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<ul><li><keyword id="1451985" type="COMPANY" weightage="60" keywordseo="Amarin">Amarin</keyword> plummeted as much as 31% after its appeal hearing related to invalidated patents for its key drug was "incrementally negative," according to Stifel.</li><li>Amarin received FDA approval for its fish-oil heart drug, <keyword id="1983461" type="PERSON" weightage="60" keywordseo="Vascepa">Vascepa</keyword>, in 2018.</li><li>In March, Amarin lost a court battle with generic drug manufacturers who claimed Amarin's patents related to Vascepa were invalid, clearing the path for a generic version of Vascepa to hit the shelf.</li><li>Today's appeal hearing of that March ruling lasted just 20 minutes and no questions were asked to the counsel of the generic drug companies involved in the case.</li><li><a href="https://www.businessinsider.com/?hprecirc-bullet?utm_source=markets&amp;utm_medium=ingestgest" target="_blank" rel="noopener">Visit Business Insider's homepage for more stories</a>.</li></ul>Investors fled <a href="https://markets.businessinsider.com/stocks/amrn-stock">Amarin</a> on Wednesday amid a court appeal hearing related to its invalidated patents for its key heart drug, Vascepa.Shares traded down as much as 31%, to $5.01, on Wednesday.Vascepa is a heart drug that is made up of fish oil. The drug received FDA approval to reduce the risk of stroke in patients in late 2018, and since then analysts have expected Vascepa to become a blockbuster drug with more than $1 billion in sales.But a lawsuit that invalidated Amarin's Vascepa patents threw a wrench into those analyst projections.In March, Amarin lost a key court battle with generic drug manufacturers who argued they should be allowed to begin selling a generic version of Vascepa due to invalid patents.The court agreed with the generic companies, paving the way for Amarin's multi-year exclusive selling window to vanish overnight.Today, the court held an appeal hearing related to the case.Read more: <a href="https://www.businessinsider.com/stock-market-trades-value-sectors-to-buy-for-economic-recovery-2020-9" target="_blank" rel="noopener">A $7 billion fund manager breaks down why the perfect storm is brewing for investors' most-loved stocks as the election nears — and shares 4 trades to capitalize on their downfall</a>According to Stifel, the hearing was "incrementally negative" for Amarin and gave no confidence that Amarin will prevail in the trial. Stifel noted that the hearing lasted just 20 minutes, one of the 3 judges remained silent throughout the hearing, and no questions were asked to counsel representing the generic drug companies."Our take is that Judge Dyk is likely to rule against Amarin - which is consistent with our consultant feedback," Stifel noted, adding that its too tough to make a call on how the two other judges will rule.A final decision in the patent case is expected in the fourth quarter of 2020 or early 2021, Stifel said. The firm expects Amarin to surge 299% from Wednesday's low to $20 if it prevails in the appeal case.Read more: <a href="https://www.businessinsider.com/investing-strategy-for-small-companies-from-mircocap-expert-ian-cassel-2020-9" target="_blank" rel="noopener">'You can make 5, 10, 50x your money': Here's an inside look at the 7-part strategy small-stock expert Ian Cassel is using to unearth the market's most overlooked gems</a>But if Amarin loses the appeal, Stifel said shares could sink another 20% to $4 per share.Despite the legal overhang for Vascepa, Amarin has managed to steadily build up sales of the drug. In its latest quarter, Vascepa recorded sales of $135.3 million, representing year-over-year growth of 34%."We would not be buying shares here," Stifel concluded. The firm has a Hold rating on the stock and an $8 price target.Shares of Amarin are down 62% year-to-date.Read more: <a href="https://www.businessinsider.com/stock-market-investing-strategy-winning-trade-v-shaped-recovery-ms-2020-9" target="_blank" rel="noopener">Morgan Stanley lays out the evidence that a lasting recovery is still well underway — and shares 'one of the best' remaining trades to profit from it</a><div type="image" title="amarin chart.JPG" height="663" width="837" msid="77899942" hostid="261"></div>

