Vounatsos has served as CEO since 2017. By checking this box, you confirm that you have read and are agreeing to our terms of use regarding the storage of the data submitted through this form. Despite its setback with Aduhelm, Biogen says it will continue development of another anti-amyloid drug for treating Alzheimer disease, lecanemab, which it is partnered with Eisai, who was also Biogens partner for Aduhelm. "However," he added, "given that we are in a long product cycle business, and in light of the [Medicare] decision, we recognize there is more we must do today to provide better clarity and visibility into the company's future.". Read more at The Business Times. The announcement comes on the heels of Biogens recent withdrawal of its application for Aduhelm with European regulators. REUTERS/Dado Ruvic/Illustration/File Photo. The pharmaceutical giant on Wednesday shared its second quarter earnings, which . The accelerated approval pathway provides patients with a serious disease earlier access to drugs when there is an expectation of clinical benefit despite some uncertainty about the clinical benefit with follow-up trials required. The company reported a 26% fall in. (2020). STORY: Biogen said on Tuesday that its CEO Michel Vounatsos will step down and that the company is pulling back from selling its Alzheimer's drug Aduhelm after the U.S . The company did not include a reason for Capello's departure. (Reuters) -Biogen Inc said on Tuesday that chief executive Michel Vounatsos will step down and that the company is pulling back on selling its . With CNBC's Melissa Lee and the Fast Money traders, Guy Adami, Tim Seymour, Karen Fine. For the first quarter of 2022, Biogen took $275 million in charges from Aduhelm inventory write-offs as well as approximately $45 million in idle-capacity charges. May 4, 2022 00:22 JST Updated on May 4, 2022 02:31 JST. Biogen is partnered with Sage Therapeutics, a Cambridge, Massachusetts-based bio/pharmaceutical company, to advance zuranolone. Following lower-than-expected results and diminished prospects for its Alzheimers drug, Aduhelm (aducanumab), once touted as a potential blockbuster, Biogen announced that its CEO is stepping down, and the company is implementing a $500-million cost-reduction program, which involves substantially eliminating the commercial infrastructure for the drug. Biogen's stock is down 13.4% this year, while the S&P 500 SPX, -0.78% has declined 12.8%. To learn more, please visit www.dcat.org. Year-to-date, BIIB is down more than 12%. Biogen's Chief Executive Officer Michel Vounatsos is stepping down, at a time the drugmaker is grappling with Medicare restricting coverage for its Alzheimer's drug Aduhelm to patients in. Biogen expects the Phase II readout for BIIB104, its other key drug candidate, in mid-2022. What Does the Launch of This Hot New Meme Coin Mean for Dogecoin? Biogen is searching for a new CEO along with additional ways to cut costs after another quarter of paltry sales for its closely watched Alzheimer's disease drug. "We recognize that Biogen is facing a number of near-term challenges," said CEO Michel Vounatsos on a Tuesday morning call with investors. Mr. Scangos was waiting for a suitable successor to step down from the position and it only took a year with the company for them to decide that Vounatsos was the best candidate. This category only includes cookies that ensures basic functionalities and security features of the website. Biogen said Vounatsos, who was named as the CEO in 2016, will continue in his role until a successor is appointed . 5 MINUTES WITH: Stuart Needleman, Chief Commercial Officer, Piramal Pharma Solutions. -2.54%. May. Necessary cookies are absolutely essential for the website to function properly. Earlier this month (April 2022), Biogen withdrew its marketing authorization application (MAA) from the European Medicines Agency for Aduhelm following discussions with the EMA, which had indicated that data provided thus far would not be sufficient to support a positive opinion for marketing authorization. Biogen ended the first quarter with $2.07 billion in net product revenue, down almost 7% from the same period a year prior. (Reuters) - Biogen Inc said on Tuesday its Chief Executive Officer Michel Vounatsos will step down and the company has started a search for a successor. Biogen Inc. announced that Chief Executive Officer Michel Vounatsos will step down and that the company is pulling back on selling its controversial Alzheimer's drug Aduhelm, in what appears to be a final blow to its prospect of becoming a big seller. Following lower-than-expected results and diminished prospects for its Alzheimer's drug, Aduhelm (aducanumab), once touted as a potential blockbuster, Biogen announced that its CEO is stepping down, and the company is implementing a $500-million cost-reduction program, which involves substantially eliminating the commercial infrastructure for the drug. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); By Simon Spichak, MSc | Dies geschieht in Ihren Datenschutzeinstellungen. Biogen said on Tuesday (May 3) that Chief Executive Michel Vounatsos will step down and that the company is pulling back on selling its Alzheimer's drug . The company is "effectively throwing in the towel on Aduhelm," he wrote in a note to clients, while its strategy moving forward is "somewhat vague" and contingent on clinical trial readouts and, likely, incoming management. How a Japanese Drugmaker Got The 'Clean Win' Over Alzheimer's. This website uses cookies to improve your experience while you navigate through the website. CNBC's Meg Tirrell joins 'Squawk Box' to report that Biogen CEO Michel Vounatsos will step down amid the company's troubled launch of its historic Alzheimer's drug Aduhelm. He will be replaced by Michael McDonnell, CFO of contract research organization IQVIA. Please help support our mission. Biogen Inc. is shedding Chief Executive Michel Vounatsos and effectively abandoning its high-profile Alzheimer's disease treatment Aduhelm as it attempts to chart . Biogen Inc said on Tuesday that Chief Executive Michel Vounatsos will step down and that the company is pulling back on selling its Alzheimer's drug Aduhelm after the U.S. government's . The company plans to "substantially" eliminate the commercial team supporting Aduhelm, which has recorded paltry sales. Shares in Biogen have fluctuated widely in value over the course of Aduhelm's unusual development and regulatory review, peaking at $430 per share after the drug's approval. Frustrated by the lack of an editorially independent source of information on brain health and Alzheimers disease, we decided to create Being Patient. Analysts expect the drug will continue to struggle, particularly in light of a recent decision from the government agency that runs Medicare, which insures the largest proportion of Alzheimer's patients in the U.S. Biogen says that additional actions on the drug may be informed by upcoming data readouts as well as further engagement with the FDA and CMS. Data is a real-time snapshot *Data is delayed at least 15 minutes. 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Jobs report shows labor market remains tight, says Richmond Fed President Tom Barkin, Jim Cramer reacts to October's strong jobs report: Investors can look for opportunities, Starbucks CFO Rachel Ruggeri on earnings: We are focused on the customer experience, Stock futures edge higher Friday following strong jobs report, U.S. hiring remains strong as economy adds 261,000 jobs in October. the global Bio/Pharmaceutical You also have the option to opt-out of these cookies. Vounatsos, who has been at the helm since 2016, will stay until a new executive is hired. In its Q1 2022 earnings call in early May, Vounatsos said he would be stepping down as CEO once his replacement has been found. Yet, Biogen has hit significant setbacks. (Reuters) -Biogen Inc said on Tuesday that chief executive Michel Vounatsos will step down and that the company is pulling back on selling its controversial Alzheimer's drug Aduhelm, in what. The future of Aduhelm has been in doubt since the U.S. government's Medicare program restricted coverage of the medicine to patients in . In June 2021, Aduhelm was approved under FDAs accelerated approval pathway. Advertisement Biogen Inc said on Tuesday that Chief Executive Michel Vounatsos will step down and that the company is pulling back on selling its controversial Alzheimer's drug Aduhelm, in what appears to be a . The company also invested in gene therapy research through various partnerships and the acquisition of Nightstar Therapeutics. Wed May 4 2022 - 08:06. "In total, 395 CEOs left their positions during the first quarter of 2022marking the highest quarterly total since Q1 2020, which had 441 recorded CEO exits." In this article, you'll find every notable CEO stepping down since 2020. Sign up now for our free weekly email with in-depth reporting on topics important to patients and caregivers of Alzheimer's & other dementias. Get this delivered to your inbox, and more info about our products and services. 