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<ul><li><strong><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.</strong></li><li><strong>Amarin received FDA approval for its fish-oil heart drug, <keyword id="1983461" type="PERSON" weightage="60" keywordseo="Vascepa">Vascepa</keyword>, in 2018.</strong></li><li><strong>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.</strong></li><li><strong>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.</strong></li><li><strong><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>.</strong></li></ul><p>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.</p><p>Shares traded down as much as 31%, to $5.01, on Wednesday.</p><p>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.</p><p>But a lawsuit that invalidated Amarin's Vascepa patents threw a wrench into those analyst projections.</p><p>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.</p><p>The court agreed with the generic companies, paving the way for Amarin's multi-year exclusive selling window to vanish overnight.</p><p>Today, the court held an appeal hearing related to the case.</p><p><em><strong>Read more:</strong> <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></em></p><p>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.</p><p>"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.</p><p>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.</p><p><em><strong>Read more:</strong> <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></em></p><p>But if Amarin loses the appeal, Stifel said shares could sink another 20% to $4 per share.</p><p>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%.</p><p>"We would not be buying shares here," Stifel concluded. The firm has a Hold rating on the stock and an $8 price target.</p><p>Shares of Amarin are down 62% year-to-date.</p><p><em><strong>Read more:</strong> <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></em></p><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><strong>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. </strong></li><li><strong>Shares of Amarin shed nearly 70% Tuesday on the news. </strong></li><li><strong>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>.</strong></li><li><strong><a href="https://markets.businessinsider.com/stocks/amrn-stock">Watch Amarin trade live on Markets Insider</a>.</strong></li><li><strong><a href="https://www.businessinsider.com/">Read more on Business Insider</a>.</strong></li></ul><p>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.</p><p>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. </p><p>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. </p><p>"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></p><p><em><strong>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></strong></em></p><p>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. </p><p>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></p><p>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%. </p><a href="https://markets.businessinsider.com/stocks/amrn-stock"></a><p class="tagline"><i>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.</i></p><p><i>And get the latest <a href="/coronavirus-covid19">coronavirus analysis and research</a> from Business Insider Intelligence on how COVID-19 is impacting businesses.</i></p>

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

<p><strong><div class="KonaFilter image-container display-table"><div><div class="image on-image"><p class="source"><span>Reuters</span></p><p class="caption">A scientist works at Zai Lab's drug development facility in Shanghai, China October 18, 2017.</p></div><p></p></div></div></strong></p><ul class="summary-list"><li><strong><a href="https://markets.businessinsider.com/stocks/amrn-stock">Amarin</a> and <a href="https://markets.businessinsider.com/stocks/gern-stock">Geron</a> are two of the most popular stocks on the free stock-trading app Robinhood. </strong></li><li><strong>One stock has quadrupled in value in recent weeks while the other has seen its shares crash. In both cases, millennial investors appear to be hoping more gains are in store. </strong></li><li><strong>Follow <a href="https://markets.businessinsider.com/stocks/amrn-stock">Amarin</a> and <a href="https://markets.businessinsider.com/stocks/gern-stock">Geron</a> in real time here. </strong></li></ul><p>Every week, Business Insider analyzes what investors on the free stock-trading app Robinhood are buying and selling with the hopes of finding something out of the ordinary.</p><p>Usually any changes in the app's Top-100 list are reflective of broader market movements - like the <a href="http://markets.businessinsider.com/news/stocks/marijuana-canopy-growth-stock-price-millennials-flocking-nyse-pot-company-2018-6-1027328228">recent rally in weed stocks</a> or <a href="http://uk.businessinsider.com/nike-kaepernick-ad-attracts-millennial-investors-2018-9">chasing Nike's gains after it premiered an ad starring the controversial football player Colin Kaepernick</a>. But this week, two relatively obscure biotech names popped up on the list: <a href="https://markets.businessinsider.com/stocks/amrn-stock">Amarin</a> and <a href="https://markets.businessinsider.com/stocks/gern-stock">Geron</a>.</p><p>In the case of Amarin, shares of the biopharmaceutical company have quadrupled since its <a href="https://www.bloomberg.com/news/articles/2018-10-02/amarin-s-4-billion-boom-has-helped-ignite-takeover-speculation">drug made from purified fish oil showed breakthrough results in a clinical trial on September 24.