Amarin plummets 31% after appeal hearing related to its heart drug is 'incrementally negative,' analyst says to not buy shares

<ul><li>The United States District Court of Nevada on Monday ruled that <a href="https://markets.businessinsider.com/stocks/amrn-stock">Amarin's</a> patent <a href="https://www.bloomberg.com/news/articles/2020-03-30/amarin-loses-ruling-in-bid-to-block-generic-vascepa?utm_medium=social&amp;utm_campaign=socialflow-organic&amp;cmpid=socialflow-twitter-business&amp;utm_content=business&amp;utm_source=twitter">claims for Vascepa, a heart drug that uses fish oil to lower triglycerides, are invalid</a>, potentially giving generic drugmakers the opportunity to knock off the treatment. </li><li>Shares of Amarin shed nearly 70% Tuesday on the news. </li><li>Vascepa accounted for nearly all of Amarin's revenue last year, <a href="https://www.bloomberg.com/news/articles/2020-03-30/amarin-loses-ruling-in-bid-to-block-generic-vascepa?utm_medium=social&amp;utm_campaign=socialflow-organic&amp;cmpid=socialflow-twitter-business&amp;utm_content=business&amp;utm_source=twitter">Bloomberg reported</a>.</li><li><a href="https://markets.businessinsider.com/stocks/amrn-stock">Watch Amarin trade live on Markets Insider</a>.</li><li><a href="https://www.businessinsider.com/">Read more on Business Insider</a>.</li></ul>Shares of <a href="https://markets.businessinsider.com/stocks/amrn-stock">Amarin</a> plunged nearly 70% Tuesday, falling to as low as $4.16 per share from Monday's close of $13.58 per share after the company lost a key patent battle over its premiere drug, Vascepa.The United States District Court of Nevada on Monday ruled that the company's patent <a href="https://www.bloomberg.com/news/articles/2020-03-30/amarin-loses-ruling-in-bid-to-block-generic-vascepa?utm_medium=social&amp;utm_campaign=socialflow-organic&amp;cmpid=socialflow-twitter-business&amp;utm_content=business&amp;utm_source=twitter">claims for Vascepa, a heart drug that uses fish oil to lower triglycerides, are invalid</a>. The ruling could open the door for other drugmakers to make generic versions of the key drug. Amarin said it would appeal the decision. Vascepa accounted for nearly all of the company's nearly $430 million in revenue last year, <a href="https://www.bloomberg.com/news/articles/2020-03-30/amarin-loses-ruling-in-bid-to-block-generic-vascepa?utm_medium=social&amp;utm_campaign=socialflow-organic&amp;cmpid=socialflow-twitter-business&amp;utm_content=business&amp;utm_source=twitter">according to Bloomberg</a>. The US Food and Drug Administration has yet to approve any generic versions of Vascepa. "Amarin strongly disagrees with the ruling and will vigorously pursue all available remedies, including an appeal of the Court's decision and a preliminary injunction pending appeal to, if an ANDA is approved by FDA, prevent launch of generic versions of Vascepa in the United States," said Amarin CEO John Thero <a href="https://investor.amarincorp.com/news-releases/news-release-details/amarin-comments-ruling-vascepar-anda-litigation">in a statement.</a>Read more: <a href="https://www.businessinsider.com/coronavirus-corporate-credit-experts-on-where-to-invest-biggest-risks-2020-3">5 corporate-debt experts break down how the coronavirus crisis is ravaging cash-strapped firms - and share what they're buying to avoid risky 'zombie' companies</a>He continued: "as we work to take all legal actions necessary to defend and protect our intellectual property, we will continue to press forward with our educational and promotional efforts for Vascepa in treating indicated patients at high risk of cardiovascular events, such as heart attack and stroke," Thero said. In addition to the battle over Vascepa, Amarin has had its own share of woes related to the coronavirus pandemic. Earlier this month, the company suspended all in-person interactions of its sales representatives, <a href="https://www.reuters.com/article/amarin-stocks/amarin-loses-patent-lawsuit-on-main-drug-shares-tumble-idUSL4N2BO3V9">Reuters reported.</a>Amarin has <a href="https://markets.businessinsider.com/stocks/amrn-stock">lost 37% year-to-date through Monday's close.</a> Including Tuesday's decline, it's down more than 80%. <a href="https://markets.businessinsider.com/stocks/amrn-stock"></a>Do you have a personal experience with the coronavirus you'd like to share? Or a tip on how your town or community is handling the pandemic? Please email <a href="mailto:covidtips@businessinsider.com">covidtips@businessinsider.com</a> and tell us your story.And get the latest <a href="/coronavirus-covid19">coronavirus analysis and research</a> from Business Insider Intelligence on how COVID-19 is impacting businesses.