3, 2022, 11:11 AM InvestorPlace - Stock Market News, Stock Advice & Trading Tips Drug manufacturer Biogen (NASDAQ: BIIB) is seeing some attention this morning after announcing its Chief. We want to hear from you. Got a confidential news tip? STORY: Biogen said on Tuesday that its CEO Michel Vounatsos will step down and that the company is pulling back from selling its Alzheimer's drug Aduhelm after the U.S. government's Medicare program restricted coverage of the controversial treatment to patients in clinical trials. "We could not afford to keep the team unfortunately for that many months," he told investors. Biogens MAA had been under review by an EMA advisory committee in response to the companys request for a re-examination of a negative opinion issued by the committee in December (December 2021). The UK Pension Problem That Threatened to Wreck the Gilt Market. manufacturing value chain. Biogen CEO Michel Vounatsos to step down . Subscribe to the BioPharma Dive free daily newsletter, Subscribe to BioPharma Dive for top news, trends & analysis, The free newsletter covering the top industry headlines, Ermath, Michael. Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. Recommendations by FDA advisory committees are non-binding, but are usually in line with final FDA decisions, although not in this particular case. Biogen said Chief Executive George Scangos is stepping down, news that came as the biopharmaceutical company provided an upbeat earnings outlook and unveiled a $5 billion share buyback. Keep up with the story. (Reuters) -- Biogen said on Tuesday that Chief Executive Michel Vounatsos will step down and that the company is pulling back on selling its . #Biogen #MichelVounatsos #A. today that CEO Michel Vounatsos will be stepping down from the company. Artificial Intelligence in Digital Pathology Diagnostics: What Do Physicians Know and Expect? 3 May 2022, 12:34 pm. Vounatsos, who was appointed Biogen's CEO in 2017, will continue to stay on in the role while the company searches for his replacement. development association for companies engaged in the global bio/pharmaceutical manufacturing value chain. Biogen CEO Michel Vounatsos will resign as the company begins to substantially reduce its infrastructure for producing Aduhelm. (Reporting [] (Reuters) - Biogen Inc said on Tuesday its Chief Executive Officer Michel Vounatsos will step down and the company has started a search for a successor. Biogen is searching for a new CEO along with additional ways to cut costs after another quarter of paltry sales for its closely watched Alzheimer's disease drug. To Marc Goodman, an analyst at the investment firm RBC Capital Markets, Tuesday's announcements represent a "pivot point" for Biogen. Michel Vounatsos plans to step down from the top job once a successor is appointed, Biogen said in a statement on Tuesday. These cookies will be stored in your browser only with your consent. Biogen said on Tuesday (May 3) that Chief Executive Michel Vounatsos will step down and that the company is pulling back on selling its Alzheimer's drug Aduhelm after the US government's Medicare program restricted coverage of the controversial treatment to patients in clinical trials. and Leroy Leo May 3 (Reuters) - Biogen Inc (BIIB.O) said on Tuesday that chief executive Michel Vounatsos will step down and that the company is pulling back on selling its controversial. -Jaimy Lee Durch Klicken auf Alle akzeptieren erklren Sie sich damit einverstanden, dass Yahoo und seine Partner Ihre personenbezogenen Daten verarbeiten und Technologien wie Cookies nutzen, um personalisierte Anzeigen und Inhalte zu zeigen, zur Messung von Anzeigen und Inhalten, um mehr ber die Zielgruppe zu erfahren sowie fr die Entwicklung von Produkten. "Are they meaningful buyers? BIOGEN said on Tuesday (May 3) that chief executive Michel Vounatsos will step down and that the company is pulling back on selling its controversial Alzheimer's drug Aduhelm, in what appears to be a final blow to its prospect of becoming a big seller. CNBC's Meg Tirrell on Biogen CEO Michel Vounatsos leaving the company. Biogen CEO Scangos Stepping Down July 21, 2016 Share George A. Scangos, Ph.D., will step down as CEO of Biogen "in the coming months" once a successor is identified, the company. This Watertown biotech wants to change that. The company reported a 26% fall in quarterly profit as sales of its blockbuster multiple sclerosis drug Tecfidera continued to be pressured by cheaper versions of the treatment. Over the five years with Vounatsos at the helm, Biogen attempted to expand beyond its core business of multiple sclerosis drugs. Subsequently, sales were much lower than projected, in no small part due to a refusal on the part of some healthcare providers to prescribe it, and on the part of some insurers to cover it. Biogen CEO Michel Vounatsos to step down as the drugmaker announces plans to pull back on selling the Alzheimer's drug Aduhelm. Vounatsos, who has been at the helm since 2016, will stay until a new executive is hired. We are a team of dedicated journalists covering the latest research on Alzheimers, bringing you access to the experts