AMARIN CORP. PLC REG.SHS(SP.ADRS NEW)/1 LS-,50 (WK

RV 10 hat keine Ahnung.......

Amarin to Report First Quarter 2020 Results and Host Conference Call on April 30, 2020
[GlobeNewswire]
GlobeNewswire•April 28, 2020

DUBLIN, Ireland and BRIDGEWATER, N.J., April 28, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN) today announced that it will host a conference call with members of Amarin senior management to discuss the company's first quarter 2020 financial results and provide an operational update on Thursday, April 30, 2020, at 7:30 a.m. ET. The conference call will follow the anticipated release of the company's financial results earlier that day.

Conference Call and Webcast Information:

Amarin will host a conference call April 30, 2020, at 7:30 a.m. ET to discuss this information. The conference call can be heard live on the investor relations section of the company's website at www.amarincorp.com, or via telephone by dialing 877-407-8133 within the United States, 201-689-8040 from outside the United States, or by using the call back feature at https://bit.ly/2Knoe4L. A replay of the call will be made available for a period of two weeks following the conference call. To hear a replay of the call, dial 877-481-4010, PIN: 34453. A replay of the call will also be available through the company's website shortly after the call.

To Ask Questions:

During the teleconference, following prepared remarks, management will respond to questions from investors and analysts, subject to time limitations. Participants in the live teleconference will be provided an opportunity to ask questions. Investors may also e-mail their questions to investor.relations@amarincorp.com. Email questions will be accepted until Wednesday, April 29, 2020 at 4:00 p.m. ET.

About Amarin

Amarin Corporation plc is a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to cost-effectively improve cardiovascular health. Amarin’s lead product, VASCEPA® (icosapent ethyl), is available by prescription in the United States, Canada, Lebanon and the United Arab Emirates. Amarin, together with its commercial partners in select geographies, is pursuing additional regulatory approvals for VASCEPA in China, the European Union and the Middle East. For more information about Amarin, visit www.amarincorp.com.

Availability of Other Information About Amarin

Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Amarin Contact Information

Investor and Media Inquiries:
Elisabeth Schwartz
Investor Relations
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com (investor inquiries)
PR@amarincorp.com (media inquiries)

Lee M. Stern
Solebury Trout
In U.S.: +1 (646) 378-2992
lstern@soleburytrout.com  

Dann hoffe ich mal, das es nicht viel länger als Q1 2021 dauern wird, bis eine Entscheidung fällt. Aus der heutigen Pressemitteilung zu den Q1 Ergebnissen:

This proposed timing should facilitate a hearing in Q3 2020 (or perhaps early Q4 2020) and position the court to rule thereafter potentially in 2020 or in early 2021.  

Zahlen für Q1/20

• Umsätze 155 Mio. $ (+112% zu Q1/19)
  
• Berufungsverfahren im Patentrechtsstreit soll beschleunigt werden
  
• Anhörung in Q3/20 oder im frühen Q4/20 geplant
  
• Gerichtsentscheidung könnte dann 2020 oder Anfang 2021 erfolgen
  

https://investor.amarincorp.com/news-releases/...results-and-provides

 

Anal-ysten erhöhen nach einem Monat das Kursziel auf das Doppelte, es scheint als hätten sich die Klienten zum Teil eingedeckt, Dreckspack:

Citi doubles Amarin price target to $12 ahead of appeal decision Citi analyst Joel Beatty doubled the firm's price target on Amarin to $12 from $6 and keeps a Buy rating on the shares. The stock closed Thursday down 65c to $7.61. Beatty sees a "relatively high likelihood" of share upside from a European partnership in the second half of 2020, and also believes competitors are unlikely to launch a generic version of Vascepa before the appeal decision expected by the end of the year. While acknowledging a high risk to the stock from the appeal decision, he believes his 20%-40% probability of success on appeal for Amarin still provides a "favorable enough risk/reward" to buy the stock at the current price. Shares of Amarin are worth $24 on an appeal win, and $7 on a loss, Beatty tells investors in a research note.