Amarin stock tanks nearly 70% after losing a patent battle over its key heart drug

<ul class="summary-list"><li>Esperion Therapeutics just got its first heart drug approved in the US, and the CEO told Business Insider the company is pricing the cholesterol-lowering medication at around $10 per day.</li><li>"Our industry was built on once-a-day pills for chronic disease," Esperion CEO Tim Mayleben said in an interview.</li><li>It's an old-school approach that supports blockbuster hopes for Esperion's pill.</li><li>Other companies that have set higher prices for their heart drugs have fallen short in recent years.</li><li><a href="https://www.businessinsider.com/?hprecirc-bullet">Visit Business Insider's homepage for more stories</a>.</li></ul>Esperion Therapeutics just received its first US approval on Friday, clearing the way to launch its first heart drug.The approval wraps a long, strange journey for the Ann Arbor, Michigan-based biotech and its cholesterol-lowering pill, Nexletol. Esperion was acquired by pharma giant Pfizer in 2003 for $1.3 billion. A few years later, Pfizer ditched the business as part of a massive restructuring.But Esperion's original founder and CEO, Roger Newton, wasn't done. He negotiated with Pfizer for about a year to sell back the Esperion name as well as an experimental heart drug that Pfizer had shelved. Esperion, version two, was launched in 2008, and that pill is now a US-approved heart therapy. Even as cutting-edge therapies have arrived to treat or prevent heart disease, Esperion is betting an old-school approach will win out with this the Nexletol pill. The company plans to price it at around $10 per day before discounts and rebates. (Exact pricing details weren't immediately available.)"Our industry was built on once-a-day pills for chronic disease," Tim Mayleben, who took over for Newton as Esperion's CEO in 2012, said in an interview.Esperion isn't alone in avoiding a sky-high price for its heart treatment, at a time when parts of the industry are launching transformative drugs with six- and seven-figure price tags. <a href="https://markets.businessinsider.com/stocks/amrn-stock">Amarin</a> has put forward a sales strategy based on selling lots of pills at a yearly list price of roughly $4,000 for its fish-oil-based pill, Vascepa. That drug has vaulted the little-known New Jersey pharma company to a $6 billion market value, more than quadrupling its stock price since the critical late-stage trial succeeded. Esperion's treatment, called bempedoic acid, has shown it can reduce cholesterol, in addition to what statins can provide patients. The company is also expecting an approval decision next week for a pill that combines bempedoic acid with a low dose of a statin."It's not groundbreaking by itself," said <a href="https://www.bcm.edu/people/view/peter-jones-m-d/b18e6af2-ffed-11e2-be68-080027880ca6">Dr. Peter Howard Jones</a>, a heart clinical researcher at Baylor College of Medicine, who has helped run trials for bempedoic acid and for other heart-disease drugs.Compare Nexletol and Vascepa to the fancier therapies, known as PCSK9 inhibitors. With a growing understanding of genetics in recent years, targeted therapies have been developed aiming to lower the risk of heart attacks and strokes.<h2>Some high-priced heart drugs have been commercial disappointments</h2>The first two of these therapies turned into <a href="https://www.bloomberg.com/news/articles/2020-01-09/these-big-drug-flops-show-how-healthcare-economics-have-changed?sref=Hhue1scO">surprise commercial flops</a>, as health insurers pushed back against their prices. Both drugs are given as injections and have shown they can help patients by lowering the risk of heart attacks, strokes, and other events.But the sales haven't matched the scientific excitement since launching in 2015. Despite significant promotion efforts, Amgen's Repatha netted $661 million in 2019 sales, while Sanofi and Regeneron's Praluent logged $287 million last year.In late 2018, these leading pharmas recognized the disappointing sales, and in an unusual step slashed the list prices of Repatha and Praluent, from about $14,000 to $6,000 per year.These contrasting approaches will only become more stark over the next few years. While Esperion and Amarin bank on the industry's history of successfully selling pills for chronic disease, new technologies like RNA interference are beginning to come of age and could soon yield new heart-disease treatments.Novartis CEO Vas Narasimhan has likened its RNA interference drug to a potential vaccine for heart disease. The therapy, called inclisiran, targets the PCSK9 gene and is a twice-yearly injection.The Swiss pharma giant acquired the drug this year through its nearly $10 billion acquisition of The Medicines Company.