In this segment from Industry Focus: Healthcare, host. About 130,000 people of nearly 150 nationalities work at Novartis around the world. In addition, the drug is anticipated to receive approval in Japan and the European Union later this year. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. The company also intends to expand the study of gene therapy into two additional rare neurological monogenic disorders: Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene. Neither can there be any guarantee that such products will be commercially successful in the future. If approved, AVXS-101 would be a first-in-class one-time therapy that addresses the root genetic cause of SMA by effectively replacing the defective SMN1 gene. Until the acquisition is completed, both AveXis and Novartis must continue to operate as independent entities and carry on their respective businesses as usual. Our initial product candidate, Zolgensma, is its proprietary gene therapy currently in development for the treatment of spinal muscular atrophy, or SMA. Novartis acquisition of AveXis : Swiss pharma company Novartis has struck a $8.7 billion deal to acquire US gene therapy company AveXis in a move to bolster its gene therapy and neuroscience pipeline. We would gain with the team at AveXis another gene therapy platform, in addition to our CAR-T platform for cancer, to advance a growing pipeline of gene therapies across therapeutic areas. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as "to acquire," "to transform," "candidate," "potential," "Breakthrough Therapy Designation," "PRIME designation," "Sakigake," "expected," "offers," "to accelerate," "future," "ongoing," "would," "potentially," "believe," "can," "hopefully," "excited," "pipeline," "Orphan Drug Designation," "would," "ambition," "priorities," "to strengthen," "opportunity," "pending," "will," "expects," "subject to," "planned," or similar expressions, or by express or implied discussions regarding the potential outcome of the tender offer for the shares of AveXis Inc. to be commenced by Novartis, and the potential impact on Novartis of the proposed acquisition, including express or implied discussions regarding potential future sales or earnings of Novartis, and any potential strategic benefits, synergies or opportunities expected as a result of the proposed acquisition; and regarding potential marketing approvals, new indications or labeling for the potential, investigational or approved products described in this press release, or regarding potential future revenues from such products. This could spell big trouble for Cambridge, Massachusetts-based Biogen. You should not place undue reliance on these statements. Sign up to follow @Novartis athttp://twitter.com/novartis For Novartis multimedia content, please visitwww.novartis.com/news/media-library For questions about the site or required registration, please contact [emailprotected]. And yesterday it emerged that the group had phased out top scientists from Avexis, the originator of Zolgensma, three months ago, raising more questions about conduct at the subsidiary. The lead AveXis gene therapy candidate, AVXS-101, has highly compelling clinical data in treating SMA Type 1, which is the number one genetic cause of death in infants, where 9 out of 10 infants do not live to their second birthday or are permanently ventilator dependent. The drug previously received Breakthrough Therapy designation and has been granted Priority Review by the FDA, with regulatory action anticipated in May 2019. Novartis acquired Avexis. Details can be found at https://www.novartis.com/investors/event-calendar. Meaningful factors which could cause actual results to differ include, but are not limited to, the scope, progress, expansion, and costs of developing and commercializing AveXis' product candidates; regulatory developments in the U.S. and EU, as well as other factors discussed in the "Risk Factors" and the "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of AveXis' Annual Report on Form 10-K for the year ended December 31, 2016, filed with the SEC on March 16, 2017, and AveXis' Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, filed with the SEC on November 9, 2017. Excelled as part of high performance global matrix teams on 7 global product launches. the importance of closing certainty to the Board and various regulatory considerations relevant to a potential acquisition of the Company by Novartis. It could spur interest and investment in Chicago's biotech startup mix. Investment in the Longmont campus adds to existing $115 million investment in Durham facility, leading to creation of more than 1,000 US-based, . Novartis, which became the first pharma company to secure FDA approval for a gene therapy last year, has acquired AveXis for $8.7 billion, which has developed a treatment for spinal muscular. The addition of the six-building Longmont campus consists of nearly 700,000 square-feet of space for biologic drug manufacturing, offices, laboratories, warehousing and utilities. