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Section 8 of the Hatch Waxman act has resulted in many infringements by generic cos. with consequent lawsuits
"Section viii of the Hatch-Waxman Act permits an Abbreviated New Drug Application (ANDA) applicant to obtain FDA approval to market a generic version of a drug for a non-patented use where the reference listed drug (RLD) has multiple indications, not all of which are covered by a method-of-use patent."
The obvious simple solution to this plethora of lawsuits is...for congress to amend the HW law so that...
medical insurance companies would be required to...
1.make lists of medicines with multiple indications in their formularies...declaring that they will provide coverage ONLY for the approved indications
2. require that prescriptions for medicines must always specify a particular indication in order to have insurance coverage for that patient prescription
Governments and medical insurance companies should approve of this amendment to HW...since it would reduce their costs while enabling patients to get the medicine they need for the correct indication.
As well as strengthening patent law..and reducing patent lawsuits
NS....Amarin is a competitor of generic Vascepa companies...If Amarin would just leave the U.S. market to them, they would have 100% OF THE icosapentethyl sales in the U.S....rather than just the 50% that they now have...through their infringement on Amarin's CVD patent.
Anything the generic companies can do to hurt Amarin, helps themselves....They would like it if they could induce Amarin to just retreat to the EU and leave the U.S. market to them entirely...Even if/when the generic Cos. lose their Sherman act lawsuits, they can still damage tiny Amarin by having them deplete their cash by instigating meritless law suits against Amarin.
NS...Hikma, Teva, Dr. Reddy, and Apotex (manufacturers of generic Vascepa), are involved in an illegal conspiracy to cripple Amarin and thereby protect their aim to continue infringing on Amarin's CVD patent, though which they have stolen millions of dollars in revenue, which rightfully belong to Amarin.
The purpose of a counter-suite by a defendant can be to induce the settlement of a suit initiated by a plaintiff.
However, in the case of Amarin's "monopolizing " the market through large orders of EPA from suppliers, those orders were clearly made by Amarin in anticipation of larger markets...before the infringement of Amarin's CVD patents by Hikma and other generic companies, made possible by the Du decision.
Capt...Vascepa is like a firecracker with a slow fuse... The fuse has been lit and it is smoldering...making its way towards the moment when it explodes.
Dar53...Amarin is a company, which depends on a volume of sales from its ONE product...Generics are companies, which depend on volumes of sales from their MANY products...When generic companies assess their balance sheets, they tolerate a small volume and a small margin from any ONE of their MANY products.
Generic companies then insure their profits by NOT advertising and NOT innovating(while they don't hesitate to cheat on patented products).
Some politicians(and some judges) think generic companies are a force for good...but are they really?
DMC....QUOTE..."In this prospective, multicenter, randomized, open-label, blinded end-point study, patients with stable coronary artery disease and a low EPA/AA ratio (<0.4) were randomized to EPA (1800 of icosapent ethyl administered daily)"
This study demonstrates that the dosage of EPA is important...In the RI study, the daily dosage of EPA was over twice as much as in this study....i.e. 4000 mgms. of EPA daily in R.I. as compared with 1800 in this study.
This is further evidence that OTC omega 3 products, containing lesser amounts of EPA than Vascepa(together with unhelpful DNA) are not as effective as pure Vascepa.
Capt...."Reasons for the seemingly peculiar effects of EPA when administered alone are unclear, but appear NOT directly related to the decrease of triglyceride levels"
The FDA indications for Vascepa, as promulgated in the Adcom of 2019, included patients, who have triglycerides of "equal to, or over 150 mgms./dcl."
Amarin should (in view of this new information having been just released)...return to the FDA and ask for a new Adcom for the purpose of approving Vascepa for patients, who do NOT have have triglycerides above150 mgms./dcl, but who do have have cardiovascular risks such as previous heart attacks, diabetes, or hypertension ??
Generic companies are selling gV ostensibly on the basis of high triglycerides rather than on the basis of reduction of CVD...Now we know that high triglycerides are NOT the reason why Vascepa is so effective in reducing CVD...This could be a game changer for patients and for Vascepa.