Read more at:
https://thefly.com/landingPageNews.php?id=3083795  

:-) hat gestern ein analyst von sich gegeben, trau mich fast nicht, den link hier einzustellen :-)
schönes we !!  

Wainwright:

Amarin hired good attorney for Vascepa appeal, says H.C. Wainwright 07:14 AMRN H.C. Wainwright analyst Andrew Fein believes Amarin (AMRN) hired a good attorney for the Vascepa patent litigation appeal process in Jonathan Singer, head of the life sciences litigation practice at intellectual property litigation leader Fish & Richardson. In consultation with a patent attorney, Fein learned that Singer has tried several high profile cases, including being on the team that won an appeal on behalf of Gilead Sciences (GILD) regarding the hepatitis C drug sofosbuvir, in which the judge overturned a $2.5B jury verdict and the Federal Circuit affirmed. The analyst reiterates a Buy rating on Amarin with a $51 price target. While Fein thinks Vascepa growth can continue in the near term, he believes the combination of in-person Vascepa sales calls being suspended and reduced patient visits to physician offices amid the COVID-19 pandemic can have a continued impact on new prescriptions looking ahead to Q2.

Read more at:
https://thefly.com/landingPageNews.php?id=3083883  

Nicht nur Wainwright sieht großes Potential, auch Roth Capital sieht Amarin als "strong buy" mit einem Kursziel von US Dollar 31, also 4-5 Bagger:

Amarin a 'strong buy' ahead of federal circuit ruling, says Roth Capital Roth Capital analyst Yasmeen Rahimi sees COVID-19 disruptions as only a "minor distraction" from Amarin's continued commercial rollout of Vascepa. Although the pandemic has made it difficult for the company to fully take advantage of its sales expansion started in 2019, Amarin has taken innovative steps to keep interactions between sales reps and doctors, Rahimi tells investors in a research note. Further, the analyst notes that Amarin bumped up the timeline for a Vascepa appeals decision, with a hearing as early as Q3 and ruling thereafter by the end of 2020 or early 2021. With an expedited timeframe for its appeal, Amarin is a "strong buy" ahead of a potential federal circuit ruling, contends Rahimi. Following a deep dive with a "patent law guru," the analyst sees a high probability of success for the company on appeal. Alongside the "strategic optionality" being explored for Vascepa commercialization in Europe and a "strong resiliency" in the COVID crisis, Amarin shares offer "significant upside" potential for 2020, says Rahimi. The analyst keeps a Buy rating on the name with a $31 price target.:D The stock closed Friday at $7.34. Read more at: https://thefly.com/landingPageNews.php?id=3084953

Amarin - The Science Of Lipid Therapy | wallstreet-online.de - Vollständige Diskussion unter:
https://www.wallstreet-online.de/diskussion/...herapy#neuster_beitrag  

Northland starts Amarin at Outperform amid 'major paradigm shift' 10:13 AMRN Northland analyst Carl Byrnes initiated coverage of Amarin with an Outperform rating and $15 price target. The stock closed Monday up 28c to $7.62. The expanded label given to Vascepa represents a "major paradigm shift" in lipid management, addressing "sizeable" market opportunities in the U.S., Europe and the rest of the world, Byrnes tells investors in a research note. And while the ongoing patent litigation represents a "major risk," potential generic entrants will not be able to procure sufficient quantities of FDA-grade icosapent ethyl to pose a material commercial threat, predicts the analyst. Byrnes anticipates a ruling in the patent appeal in late 2020 or early 2021. The risk/reward profile of Amarin shares is compelling, says the analyst.

