Initial public offerings, or IPOs, usually garner lots of attention. IPOs carry tremendous amounts of risk, and trading publicly begins a new phase in the company's life. Drug development firms add in layers of additional risk -- clinical trial efficacy and safety risks, regulatory risk such as approval by the U.S. Food and Drug Administration (FDA), and reimbursement risk.
DUBLIN, Ireland and BRIDGEWATER, N.J., May 21, 2020 -- Amarin Corporation plc (NASDAQ:AMRN), today announced support for a clinical trial to investigate the effects of.
U.S. patents protecting the only revenue source for this biotech company were recently invalidated, and the dust won't settle anytime soon.
As of late, it has definitely been a great time to be an investor in Amarin.
The Amarin (AMRN) vs the Generics drama has entered a new stage. For the uninitiated, a quick recap: In March, Amarin lost a patent trial against two generic drug makers (Dr Reddy’s and Hikma Pharmaceuticals) seeking to sell their own versions of Amarin’s high triglycerides treatment, Vascepa.Amarin has now filed its appeal with the U.S. Court of Appeals for the Federal Circuit. As Vascepa is Amarin’s sole product, much hinders on the appeal’s outcome.Taking the opportunity to assess Amarin’s case, H.C. Wainwright analyst Andrew Fein consulted a patent attorney for an “initial perspective” on Amarin’s opening appeal brief.“We point out that the appeals court reviews issues of law de novo and issues of fact for clear error. The clearly erroneous standard is highly deferential to the district court, while the de novo standard permits the appellate court to substitute its own judgment for that of the district court,” Fein explained.So basically, Amarin will have the upper hand, if it can convincingly argue the district court made a mistake when reaching its conclusion.According to the patent attorney, Amarin has presented its case in the “best way possible,” with the brief laying out Amarin’s tech, the background to the invention, the reason it was needed and the company’s approach when trying “to solve the problem of lowering triglycerides (TGs) in patients with severe hyperlipidemia without raising LDLs.”Scouring the content, Fein notes Amarin’s appeal rests on two lines of argument: “(1) that the court erred in finding a prima facie case of obviousness because it did not apply the correct analytical framework; and (2) that the court erred in its approach to secondary considerations.”Fein notes the attorney found Amarin's second line of argument particularly persuasive, “both on the merits and on the clarity and force of argument.”Fein concludes optimistically, “The company only needs to be right on one.”The saga now awaits the generics’ response brief, which is anticipated by June 16, with Amarin’s reply brief expected by June 26. The appeal court’s ruling is anticipated by the end of 2020 or early 2021.Until further developments, Fein stays with the bulls. The 5-star analyst rates Amarin shares a Buy, along with a $51 price target. The implication for investors? Upside of a generic busting 560% from current levels. (To watch Fein’s track record, click here)Overall, Wall Street is split between the bulls and those choosing to play it safe. Based on 15 analysts polled in the last 3 months, 6 rate AMRN stock a Buy, while the other 5 remain sidelined. Notably, the 12-month average price target stands at $15, marking about 94% upside potential. In other words, even the analysts that are hedging their bets have some optimism reflected in expectations. (See Amarin stock analysis on TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.