IMO the G-BA focus on Vaskepa is primarily interested in the price more than in the science...When an AG for Vaskepa comes to Germany... at lower prices than at present, the attitude of the G-BA will change and the German market will become open.
As the old saying goes...You can lose a little on every sale, but make it up on the volume.
djiks...National health systems depend on federal budgets, which, in turn, depend on tax collections...This introduces political considerations into the equation...which may, at times, override scientific medical considerations.
About an Amarin AG for Vascepa...Profitability could be achieved by...
-really high sales volumes of Vascepa sales by Amarin due to lower Vascepa prices and (Amarin) generic V prices in the U.S. and elsewhere...This would be made possible by...really low prices of API to Amarin from its suppliers...This would, in turn, be made possible by
-really increased EPA sales volumes in Europe, together with the ROW(which other generics could not match)
Its a challenge, but what other options are available to Amarin?
LOTS...From my point of view, these PBMs dropping Vascepa from their formulary, are just begging Amarin to sue them.
cloudera...I assume that Amarin might continue to market branded Vascepa while marketing the same product as a generic V....BUT marketing generic V with a different label from Vascepa, calling the generic V Icosapentethyl, but that is just an off the cuff guess.
The generic companies use an inferior capsule, which causes more oxidization of the EPA, but I'm not sure how Amarin would handle that issue.
Denisk...We have no information on the exact reasons or the exact terms of Holt's resignation, but it seems to have been on good terms.
an AG is an authorized generic
It is now my belief that we will see an announcement of an AG for Vascepa by the end of June...Holt had no experience in dealing with the U.S. FDA and with marketing in the U.S... and he graciously ceded the CEO position to Berg in this critical time for Amarin....Berg does have experience with the FDA and with marketing...The CEO job for Amarin has now switched from getting Vascepa approved in Europe...to getting Vascepa approved by the FDA in the U.S...and then to market an AG in the U.S....both formidable challenges.
It is a job that was more suited to Berg's skills and experience than to Holt's...Holt understood the situation and appropriately resigned.
Berg's long affiliation with Amarin as a marketer will be helpful in accomplishing Amarin's goals.
Vascepa has an exclusive for many years in Europe (where there is no gV)...Amarin can attain high volumes of Vascepa sales in U.S through lower prices with an AG.... combined with their sales in Europe, where there is no gV....thus Amarin can afford to lower their prices even further in the U.S. and around the world in order to enhance these volumes, thereby surpassing the volumes of gV in the U.S....These lower prices and enhanced volumes for Amarin will lead to lower costs to Amarin for their API...and can make the lower priced Vascepa profitable for Amarin, while making gV less profitable for gV companies, who will have to pay more for API their own gV product.
John Thero said years ago..."Vascepa is a volume play...not a price play." Now is the time to enact his idea.
We know Vascepa is the right product...Perhaps it is just the price, which is wrong!
In retrospect, I feel that the replacement of Berg for Holt was a strategic one...Berg was more familiar with the U.S. market...and, in the near term, the U.S. market is going to require a lot more attention due to the new policy of CVS/Caremark to infringe on Amarin's Vascepa CVD patent in favor of generic V....It has been mentioned that Holt's leaving and the dropping of Vascepa by the Caremark PBM are linked...and I agree.
Both KM and Holt were hired for their experience in Europe...and the results have not as excellent as expected.
Previously, Amarin hesitated to sue PBM's for fear of drastic responses...Now that consideration must be considered as fulfilled!
North..PBM'S (pharmacy benefit managers) are well aware that generic IPE's are infringing on Amarin's CVD patent for Vascepa...yet they provide monetary inducements for pharmacies to dispense generic V, sometimes even if an RX for Vascepa is written as a DAW(dispense as written)...In your opinion, is it practical for Amarin initiate an infringement suit against a PBM?
Rather than have Amarin execute a buy back of 50 million shares, I would prefer to have Amarin spend its cash by suing the PBM, which just eliminated Amarin from its inventory of covered meds...a suit which would claim infringement of Amarin's Vascepa patents for CVD.
At least, that strategy would have a chance of returning cash to Amarin...in addition to sending a signal to other infringers to desist from their own infringing.
