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Thankfully, we're well past the patent cliff, and AstraZeneca's product portfolio is looking as robust as ever. Meanwhile, Alexion has been trying to … Alexion's main patent on Soliris, which treats two rare blood disorders, runs through 2021. ULTOMIRIS for Dermatomyositis (DM) ULTOMIRIS is a long-acting C5 inhibitor. But analysts remain optimistic: Of the 20 who cover the stock tracked by FactSet, 15 rate it a Buy or Overweight. Alexion's beating forecasts with Soliris-to-Ultomiris switch. All rights reserved. If Roche Holding AG follows through with a purchase of Alexion Pharmaceuticals Inc., it may face one of the biotechnology industry’s most expensive takeover bills. Your ability to comment is currently suspended due to negative user reports. Alexion plans to initiate a Phase 2/3 study of ULTOMIRIS in DM in the second half of 2021, pending regulatory feedback. 3 Speen Street, Suite 300, Framingham, MA 01701. Soliris currently makes up around 88% of Alexion’s overall sales at $980.8 million in the second quarter and isn’t expected to face biosimilar challengers for several years—2022 in the EU and 2027 in the U.S. RELATED: Is a Soliris patent review that big a threat to Alexion? In November 2017 the company received a patent for Soliris from the Japanese Patent Office. Astra’s share price fell 5% by mid-morning in London, amid some worry that it may yet get dragged into a bidding war. Breaking News . The biotech filed for protection of a new formulation. But on Monday, the European Patent Office voted against issuing the … The beauty of it is that Alexion’s business, which depends heavily on a single blockbuster drug, should command a higher valuation when incorporated into a broader portfolio of drugs. Reproduction in whole or part is prohibited. Rumors have swirled about top pharmaceutical companies targeting Alexion as an acquisition candidate with the massive patent cliff looming, particularly after … Dividend cover, it added, will be “materially enhanced.” While the company is borrowing another $17.5 billion to finance the deal, around 20% of that will go to refinancing Alexion’s debt. By doing so, you and %USER_NAME% will not be able to see Biddingwar gainst who? It drove 86% of 2018 revenue, which raises worries about a potential patent cliff. If there is bidding war lets drop the deal and then Alexions price will go freefall. ... Tecfidera patent cliff, and details may be shared on marketing strategies to drive uptake of the drug. By Allison DeAngelis – Life Sciences Reporter, Boston Business Journal . Sign up to create alerts for Instruments, Consequently, Ultomiris is meant to replace Soliris, as it requires treatment every eight weeks instead of two, and is cheaper than Soliris. So what's up with its pesky stock price. © 2021 Questex LLC. Deal sounds good but AZN can live with out it too. © 2007-2021 Fusion Media Limited. In doing so, it will diversify its own revenue stream, protect itself against patent cliff … Publication number: 20200123238. However, in order to maintain the high level of discourse we’ve all come to value and expect, please keep the following criteria in mind: Perpetrators of spam or abuse will be deleted from the site and prohibited from future registration at Investing.com’s discretion. Amgen is coming for Alexion — but not in the form of a rumored, and largely dispelled, takeover. The intense spotlight on the race for a Covid-19 vaccine has left much of the longer-term action in the biotech sector in the shadows. That the PTAB chose to institute review of all three surprised analysts on Wall Street, who hadn't expected the patent court to buy into Amgen's case. That patent cliff has depressed the valuation of the stock. Inventors: Rui-Ru Ji, Andrew Hutchinson, Nina Jain, Christen D. Forbes. Economic Calendar - Top 5 Things to Watch This Week, Precious Metals & Energy - Weekly Review and Calendar Ahead, Outgoing CEO says Panasonic must cut Tesla reliance as battery tie-up evolves: FT, Stock Market Volatility Is Likely To Surge, 3 Stocks To Watch In The Coming Week: Nike, FedEx, Tesla, Week Ahead: Ongoing Treasury Selloff To Pressure Tech; Bitcoin