Amarin Corporation plc (NASDAQ: AMRN) shares, which were higher in after-hours trading Thursday following the company's announcement regarding a third-party pilot trial of its Vascepa in COVID-19, were giving back the gains Friday. First Vascepa Generic Greenlighted The negative sentiment is attributable to another announcement by U.K.-based generic manufacturer Hikma Biologics that its U.S. subsidiary Hikma Pharmaceuticals USA has received FDA approval for a generic version of Amarin's Vascepa. This makes Hikma the first to receive approval for an abbreviated new drug application for a generic version of Vascepa. Indian generic manufacturer Dr.Reddy's Laboratories Ltd (NYSE: RDY) has also filed an ANDA with the FDA for Vascepa.Why A Vascepa Generic Launch Many Not Be Imminent Despite the generic approval, Hikma is unlikely to launch at-risk, SVB Leerink analyst Ami Fadia said in a Friday note. An at-risk generic launch occurs when a company introduces a generic drug even as litigation contesting validity and infringement of patents is still ongoing.After the U.S. District Court for the District of Nevada invalidated six key Vascepa patents owned by Amarin in March, clearing the way for a generic launch, Amarin filed a notice of appeal. The company has suggested that, with an expedited appeal, a new ruling could come by the end of 2020 or in early 2021."While Hikma could theoretically launch its generic at-risk, we believe this is unlikely to occur, given both Amarin and the generic defendants Hikma and Dr. Reddy's have agreed to the expedited appeals process," Fadia said.The analyst said Hikma is likely to let the process play out before potentially launching a generic. Manufacturing the product is complicated, and generics may take time to secure supply, she said. "What is uncertain is how difficult it will be for generics to ramp up supply, although we have made the assumption that sooner or later they can get there." Dr. Reddy's generic launch could come in the near-term, according to SVB Leerink. "Our understanding is that Dr. Reddy's has a goal date later this year for its generic, and the company doesn't foresee any challenges to the file," Fadia said. SVB Leerink has an Outperform rating on Amarin with a $9 price target. AMRN Price Action At last check, Amarin shares were slipping 1.1% to $7.20. Related Links:The Daily Biotech Pulse: FDA Nod For Aquestive, Tetraphase M&A Plot Thickens, Amarin's Vascepa In COVID Fray PreMarket Prep Stock Of The Day: Amarin Latest Ratings for AMRN DateFirmActionFromTo May 2020Aegis CapitalMaintainsBuy May 2020SVB LeerinkMaintainsOutperform Apr 2020CitigroupMaintainsBuy View More Analyst Ratings for AMRN View the Latest Analyst RatingsSee more from Benzinga * The Daily Biotech Pulse: FDA Nod For Aquestive, Tetraphase M&A Plot Thickens, Amarin's Vascepa In COVID Fray * The Daily Biotech Pulse: FDA Nod For GlaxoSmithKline, Hologic To Launch Coronavirus Test, Amarin's Strong Q1 * The Daily Biotech Pulse: Amarin Reports Strong Q1 Vascepa Sales, BeiGene Aces Late-Stage Lung Cancer Study, Glaxo, Sanofi Strike COVID-19 Vaccine Partnership(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Amarin's (AMRN) strong revenue growth in the first quarter is attributable to continued solid demand for its cardiovascular drug, Vascepa.
Amarin's (AMRN) first quarter earnings were in line with expectations. However, sales beats estimates. Stock down.
Barely a month ago, investors of Amarin (AMRN) were left dismayed following a lost patent trial against two generic drug makers seeking to sell their own versions of Amarin’s high triglycerides treatment, Vascepa. After which, Amarin’s share price was sent tumbling by an almighty 70% in one session.As Vascepa is Amarin’s sole product, many wondered where the biopharma could go next, with limited commercial opportunities in tow. Although Amarin is expected to file an appeal next week – with hope of a verdict by year’s end or early next year – its whole raison d'etre was bought into question. That said, while some project uncertainty, others see opportunity.Earlier today, Northland Securities analyst Carl Byrnes initiated coverage of Amarin with an Outperform rating and a $15 price target. Investors could be taking home gains in the magnitude of a blockbusting 92%, should the target be met in the coming months. (To watch Byrnes’ track record, click here)So, in the midst of such anxious times, what has instigated the glowing assessment?Although Byrnes acknowledges the patent litigation is still a “major risk," the analyst maintains the “potential threat from generic competition may prove to be greatly overstated.”Why? Byrnes explains: “First, it is our belief that Amarin has secured the majority of existing capacity to produce FDA grade icosapent ethyl. Secondly, we estimate the costs associated with building out capacity to produce sufficient quantities of FDA-grade icosapent ethyl could easily exceed $750MM due to the complexity of the separation and purification technologies necessary to insure batch consistency, purity, stability, and other criteria, making it economically infeasible.”The conclusion for Byrnes is clear, as he forcefully surmises “the potential generic competitors will NOT have access to sufficient quantities of FDA-grade API for commercial purposes.”Taking a step back from the litigation issues, it should be noted that things looked very different for Amarin at the turn of the year. In December, the FDA approved Vascepa’s label expansion to include patients at risk of a heart attack and other major adverse cardiovascular events (MACE). Following the label’s expansion, Amarin doubled its US salesforce, received “preferred brand status from key payers," and, consequentially, sales in 1Q20 were up 110% year-over-year and reached $152 million.Byrnes estimates the TAM (total addressable market) for Vascepa in the US to be more than $24 billion with potential peak sales over $6 billion, while EU sales could surpass $2 billion. Vascepa is currently in development in China with topline data expected by the end of the year, which could act as a further catalyst.What about the rest of the Street’s take? Based on 6 Buys and 5 Holds, Amarin currently has a Moderate Buy consensus rating. At $15, the average price target is identical to Byrnes’. (See Amarin price targets and analyst ratings on TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.