Tal...I agree...Amarin needs to preserve its cash (possibly for spending on marketing an AG in the U.S.)...much more than it needs to elevate its stock price a few cents for a few months....even if it means temporary delisting of Amarin.
We can not wait until Europe becomes a cash cow!
Holt picked an odd time to bow out...with so many potentially positive catalysts around the corner....He could have seen a sale of Amarin to a BP as a negative for him....OR he might have seen a switch to an Amarin emphasis on the U.S. market as a negative.
U.S.
Aaron Berg...for the newbees on the board...
"DUBLIN and BRIDGEWATER, N.J., June 04, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that the Company’s Board of Directors has appointed Aaron Berg, currently Amarin’s Executive Vice President and President of the U.S. Business, as President and Chief Executive Officer (CEO). The appointment of Mr. Berg follows the resignation of Patrick Holt as President & CEO of the Company.
“On behalf of the Company’s Board of Directors, I thank Pat for his contributions to Amarin, and I welcome working closely again with Aaron as President & CEO,” said Odysseas Kostas, MD, the Chairman of the Board. “No one knows the company better than Aaron, and we look forward to him contributing meaningfully as CEO.”
“As I begin this new role, my focus is clear – to find ways to deliver value for investors, and to maximize the potential of VASCEPA®/VAZKEPA for patients,” said Aaron Berg, President & CEO, Amarin. “I look forward to continuing to work with our Board of Directors and our tremendous team focusing on these priorities for the Company as we move forward.”
Mr. Berg joined Amarin in November 2012 and has more than 30 years of biopharmaceutical industry experience. Mr. Berg initially served as Amarin’s Vice President, Marketing and Managed Care. He was promoted to Senior Vice President, Marketing and Sales in February 2014, and to the position of Senior Vice President and Chief Commercial Officer in April 2018. Before joining Amarin, Mr. Berg served as President and Chief Executive Officer for Essentialis, Inc., a development stage pharmaceutical company where he led the company's work on triglyceride management. Prior to joining Essentialis, Mr. Berg served as Vice President of Marketing and Sales at Kos Pharmaceuticals (Kos), where he was instrumental in driving annual revenues approaching $1 billion. Mr. Berg worked at Kos until it was acquired by Abbott Laboratories in December 2006 for $3.7 billion."
Does this imply that Amarin will now be switching to more of a focus on the U.S. market?...
Holt had mentioned in a recent C.C. that Amarin was looking at an authorized generic....Does this event presage an AG for the U.S.?
Holt understood that a sale of Amarin to a BP was in the cards anyway...
What effect would a sale of Amarin to a BP have had on the stock options Holt had been granted?
Capt...the "Plaque-Busting" RCT(random controlled trial), 'EVAPORATE', showed that EPA actually regresses all types of plaque!
Amarin needs to advertise to the public and to government health services that safe, life saving Vascepa is more convenient and more cost effective than coronary stenting.
DMC...QUOTE.."This study supports a role for omega-3 fatty acids, particularly EPA, in the aetiology of depression, although pleiotropic mechanisms cannot be ruled out. The findings support guidelines highlighting the importance of EPA dose and ratio for MDD and question whether targeted interventions may be superior to universal prevention trials, as modest effect sizes will limit statistical power."
Could manic depressive disease be another important patient indication for Vascepa ?
KIWI..."Buybacks can offset the dilutive effect of stock options issued to employees, preventing an increase in outstanding shares that would otherwise reduce earnings per share."
My cynical mindset suspects this to be a major reason.
A buy back does not add money to Amarin's till...It is an accounting measure, which depletes Amarin's assets... It does not help increase revenues...Cash, which is spent on spent on projects that have the goal of increasing Amarin's revenues and earnings are preferable...It is probably why the U.K. has put up barriers to impede buy backs...
I would prefer a stock to be on the OTC rather than to have it be on the Nasdaq, only executing a buy back to avoid delisting from the Nasdaq.
Even a loathsome reverse split would not deplete the cash that Amarin could otherwise spend on worthwhile projects, e.g....such as a new version of EPA or an expanded indication...Oh!...That might be too much work.