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas. Basel, April 9, 2018-Novartis announced today that it has entered into an agreement and plan of merger with AveXis, Inc. to acquire the US-based Nasdaq-listed clinical stage gene therapy company for USD 218 per share or a total of USD 8.7 billion in cash. This offer represents a premium of 88% to AveXis' closing price on April 6. Choose Location What Novartis Bought in AveXis | The Motley Fool Please ensure. AveXis acquires exclusive rights to entire NAV Technology Platform for the development of treatments for SMA Amended agreement permits assignment by AveXis upon a change of control without REGENXBIO's consent REGENXBIO could receive up to $260 million, including $140 million in guaranteed upfront and annual payments As previously announced, Novartis and Novartis AM Merger Corporation, its indirect wholly-owned subsidiary ("Purchaser"), commenced a tender offer on April 17, 2018 for all of the outstanding . Given its willingness to spend $8.7 billion for AveXis, Novartis appears pretty confident that this pivotal study will hit its mark. In addition to the risks described above and in the Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect AveXis' results. Vas Narasimhan M.D., CEO of Novartis, said: "We are delighted to add AveXis' leading gene therapy technology to our company and to welcome ourAveXiscolleagues to Novartis. Readers are cautioned not to rely too heavily on the forward-looking statements contained in this press release. Last week, Novartis ( NVS 1.03%) paid up almost $10 billion for AveXis . Under the terms, the Swiss drug maker will gain AveXis' gene therapy platform and pipeline treatments for spinal muscular atrophy (SMA). DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 that can generally be identified by words such as "proposed," "tender offer," "commenced," "subject to," "scheduled," "unless," "offer," "conditions," or similar expressions, or by express or implied discussions regarding the potential outcome of the acquisition of AveXis by Novartis. About NovartisNovartis provides innovative healthcare solutions that address the evolving needs of patients and societies. In particular, our expectations could be affected by, among other things: regulatory actions or delays or government regulation generally, including potential regulatory actions or delays relating to the completion of the potential acquisition described in this release, as well as potential regulatory actions or delays with respect to the development of the products described in this release; the potential that the strategic benefits, synergies or opportunities expected from the proposed acquisition may not be realized or may take longer to realize than expected; the successful integration of AveXis into the Novartis Group subsequent to the closing of the transaction and the timing of such integration; potential adverse reactions to the proposed transaction by customers, suppliers or strategic partners; dependence on key AveXis personnel and customers; the uncertainties inherent in the research and development of new healthcare products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection; safety, quality or manufacturing issues; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; the particular prescribing preferences of physicians and patients; uncertainties regarding actual or potential legal proceedings, including, among others, potential legal proceedings with respect to the proposed acquisition; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward looking statements. The Schedule TO Tender Offer Statement and related materials are available for free under the "Investors - Financial Data" section of Novartis' website at https://www.novartis.com/investors/financial-data/sec-filings. Traducciones en contexto de "Drugmaker Novartis'" en ingls-espaol de Reverso Context: Drugmaker Novartis' sales in the fourth-quarter rose by 18%, but the Swiss company's earnings. Such forward looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Those materials and all other documents filed by, or caused to be filed by, Novartis and Purchaser and the Company with the SEC will be available at no charge on the SEC's website at www.sec.gov. Hot on the heels of selling its stake in a shared consumer health business to GSK for $13 billion, Novartis has used the funds to acquire gene therapy biotech AveXis. Sign up to follow @Novartis at http://twitter.com/novartisFor Novartis multimedia content, please visit www.novartis.com/news/media-libraryFor questions about the site or required registration, please