Shoots Past $60K, Vanguard Total Bond Market II Index Fund Investor, PIMCO Commodity Real Return Strategy Institutional, SG FTSE MIB Gross TR 5x Daily Short Strategy RT 18, Vontobel 7X Long Fixed Lever on Natural Gas 8.06, VW to cut up to 4,000 jobs via early retirement, sources say, Saudi Arabia stocks higher at close of trade; Tadawul All Share up 0.80%, Direxion Daily Junior Gold Miners Bull 2X Shares. Date of Patent: April 28, 2020. Phase 2. All Rights Reserved, This article has already been saved in your, Avoid profanity, slander or personal attacks. Preclinical. FDA approvals patent cliff biosimilar Alexion Soliris Ultomiris (ravulizumab-cwvz) U.S. FDA Amgen U.S. Patent & Trademark Office GET THE NEWSLETTER Subscribe to … SVB Leerink analyst Geoffrey Porges updated Amgen’s chances of success to 50% in a September note to investors and added an 8% to 12% “incremental erosion” to Soliris sales beyond 2022 when Amgen’s biosim challenger would likely hit the market. Subscribe to FiercePharma to get industry news and updates delivered to your inbox. Kanuma Phase 3. Alexion scores 2nd FDA nod for Soliris successor drug as switching campaign continues, Is a Soliris patent review that big a threat to Alexion? "A decade ago, pharma companies were facing a 'patent cliff' with generic competition set to slash sales of small-molecule blockbusters. Looking For Dividends? Alexion plans to file for regulatory approval for a new indication for the drug in treating patients with refractory generalized myasthenia gravis in the first quarter of next year. In a September note, Schimmer pointed out that Soliris has orphan drug designations that would secure U.S. exclusivity in aHUS until November 2023, myasthenia gravis (MG) until October 2024 and neuromyelitis optica (NMO) until mid-2026. In late August, the U.S. Patent and Trademark Office launched a review of Soliris’ U.S. patents after Amgen requested a broad challenge. Quotes. Please note that all comments are pending until approved by our moderators. - Aradhana Sarin, M.D., to become CFO after filing of Q3 2019 results - - Paul Clancy to step down as CFO and serve as senior advisor through mid-2020 - BOSTON--(BUSINESS WIRE)--Sep. 17, 2019-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced plans for the transition of Executive Vice President and Chief Financial Officer Paul Clancy later this year. Amgen’s challenge comes shortly after Alexion secured an extension to its patent protection for Soliris until 2027, and sparked a decline in the latter’s share price as investors reacted to the news of a fresh challenge to the company’s intellectual property. The Petri Dish: A new biotech fund, $150M IPO and Alexion's patent case. A patent challenge by Amgen (NADSAQ: AMGN ) added to those fears and led ALXN stock to sell off in August. Phase 1. Alexion is a global biopharmaceutical company focused on developing life-changing therapies for people living with rare disorders. Patent number: 10126293 Abstract: The disclosure relates to methods for detecting PNH Type II cell populations in biological samples as well as methods for determining whether a patient is at an increased risk for developing thrombocytopenia or thrombosis based on the percentage of PNH Type II cells in the patient's blood. The deal shows that the company hasn’t forgotten to plan for life beyond the pandemic – rightly so, given that it isn’t likely to earn much out of its vaccine: it has promised to distribute that more or less at cost as long as the pandemic lasts. The deal may assuage worries about future patent cliff effects at Alexion, which relies overwhelmingly on two drugs, Soliris and Ultomiris, for its cash flows. This comment has already been saved in your. Now, the major threat is biosimilars." Alexion’s share price has gone nowhere for the last four years not least because of concerns about patent expiry that have only partly been allayed by the development of Ultomiris, a second-generation version of its cash cow Soliris. Analysts are split. Even if Amgen is successful in challenging Soliris' patents, its ability to compete with the Alexion drug would be limited for several years, Evercore ISI analyst Josh Schimmer