<h2>A generational split? </h2>Jones, the physician, said he's excited for some of these gene-based approaches, including the potential of Novartis' inclisiran going forward. He also said he thinks bempedoic acid will help some patients, particularly as he expects preferences to split by age.Younger patients who aren't regularly taking pills may find the idea of a PCSK9 injectable more appealing, he said, while older patients already on medication can more easily add another pill to their medication regimen, he said.In order to reach patients, both Amarin and Esperion are revving up their sales forces.Amarin boosted its salesforce from 200 to 800 representatives in the past couple years. Esperion's Mayleben said the company will have a sales force of 300 in the field within four weeks, focused on a group of 36,000 doctors who write about 40% of all prescriptions for cholesterol-lowering drugs.The huge patient population has helped stir investor interest in acquisitions. Biotechs about to make the leap to commercial markets are often seen by Wall Street analysts and investors are prime takeout targets, given big pharma's already-built commercial infrastructure. Could Esperion be bought again? Esperion's CEO demurred on the potential for Pfizer, or another large drugmaker, to come calling."Our mindset is we are going to launch these drugs ourselves, but we are always open to collaborations or partnerships or more strategic relationships that would really bring maximum value to our shareholders," Mayleben said."We won't foreclose any discussion," he added. "We are open to any discussion."<ul class="read-more-links"><li>Read more:</li><li><a href="https://www.businessinsider.com/amarins-stock-soars-after-its-fish-oil-capsule-was-found-to-dramatically-reduce-cardiovascular-risks-2018-9">Amarin's stock soars after its fish oil capsule was found to dramatically reduce cardiovascular risks</a></li><li><a href="https://www.businessinsider.com/pharmaceutical-drugs-investors-to-watch-next-year-2018-12">From the gene therapy that spurred a $9 billion acquisition to a CBD medication for rare types of childhood epilepsy, here are the 12 promising drugs to watch in 2019</a></li><li><a href="https://markets.businessinsider.com/news/stocks/millennials-piling-into-2-biotech-stocks-youve-probably-never-heard-of-2018-10-1027593412">Millennials are piling into 2 biotech stocks you've probably never heard of</a></li><li><a href="https://www.businessinsider.com/pcsk9-cholesterol-drugs-2015-9">A new set of drugs could revolutionize the never-ending battle against high cholesterol - but there's a huge catch</a></li></ul><a href="/intelligence/digital-health?IR=T&amp;itm_source=businessinsider&amp;itm_medium=ctgr_bii&amp;itm_term=ctgr_subscription&amp;itm_content=health&amp;itm_campaign=digital-health"></a>Featured Digital Health Articles: - <a href="/telehealth-industry-explained">Telehealth Industry: Benefits, Services &amp; Examples</a> - <a href="/value-based-care-pay-for-performance-healthcare-model">Value-Based Care Model: Pay-for-Performance Healthcare</a> - <a href="/senior-care-market-trends">Senior Care &amp; Assisted Living Market Trends</a> - <a href="/wearable-technology-healthcare-medical-devices">Smart Medical Devices: Wearable Tech in Healthcare</a> - <a href="/artificial-intelligence-healthcare">AI in Healthcare</a> - <a href="/remote-patient-monitoring-industry-explained">Remote Patient Monitoring Industry: Devices &amp; Market Trends</a>

A tiny biotech's huge bet on a heart pill abandoned by Big Pharma just paid off. Esperion's CEO shares the old-school sales strategy he's planning for the drug.