contact [emailprotected], Novartis Media RelationsCentral media line: +41 61 324 2200E-mail: [emailprotected], Eric AlthoffNovartis Global External Communications+41 61 324 7999 (office)+41 79 593 4202 (mobile)[emailprotected], Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: [emailprotected], This site is intended for a global audience, Novartis provides update on proposed acquisition of AveXis, Diversity & Inclusion Governance and Community, Novartis Commitment to Patients and Caregivers, Novartis Gene Therapies Managed Access Program, Healthcare Professional Resources by Country, Novartis Institutes for BioMedical Research, Cardiovascular and metabolic disease research at Novartis, Autoimmunity, transplantation and inflammatory disease research at Novartis, Musculoskeletal Disease Research at Novartis, DAx: exploratory disease research at Novartis, Community Exploration & Learning Lab (CELL), https://www.novartis.com/investors/financial-data/sec-filings, http://investors.avexis.com/phoenix.zhtml?c=254285&p=irol-IRHome. SMA Type 1 is the leading genetic cause of infant mortality. Such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Consummation of the tender offer remains subject to other customary conditions, including satisfaction of the minimum tender condition, under the Agreement and Plan of Merger dated April 6, 2018 entered into by Novartis, Purchaser and AveXis. The Eurographics Annual Conference is the major annual computer graphics conference in Europe. The tender offer and withdrawal rights thereunder are scheduled to expire at 12:00 midnight New York City time at the end of the day of Monday, May 14, 2018, unless the offer is extended. The first one we announced is a project for Friedreich's ataxia, a muscle-wasting disease. AveXis has several ongoing clinical studies for the treatment of SMA, an inherited neurodegenerative disease caused by a defect in a single gene, the survival motor neuron (SMN1). Saarbrcken (German pronunciation: [zabk] (); French: Sarrebruck; Rhine Franconian: Saarbrigge [zab]; Luxembourgish: Saarbrcken [zabekn]; Latin: Saravipons, lit. Novartis AG announced that it has completed the acquisition of AveXis, Inc. through the consummation of a merger of its indirect wholly-owned subsidiary, Novartis AM Merger Corp, with and into AveXis without a vote of the AveXis stockholders in accordance with Section 251 (h) of the Delaware General Corporation Law. Since then, we started partnering with [the Novartis Institutes of Biomedical Research] to apply this platform to different diseases. This decision was based partly on the success of Zolgensma, originally developed by AveXis, as a gene therapy for spinal muscular atrophy (SMA) that is approved in the U.S., Japan, Europe, and Brazil as . We believe AVXS-101 could create a lifetime of possibilities for the children and families impacted by this devastating condition. This is Novartis AG's 14th transaction in the United States. Novartis will absorb AveXis into its global quality control organization as part of the Swiss pharma's response to a data scandal that's enveloped the gene therapy biotech it bought last year for $8.7 billion. Basel, April 1, 2019 -- AveXis, a Novartis company, today announced it signed an agreement to purchase an advanced biologics therapy manufacturing campus in Longmont, Colorado, further expanding AveXis' production capacity as it prepares to launch Zolgensma (onasemnogene abeparvovec-xioi[1]) an investigational gene therapy awaiting global regulatory approvals for the treatment of spinal muscular atrophy (SMA) Type 1 and for future gene therapy treatments in development. In addition to developing Zolgensma to treat SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene. Under the terms of the amendment, REGENXBIO granted AveXis exclusive, worldwide rights to all vectors in REGENXBIO's NAV Technology Platform for the treatment of SMA in addition to adding and amending certain terms of the 2014 License Agreement, including the modification of the assignment provision to now permit assignment in the event of a change of control by AveXis without REGENXBIO's consent. . Neither can there be any guarantee that Novartis or any potential products which would be obtained with AveXis will achieve any particular future financial results, or that Novartis will be able to realize any of potential strategic benefits, synergies or opportunities as a result of the proposed acquisition. "Our Longmont, Colorado, campus, along with our existing manufacturing sites in Illinois, California and North Carolina, will play a crucial role in helping us achieve the future manufacturing capacity required to meet the global patient need for novel gene therapies," said Andrew Knudten, Senior Vice President, Global Strategic Operations. Initial start-up activities in Longmont will include preparing the facility for scaling, manufacturing and testing of gene therapies and hiring staff. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. Vas Narasimhan, CEO of Novartis, said: "The proposed acquisition of AveXis offers an extraordinary opportunity to transform the care of SMA. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Find Lance's email address, mobile number, work history, and more. Disclaimer This press release contains forward-looking statements that can generally be identified by words such as "will," or similar expressions. AveXis undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. The transaction was unanimously approved by the Boards of both companies. We relish the opportunity to leverage our expertise, our 70-plus year heritage in neuroscience and our global footprint to help AVXS-101 benefit high-need SMA patients around the world.". Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward looking statements. AveXis announced today that it has entered into an agreement to be acquired by the pharmaceutical company, Novartis. Novartis acquisition of AveXis : Swiss pharma company Novartis has struck a $8.7 billion deal to acquire US gene therapy company AveXis in a move to bolster its gene therapy and neuroscience pipeline. Published Sept. 24, 2019. Sign up to follow @Novartis at http://twitter.com/novartisFor Novartis multimedia content, please visit www.novartis.com/news/media-libraryFor questions about the site or required registration, please contact [emailprotected], Novartis Media RelationsCentral media line: +41 61 324 2200E-mail: [emailprotected], Eric AlthoffNovartis Global External Communications+41 61 324 7999 (office)+41 79 593 4202 (mobile)[emailprotected], Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: [emailprotected], This site is intended for a global audience. Swiss-based Novartis has struck a deal to acquire Bannockburn, Illinois-based AveXis for $8.7 billion. Novartis will acquire AveXis in a transaction unanimously approved by the Boards of Directors of both companies. In December, the FDA accepted the company's Biologics License Application for use of Zolgensma with SMA Type 1 patients. Executive Director, US Trade, Distribution & Patient Services - (formerly AveXis, Inc.) Novartis Gene Therapies Sep 2020 - Present 2 years 3 months The change signifies the growing importance of gene therapy to building a leading, focused medicines company with advanced therapy platforms. The incidence of SMA is approximately one in 10,000 live births and is the leading genetic cause of infant mortality. Novartis is on Twitter. AveXis' initial proprietary gene therapy candidate, AVXS-101, is in a pivotal trial for the treatment of SMA Type 1, and a Phase 1 trial for SMA Type 2. AveXis is a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases. ", "AveXis' success requires not just medical breakthroughs, but innovations in R&D and manufacturing. About NovartisNovartis provides innovative healthcare solutions that address the evolving needs of patients and societies. There can be no assurance that the actual results or developments anticipated by AveXis will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, AveXis. The deal is expected to close in mid-2018. This press release includes "forward-looking statements," within the meaning of Section27A of the Securities Act of 1933, as amended, and Section21E of the Securities Exchange Act of 1934, as amended. Novartis Acquisition of AveXis As per the latest pharma acquisition news, Novartis has agreed to pay $218 for each of the AveXis shares. Novartis acquires AveXis for $8.7 billion. The incidence of SMA is approximately one in 10,000 live births. Novartis Group companies employ approximately 124,000 full-time-equivalent associates. The merger agreement includes customary termination provisions for both AveXis and Novartis, including a right for either party to terminate if the transactions have not been completed . - of the proceeds from the aforementioned GlaxoSmithKline deal to acquire Avexis for $218 per share or $8.7 billion in total, gaining the lead compound AVXS-101. Such forward looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Swiss-based Novartis has struck a deal to acquire Bannockburn, Illinois-based AveXis for $8.7 billion. AveXis was acquired by Novartis in 2018 for USD 8.7 billion. Zolgensma represents the first in a proprietary platform to treat rare, monogenic diseases using gene therapy. Novartis. AveXis has several clinical studies in progress for the treatment of SMA, an inherited neurodegenerative disease caused by a defect . Highlights of the announcement follow: The proposed purchase includes AveXis' lead compound for SMA as well as the pipeline programs for Rett Syndrome and ALS. Two years after acquiring the gene