</a> Not only did it reduce the risk of heart attack, stroke, and other catastrophic cardiovascular events by 25% in high-risk patients, it did so without side effects and is relatively cheap to produce.</p><p>Amarin first popped up on Robinhood's Top-100 list last week, with 11,000 of its users holding shares. It has continued to rise in popularity, with more than 17,000 users currently holding the stock. It's now the 75th most popular.</p><p>Geron, on the other hand, wasn't quite the easy money many of Robinhood's users may have been hoping for. The stock has cratered nearly 75% in the past week after consumer giant <a href="http://ir.geron.com/news-releases/news-release-details/geron-announces-discontinuation-imetelstat-collaboration-janssen">Johnson &amp; Johnson announced it would end a collaboration with the company for its drug Imsetelstat</a>, which is used to treat blood and bone marrow disorders</p><p>Still, Robinhood users appear to be hoping there's an upside following the crash. Geron now owns all of the rights for the drug, but won't receive more capital from Johnson &amp; Johnson.<span> </span>Robinhood investors seem to be holding out hope that the drug will be approved. Of course, Geron will likely need the salesforce and expertise of a partner like Johnson &amp; Johnson in order to actually make a profit from selling it.</p><p>Before the massive rout, Geron saw an impressive 250% rise in its stock price. That climb helped it amass more than 30,000 investors on Robinhood, making it the 48th most-popular stock on the app.</p><h2>Now read:</h2><ul><li><a href="https://www.businessinsider.com/stanley-druckenmiller-passive-investing-machine-commentary-how-its-impacted-returns-2018-10?r=promo-below-article">'I pray it blows up' - billionaire investor Stanley Druckenmiller unloads on the unstoppable machines disrupting markets and explains how they've kept him from dominating</a></li><li><a href="https://www.businessinsider.com/next-recession-market-crash-commonwealth-cio-brad-mcmillan-shares-4-part-checklist-issues-warning-2018-10?r=promo-below-article">A $150 billion investment chief lays out his 4-part recession checklist - and warns we're approaching dangerous territory</a></li></ul><p><div class="KonaFilter image-container display-table"><div><div class="image on-image"><p class="source"><span><a href="https://markets.businessinsider.com/stocks/amrn-stock?utm_source=markets&amp;utm_medium=ingest">Markets Insider</a></span></p></div><p></p></div></div></p>    <div class="margin-top">        <h3>NOW WATCH: <a href="https://www.businessinsider.com/is-it-bad-to-eat-moldy-bread-2018-8">Never eat the 'clean' part of moldy bread</a></h3>        <div>                    </div>    </div>

Millennials are piling into 2 biotech stocks you've probably never heard of

<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><p>Esperion Therapeutics just received its first US approval on Friday, clearing the way to launch its first heart drug.</p><p>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.</p><p>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. </p><p>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.)</p><p>"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.</p><p>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.  </p><p>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. </p><p>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.</p><p>"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.</p><p>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.</p><h2>Some high-priced heart drugs have been commercial disappointments</h2><p>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.</p><p>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.</p><p>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.</p><p>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.</p><p>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.</p><p>The Swiss pharma giant acquired the drug this year through its nearly $10 billion acquisition of The Medicines Company.</p><h2>A generational split? </h2><p>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.</p><p>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.</p><p>In order to reach patients, both Amarin and Esperion are revving up their sales forces.</p><p>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.</p><p>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. </p><p>Could Esperion be bought again? Esperion's CEO demurred on the potential for Pfizer, or another large drugmaker, to come calling.</p><p>"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.</p><p>"We won't foreclose any discussion," he added. "We are open to any discussion."</p><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><p class="tagline"><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></p><p>Featured Digital Health Articles:<br />- <a href="/telehealth-industry-explained">Telehealth Industry: Benefits, Services &amp; Examples</a><br />- <a href="/value-based-care-pay-for-performance-healthcare-model">Value-Based Care Model: Pay-for-Performance Healthcare</a><br />- <a href="/senior-care-market-trends">Senior Care &amp; Assisted Living Market Trends</a><br />- <a href="/wearable-technology-healthcare-medical-devices">Smart Medical Devices: Wearable Tech in Healthcare</a><br />- <a href="/artificial-intelligence-healthcare">AI in Healthcare</a><br />- <a href="/remote-patient-monitoring-industry-explained">Remote Patient Monitoring Industry: Devices &amp; Market Trends</a></p>

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.

