide high-quality care for your patients.

Exhibitors & Map

View the ACC.22 Expo Floor Plan and use the Exhibitor List or Advanced Search buttons to search for a company or product by keyword, product category or pavilion. The results will display a list of matching exhibitors. Click on an exhibitor's name or an exhibitor's booth to bring up the company profile, which includes contact information, website, company description and product categories.

Expo Map & Exhibitor List

Agree with your points, Ziploc. Also agree with Kiwi that reimbursement is a separate matter, which has taken longer to negotiate in EU after regulatory approval in Jan 2021 than many of us expected. And agree with CBB that BP would certainly have managed rollout more effectively, although there could be many compelling reasons why Amarin was not ready or willing at the time to get locked into a specific BP partnership. It limits ultimate flexibility in negotiating an eventual BO. I expect when a BO takes form, Eddingpharm will be a small additional minnow like HLS for that same BP to swallow to gain complete control at that later time.

Full text of Eddingpharm PR dated 3/29/2022

What I just noticed & found interesting is line below “approval on February 23rd 2022.” Why if Hong Kong health authority approved 2/23 did they wait nearly 5 weeks to PR? Perhaps delayed bc Russia invaded Ukraine on 24 February 2022? Also notable is “The company is evaluating launch opportunities and is planning a potential commercial launch later this year. The new drug application (NDA) for VASCEPA in Mainland China is currently under review by the Chinese National Medical Products Administration (NMPA).” Probably as others have suggested they 1st need mainland approval to execute IPO needed to secure sufficient funds with which to launch.

http://www.eddingpharm.com/EN/newsDetail/160

EDDING today announced that VASCEPA® (icosapent ethyl) has been approved for a cardiovascular risk reduction (CRR) indication “as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease” by the China Hong Kong authority.

EDDING and Amarin Corporation plc entered into an exclusive license agreement in 2015 for the development and commercialization of VASCEPA in Greater China, which encompasses Mainland China, Hong Kong, Macau and Taiwan.

VASCEPA is a single-molecule product. It is a highly purified omega-3 fatty acid (EPA) ethyl ester. VASCEPA is the first drug approved by the FDA as an adjunct to maximally tolerated statin therapy for the approved cardiovascular risk reduction (CRR) indication. The REDUCE-IT cardiovascular outcomes trial, which was published in The New England Journal of Medicine in 2018, showed that, VASCEPA can provide a 25% risk reduction in the five-point major adverse cardiovascular event primary composite endpoint on top of standard statin treatment compared to statin therapy plus placebo.

Based on the research data of REDUCE-IT and the approvals of VASCEPA in the United States, Canada and other countries, the application for drug approval of VASCEPA was submitted to the Hong Kong health authority, and approval on February 23rd 2022. The company is evaluating launch opportunities and is planning a potential commercial launch later this year. The new drug application (NDA) for VASCEPA in Mainland China is currently under review by the Chinese National Medical Products Administration (NMPA), and the NDA includes the previously announced successful results of the Phase 3 study conducted by EDDING and all of the Phase 3 studies conducted by Amarin.

“We are very pleased to know that VASCEPA was approved in Hong Kong for a CRR indication.” stated Weidong Huang, Chief Operation Officer, EDDING, “VASCEPA has been a recommendation on multiple professional ASCVD guidelines or scientific/consensus statements in the U.S. and Europe including ADA, ESC, etc. It is also recognized by more than 20 treatment guidelines, scientific or consensus statements on cardiovascular diseases and diabetes, including in China. Cardiovascular Disease (CVD) is the heaviest disease burden and the leading cause of death in China and there are still a large number of unmet needs. We believe the launch of VASCEPA in Hong Kong will help Chinese patients live a healthier and longer life. EDDING commits to provide patients with high-quality global medical products. This approval of VASCEPA in Hong Kong is a new milestone for us.”

About REDUCE-IT®
REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort).

REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology. The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018. Compared to placebo, administration of VASCEPA 4 g/d demonstrated 25% risk reduction in major adverse cardiovascular events (5 MACE composite endpoint). The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.


About VASCEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the U.S. FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. In December 2019, the new cardiovascular risk indication for VASCEPA was approved by the FDA and it was launched as the first drug for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. VASCEPA has approval to be marketed in the USA, Europe (centralized procedure), Great Britain, Canada, Lebanon, the United Arab Emirates, Qatar, Bahrain and Kuwait.

I have no idea about that

EDDING Receives Approval of VASCEPA® to Reduce Cardiovascular Risk in Hong Kong

2022-03-29
From ST poster evila

https://stocktwits.com/evila/message/448021257

http://www.eddingpharm.com/EN/newsDetail/160

EDDING today announced that VASCEPA® (icosapent ethyl) has been approved for a cardiovascular risk reduction (CRR) indication “as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease” by the China Hong Kong authority.

EDDING and Amarin Corporation plc entered into an exclusive license agreement in 2015 for the development and commercialization of VASCEPA in Greater China, which encompasses Mainland China, Hong Kong, Macau and Taiwan.

VASCEPA is a single-molecule product. It is a highly purified omega-3 fatty acid (EPA) ethyl ester. VASCEPA is the first drug approved by the FDA as an adjunct to maximally tolerated statin therapy for the approved cardiovascular risk reduction (CRR) indication. The REDUCE-IT cardiovascular outcomes trial, which was published in The New England Journal of Medicine in 2018, showed that, VASCEPA can provide a 25% risk reduction in the five-point major adverse cardiovascular event primary composite endpoint on top of standard statin treatment compared to statin therapy plus placebo.

Based on the research data of REDUCE-IT and the approvals of VASCEPA in the United States, Canada and other countries, the application for drug approval of VASCEPA was submitted to the Hong Kong health authority, and approval on February 23rd 2022. The company is evaluating launch opportunities and is planning a potential commercial launch later this year. The new drug application (NDA) for VASCEPA in Mainland China is currently under review by the Chinese National Medical Products Administration (NMPA), and the NDA includes the previously announced successful results of the Phase 3 study conducted by EDDING and all of the Phase 3 studies conducted by Amarin.

“We are very pleased to know that VASCEPA was approved in Hong Kong for a CRR indication.” stated Weidong Huang, Chief Operation Officer, EDDING, “VASCEPA has been a recommendation on multiple professional ASCVD guidelines or scientific/consensus statements in the U.S. and Europe including ADA, ESC, etc. It is also recognized by more than 20 treatment guidelines, scientific or consensus statements on cardiovascular diseases and diabetes, including in China. Cardiovascular Disease (CVD) is the heaviest disease burden and the leading cause of death in China and there are still a large number of unmet needs. We believe the launch of VASCEPA in Hong Kong will help Chinese patients live a healthier and longer life. EDDING commits to provide patients with high-quality global medical products. This approval of VASCEPA in Hong Kong is a new milestone for us.”

NPR story produced in partnership with “Kaiser Health News”, as in MITIGATE sponsor Kaiser

We know about long COVID. Should there be a medium COVID?

“When COVID-19 symptoms linger for weeks, but not long enough to become long COVID, it’s confusing and scary for patients. Doctors say this is common. Should we start talking about medium COVID?”

https://one.npr.org/i/1088720620:1088720621

“The omicron wave is ebbing now, but record numbers of Americans were infected. That means more people than ever before are recovering from COVID. And they might be — for awhile.
For NPR news, I’m Nina Feldman in Philadelphia.
This story comes from NPR’s partnership with WHYY and Kaiser Health News.”

IP watchdog article by Zachary Silbersher

MARCH 23, 2022

Above my pay grade.
Point of following unclear to me: “Amarin Pharmaceuticals recently asserted a handful of patents, which were invalidated during litigation, even though Amarin allegedly previously characterized the prior art to both the FDA and investors as seemingly anticipatory of the very patents it subsequently sought to defend in court.”

“For years, there has been a chorus of voices lamenting that brand pharmaceutical companies are delaying entry of lower-cost generic drugs with patents that do not, in fact, embody years of expensive R&D. Getting the data right is therefore just as important as getting the conclusions right about what that data actually means.”

“The debate around whether patents are unnecessarily propping up drug prices has been simmering for years. A recent policy memo from the Hudson Institute has thoughtfully raised concerns about the data underlying this debate, and the memo made its way up to the U.S. Senate Judiciary Subcommittee on Intellectual Property. While the memo may have successfully poked holes in some of the data, it draws questionable conclusions regarding what those holes might mean. Unpacking this debate is therefore necessary to guide the correct policy on the intersection of patents and drug prices.”