figures. Alexion has already received orphan drug designation in Europe for treating STEC-HUS. Celgene Patent No. But Amgen's challenge could change that. The three patents Amgen is challenging extend that patent protection by another six years, until 2027. exclude terms. Alexion's Ultomiris scored an FDA nod to treat atypical hemolytic uremic syndrome (aHUS). Alnylam Pharmaceuticals, Inc. (ALNY) Use a + to require a term in results and - to BERLIN (Reuters) - Carmaker Volkswagen (DE:VOWG_p) plans to cut up to 4,000 jobs at its plants in Germany by offering early or partial retirement to older employees in a move that... Investing.com – Saudi Arabia stocks were higher after the close on Sunday, as gains in the Hotels & Tourism, Building & Construction and Industrial Investment sectors led shares... (Reuters) - Panasonic (OTC:PCRFY) Corp's outgoing Chief Executive Kazuhiro Tsuga said the company will need to reduce its heavy reliance on Tesla (NASDAQ:TSLA) Inc by making... We encourage you to use comments to engage with users, share your perspective and ask questions of authors and each other. The company has agreed to buy U.S.-based Alexion (NASDAQ:ALXN) for $39 billion, a move that will launch it into the high-margin world of treatments for rare diseases. Ready to hold long time. It’s been easy to forget that this is the kind of move that had already made AstraZeneca the most valuable stock in the FTSE100 even before the events of this year. Assignee: Alexion Pharmaceuticals, Inc. Economic Events and content by followed authors, StockBeat: AstraZeneca's Alexion Move Deserves a Better Reaction. RELATED: Alexion's beating forecasts with Soliris-to-Ultomiris switch. In any case, Astra is covering two-thirds of the cost with its own generously-valued stock, reaping the rewards of past value creation under chief executive Pascal Soriot. Alexion had hoped to extend patent protection in Europe until 2027. AstraZeneca said the deal would raise earnings per share by 10% over the next three years, “materially” improving its ability to pay a higher dividend, as promised. It helped that I sold friday 933kr. Ultomiris, which is seeking approval in NMO and MG, could launch in those indications as soon as late 2022, giving Alexion an even better chance of switching patients away. Analysts are split. Alexion’s patent exclusivity for Soliris is uncertain, with a major patent possibly expiring in 2021. In December, AstraZeneca got a head start, announcing its acquisition of Alexion . On Friday, the U.S. Patent Office's appeal board disclosed that it will review three of Alexion’s patents, placing the company’s expected eight-year hold on … Celgene (CELG) and Alexion Pharmaceuticals (ALXN) are two big biotech stocks facing a similar problem -- … For an Amgen biosim to counteract that trend, the copycat would need a compelling price point that Schimmer said would be “daunting” to achieve. Strensiq. A hearing over Alexion’s composition of matter patent application with the European Patent Office is expected to kick off Sept. 5. Alexion has benefited from its focus on rare diseases, which has allowed them to have little or even zero competing products in indications, allowing the company to charge higher prices. It may therefore take some time before it appears on our website. That’s because of Alexion's faster-than-expected campaign to switch patients over to Ultomiris, which has been a rousing success so far. The price represents a premium of around 43% on the one-month average price for Alexion, which may look expensive at first glance, but is par for the course in the sector. EFFICACY OF AN ANTI-C5 ANTIBODY IN THE PREVENTION OF ANTIBODY MEDIATED REJECTION IN SENSITIZED RECIPIENTS OF A KIDNEY TRANSPLANT. Are you sure you want to delete this chart? Enclose phrases in quotes. Your status will be reviewed by our moderators. While Soliris accounts for the majority of the company's sales, it's uncertain how much longer the drug's patent exclusivity will last. Investing.com -- AstraZeneca (NASDAQ:AZN) has come up with a good, old-fashioned acquisition to remind everyone what biotech M&A used to be all about before the pandemic. Rumors have swirled about top pharmaceutical companies targeting Alexion as an acquisition candidate with the massive patent cliff looming, particularly after Goldman Sachs … Consider These 2 ETFs. any of each other's Investing.com's posts. Pomalyst is … %USER_NAME% was successfully added to your Block List. StockBeat: AstraZeneca's Alexion Move Deserves a Better Reaction. The company has agreed to buy U.S.