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613:; by 2004 the field was shifting to second generation modifications. Clinical trials of antisense therapeutics by all the companies in the early 2000s were also plagued by lack of efficacy and immune reactions to drug candidates. Isis cut its workforce by 40% in 2005 due to weak sales of fomivirsen and lack of confidence by the market in antisense technology.
671:
on development starting in 2012; in 2015 Biogen acquired an exclusive license to the drug for a $ 75 million license fee, milestone payments up to $ 150M, and tiered royalties between 10 and 15% thereafter; Biogen also paid for all development subsequent to taking the license. The license to Biogen
651:
in 2012 and again in 2013; it was approved by the FDA in 2013. In
January 2016, Ionis terminated its arrangement with Genzyme, stating that the drug had been poorly marketed. In May 2016, Ionis licensed the rights to the drug to Kastle Therapeutics for $ 15 million upfront with another $ 10 million
590:. It was approved by the FDA for CMV in August 1998 as the first antisense drug. Novartis withdrew the marketing authorization for fomivirsen in the European Union in 2002 and in the United States in 2006. The drug was withdrawn because the development of
998:
652:
due in May 2019, up to $ 70 million in milestones based on sales, and royalties, with Ionis paying 3% royalty and 3% of non-cash royalty it receives to
Genzyme. Mipomersen has still not been approved in Europe.
647:, and other drug candidates ; the deal included Genzyme buying $ 150 million of Isis stock and paying a $ 175 million license fee, as well as milestone fees and royalties. Mipomersen was rejected by the
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The antisense field anticipated that the approval of fomivirsen marked the beginning of a new age of antisense drug treatments that would be similar to the uptake of
1428:
1429:"Biogen and Ionis Pharmaceuticals Report Nusinersen Meets Primary Endpoint at Interim Analysis of Phase 3 ENDEAR Study in Infantile-Onset Spinal Muscular Atrophy"
586:(CMV) in immunocompromised patients). It was discovered at the NIH and was licensed and initially developed by Isis, which subsequently licensed it to
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In
December 2015, Isis Pharmaceuticals changed name to Ionis Pharmaceuticals, driven in part by the rise of a international terrorist group,
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601:, but the next FDA approval of an antisense drug came in 2013. Part of what held up all companies in the field was the way that the
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included licenses to intellectual property that Ionis had acquired from Cold Spring Harbor and
University of Massachusetts.
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In 2017, the company completed the corporate spin-off of its rare lipid disorder subsidiary, Akcea
Therapeutics.
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1041:"Public Statement on Vitravene (fomiversen): Withdrawal of the Marketing Authorization in the European Union"
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The company was founded in 1989 as Isis
Pharmaceuticals by Stanley T. Crooke, a former head of research of
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and Lynx
Therapeutics working in the field. Gilead sold its patents, developed around antisense, to Isis.
488:
659:(Spinraza) was approved by the FDA. It had been discovered in a collaboration between Adrian Krainer at
312:
1294:
Garber, K (October 11, 2016). "Big win possible for Ionis/Biogen antisense drug in muscular atrophy".
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730:"Elizabeth L. Hougen Chief Financial Officer & Executive VP-Finance, Ionis Pharmaceuticals, Inc"
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999:"Value-Engineered Translation: Developing Biotherapeutics That Align With Health-System Needs"
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1023:"Biotech comes to its 'antisenses' after hard-won drug approval : Spoonful of Medicine"
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467:-targeted therapeutics. The company has three commercially approved medicines: Spinraza (
1368:"CSHL FDA approval of life-saving SMA drug is hailed by its researcher-inventor at CSHL"
903:
628:, to apply their intellectual property and knowledge around oligomer biotherapeutics to
145:
Please help update this article to reflect recent events or newly available information.
1411:"Biogen Shells Out $ 75M to Develop Ionis' Nusinersen after Positive Phase III Results"
1123:
206:
1246:"Ionis Sells Kynamro Rights to Kastle for Up to $ 95M+ Biotech from Bench to Business"
533:
drug candidate. The FDA approval marked the first time for the company to conduct any
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1339:"Updated: FDA approves drug that rescues babies with fatal neurodegenerative disease"
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755:"Ionis announces changes to its board of directors at annual meeting of stockholders"
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705:"Brett P Monia Chief Executive Officer/Co-Founder, Ionis Pharmaceuticals Inc"
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gene-lowering antisense molecule for
Huntington's disease in clinical trial.
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failed in clinical trials and Isis terminated development. By that time,
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had left the field of antisense therapy, leaving only Isis, Hybridon,
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943:"Ionis Pharma Spins Out Lipid Disorder Unit Akcea with Plans for IPO"
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223:
667:. The drug was initially developed by Ionis, which partnered with
591:
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1202:"Refusal of the marketing authorisation for Kynamro (mipomersen)"
683:, was in a Phase III trial run by another company. It also had a
1184:"EMA committee shoots down Sanofi's cholesterol drug mipomersen"
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923:"When You're Named Isis for the Goddess, Not the Terror Group"
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1113:"Company News; Isis Pharmaceuticals to Cut 40% of Workforce"
784:"Ionis Pharmaceuticals, Inc. 2022 Form 10-K Annual Report"
675:
As of
December 2016, Ionis had ten candidates for various
1387:
Saltzman, Jonathan; Weisman, Robert (December 16, 2017).
594:
dramatically reduced the number of cases of CMV rinitis.