and elevating the patient perspective on what its like to live with dementia. Biogen says that lecanemab and two other drugs in its neuroscience pipeline are part of its R&D prioritization for 2022: zuranolone for treating major depressive disorder (MDD) and post-partum depression (PPD) and BIIB104, a drug in Phase II development for treating cognitive impairment associated with schizophrenia. Reuters. BIIB Stock Treks Higher Amid News That Biogen CEO Michel Vounatsos Is Stepping Down. 2022 CNBC LLC. By Mrinalika Roy and Leroy Leo (Reuters) -Biogen Inc said on Tuesday that chief executive Michel Vounatsos will step down and that the company is pulling back on selling its controversial. Biogen is also scaling down their commercial infrastructure for producing their controversial anti-amyloid Alzheimers treatment Aduhelm (aducanumab) substantially, in response to insurance coverage restrictions by the U.S. Centers for Medicare and Medicaid Services, per its recent earnings report. But they may not get developed if drugmakers cant build a sustainable business around them, CBER director Peter Marks said at a conference. Michel Vounatsos to Step Down as Chief Executive Officer of Biogen. By clicking Accept, you consent to the use of ALL the cookies. The company believes the much smaller support for Aduhelm, as well as other cost reductions, will also yield another $500 million in annualized savings. Biogen announced today that CEO Michel Vounatsos will be stepping down from the company. Biogen said on Tuesday chief executive Michel Vounatsos will step down and that the company is pulling back on selling its controversial Alzheimer's drug Aduhelm, in what . Get the free daily newsletter read by industry experts. While Biogen hoped the drugs landmark approval by the Food and Drug Administration would lead to more sales, the drug was mired in controversy over its efficacy. Lecanemab, another collaboration between Biogen and Eisai, is the next anti-amyloid drug in their pipeline. By Shrey Dua, InvestorPlace Assistant News Writer May 3, 2022, 1:11 pm EDT Drug manufacturer Biogen (NASDAQ: BIIB) is seeing some attention this morning after announcing its <b>Chief Executive. Biogen said Vounatsos, who was named as the CEO in 2016, will continue in his role until a successor is appointed . document.getElementById( "ak_js_2" ).setAttribute( "value", ( new Date() ).getTime() ); Editorially independent, supported by our community. (Reuters) - Biogen Inc said on Tuesday its Chief Executive Officer Michel Vounatsos will step down and the company has started a search for a successor. The companies plan to complete the rolling submission for lecanemab under the accelerated approval pathway in the US in the second quarter of 2022. he wrote to clients. We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. Once considered a blockbuster-in-waiting, Aduhelm, as the drug is known, has faced strong pushback from insurers and some doctors since its approval last June. Gene therapies could help treat many ultra-rare diseases. DCAT Value Chain Insights is produced by the Drug, Chemical & Pfizer dominates the COVID drug market. Biogen Inc said on Tuesday its Chief Executive Officer Michel Vounatsos will step down and the company has started a search for a successor. If you find our articles and interviews helpful, please consider becoming a supporting member of our community. Klicken Sie auf Einstellungen verwalten, um weitere Informationen zu erhalten und Ihre Einstellungen zu verwalten. After more than five years at the helm of embattled Biogen Inc., Michel Vounatsos is stepping down as CEO, the company announced Tuesday morning, and plans to implement "additional cost-reduction . Revenue from both Spinraza and its top-selling multiple sclerosis drug have been in decline as newer, rival treatments entered the market. Vounatsos has served as CEO since 2017. Biogen CEO Stepping Down; Announces $500-M Cost-Cutting Plan for Alzheimers Drug. Lindsay Rosenwald's Fortress Bio 'Uniquely' Positioned to Capitalize on Current Long Biotech Winter. In its latest earnings report, Biogen recorded $2.8 million from Aduhelm over the first three months of this year, accounting for less than 1% of its overall revenue. Could they be willing sellers at some point (and, if so, who's interested)?" (Reuters) - Biogen Inc's Chief Executive Officer Michel Vounatsos is stepping down, at a time the drugmaker is grappling with insurance coverage issues related to its Alzheimer's drug Aduhelm. One of the key events analysts and investors are keeping an eye on is a late-stage study for lecanemab, an experimental Alzheimer's drug that, like Aduhelm, is meant to bind and remove toxic buildups of protein in the brain. Biogen CEO Steps Down, Downsizing