Amarin is expected to institute a $50 million buyback in the next 6 months..Additional events would help the share price even more...
- increase in revenues
-increase in cash flow
-increase in earnings
-initiation of a dividend as low as 1 cent per share would allay investor's fears and instill their confidence in the future of Amarin.
QUOTE..."On May 24, 2024, Amarin Corporation plc (the “Company”) received a deficiency letter from the Nasdaq Listing Qualifications Department (the “Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that, for the last 30 consecutive business days, the closing bid price for the Company’s American Depositary Shares (“ADSs”), each representing one ordinary share of the Company, has been below the minimum $1.00 per share required for continued listing on The Nasdaq Global Market pursuant to Nasdaq Listing Rule 5450(a)(1) (the “Bid Price Requirement”). The Nasdaq deficiency letter has no immediate effect on the listing of the Company’s ADSs, and its ADSs will continue to trade on The Nasdaq Global Market under the symbol “AMRN” at this time....i.e. a rise in the price of AMRN shares of at least 15% over where they are now by sometime in 2024
Nothing in the stock market is guaranteed but this seems like a pretty good bet.
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been given 180 calendar days, or until November 20, 2024, to regain compliance with the Bid Price Requirement. If at any time before November 20, 2024, the bid price of the Company’s ADSs closes at $1.00 per share or more for a minimum of 10 consecutive business days, the Staff will provide written confirmation that the Company has achieved compliance with the Bid Price Requirement.
If the Company does not regain compliance with the Bid Price Requirement by November 20, 2024, the Company may be afforded a SECOND 180 calendar day period to regain compliance or be subject to delisting. To qualify for an additional compliance period, the Company would need to transfer the listing of the ADSs to the Nasdaq Capital Market and meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, except for the minimum bid price requirement. In addition, the Company would be required to notify Nasdaq of its intent to cure the deficiency during the second compliance period.
The Company intends to actively monitor the closing bid price for its ADSs and may, if appropriate, consider available options to resolve the deficiency and regain compliance with the Bid Price Requirement. However, there can be no assurance that the Company will be able to regain compliance with the Bid Price Requirement."
I assume that this means that Amarin plans to execute a buy back of 50 million of its shares within the next 6 months.
* * *
Ramfan...I hope your correct, but no mention of this is in the PR..
"Under the terms of the agreement, Vianex S.A. will be the sole and exclusive distributor of VAZKEPA® in the territory to import, register, distribute and commercialize the product. Amarin will be responsible for supplying finished product to Vianex at a TRANSFER PRICE paid to Amarin."
I know this deal is good for Greek patients...but is it also good for Amarin?
RMB...My fear is that, by Amarin repeatedly entering into royalty agreements with foreign partners...i. e. for Vascepa to be sold in several of these countries...with these foreign partners agreeing to pay Amarin royalties for Vascepa sales in their country, Amarin is making it that much more difficult for potential BP's to use the BP's own strategies to maximize their profits from Vascepa and to pay Amarin a substantial price for a subsequent BO.
This partnership policy, to have Vascepa sold by foreign partners, may increase revenues to Amarin in the short term, but may actually harm Amarin in the long term, when it comes to selling the company to a BO?
Do you think Vianox is going to commit a lot of its resources to VASCEPA ND THEN HAVE THE CONTRACT CANCELLED ON SHORT NOTICE?
JAS... JL was my friend, introducing me to Amarin circa 2009...He moved to Florida a few years ago and retired from his successful plastic surgery practice...I just spoke with him a few months ago and I have occasionally seen him still post on Ihub.
He prescribed Vascepa, pre and post-operatively, on his face lift patients and noted improved post operative results...he also used Vascepa for amelioration of his own dry eyes condition.
I never knew Jason, except in observing the eternal optimism expressed in his posts on Vascepa...He was so overconfident about Amarin management, overconfident in justice in the legal system, overconfident in the medical enlightenment of Docs, patients, and government health systems...but there was one thing that will eventually prove Jason to have been right in...that is, in the eventual value of EPA to human beings...His death was a terrible sacrifice to his ideals....I am truly sorry I never got to meet him.