Read more at:
https://thefly.com/landingPageNews.php?id=3086235  

 

Der Appealbrief von Amarin scheint gut zu sein:

Patent attorney finds Amarin appeal brief effective, says H.C. Wainwright
With Amarin having filed its opening appeal brief with the U.S. Court of Appeals for the Federal Circuit, H.C. Wainwright analyst Andrew Fein consulted with a patent attorney on initial perspectives. The patent attorney concluded that Amarin has done a thorough job presenting its case and effectively presented its opening shot in the best light possible, Fein tells investors in a research note. The attorney further believed the brief explained the Vascepa technology and the basis of the invention thoroughly, why it was needed and the approach the inventor took to solve the problem of lowering triglycerides in patients with severe hyperlipidemia without raisi ng LDLs, adds the analyst. Fein points out that Amarin essentially has two main lines of argument: that the court erred in finding a prima facie case of obviousness because it did not apply the correct analytical framework and erred in its approach to secondary considerations. Fein's consulted attorney found Amarin's second line of argument compelling, both on the merits and on the clarity and force of argument. That said, the company only needs to be right on one, Fein adds. He keeps a Buy rating on Amarin with a $51 price target  

Sensationelle Ergebnisse gestern und der Kurs macht fast Nichts, dank dem krassen Fehlurteil von Richterin Du.....

Amarin Corporation plc (AMRN)EQUITY RESEARCHMay 14, 2020Price: $7.42Price Target: $35.00Rating: OverweightKey Statistics:SymbolNASDAQ: AMRN52-Week Range$3.95 - $26.12Market Cap (M)2,860.3ADV (3 mo)15,538,966Shares Out (M)385.5Research Analysts:Louise Chen212-915-1794Louise.Chen@cantor.comBrandon Folkes, CFA212-294-8081Brandon.Folkes@cantor.comJennifer Kim212-829-4860Jennifer.Kim@cantor.comCarvey Leung212-915-1917Carvey.Leung@cantor.comOne-Year Price History3025201510505/1908/1911/1902/2005/20AMRNCreated by BlueMatrixQuick TakeSteady Stream of Positive Data Supporting VascepaDoesn't Skip a BeatTakeawaysnToday  (5/14),  AMRN  announced  data  from  the  REDUCE-IT  study  presented  byBenjamin  E.  Peterson,  M.D.,  Brigham  and  Women’s  Hospital  Heart  &  VascularCenter  and  Harvard  Medical  School,  at  the  Society  for  Cardiovascular  Angiography&  Interventions  2020  Scientific  Sessions.  The  study  showed  that  administrationof  4g/day  of  Vascepa  resulted  in  a  significant  34%  reduction  in  first  coronaryrevascularizations  versus  placebo  (p<0.0001).  Similar  reductions  of  36%  wereobserved in total, or first and subsequent, revascularizations (p<0.0001). These datasupport our OW rating on the stock and our belief that the peak sales potential ofVascepa is still underappreciated. Please see here for the post hoc analyses.nCoronary revascularization procedures are invasive, carry multiple risks, and can havesignificant direct and indirect costs. Patients with elevated triglycerides, despite statintherapy, have increased risk for ischemic events, including coronary revascularizations.These procedures, whether pre-scheduled or performed in an emergency, often resultin additional time spent in a healthcare setting.nThe  analyses  from  the  REDUCE-IT  study  included  several  types  of  coronaryrevascularization   events   in   statin-treated   patients   with   persistent   elevatedtriglycerides (135-499mg/dL), who also had either cardiovascular disease or diabetesand  additional  cardiovascular  risk  factors.  Prespecified  tertiary  endpoint  analysesshowed  that  times  to  first  revascularization  events  were  significantly  reduced  byVascepa versus placebo across subtypes of intervention, including urgent, emergent,and elective revascularizations, which were reduced by 34% (p<0.0001), 38% (p=0.02),and 32% (p<0.0001), respectively. In post hoc analyses, Vascepa significantly reducedpercutaneous  coronary  intervention  (PCI)  by  32%  (p<0.0001)  and  coronary  arterybypass grafting (CABG) by 39% relative to placebo (p=0.0005).nREDUCE-IT  was  not  specifically  powered  to  examine  individual  cardiovascularendpoints;  therefore,  p-values  presented  for  these  revascularization  analyses  arenominal and exploratory with no adjustment for multiple comparisons. In addition,coronary revascularization as an endpoint can sometimes be considered subjective;however,  these  endpoints  were  adjudicated  by  an  independent,  blinded  clinicalendpoint  committee.  Results  from  the  total  coronary  revascularization  eventsanalyses  are  consistent  across  the  various  recurrent  event  statistical  models  andare also consistent with the first coronary revascularization events results. Together,the REDUCE-IT first and total coronary revascularization events results support therobustness  and  consistency  of  the  clinical  benefit  of  Vascepa  therapy  in  reducingcoronary revascularization.Investment ThesisWe  reaffirm  our  OW  rating  and  think  the  peak  sales  potential  of  Vascepa  isunderappreciated. Therefore, upward earnings revisions to levels not reflected in FactSetconsensus expectations should drive AMRN shares higher.The Disclosure Section may be found on pages 3 - 4.
ValuationWe continue to use a blend of DCF and multiples (EV/EBITDA) analysis to get to our 12-month price target of $35.RisksAmarin  Corporation  is  a  commercial-stage  company,  although  it  is  still  involved  in  theclinical pathway to expand the label for its currently approved product. As such, Amarinis subject to certain risks.Regulatory  Risk:  Actual  clinical  results  and  the  FDA's  conclusions  may  deviate  fromexpectations.  Many  of  our  model  assumptions  are  based  on  incomplete  clinical  data.Ultimately,  it  is  the  regulatory  bodies  of  the  Food  &  Drug  Administration  (FDA)  andEuropean Medicines Agency (EMA) that will determine the approval process of the clinicalfind  