<p><div class="KonaFilter image-container display-table"><div><div class="image"></div></div></div></p><p>Hello,</p><p>Welcome to your regularly scheduled Friday edition of Dispensed, where we're looking forward to the weekend after finally getting out our list of <a href="https://www.businessinsider.com/30-people-under-40-changing-healthcare-2019-7">30 leaders under 40 transforming healthcare</a>. We hope you all have enjoyed the project as much as we enjoyed getting to know the honorees this summer. <strong><a href="https://www.businessinsider.com/30-people-under-40-changing-healthcare-2019-7">Click here to see the whole list.</a></strong></p><p>But first, I wanted to quickly catch up on the drama surrounding <a href="https://www.businessinsider.com/pillpacks-feud-with-surescripts-amplifies-patient-health-data-debate-2019-8">Amazon's online pharmacy PillPack</a>.</p><p>Last week, I spent some time digging into the back-and-forth between the tech giant and health data company Surescripts over access to medication history information that Surescripts collects. Between threats of lawsuits and claims of reporting companies to the FBI, it's sure escalated quickly.</p><p>That, combined with CNBC's <a href="https://www.cnbc.com/2019/08/06/amazons-pillpack-expansion-faces-resistance-from-cvs-and-walgreens.html">report Tuesday that PillPack has run into issues working with retail pharmacy giants Walgreens and CVS</a> when trying to transfer over prescriptions, to me gets to the heart of a key issue facing the pharmacy industry: Who should be allowed to have what patient data, when?</p><p>I spoke with independent pharmacists to get some more context about how medication information is shared today and the pros and cons that come with having more data at your fingertips. <strong><a href="https://www.businessinsider.com/pillpacks-feud-with-surescripts-amplifies-patient-health-data-debate-2019-8">Find out more about the debate here</a>. </strong></p><p><strong><em>Are you new to<span> </span><a href="https://www.businessinsider.com/category/dispensed">our newsletter</a>? You can<span> </span><a href="http://newsletter.businessinsider.com/join/health-insider">sign up for Dispensed</a> here.</em></strong></p><p>And then in case you missed it, we introduced our <strong><a href="https://www.businessinsider.com/30-people-under-40-changing-healthcare-2019-7">30 leaders under 40 transforming healthcare</a></strong> this week. </p><p><div class="KonaFilter image-container display-table"><div><div class="image"><a href="https://www.businessinsider.com/30-people-under-40-changing-healthcare-2019-7"></a></div></div></div></p><h3><a href="https://www.businessinsider.com/30-people-under-40-changing-healthcare-2019-7">Meet the 30 young leaders who are transforming the future of healthcare and disrupting a $3.5 trillion industry</a></h3><p>Over the next few weeks, we'll be putting out stories based on the conversations we had with the nominees. </p><ul><li>From <a href="https://www.businessinsider.com/author/clarrie-feinstein">Clarrie Feinstein's</a> conversation with Fred Hutch's Emily Silgard: <strong><a href="https://www.businessinsider.com/advice-on-moving-from-programmer-to-team-lead-emily-silgard-2019-8">A top leader using tech to tackle cancer told us how to get through the challenges of a career switch</a></strong></li><li>From <a href="https://www.businessinsider.com/author/emma-court">Emma Court</a>'s conversation with Blue Shield of California's Chris Esguerra: <strong><a href="https://www.businessinsider.com/blue-shield-of-californias-chris-esguerra-on-social-needs-specialists-2019-8">A top US health insurer has saved $4 million in one year by making a simple change, and it could be a lesson for others on how to transform a system from the inside out</a></strong></li><li>From my conversation with Providence St. Joseph Health's Sara Vaezy: <strong><a