Millions of people, year after year, waste their money by buying fish oil, in the mistaken idea that it reduces CVD...Vascepa's only hope to avoid this confusion was to advertise to the public and to Docs that Vascepa is purified EPA from fish oil, but is NOT the same as fish oil...and Vascepa ACTUALLY DOES reduce CVD.
Amarin was sucker punched by judge Du who caused Amarin to lose the revenues that it needed to get this message out...Now That job will have to go to a BP that buys Amarin.
Kiwi...DME Rx has mainly been done by retina specialists due to potentially serious complications from serial intra-ocular injections of anti-VEGF meds...oral Rx for DME would present a landmark improvement in the Rx of DME... if it is proven successful.
DMC...Thank you for posting on these studies on IPE
One study, you linked ,especially caught my interest...It showed the beneficial effects that Icosapent ethyl can have on cardiovascular outcomes in cigarette smokers...Smoking and CVD's is a world wide problem,which can be ameliorated with IPE...
"In REDUCE-IT, IPE treatment was associated with a reduced risk of CV events in current and former smokers to levels observed in never smokers. While smoking cessation should always be recommended, these data raise the possibility that IPE treatment may attenuate CV hazards attributable to smoking"
Its difficult for Amarin to sue individual Docs for patent infringement...but pharmacy chains and pharmacy benefit managers(PBM's) and insurance companies are not immune from infringement suits.
Nuke...Docs hate wasting time, writing Rx's...Perhaps it would be a worthwhile trial for Amarin to distribute free Rx pads to Docs...inscribed, among the writings..."Vasepa 1 gram Q.I.D. P.O....along with the letters DAW".
Pharmacies would still ignore the Rx pads' DAW in some cases, but not in all.
At the very least, it would provide Docs with some inexpensive exposure to Vascepa, even if many Docs eventually throw the Rx pads away, as many of them would.
Capt....Nice U.K. growth in Vascepa usage....What stood out for me in your charts is that there were 185 MILLION Lipitor doses and only 189 THOUSAND doses of Vaskepa
Since most of the patients presently on Lipitor would be able to benefit by being on Vascepa, in addition to a statin...these figures point out the potential for outstanding growth in future Vaskepa sales volumes in the U.K.!
interesting study on EPA and breast cancer in 2018, published in oncogene...never followed up with clinical studies
Eicosapentaenoic acid in combination with EPHA2 inhibition shows efficacy in preclinical models of triple-negative breast cancer by disrupting cellular cholesterol efflux
Angie M. Torres-Adorno,1,2 Heidi Vitrac,3 Yuan Qi,4 Lin Tan,5 Kandice R. Levental,6 Yang-Yi Fan,7 Peiying Yang,5 Robert S. Chapkin,7 Bedrich L. Eckhardt,2,* and Naoto T. Ueno2,*
The publisher's final edited version of this article is available at Oncogene
Abstract
Triple-negative breast cancer (TNBC), the most aggressive breast cancer subtype, currently lacks effective targeted therapy options. Eicosapentaenoic acid (EPA), an omega-3 fatty acid and constituent of fish oil, is a common supplement with anti-inflammatory properties. Although it is not a mainstream treatment, several preclinical studies have demonstrated that EPA exerts anti-tumor activity in breast cancer. However, against solid tumors, EPA as a monotherapy is clinically ineffective; thus, we sought to develop a novel targeted drug combination to bolster its therapeutic action against TNBC. Using a high-throughput functional siRNA screen, we identified Ephrin type-A receptor 2 (EPHA2), an oncogenic cell-surface receptor tyrosine kinase, as a therapeutic target that sensitizes TNBC cells to EPA. EPHA2 expression was uniquely elevated in TNBC cell lines and patient tumors. In independent functional expression studies in TNBC models, EPHA2 gene-silencing combined with EPA significantly reduced cell growth and enhanced apoptosis compared with monotherapies, both in vitro and in vivo. EPHA2 specific inhibitors similarly enhanced the therapeutic action of EPA. Finally, we identified that therapy-mediated apoptosis was attributed to a lethal increase in cancer cell membrane polarity due to ABCA1 inhibition and subsequent dysregulation of cholesterol homeostasis. This study provides new molecular and pre-clinical evidence to support a clinical evaluation of EPA combined with EPHA2 inhibition in patients with TNBC.