<div class="KonaFilter image-container display-table float_right"><div><div class="image on-image">Reuters/Regis Duvignau</div></div></div>A First Amendment debate has been brewing in the pharmaceutical industry. It deals with the question of whether it's OK for drugmakers to tell doctors about other conditions their medication may treat - even if it hasn't been officially approved by the government's chief drug regulator, the Food and Drug Administration. On Tuesday, the drug company Amarin Corporation settled its case with the FDA. The settlement, which upholds a district court ruling from August 2015, gives the company the ability to provide "<a href="http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=959511">truthful and non-misleading speech</a>" promoting off-label (meaning not approved by the FDA) use of their <a href="http://www.vascepa.com/about.html">Vascepa capsules</a>, a prescription form of the Omega-3 fatty acids found commonly in fish oil.Jim Stansel, a partner with <a href="http://www.sidley.com/people/james-c-stansel">Sidley Austin</a> and the former acting general counsel of the US Department of Health and Human Services (of which the FDA is a part) says the settlement is important for two reasons.First, it draws on the First Amendment's protection of free speech, since the agency is allowing drugmakers to provide off-label information so long as that information isn't deceptive."What it does recognize - and what it shows that the FDA is sort of forced to recognize - is that there is a place for truthful, non-misleading information that is off label," Stansel told Business Insider. "It's encouraging in the sense that the FDA has sort of been forced to recognize that there is a place for that kind of a conversation."In this case, Amarin successfully defended its right to provide doctors with information grounded in scientific evidence. While the medication in question is not officially approved to treat a certain disease, they do have some scientific evidence which suggests it's at least somewhat effective at treating that disease.The case is also a good example of a bigger issue: The delay between clinical trials, which can take anywhere from a few months to a number of years and result in getting evidence of how safe and effective a certain medicine is, and federal approvals, which adds even more time, and results in either approval or denial based on how strong that evidence is."I think as long as you have a system where you've got this delay between clinical trial results and approvals, you're always going to have this period where there's more information out there than there's actual backing from an official stamp from an FDA kind of perspective," Stansel said.The settlement allows drugmakers to tell the full story of a drug, complete with positive and negative outcomes, so that doctors can come to informed conclusions about whether their patient would benefit from using the drug under a faster timeframe than if the drug had to meet every regulatory validation, a process that could take years.Still, the settlement doesn't establish the legal framework that Stansel thinks would be necessary for this to start happening frequently. "It certainly doesn't go so far as to make a policy," he added. <div class="margin-top"> <h3>NOW WATCH: <a href="http://www.businessinsider.com/richard-branson-gets-fresh-water-private-necker-island-2016-3">How Richard Branson gets fresh water on his private island</a></h3> <div> <div> <div class="ooyala-video-player" data-video-autoplay="false" data-video-id="x4a2MzNjqxnaDciCyAXi2sUVdgB4W9we" data-player-variable="ooyalapopvideo" id="ooyalaplayer_popvideo" style="width:1280px;height:720px"></div> </div> </div> </div>

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Amarin plummets 31% after appeal hearing related to its heart drug is 'incrementally negative,' analyst says to not buy shares

Matthew Fox

Amarin stock tanks nearly 70% after losing a patent battle over its key heart drug

Carmen Reinicke

A tiny biotech's huge bet on a heart pill abandoned by Big Pharma just paid off. Esperion's CEO shares the old-school sales strategy he's planning for the drug.

Andrew Dunn

The US government just said a drugmaker could market its product for conditions it may not actually treat - and it could forever change the industry

Lydia Ramsey

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