Danke für Deine Infos. Das wäre ja ein Traum, wenn sich die Richterin geirrt hat und die Berufung zugunsten von Amarin ausgehen würde ! UND dieses Kursziel wäre natürlich auch ein Traum ! Leider wird sich das Thema wohl noch sehr lange hinziehen ! Ich bin zu 7 Euro mit einer ersten kleinen Position eingestiegen. Überlege aber, hier nochmal nachzulegen.... Kann halt nur nicht die Sachlage und die erste Entscheidung der Richterin richtig einschätzen !?  

 

Generkia heute von der FDA approved.

https://seekingalpha.com/pr/...eives-fda-approval-for-generic-vascepa

Heißt aber letztlich nicht, dass die Company das Produkt auch noch vor der Gerichtsentscheidung auf den Markt bringt. Dennoch verstimmt das natürlich den Markt und die Investoren.

 

FDA erteilt Hikma Pharmaceuticals die Zulassung für deren Vascepa® Generikum

Eine Zulassung ist noch keine Produktion, ich glaube Hikma wird die Gerichtsentscheidung erstmal abwarten, bevor sie auch nur einen Dollar in die Hand nehmen werden um die notwendigen Produktionsanlagen zu entwickeln. Die Errichtung würde ca. 6 Monate dauern. Die Berufungsentscheidung wird wahrscheinlich frühstens im Dezember 2020 getroffen.

https://www.fiercepharma.com/pharma/...allenge-loss-for-vascepa-maker (siehe Posting #323)

 

beruhige mich auch :)
an euch: schönes Wochenende  

Potential combo therapy with Remdesivir !!!

https://www.reuters.com/article/...-vaccine-for-coronavirus-soon-idUS

The trial primary endpoint is the effect of VASCEPA versus usual care on high-sensitivity C-reactive protein levels from baseline to 14 days in adults with a COVID-19-positive diagnosis. The clinical study design also includes other endpoints that assess rates and severity of COVID-19 infection in this high-risk group.
Based on our current understanding of the biological effects of a COVID-19 infection, including that patients at high risk of cardiovascular disease are at higher risk of mortality and severe effects from a COVID-19 infection, and based on data related to the mechanism of action and effects of VASCEPA in lowering cardiovascular risk in certain high-risk patients, it is believed that VASCEPA could play a beneficial clinical role in helping patients infected by the virus.