href="https://www.businessinsider.com/providence-st-joseph-health-digital-strategy-exec-sara-vaezy-advice-2019-7">A top young executive at a 160-year-old health system reveals why leaders looking to disrupt healthcare from within can't think in decade-long timeframes</a></strong></li><li>From Emma's conversation with 23andMe VP Emily Drabant Conley: <strong><a href="https://www.businessinsider.com/how-to-ask-for-a-promotion-23andme-emily-drabant-conley-2019-8">A VP at a $2.5 billion startup reveals exactly how she asked her boss for a big promotion at just 33 years old - and got it</a></strong></li><li>From Clarrie's chat with UniteUs founder Dan Brillman: <strong><a href="https://www.businessinsider.com/advice-for-healthcare-entrepreneurs-from-unite-us-ceo-dan-brillman-2019-8">How an Air Force Reserve pilot raised $45 million to build a company after struggling to help his fellow veterans</a></strong></li></ul><p>And we asked all our nominees for their best career advice. And wow, there's a lot of good stuff they shared (Definitely taking CVS Health's Ben Wanamaker's advice to "Show up on time" to heart). <a href="https://www.businessinsider.com/career-advice-from-young-leaders-transforming-healthcare-2019-8">Read all of their advice</a>. </p><h3><a href="https://www.businessinsider.com/career-advice-from-young-leaders-transforming-healthcare-2019-8">How to make an impact on the $3.5 trillion healthcare industry, according to 30 young leaders who are transforming it</a></h3><p>Up next: A little biotech dispatch from our pharma reporter, <a href="https://www.businessinsider.com/author/emma-court">Emma Court</a>:</p><p>This week has been a tumultuous one for biotech companies. The FDA <a href="https://www.fda.gov/news-events/press-announcements/statement-data-accuracy-issues-recently-approved-gene-therapy">revealed that there had been "data manipulation"</a> with a brand-new gene therapy treatment from the biotech AveXis (now owned by Novartis), but said it was only a small portion of the data and the gene therapy, Zolgensma, should stay on the market. Then there was <a href="https://www.marketwatch.com/story/sarepta-stock-drops-on-erroneous-adverse-event-report-to-fda-2019-08-08">Sarepta</a>, <a href="https://www.businesswire.com/news/home/20190808005767/en/Kala-Pharmaceuticals-Receives-FDA-Complete-Response-Letter">Kala</a>, <a href="https://www.statnews.com/2019/08/08/amarin-now-says-fda-plans-outside-panel-review-of-its-vascepa-heart-drug-delaying-approval-decision/">Amarin</a>, <a href="https://markets.businessinsider.com/news/stocks/nektar-therapeutics-stock-price-reaction-issue-with-key-cancer-drug-2019-8-1028434534">Nektar</a> and more - all saw their stocks seesawing this week on new developments. </p><p>We think biotech investor Brad Loncar put it best, <a href="https://twitter.com/bradloncar/status/1159566619443703810">here</a>. </p><p>Lastly, Clarrie rounded up the <a href="https://www.businessinsider.com/artificial-intelligence-startups-valued-at-1-billion-or-more-list-2019-8">41 hottest AI startups</a> out there, even looking beyond healthcare to finance, transportation, etc. Thanks to CB Insights for pulling that data together. </p><p>Clarrie breaks down what each company is working on and how they've made it to $1 billion valuations. </p><h3><a href="https://www.businessinsider.com/artificial-intelligence-startups-valued-at-1-billion-or-more-list-2019-8">These are the 41 hottest AI startups worth at least $1 billion, across healthcare, finance, transportation and more</a></h3><p>Clarrie and Emma also had a big report out this week on how much each candidate in the 2020 presidential campaign has taken from people who work in healthcare (In light of Sen. Bernie Sanders' commitment not to take donations from the pharmaceutical and health insurance industries).