Iovance's (IOVA) first-quarter loss wider than estimated. The company progressing well with its lead pipeline candidates.
Here's a roundup of top developments in the biotech space over the last 24 hours.Scaling The Peaks (Biotech Stocks Hitting 52-week Highs May 21) * ADC Therapeutics SA (NYSE: ADCT) (IPOed May 15) * Allogene Therapeutics Inc (NASDAQ: ALLO) * AstraZeneca plc (NYSE: AZN) ( announced $1 billion BARDA funding for coronavirus vaccine program) * Biondvax Pharmaceuticals Ltd - ADR (NASDAQ: BVXV) * Cellectis SA (NASDAQ: CLLS) * ChemoCentryx Inc (NASDAQ: CCXI) * Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP) * Cue Biopharma Inc (NASDAQ: CUE) * Fate Therapeutics Inc (NASDAQ: FATE) * Harpoon Therapeutics Inc (NASDAQ: HARP) * Horizon Therapeutics PLC (NASDAQ: HZNP) * Intellia Therapeutics Inc (NASDAQ: NTLA) * Kamada Ltd. (NASDAQ: KMDA) * Minerva Neurosciences Inc (NASDAQ: NERV) * Ovid Therapeutics Inc (NASDAQ: OVID) * Passage Bio Inc (NASDAQ: PASG)(FDA granted Rare Pediatric Disease designation to its gene therapy PBGM01 broadly for the treatment of GM1 gangliosidosis) * Soleno Therapeutics Inc (NASDAQ: SLNO) * Surface Oncology Inc (NASDAQ: SURF)Down In The Dumps (Biotech Stocks Hitting 52-week Lows May 21) * Akorn, Inc. (NASDAQ: AKRX) (filed for Chapter 11 bankruptcy) * Digirad Corporation (NASDAQ: DRAD) * Genfit SA (NASDAQ: GNFT)Related Link: These 6 Coronavirus Vaccine Candidates Are The Likeliest To Succeed, Says Morgan StanleyStocks In Focus Aquestive's Partnered Parkinson's Drug Gets FDA Nod Aquestive Therapeutics Inc's (NASDAQ: AQST) development partner Sunovion announced FDA approval for Kynmobi sublingual film - APL-130277 - for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease. The drug is expected to be available in the U.S. pharmacies in September.Following the approval, Aquestive said it plans to monetize its PharmFilm based therapies."We continue to expect that we will receive between $50 to $100 million of non-dilutive capital from the monetization, in one or a series of transactions," the company said.The stock rose 5.2% to $6.47 in after-hours trading.Syndax's Lead Breast Cancer Drug Flunks Late-stage Study Syndax Pharmaceuticals Inc (NASDAQ: SNDX) said a late-stage study that evaluated its investigational compound entinostat along with exemestane in patients with HR+, HER2- breast cancer who have progressed on a non-steroidal aromatase inhibitor did not achieve the primary endpoint of demonstrating a statistically significant overall survival benefit over hormone therapy alone.The study was conducted by ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute.The stock slumped 19.41% to $16.52 in after-hours trading.Tiziana To Spin-off Its Personalized Medicines Businesses TIZIANA LF SCIE/S ADR (NASDAQ: TLSA) said it intends to demerge its StemPrintER and SPARE genomics-based personalized medicine businesses into a separate company and effect a capital reduction to facilitate the spin-out and listing of StemPrintER as an independent entity.Amarin To Support Pilot Study Of Vascepa In Treating COVID-19 Amarin Corporation plc (NASDAQ: AMRN) said it supports a clinical trial to investigate the effects of its Vascepa on inflammatory biomarkers and other patient outcomes in individuals with COVID-19. The trial is sponsored by the Canadian Medical and Surgical Knowledge Translation Research Group, the company said.Separately, generic pharma company Hikma Pharmaceuticals announced its wholly-owned U.S. subsidiary Hikma Pharmaceuticals USA Inc. has received FDA approval for its generic equivalent to Vascepa.In pre-market trading Friday, Amarin stock was adding 3.85% to $7.56.Navidea Reports Positive Mid-stage Results For Rheumatoid Arthritis Treatment Navidea Biopharmaceuticals Inc (NYSE: NAVB) announced positive preliminary results from the second interim analysis of its ongoing NAV3-31 Phase 2B study"Analysis demonstrates that these interim data further corroborate Navidea's hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis, and that this imaging can provide an