The clinical effects of VASCEPA are multi-factorial...

https://ih.advfn.com/stock-market/NASDAQ/...investigate-the-effects-o

Und zu Hikma, das ist keine Neuigkeit in dem Sinne, sondern Hikma sind einfach die Ersten von weiteren Generika Herstellern, die, wie Hikma, seit 2016 auf der Matte stehen. So sieht
Cantor Fitzgerald analyst Louise Chen es  “still positive” on Amarin, DESPITE the FDA approval of the Hikma generic. She said it seemed UNLIKELY that Hikma would begin selling its generic before a decision on the appeal, and thinks AMARIN WILL WIN IT APPEAL. She also noted the Vascepa supply chain is complicated, and said it could be hard for Hikma to manufacture a large amount of the drug."

Alles nur meine Meinung. KZ 15-35 $$... :-)

 

nett zu lesen, sehr interessant!  

Amarin Plans to Increase VASCEPA® (icosapent ethyl) Promotion and Education
[GlobeNewswire]
GlobeNewswire•June 1, 2020

Significant Opportunity Seen as Patient Visits Resume to Emphasize VASCEPA as the First and Only Drug Approved for Its Current Cardiovascular Risk Reduction Indication

DUBLIN, Ireland and BRIDGEWATER, N.J., June 01, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (AMRN), today announced that it intends to increase the level and breadth of its promotion and education initiatives regarding VASCEPA® (icosapent ethyl).  As early signs emerge of patients returning to physicians’ offices, Amarin plans to emphasize its key marketing messages including positioning VASCEPA as the only FDA-approved drug for lowering the persistent cardiovascular risk beyond statin therapy for millions of high-risk patients.

While VASCEPA has been developed and clinically tested for over a decade, it was less than six months ago (December 2019) that the FDA approved VASCEPA for its unique cardiovascular risk reduction indication. Most healthcare professionals and at-risk patients are unaware that VASCEPA is the first and only drug with this important new indication. For this reason, and the emerging return of patients, Amarin believes the opportunity exists for increasing awareness of VASCEPA and its potential to provide an important healthcare solution to reduce cardiovascular risk in high-risk patients.  

In the United States alone, someone suffers a heart attack, stroke, or other major adverse event from cardiovascular disease on average every 13 seconds. Cardiovascular disease impacts adults of all ages and is the number one cause of death in the United States. Urgent attention and a proven treatment, such as VASCEPA, is needed for the vast and growing need to reduce the risk of major adverse cardiovascular events in high-risk cardiovascular patients.

Amarin’s president and chief executive officer, John Thero, commented, “Particularly in these difficult times, Amarin believes that patients would benefit from receiving preventative healthcare solutions with demonstrated outcomes-based results. VASCEPA is one of those solutions. It is proven to reduce risk, it has been found to be affordable and cost-effective and it is covered by most insurance policies. However, while millions of people are included within the new VASCEPA indication, most are unaware of VASCEPA.” He added, “As American society begins to open up again, Amarin currently plans to restore approximately $80 million in educational and promotional spending in 2020 to increase awareness of VASCEPA as an important new treatment recently approved to lower the risk of heart attacks, strokes, and other major adverse cardiovascular events in high risk patients beyond standard of care statin therapy.”

Planned promotion and educational efforts include the sponsorship of continuing medical education, social media-based communications, and advertisements on television and other forms of media. Amarin also plans increased sponsorship of investigator-initiated research, such as the recently announced clinical investigation of VASCEPA in the treatment of COVID-19. These initiatives should become increasingly visible in July 2020 and beyond. At the start of 2020, Amarin had intended to commence such expanded promotion in mid-2020 but cancelled such plans following the onset of COVID-19 and the prospects for a potential launch of generic versions of VASCEPA. Amarin’s current plans restore most of that intended promotion.