Triple-negative breast cancer (TNBC) is an aggressive disease that comprises 10–20% of all breast cancers. It is a heterogeneous disease that is often characterized by its strong metastatic potential and poor prognosis compared to estrogen receptor (ER)/progesterone receptor (PgR)-positive and HER2-positive breast cancers 1. While conventional chemotherapy is effective in the short term, TNBC often becomes refractory, and the lack of targeted therapy hampers a clinical solution for this disease 2.
Inflammation, a biological process designed to fight infections and heal wounds, can inadvertently support tumor formation and growth by supplying bioactive molecules that facilitate tumor progression and metastasis 3. Pathological assessment of TNBC has identified increased expression of molecular mediators of inflammation, such as prostaglandin G/H synthase 2 (COX2), and prostaglandin E2 (PGE2), representing potential therapeutic targets 4. Recent finding by our laboratory have observed that inhibition of inflammatory pathways through administration of celecoxib (a COX2 inhibitor) 5, or as observed by other using Lovaza (a highly purified, prescription-strength form of the omega-3 acid ethyl esters [O3AEE]: docosahexaenoic acid, DHA, and eicosapentaenoic acid, EPA) 6, can impair the growth of TNBC cells in vitro. Supporting our results, omega-3 fatty acid supplementation has been shown to reduce the growth of rat sarcoma tumors and DMBA-induced mammary tumors in vivo 7–9. Collectively, these studies suggest that the anti-inflammatory action of O3AEE have therapeutic potential. However, the translation of these compounds has been hindered by: 1) inconsistencies in sources, routes of administration and O3AEE composition 9, 2) absence of an established biomarker for therapeutic action, and 3) no definitive subpopulation of breast cancer patients that would benefit from therapy. As a result, there is a critical and unmet need to develop a rational, targeted-approach for the clinical testing of O3AEE in TNBC.
Towards greater clarity regarding the use of O3AEE as a therapeutic, we sought to investigate the anti-tumor effect of highly purified EPA (Vascepa, icosapent ethyl; Amarin Pharma Inc), which was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypertriglyceridemia 10. We demonstrate that EPA has potent tumor suppressive activity in preclinical models of TNBC. However, with no established therapeutic role for EPA in the TNBC patient population, translation of an EPA-based therapy through combination with conventional cancer therapy requires justification.
The main goal of this study was to identify a molecular target that could be targeted in combination with EPA for the effective clinical treatment of TNBC. To this end, we detail a functional genomics-based screen that identified the receptor tyrosine kinase EPHA2 as a therapeutically druggable target that enhances EPA-based therapy in TNBC, and present relevant preclinical studies that ESTABLISH THE RATIONAL FOR A PHASE 1 CLINICAL TRIAL the rationale for patients with TNBC....(however, phase 1 testing has never been done, to my knowledge)
Results
EPA inhibits the growth of TNBC tumor xenografts
While O3AEE demonstrate anti-tumor effects 8, EPA as a monotherapy in TNBC has not yet been tested. Thus, we initially assessed the anti-tumorigenic potential of EPA in a preclinical xenograft tumor model of TNBC (SUM149PT). EPA therapy was well tolerated at both 0.4 g/kg and 0.8 g/kg doses (equivalent to the human FDA-approved EPA dose; Supplementary Figure S1), with no change in body weight noted (data not shown). EPA levels were readily detectable in the sera obtained from mice undergoing therapy (Figure 1A) and, importantly, were significantly elevated in the cell membrane (phospholipid) fraction of TNBC tumor xenografts (Figure 1B). EPA therapy dose-dependently inhibited the growth of SUM149PT xenografts (Figure 1C), which led to a significant extension in survival (designated as the time required to obtain a 1 500 mm3 tumor) (Figure 1D). These data suggest that EPA is THERAPEUTICALLY ACTIVE active in VIVO and can reduce the growth of aggressive TNBC xenografts.