early indicator of treatment efficacy in patients with active RA," the company said.The stock was seen skyrocketing 65.35% to $2.10 in pre-market trading.Roche Buys Gene Sequencing Tech Company Roche Holdings AG (OTC: RHHBY) announced acquisition of Stratos Genomics, an early-stage sequencing technology company to advance the development of its nanopore sequencer.The company did not disclose the financial terms of the dealTetraphase Deems Melinta's Latest All-Cash Offer As Superior, Notifies AcelRx Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH), which has been pursued by multiple companies, said its board has determined that the latest proposal from Melinta Therapeutics, Inc. is a "Superior Offer."'Melinta has offered $27 million in cash, plus an additional $12.5 million in cash potentially payable under contingent value rights to be issued in the proposed acquisition.View more earnings on IBBTetraphase, which agreed to a deal to be bought byAcelRx Pharmaceuticals Inc (NASDAQ: ACRX), said it has informed about its determination concerning the Melinta offer and given AcelRx time until May 29 to either terminate the merger or revise the terms of the merger.Incidentally, La Jolla Pharmaceutical Company (NASDAQ: LJPC) had also tabled an offer for Tetraphase.In pre-market trading, AcelRx shares were adding 2.74% to $1.50.Amag Divests Intrarosa For Upto $125M AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) said it has completed the sale of its rights to Intrarosa to Millicent Pharma Limited, for up to $125 million, including upfront fixed consideration of $20 million and contingent, sales-based milestone payments of up to $105 million.The company said the sale is consistent with its previously announced strategic decision to divest its women's health assets. It also said it remains committed to the divestiture of Vyleesi and associated expense reductions as previously announced.Offerings ContraFect Corp Stock (NASDAQ: CFRX) said it has priced its underwritten public offering of 11.8 million shares of its common stock and related warrants to purchase 8.85 million shares. The gross proceeds from the public offering will be approximately $52.5 million, it said. All shares in the public offering are to be sold by ContraFect.In premarket trading Friday, the stock was slipping 11.87% to $4.75.Hoth Therapeutics Inc (NASDAQ: HOTH) priced its underwritten public offering of 1.82 million shares of common stock at $2.75 per share, for raising gross proceeds of $5 million. The offering is expected to close on or about May 27.The stock was slipping 5.36% to $3 in premarket trading Friday.Dynavax Technologies Corporation (NASDAQ: DVAX) priced its previously announced underwritten public offering of 14 million shares of its common stock at $5 per share. The gross proceeds to Dynavax from the offering are expected to be approximately $70. The offering is expected to close on or about May 27.The stock was retreating 10.25% to $5.08 in premarket trading Friday.PPD Inc (NASDAQ: PPD) said it upsized and finalized the terms of the offering of $500 million aggregate principal amount of 4.625% senior notes due 2025 and $700 million aggregate principal amount 5.000% senior notes due 2028. The aggregate principal amount of the notes to be issued in the offering was increased to $1.2 billion from the previously announced $700 million, the company said.In premarket trading Friday, the stock was adding 1.23% to $28.Geron Corporation (NASDAQ: GERN) said it intends to offer and sell shares of its common stock and accompanying warrants to purchase shares of its common stock in an underwritten public offering. All the securities earmarked for the offering are being sold by the company.The stock was slipping 20.92% to $1.55 in pre-market trading.On The Radar Clinical Readouts Atara Biotherapeutics Inc's (NASDAQ: ATRA) abstract on the Phase 1 data for ATA188 in multiple sclerosis, regarding its European Academy for Neurology presentation, will be made available online at 12:30 pm ET.Earnings Teligent Inc (NEW JERSEY) (NASDAQ: TLGT)IPO Inari Medical, a medical device company, priced its upsized initial public offering of 8.203 million shares of its common stock at $19.00 per share, for total gross proceeds of approximately $156 million. The company had earlier planned for a 7.33-million stock offering, with an estimated price of $17-$18 per share. The shares are to be listed on the Nasdaq under the ticker symbol NARI.See more from Benzinga * The Daily Biotech Pulse: Mixed Filgotinib Readout For Gilead-Galapagos, Akorn To File For Chapter 11, D-Day For Aquestive * The Daily Biotech Pulse: Aldeyra Jumps Into COVID-19 Drug Fray, FDA Nod For Myriad's Companion Diagnostic Test * The Daily Biotech Pulse: FDA Nod For Roche, Arbutus Releases Positive Readout For HBV Therapy, Moderna Announces .34B Common Stock Offering(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Image source: The Motley Fool. Amarin Corporation plc (NASDAQ: AMRN)Q1 2020 Earnings CallApr 30, 2020, 7:30 a.m. ETContents: Prepared Remarks Questions and Answers Call Participants Prepared Remarks: OperatorWelcome to Amarin Corporation's Conference Call to discuss its Preliminary First Quarter Financial Results and Operational Updates.
Shares in Amarin (AMRN) are plunging 10% in Friday’s pre-market trading on the news that Hikma Pharmaceuticals (HKMPY) has received approval from the US Food and Drug Administration (FDA) for its Icosapent Ethyl Capsules, 1 gm, the generic equivalent to Amarin’s Vascepa.In March 2020, the United States District Court for the District of Nevada invalidated six key Vascepa patents owned by Amarin. Amarin is now appealing this District Court decision.Brian Hoffmann, Hikma’s President of Generics said, “The approval for our generic version of Vascepais an important milestone towards bringing this product to market. This approval demonstrates the strength of our regulatory capabilities and our commitment to provide patients and healthcare providers in the US with the high-quality medicines they need.”However Stifel Nicolaus analyst Derek Archila stated: “The approval and timing, which are generally hard to predict with generics, does come ahead of our expectations but, in our view, we think there is a low probability Hikma launches at-risk.”He continued: “Given AMRN’s ongoing appeal of the district court’s ruling invalidating Vascepa’s patents on obviousness and the fact the trial has been expedited by the court, we think it is unlikely Hikma will launch at-risk and risk potential treble damages if AMRN were to prevail on the appeal.”Amarin management has previously indicated that with an expedited appeal a ruling could potentially come by the end of 2020 or early 2021. The next major update in the appeal will be around 6/16 when the generics file their response briefs.But as Archila, who has a hold rating on Amarin, also points out “It’s hard to definitively know whether Hikma will launch in the near-term and there is always the possibility of the other generic filer – Dr. Reddy’s – also receiving approval for their generic Vascepa and potentially launching at-risk.”Overall Amarin has a cautiously optimistic Moderate Buy consensus with an average analyst price target of $16 (119% upside potential). Shares have dropped 66% so far year-to-date. (See Amarin stock analysis on TipRanks)Related News: Gilead and Galapagos Score Positive Topline Results For Ulcerative Colitis Trial Moderna Spikes 21% Amid “Positive” Early-Stage Covid-19 Vaccine Data AstraZeneca-Merck Lynparza Prostate Cancer Treatment Gets FDA Approval More recent articles from Smarter Analyst: * Data Center Set to Send Nvidia Stock Soaring Even Higher * Google Pay App May Face Anti-Trust Probe In India – Report * Trump Threatens Twitter After It Labels His Tweets "Potentially Misleading" * General Electric Surges 8% Amid Sale Of Lighting Unit To Savant
Q1 2020 Amarin Corporation PLC Earnings Call
First and total coronary revascularization event reductions of 34% and 36%, respectively, shown with VASCEPA in prespecified tertiary endpoint analyses Results of prespecified.