In addition, as the United States reopens from the COVID-19 epidemic, Amarin intends to resume field-based face-to-face interactions with healthcare providers by its sales force, commencing on a pilot scale basis before the end of June 2020, based on current expectations. Assuming that these interactions prove to be helpful and other parts of the country reopen, the company plans to expand such interactions on a phased basis across select geographies. Prescription growth on a year-over-year basis in Q2’20 has, as expected due to COVID-19, been considerably slower than in Q1’20. However, Amarin believes that there are early signs that patient care for chronic conditions, such as treating the risks of cardiovascular disease, is increasing with more patients returning to their healthcare providers for routine medical visits.

Amarin plans to adjust its level of promotion and educational activities upward or downward based on various factors, including whether any generic company takes the risk of launching a generic version of VASCEPA during the patent litigation appeal process and the amount of any product launched. Amarin does not believe generic companies have made the investment of resources, know-how and time to develop sufficient quantities of quality supply to meet current and growing demand. Accordingly, Amarin believes that if any generic determines to launch its product after an FDA approval that any such launch would be limited in scope.  

If Amarin wins on its patent litigation appeal the benefits of Amarin’s planned increased promotion and education efforts should accrue to both improved patient care and to increased sales of VASCEPA by Amarin. If Amarin loses on the patent litigation appeal, increased VASCEPA usage as a result of increased promotion and education efforts should still benefit patient care. The larger market would potentially be split among branded VASCEPA, a potential authorized generic version of VASCEPA, if then launched by Amarin (which Amarin could launch rapidly if warranted), and generic versions of VASCEPA from third-parties. As noted, Amarin believes any launch of generic versions of VASCEPA by such third parties would be subject to supply limitations. Amarin reiterated that it believes that it has strong arguments in its patent litigation appeal but that it cannot predict the outcome.  

Amarin is progressing its plans for international expansion. Those plans are not directly impacted by increased promotion in the United States but could benefit from the company’s anticipated expanded educational initiative  

Starker Gegenwind für Unrechtssprecherin DU:

Federal Judge Invalidates Icosapent Ethyl Patents – But Based on a Common Statistical Mistake

17 Pages Posted: 5 Jun 2020
Gregory Curfman

American Medical Association

Date Written: June 3, 2020
Abstract

In a recent decision that stunned many in the legal and pharmaceutical communities, the chief judge of the U.S. District Court of the District of Nevada in Las Vegas, Judge Miranda Du, struck down 6 key method-of-use patents for the omega-3 fatty acid preparation, icosapent ethyl (Vascepa®). If this judgment is allowed to stand on appeal in Amarin Pharma, Inc., v. Hikma Pharmaceuticals USA, Inc., et al., it will have major implications not only for the patent protection of this drug but for pharmaceutical patents and biomedical innovation more generally.

We review the background of this judicial opinion and suggest the decision should be reversed on appeal. The Judge based her opinion on her conclusion that the patents, at the time of the invention, would have been obvious to a person having ordinary skill in the art (35 U.S.C. § 103). As we will show, a key piece of the prior art, which was central to this case, included an incorrect conclusion based on a common statistical error. Our central argument is that prior art that is scientifically incorrect should not be an acceptable basis for invalidating patents as obvious.

Keywords: Patents, Federal Circuit Court of Appeals, Omega-3 fatty acids, Cholesterol  

 

Vergleich mit Apotex im Patentstreit um Vascepa

"As part of the settlement agreement, Apotex may not sell a generic version of VASCEPA in the United States until August 9, 2029 (the same such date provided for under the 2018 settlement agreement with Teva Pharmaceuticals USA, Inc. (Teva)) or earlier under certain customary circumstances."

https://investor.amarincorp.com/news-releases/...ent-agreement-apotex

 

Amarin versucht es in Europa ohne einen Marketing-Partner

https://endpts.com/...-decision-looms-amarin-goes-it-alone-in-europe/

 

AMRN 16:05 08/25/20 Amarin initiated with an Overweight at Piper Sandler Piper Sandler analyst Yasmeen Rahimi initiated coverage of Amarin with an Overweight rating and $21 price target, which represents 210% potential upside. Amarin is the leading prescription omega-3 drug company, with Vascepa approved in 2012 for reduction of triglycerides in patients with severe hypertriglyceridemia, Rahimi tells investors in a research note. With European approval of Vascepa expected to be decided in early 2021, combined with the company's "well-capitalized position and a strong commercial sales and marketing strategy set up significant share appreciation in the near-term," says the analyst.