</p><p>Thanks to <span>Yutong Yuan on Business Insider's graphics team for the great visualization of the tallies. </span></p><p><div class="KonaFilter image-container display-table"><div><div class="image"><a href="https://www.businessinsider.com/healthcare-donations-to-2020-presidential-candidates-2019-7"></a></div></div></div></p><h3><a href="https://www.businessinsider.com/healthcare-donations-to-2020-presidential-candidates-2019-7">Read more about the donations to each candidate here. </a></h3><p>With that, I'm sure I've given you enough reading material for the whole month! Stay tuned this weekend for more from our 30 under 40 project, and we'll be back next week with more dispatches from the world of health, pharma, and biotech.</p><p>In the meantime, tips? Last-minute wedding planning advice? Thoughts on all the biotech drama that unfolded this week? You can find me at lramsey@businessinsider.com and the whole healthcare team at healthcare@businessinsider.com.</p><p>- Lydia </p> <p class="tagline"><a href="https://www.businessinsider.com/intelligence/40-big-tech-predictions-for-2019?IR=T&amp;itm_source=businessinsider&amp;itm_medium=ctgr_bii&amp;itm_term=ctgr_leadgen&amp;itm_content=amazon&amp;itm_campaign=40-big-tech-predictions-for-2019-2"></a></p>

Dispensed: Career advice from BI's young healthcare leaders, a wild week for biotechs, and a list of white-hot AI startups

<p><div class="KonaFilter image-container display-table"><div><div class="image"></div></div></div></p><ul class="summary-list"><li>Investors should keep an eye on 12 key new drugs going into 2019, according to Jefferies analyst Michael Yee.</li><li>The medications range from a gene therapy that could be a game-changer for a rare disease to a CBD product for rare childhood epilepsy and a fish-based drug that could improve heart health.</li><li>But new drug launches can be a bumpy time for companies, so buying shares in these drugmakers may not make sense, Yee said.</li></ul><p>New year, new drug launches. </p><p>In 2019, there are 12 medications investors should watch out for, according to Jefferies analyst Michael Yee. All have either been approved or could be soon.</p><p>They include the gene therapy that spurred a $9 billion acquisition, a CBD medication for rare childhood epilepsies, and a drug that could be the first specifically approved for postpartum depression. </p><p>But in spite of all the activity, Yee urged caution on buying shares in these biotech companies.</p><p>His key point: Nothing lifts a biotech's stock like a new drug approval - but what happens after that, when companies actually have to sell that medication, is often a mixed bag.</p><p>Few small to mid-sized biotech companies had unequivocally strong launches this past year, with the exception of the drugmaker Neurocrine Biosciences, Yee said. Meanwhile, the landscape for drugmakers going into 2019 <a href="https://www.businessinsider.com/pfizer-drugmakers-to-increase-drug-prices-in-2019-trump-tweet-2018-12">remains tricky</a>.</p><p>"Given the challenging glass-half empty environment, we argue the hurdle seems even higher for companies to deliver in 2019," Yee said.</p><h2>Here are Yee's picks for next year's key new medications:</h2><h3>1. An eczema medication expanding into asthma</h3><p>Already sold for the skin inflammation eczema, Regeneron's Dupixent was just approved as a maintenance medication for moderate-to-severe asthma in mid-October. The 2019 launch will be important, Yee said.</p><p>The connection between eczema and asthma may not appear obvious, but both are diseases where inflammation plays, or is thought to play, a role. Dupixent is also being tested out in many other inflammation-related diseases, including grass and peanut allergy, with plans to study it in chronic obstructive pulmonary disease as well.