therapy company AveXis, Novartis has renamed it Novartis Gene Therapies to underscore the potential value of developing such treatments for genetic diseases.. Novartis has leading positions globally in each of these areas. Novartis Group companies employ approximately 122,000 full-time-equivalent associates. The company said the data manipulation occurred on a potency test that was discontinued in June 2018, and it didn . SMA is caused by a genetic defect in the SMN1 gene that codes SMN, a protein necessary for survival of motor neurons. Nor can there be any guarantee that the potential, investigational or approved products described in this press release will be submitted or approved for sale in any market, or at any particular time. A big part of the acquisition was AveXis' lead gene therapy candidate, AVXS-101, for spinal muscular atrophy (SMA). Novartis successfully completes acquisition of AveXis, Inc. Diversity & Inclusion Governance and Community, Novartis Commitment to Patients and Caregivers, Novartis Gene Therapies Managed Access Program, Healthcare Professional Resources by Country, Novartis Institutes for BioMedical Research, Cardiovascular and metabolic disease research at Novartis, Autoimmunity, transplantation and inflammatory disease research at Novartis, Musculoskeletal Disease Research at Novartis, DAx: exploratory disease research at Novartis, Community Exploration & Learning Lab (CELL). The US Food and Drug Administration (FDA) has granted AVXS-101 Orphan Drug designation for the treatment of SMA as well as Breakthrough Therapy designation for SMA Type 1. The Tender Offer Statement (including the Offer to Purchase, the related Letter of Transmittal and other offer documents) and the Solicitation/Recommendation Statement contain important information that should be read carefully before any decision is made with respect to the Offer. Novartis' per-share acquisition price for AveXis stock is $218, a premium of 88 percent on the company's closing price as of April 6. The purchase will bolster the Swiss giant's standing as a big pharma leader in the emerging gene therapy field. Novartis will pay $218 per share, which is a 72 percent premium over AveXis's 30-day volume-weighted average stock price. This is Novartis AG's 3rd transaction in Texas. India | ENG . The plan, which was laid out in a company response to concerns . About AveXis AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Under its agreement to buy AveXis, Novartis has formed an acquisition subsidiary that would launch a tender offer to acquire the gene therapy company for $218 per share88% above AveXis'. . ZURICH, 9 avril (Reuters) - Novartis s'est renforc lundi dans la thrapie gnique avec l'acquisition de l'amricain AveXis pour 8,7 milliards de dollars (7,08 milliards d'euros) en numraire . Established Multiple Sclerosis portfolio in China and led it to #1 in the country in 2 years. Seeking Alpha - Go to Homepage. Those programs existed as part of the acquisition of AveXis. On completion, Novartis plans a smooth transition of operations and the integration of AveXis'talented and dedicated employees to continue the mission of bringing AVXS-101 to patients worldwide. The Schedule TO Tender Offer Statement and related materials also may be obtained for free under the "Investors Financial Data" section of Novartis website at https://www.novartis.com/investors/financial-data/sec-filings. The most severe form of SMA is Type 1, a lethal genetic disorder characterized by rapid motor neuron loss and associated muscle deterioration, which results in mortality or the need for permanent ventilation support by 24 months of age for more than 90 percent of patients. This is Novartis AG's 2nd largest (disclosed) transaction. The transaction to acquire AveXis is planned to be funded through available cash and short-term borrowing. Additional InformationThis press release is neither an offer to purchase nor a solicitation of an offer to sell securities. Transaction DetailsUnder the terms of the agreement and plan of merger, Novartis has formed an acquisition subsidiary, Novartis AM Merger Corporation ("Purchaser"), that will commence a tender offer to purchase all outstanding shares of AveXis for USD 218 per share. AveXis (AVXS) announced that it has entered into an agreement and plan of merger with Novartis (NVS) pursuant to which Novartis will acquire AveXis for $218 per share or a total of $8.7B in cash. Novartis is on Twitter. The expiration of the waiting period under the HSR Act satisfies one of the conditions necessary for the consummation of the pending acquisition. With the opening of our fourth location in the US, we will create more than 1,000 high-tech biologics manufacturing jobs by the end of 2019," said Dave Lennon, President.
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