-based Alexion (NASDAQ: ALXN) for $39 billion, a move that will launch it into the high-margin world of treatments for rare diseases. Alexion plans to file for regulatory approval of ANDEXXA in Japan in the first quarter of 2021. I like the company cancer will be more common as people eat prosessed food and live in polluted cityes. I bought lot today under and above 875kr. (Alexion). Can Celgene Weather A Steep Patent Cliff? The U.S. patent office will review patents on Alexion Pharmaceuticals Inc's blood disorder treatment Soliris, after Amgen Inc challenged them, court filings showed on Friday. Since you’ve just unblocked this person, you must wait 48 hours before renewing the block. Long term trend is high above todays price. Thanks for your comment. As of July, around 40% of PNH patients taking Soliris had switched to Ultomiris, putting Alexion well on track to hit its 70% conversion goal in that indication by mid-2020. Rather, the US Patent Trials Appeal Board (PTAB) has agreed to … Its main patent on the drug expires in the US in 2021. Are you sure you want to block %USER_NAME%? So what's up with its pesky stock price? The recent acquisitions are unlikely to accelerate the … Please wait a minute before you try to comment again. Despite a relatively late emergence from the industry patent cliff that largely started in 2012, Astra's strong lineup of next-generation drugs should … Ultomiris is considered Alexion's next-generation PNH treatment. All that gives AstraZeneca (NASDAQ:AZN) the confidence to say the deal will raise earnings per share by 10% over the next three years, with annual synergies of $500 million far offsetting one-off costs of $650 million. Summary. In doing so, it will diversify its own revenue stream, protect itself against patent cliff effects and – it hopes – strengthen cash generation both to service a progressive dividend policy and whittle down a debt load that is one of the few long-term concerns of shareholders. The FDA approved Ultomiris on Friday to treat patients with atypical hemolytic uremic syndrome (aHUS).The approval gives Ultomiris its second Soliris-matching indication after the follow-up drug won its initial nod to treat adult paroxysmal nocturnal hemoglobinuria (PNH) in December. 3 Pomalyst Since its launch as a third-line treatment for multiple myeloma in 2013, Pomalyst has become one of the indication's top-selling drugs. The patent disputes over the leading drug forced Alexion to seek the revenue diversification. With a patent challenge for blockbuster Soliris underway, Alexion is working hard to expand the reach of its successor drug Ultomiris. In October 2015, Alexion's second drug, Strensiq (asfotase alfa), was approved by the US FDA. With one carry-over indication already in the bag, Ultomiris just added a second to keep Alexion’s switching campaign afloat. Hematology. Analysts still figure Alexion can weather the storm—including its stagnant share price growth—even if Amgen’s patent challenge is successful. ... MRK) is another company facing the patent cliff that might look to make an acquisition. Alexion is in the midst of switching patients off older med Soliris as patent challenges ramp up pressure on the blockbuster drug. However, on the terms disclosed, there is not too much to dislike about the deal. Alexion, which makes a treatment for rare blood diseases, could command at least $148 a share, said Piper Jaffray. In its most recent update, Alexion reported that sales of Ultomiris more than tripled in year-on-year terms in the third quarter, suggesting that it is successfully transitioning patients to the new drug, whose patent protection runs for longer. Replace the attached chart with a new chart ? It is used to treat hypophosphatasia, a rare metabolic disorder.
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