“First, generic competition is not stifled by patents only because of increased litigation costs. Generic pharmaceutical companies are essentially in the litigation business. Their business plans are predicated upon being sued for patent infringement and overcoming those suits to achieve the earliest entry date possible. There exist entire statutory schemes, including the Hatch-Waxman Act for small-molecule drugs, and the Biologics Price Competition and Innovation Act for biologic drugs, that set forth how and when brand pharmaceutical companies can sue prospective generics and biosimilars for patent infringement before they enter the market. These lawsuits are, somewhat counter-intuitively, triggered by the generics themselves, namely through filing abbreviated new drug applications (ANDAs) and Paragraph IV certification letters. Indeed, generics and biosimilars are one of the few types of defendants in patent litigation—or any litigation for that matter—who know they are going to be sued, and when, even before the plaintiff does.”
“Indeed, a problem exists when the bulk of the R&D behind a drug is finished and the brand pharmaceutical companies nevertheless squeeze out an additional patent with a far off expiration date that permits the brand to continue litigating against generic entry. There are numerous examples of this. Novartis is currently asserting a patent covering its blockbuster Gilenya that purports to cover taking the chicken pox vaccine to immunize against chicken pox. Amarin Pharmaceuticals recently asserted a handful of patents, which were invalidated during litigation, even though Amarin allegedly previously characterized the prior art to both the FDA and investors as seemingly anticipatory of the very patents it subsequently sought to defend in court.”
https://www.ipwatchdog.com/2022/03/23/hudson-institute-memo-draws-wrong-conclusions-discrepancies-maks-data/id=147816/

72222

MND-2119 once daily formulation status

Spent a bit of time looking for any updates and didn't find too much but some interesting info new to me:

Amarin has been working with Mochida on this since 2018. Amarin's June 12, 2018 PR "Amarin & Mochida announce collaboration on future development of EPA-based drug products and indications" doesn't mention MND-2119.

But I found the simultaneous PR from Mochida contained some interesting "added color" in retrospect:
(can be tricky to get Google to translate this... need to use Chrome browser I believe)

The 22 week clinical trial "Efficacy of MND-2119 in Participants with Hypertriglyceridemia" started ~ 4 months later (Oct. 27, 2018) and was completed June 29, 2019 (580 participants). https://clinicaltrials.gov/ct2/show/NCT03693131

A later 52 week clinical trial "Long-term Safety and Efficacy Study of MND-2119 in Patients with Hypertriglyceridemia" started Feb. 14, 2020 and was completed July 14, 2021 (120 participants).
https://clinicaltrials.gov/ct2/show/NCT04221217

on June 23, 2021 Mochida released PR "Mochida Pharmaceutical apply for approval of new high-purity EPA preparation 'MND-2119' administered once daily."



The above timeline with same phrase "new high-purity EPA" formulation or preparation in both June 2018 Amarin-Mochida collaboration PR and June 2021 MND-2119 "once-daily" PR confirm Amarin's long term involvement AND exclusivity to license everywhere but Japan. I think it's likely this will be used for the combo statin pill under development.

The Mochida 2021 "integrated report" has no updates other than "Looking at our development pipelines, we filed for manufacturing and marketing approval of MND-2119, a new highly purified EPA drug."
https://www.mochida.co.jp/english/annual/

A Nov. 5, 2021 financial report states "In terms of clinical development, a new high-purity EPA preparation "MND-2119" is under application for manufacturing and marketing approval."

On a separate note, I found another trial for ethyl icosapentate I was unaware of with summary reading "The purpose of this study is to evaluate the efficacy and safety of ethyl icosapentate in Chinese patients with severe hypertriglyceridemia." and it appears to still be recruiting "Updated 24 Feb. 2022, days left to enroll 67"
Searching for this trial found also elsewhere at: https://clinicaltrials.gov/ct2/show/study/NCT04239950

Wondering if this has anything to do with delays of China approval? First posted Jan. 27, 2020 and I thought Eddingpharm application for approval came after that?