479:), and has four drugs in pivotal studies: tominersen for
433:
521:
In 1992, the company received its first approval by the
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and Ionis (then Isis) and preclinical work was done at
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1140:"Two Biotech Companies Agree to Form a Joint Venture"
94:, and by adding encyclopedic content written from a
1266:"Surprise Drug Approval Is Holiday Gift for Biogen"
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609:also reduced affinity to the antisense molecules'
463:, that specializes in discovering and developing
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1479:Business data for Ionis Pharmaceuticals, Inc.:
859:"Making a Difference; A Green Light for Isis"
679:in clinical trials and a drug it discovered,
8:
1517:Biotechnology companies of the United States
1092:"Oligonucleotide Therapeutics Near Approval"
180:
1522:Biotechnology companies established in 1989
882:"Isis Drops Human Trials of a Genetic Drug"
53:Learn how and when to remove these messages
1027:Nature Medicine: Spoonful of Medicine Blog
799:
797:
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1542:Health care companies based in California
879:Fisher, Lawrence M. (December 29, 1995).
840:
491:, and AKCEA-TTR-LRx for all forms of TTR
168:Learn how and when to remove this message
114:Learn how and when to remove this message
643:(Kynamro), intended to treat homozygous
639:entered into a partnered drug candidate
1547:Companies based in Carlsbad, California
997:; McCabe, Christopher (July 21, 2014).
989:
987:
788:U.S. Securities and Exchange Commission
696:
1337:Wadman, Meredith (December 23, 2016).
1222:Fikes, Bradley J. (January 11, 2016).
1090:Offord, Catherine (December 1, 2016).
578:The company's first marketed drug was
75:contains content that is written like
1446:Gallagher, James (October 19, 2015).
1225:"Ionis takes back heart drug Kynamro"
1137:Pollack, Andrew (September 7, 2007).
856:Fisher, Lawrence M. (March 8, 1992).
778:
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7:
1448:"Landmark Huntington's trial starts"
1263:Grant, Charley (December 27, 2016).
1163:"Genzyme Wins Cholesterol Drug Deal"
921:Workman, Karen (November 20, 2015).
827:Crooke, Stanley T. (July 21, 2011).
804:Fikes, Bradley (December 18, 2015).
605:were chemically modified to prevent
563:, commonly known as ISIL or ISIS in
561:Islamic State of Iraq and the Levant
1160:Pollack, Andrew (January 8, 2008).
514:, with the goal of commercializing
1021:Jiang, Kevin (February 19, 2013).
902:Jarvis, Lisa M. (April 17, 2006).
14:
1390:"At a UMass lab, a eureka moment"
1366:Tarr, Peter (December 24, 2016).
34:This article has multiple issues.
1003:American Journal of Managed Care
624:, formed a 50/50 joint venture,
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964:Basic and Clinical Pharmacology
908:Chemical & Engineering News
655:In December 2016, Ionis's drug
444:Footnotes / references
42:or discuss these issues on the
1552:Companies listed on the Nasdaq
1:
1373:Cold Spring Harbor Laboratory
661:Cold Spring Harbor Laboratory
645:familial hypercholesterolemia
1061:Filmore, David (June 2004).
962:Katzung, Bertram G. (2006).
537:and to be tested in humans.
523:Food and Drug Administration
813:The San Diego Union-Tribune
807:"From Isis Pharma to Ionis"
665:University of Massachusetts
599:monoclonal antibody therapy
453:Ionis Pharmaceuticals, Inc.
258:; 35 years ago
181:Ionis Pharmaceuticals, Inc.
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582:(Vitravene, used to treat
529:application in 1992 for a
198:Isis Pharmaceuticals, Inc.
1209:European Medicines Agency
1048:European Medicines Agency
649:European Medicines Agency
584:cytomegalovirus retinitis
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139:This article needs to be
1415:Genetic Engineering News
1250:Genetic Engineering News
527:investigational new drug
1532:Spinal muscular atrophy
1353:10.1126/science.aal0476
1272:The Wall Street Journal
1231:San Diego Union Tribune
618:Alnylam Pharmaceuticals
487:, AKCEA-APO(a)-LRx for
397:US$ 2.53 billion (2022)
498:The company was named
489:cardiovascular disease
414:US$ 573 million (2022)
1070:Modern Drug Discovery
1063:"Assessing antisense"
502:until December 2015.
313:chairman of the board
301:Elizabeth L. Hougen (
96:neutral point of view
16:Biotechnology company
1527:Huntington's disease
1308:10.1038/nbt1016-1002
1296:Nature Biotechnology
1190:. December 14, 2012.
829:"The Isis manifesto"
790:. February 22, 2023.
626:Regulus Therapeutics
500:Isis Pharmaceuticals
483:, tofersen for SOD1-
481:Huntington's disease
461:Carlsbad, California
283:Carlsbad, California
1126:. January 11, 2005.
842:10.1038/bioe.2011.7
620:, which focuses on
424:796 (December 2022)
420:Number of employees
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88:promotional content
1169:The New York Times
1146:The New York Times
1119:The New York Times
928:The New York Times
904:"Back In The Game"
888:The New York Times
865:The New York Times
759:www.prnewswire.com
635:In 2008, Isis and
616:In 2007, Isis and
90:and inappropriate
1435:. August 1, 2016.
1431:(Press release).
1417:. August 1, 2016.
1302:(10): 1002–1003.
1211:. March 21, 2013.
1050:. August 6, 2002.
977:978-0-07-145153-6
951:. March 27, 2017.
709:www.bloomberg.com
535:antisense therapy
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