</p><h3>2. A longer-lasting rare disease drug</h3><p>Alexion's blockbuster Soliris has been on the market for the ultra-rare blood disorder <span>paroxysmal nocturnal hemoglobinuria (PNH) for 11 years. Also approved for other conditions, Soliris is a linchpin product for Alexion, having brought in nearly 90% of the biotech's 2017 revenue. </span></p><p><span>It's perhaps no surprise, then, that the company is steeling for new competition. </span></p><p><span>The company's new product Ultomiris is intended as a next-generation version of the drug. Ultomiris extends the timeline that patients have to get dosed from bi-weekly to every eight weeks; it also conveniently provides new patent protections for the biotech.</span></p><p><span>Alexion got Ultomiris approved <a href="https://news.alexionpharma.com/press-release/product-news/alexion-receives-early-fda-approval-ultomiris-ravulizumab-cwvz-adults-par">last week</a>, and its plans to switch patients over "will matter a lot," Yee said. </span></p><h3><span>3. The first cannabis-derived drug in the US</span></h3><p><span><div class="KonaFilter image-container display-table"><div><div class="image"></div></div></div></span></p><p><span>The best known compound in cannabis is THC, but another, non-psychoactive component, CBD, powers the medication Epidiolex, the first cannabis-derived drug in the US.  </span></p><p><span>The prescription medication, made by GW Pharmaceuticals,</span><span> was approved over the summer for two rare childhood seizure disorders and just launched November 1.</span></p><p><em><strong>See more:</strong> <a href="https://www.businessinsider.com/marijuana-epilepsy-drug-approved-dea-cbd-2018-9">A drug derived from marijuana has triggered the first federal shift on cannabis in half a century, and experts predict an avalanche effect</a></em></p><h3>4. Two rare disease drugs in a space that once had no medications at all</h3><p>When Alnylam's Onpattro was approved in August, it became the first US treatment for the rare, progressive disease ATTR amyloidosis.</p><p>Now, there are two drugs for the disease: Onpattro and Ionis/Akcea's Tegsedi, which was approved by the FDA in October. Though distinct, both are intended for the nerve damage and pain that come with ATTR amyloidosis. </p><p>ATTR amyloidosis is known to be difficult to diagnose, and patients didn't have many options until recently, so finding patients will be the next challenge for the biotech companies.</p><h3>5. A medication that could be the first for postpartum depression</h3><p>Of the nearly 4 million births that happen each year in the US, nearly 15% of those new mothers are affected by an extended <a href="https://www.businessinsider.com/sage-therapeutics-postpartum-depression-drug-2017-11">postpartum depression</a>.</p><p>Treatment options currently include antidepressants and counseling, but there could soon be another option: the biotech Sage Therapeutics' Zulresso.</p><p>If approved, Zulresso would be the first medication approved specifically for postpartum depression. Zulresso is currently being reviewed by US drug regulators, and a decision is expected by March 19, 2019. </p><p><strong><em>Read more:</em> </strong><em><a href="https://www.businessinsider.com/sage-depression-drug-problem-2018-6">A pharma CEO says a new depression drug could have lasting effects after one short course, like antibiotics - here's what experts think</a></em></p><h3>6. A fish oil-based drug with possible heart health benefits</h3><p><div class="KonaFilter image-container display-table"><div><div class="image"></div></div></div></p><p>A common claim about fish oil supplements is that they're good for your heart, but there isn't evidence to back it up. </p><p>So imagine the surprise when Amarin Pharmaceuticals's Vascepta, which is derived from fish oil, showed promise in <a href="https://www.businessinsider.com/amarins-stock-soars-after-its-fish-oil-capsule-was-found-to-dramatically-reduce-cardiovascular-risks-2018-9">reducing cardiovascular risk</a> in a large, multi-year clinical trial. </p><p>Further data will be of interest to investors, but there's "potential for M&amp;A either way," Yee said. </p><h3>7. An antidote for life-threatening bleeding</h3><p>Drugs called anticoagulants are used to treat conditions like stroke and pulmonary embolism, a type of artery blockage. One particular type, Factor Xa inhibitors, have become increasingly popular, but they have a major complication: bleeding.   </p><p>Portola Pharmaceuticals' Andexxa, approved in the US in May, is used to reverse anticoagulation in cases when patients have life-threatening or uncontrolled bleeding. The product has since been taken to market and brought in nearly $8 million in sales in its first full quarter. </p><h3>8. A medication for patients with aggressive breast cancer</h3><p>Triple-negative breast cancer is an aggressive form of the disease, quicker to recur and spread. Immunomedics' IMMU-132 is intended for patients who have already failed to respond to at least two other medications for the disease. A US approval decision expected by late January, and if the drug is approved, it "will have a lot of focus," according to Yee. </p><h3>9. A Parkinson's disease drug launch spurring existential questions for a biotech</h3><p>Parkinson's disease drugs can do a lot of good for patients, but, as the disease progresses, they don't work optimally all of the time. Acorda Therapeutics' Inbrija got approved by the FDA last week for intermittent treatment of those "off" episodes, and is expected to become available by the first quarter of next year. </p><p>The approval decision, which came early, is also bringing new attention to what will come of the company - whether it will work to sell Inbrija, or <a href="https://www.businessinsider.com/r-acorda-therapeutics-investor-calls-for-company-to-explore-sale-2017-8">sell itself instead.</a> Notably, Parkinson's disease drugs are considered "strategically valuable," Stifel analyst Paul Matteis pointed out after the late December approval. </p><h3>10. A multiple myeloma drug with an FDA decision expected by April</h3><p>The biotech Karyopharm Therapeutics could get an FDA approval decision for its multiple myeloma drug selinexor by April 6 of 2019. </p><h3>11.The gene therapy behind a $9 billion acquisition that could threaten another biotech</h3><p><div class="KonaFilter image-container display-table"><div><div class="image"></div></div></div>When Swiss drug giant Novartis acquired the biotech AveXis for nearly $9 billion, the pharmaceutical company was clear about <a href="https://www.businessinsider.com/novartis-gene-therapy-bet-with-87-billion-avexis-acquisition-2018-4">why</a>.</p><p>AveXis's lead product, AVXS-101, could be the "first-ever one-time gene replacement therapy for spinal muscular atrophy (SMA), a disease which results in early death or lifelong disability with considerable healthcare costs," Novartis said in April.</p><p>The gene therapy, now being called <span>Zolgensma, could also pose a major competitive threat to Biogen's crucial spinal muscular atrophy therapy <a href="https://www.businessinsider.com/r-biogen-boosts-investment-in-neurology-with-1-billion-ionis-deal-2018-4">Spinraza</a>. </span></p><p>The FDA has agreed to look at Novartis's <span>Zolgensma</span> application, and a decision is expected in May.</p><h3>12. An ovarian cancer drug from a Shanghai-based biotech</h3><p>The Shanghai-based biopharmaceutical company Zai Lab Limited is carrying out its first launch, for the ovarian cancer drug Zejula in Hong Kong. Zejula is also up before the China National Medical Products Administration, where a much larger patient population could be in reach.</p><p>These could prove a "key read-through for Asia biotech," Yee said, which has attracted US investment interest of late but has also been hit by wider market conditions. </p>

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