Sales of Aduhelm. Biogen is searching for a new CEO along with additional ways to cut costs after another quarter of paltry sales for its closely watched Alzheimer's disease drug. By Mrinalika Roy and Leroy Leo (Reuters) -Biogen Inc said on Tuesday that chief executive Michel Vounatsos will step down and that the company is pulling back on selling its controversial. May 3 (Reuters) - Biogen Inc's BIIB.O Chief Executive Officer Michel Vounatsos is stepping down, at a time the drugmaker is grappling with insurance coverage issues related to its. The Phase III readout for lecanemab is expected in the fall of 2022, and Biogen plans to seek full FDA approval by the first quarter of 2023. We are glad you have chosen to leave a comment. Congress passed major drug pricing legislation in 2022, putting pharmaceutical companies on the defensive and creating a new precedent for the industry. Its investments in gene therapy have also not panned out, while a number of closely watched experimental drugs in its neurology-focused pipeline have failed in clinical testing. The company reported a 26% fall in quarterly profit as sales of its blockbuster multiple sclerosis drug Tecfidera continued to be pressured by cheaper versions of the treatment. Once considered a. Biogen CEO Michel Vounatsos will resign as the company begins to substantially reduce its infrastructure for producing Aduhelm. Biogen CEO Michel Vounatsos to step down following troubled Alzheimer's drug launch CNBC's Meg Tirrell joins 'Squawk Box' to report that Biogen CEO Michel Vounatsos will step down. The essential resource for In April, Medicare finalized a restrictive policy that severely limits coverage of Aduhelm and other Alzheimer's therapies that work in a similar way. Biogen announced today that CEO Michel Vounatsos will be stepping down from the company. Sie knnen Ihre Einstellungen jederzeit ndern. In an earnings report, Biogen said a new CEO has yet to be appointed. Design For Registration: Principles Of A Global Approach, Optimizing Signal Management Gain Efficiencies without Compromising Quality, Arrowhead capitalizes on Amgen drug progress with royalty rights deal, BioMarin signals lengthier FDA review for hemophilia gene therapy, Apellis defends change in regulatory plans for closely watched eye drug, Amgen to test new way to lower heart risk with large drug trial. Updated May 3, 2022 3:13 pm ET. Topics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more. Stifel analyst Paul Matteis took a similar view, writing that Biogen's future appears uncertain. While the company could have used the infrastructure it built around Aduhelm to help commercialize lecanemab, Vounatsos explained that maintaining such a large team until the late-stage study readout didn't make sense. At the same time, the company said it will eliminate virtually all its . FDA panel delivers mixed verdict on AstraZenecas asthma drug. Biogen Inc said on Tuesday that Chief Executive Michel Vounatsos will step down and that the drugmaker is pulling back on selling its Alzheimer's treatment Aduhelm after the struggles related to . Biogen said on Tuesday (May 3) that Chief Executive Michel Vounatsos will step down and that the company is pulling back on selling its Alzheimer's drug. Biogen previously announced a cost-cutting plan that included layoffs and was designed to save approximately half a billion dollars in annualized savings. These cookies do not store any personal information. It is involved in rolling submissions under the U.S. accelerated approval pathway before submitting for full approval in 2023. But opting out of some of these cookies may affect your browsing experience. "These challenges are all part of the biopharmaceutical business lifecycle." Vounatsos, who was named as the CEO in 2016, will continue in his role until a successor is appointed, the . The company reported a 26% fall in. (Reuters) -Biogen Inc said on Tuesday that chief executive Michel Vounatsos will step down and that the company is pulling back on selling its controversial Alzheimer's drug Aduhelm, in what appears to be a final blow to its prospect of becoming a big seller. Daten ber Ihr Gert und Ihre Internetverbindung, wie Ihre IP-Adresse, Browsing- und Suchaktivitten bei der Nutzung von Yahoo Websites und -Apps. At the time of Aduhelm's approval, the company and its development partner, Eisai, had earmarked $600 million to help support launch activities. A Division of NBCUniversal. We looked at all Fortune 100 companies plus every other CEO exit at companies with 1000+ employees. Today that CEO Michel Vounatsos will be stepping down from the company Piramal Down after Quarterly earnings Miss < /a > Got a confidential news? 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