Investors of Amarin (AMRN), the maker of high triglycerides treatment, Vascepa, have had a rough 2020. Despite a strong rebound in April, the stock is still down by a massive 65% year-to-date, mostly on account of a lost patent trial against two generic drug makers hoping to bring to market their own versions of Vascepa.As Vascepa is Amarin’s only product, the case for and against the biopharma lies solely with its success. Following last year’s label expansion approval from the FDA - thought to be a major win for the product’s sales potential - the recent negative court ruling represented a significant setback. And despite the possibility of potential commercial opportunities in the EU, Archila maintains Amarin’s upcoming appeal is what matters when considering the company as an investment. The company will file its appeal on May 12, and management believes a decision could be made by 4Q20 or early next year.Indeed, Stifel analyst Derek Archila believes the verdict will ultimately be the make or break factor for Amarin’s share price.Archila said, “Outside of a potential EU partnership announcement in 3Q20, we believe the appeal decisions remains the key catalyst for shares. With that said, operationally the company continues to face the challenges presented by COVID19 as many others do, but by pushing out DTC spend in light of the IP ruling and less F2F activity by Vascepa sales reps for a couple quarters should lead to some Opex savings in 2020… We await the appeal briefs to better understand AMRN's appeal strategy before potentially getting more constructive.”Accordingly, Archila stays on the sidelines with a Hold rating. The analyst has a $8 price target, implying a modest 5% upside. (To watch Archila’s track record, click here)Turning now to the rest of the Street -- based on 4 Buys and 5 Holds, Amarin has a Moderate Buy consensus rating. The average price target hits $16, and implies upside potential of a very strong 118%. (See Amarin stock analysis on TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.
Irish biopharmaceutical company Amarin (NASDAQ: AMRN) posted record revenue of $155 million in its first-quarter earnings reported April 30, marking an 112% year-over-year increase for a net loss of $20.6 million, or $0.06 per share. The company's sole product, Vascepa, is a drug derived from fish oil. It was approved by the U.S. Food and Drug Administration (FDA) as an add-on with statin therapy to lower the risk of heart attack, stroke, and cardiovascular disease and to bring down high levels of triglycerides in adult patients.
Millions of Americans who would like to lower their risk of a heart attack could have a new, low-cost option to help them. On Friday, the FDA approved 1 gram Icosapent Ethyl Capsules from Hikma Pharmaceuticals (OTC: HKMPY). Hikma's capsules are the generic equivalent of Vascepa from Amarin (NASDAQ: AMRN), a branded fish oil product expected to drive billions in annual sales.
British generic drugmaker Hikma Pharmaceuticals said it had received Food and Drug Administration approval to sell a generic version of Amarin’s fish oil-based heart drug.
HLS Therapeutics Supports Trial to Investigate the Effects of Vascepa® (Icosapent Ethyl) against COVID-19