Read more at:
https://thefly.com/n.php?id=3151275  

Unglaublich good news, zurück zu den alten Hochs:


ESC: Amarin's Vascepa cuts patients' arterial plaque after 18 months of treatment
by Kyle Blankenship | Aug 29, 2020 3:13am
Amarin Vascepa pill
Amarin is currently appealing a recent patent loss for Vascepa that could endanger billions in sales. (Amarin)
Teilen
Facebook
Twitter
LinkedIn
Email
Print

With its blockbuster hopes in question after a catastrophic patent loss, Amarin's Vascepa continues to pique investigators' interest over how exactly it cuts patients' cardiovascular risks. New data from an investigator-sponsored imaging study could provide a clue.

Vascepa cut patients' coronary plaque by 17% over placebo in an 18-month imaging study investigating the mechanism of action behind the pill's FDA-approved CV risk benefits, according to late-breaking science presented Saturday at the European Society of Cardiology's virtual annual meeting.

Patients treated with a daily 4-milligram dose of Vascepa after statins saw a significant reduction in plaque levels, a potential clue behind how the fish-oil derivative helps cut the risk of major cardiovascular events in patients with abnormally high triglycerides and preexisting cardiovascular disease.
Fierce Webinar
Leveraging Innovative Technologies, Best Practices and Strategies to Accelerate Biologics Development and Commercialization
Learn practical implementation of innovative technologies and solutions such as multi-attribute method, modernized cell line development workflow using high-yield cell lines and automated systems, next generation purification resins. The webinar will also showcase best practices and strategies such as phase appropriate quality systems, and integrated drug substance – drug product solutions that leverage standardized technology platforms.
Save Your Spot

The 18-month findings followed nine-month interim data from the Lundquist Institute study presented in November.

RELATED: AHA: Amarin's Vascepa halts progression of arterial plaque in key study
Understanding Vascepa's effect on arterial plaque will help Amarin learn about the "complex biology" behind how its drug—a purified form of omega-3 fatty acid EPA—works and explore its potential use in other indications, according to Chief Medical Officer Craig Granowitz.

Vascepa notched an FDA approval in December to include its heart-helping benefits on its label, which at the time marked a potential blockbuster label expansion. The agency based its review on Amarin's Reduce-It outcomes study, which showed that Vascepa cut the risk of major CV events by 25% over placebo.

One of the lingering unknowns from that trial—the effect of a mineral oil placebo, rather than a traditional placebo, on patient outcomes—was addressed in the Evaporate study, which found the mineral oil pill had no significant effect at reducing arterial plaque over another placebo.

"We’ve been very vigilant and diligent in following up on the question and there’s going to be more data," Granowitz said. "What it amounts to is, we’ve really tried to take incredible diligence and care to look at the mineral oil in every possible way we can think of."

RELATED: Disaster at Amarin: Patent loss spurs stock spiral, but all hope might not be lost

Months after Vascepa set itself up for a blockbuster run with the new label nod, the drug's chances at sales glory appeared to go up in smoke after a district judge ruled its patent protection invalid.

Amarin immediately pledged to appeal the March ruling and hoped to delay the launch of generic Vascepa, which it argues would require a big step up in manufacturing quality by its rivals.

In May, Amarin threw its weight behind an investigator-sponsored study for Vascepa to treat severe COVID-19 patients. The drugmaker said the study would examine Vascepa's potential anti-inflammatory and even potential antiviral effects on patients.
Read more on