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to the FDA by the end of 2015. An FDA committee recommended approval in April 2016, but the FDA rejected the application in
November for having insufficient data in November 2016. The drug was approved in the European Union in May 2016.
859:
479:
In
September 2018, Amicus announced that it had acquired Celenex, which had ten early stage gene therapies. Amicus paid $ 100 million upfront and could pay an additional $ 352 million if developmental milestones are achieved.
446:, which itself can be sold to another company. That drug failed its Phase III trial in 2017 and Amicus abandoned it. It had paid out around half of the milestones to Scioderm's shareholders prior to closing down the program.
912:
355:
trading symbol FOLD. This followed a 2006 planned offering and subsequent withdrawal, which would have established the trading symbol as AMTX Prior to their IPO, Amicus was funded by a variety of
476:
became FDA commissioner in 2017, the CEO of Amicus began lobbying him directly for the FDA to accept the NDA and in
February 2018 the FDA accepted it and promised a response by August 2018.
962:
952:
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for migalastat; GSK paid $ 60 million in upfront and equity payments while promising up to $ 170 million to help develop their products, GSK terminated the arrangement in 2013.
785:
942:
841:
681:
Williams, Cory (2014). "Chapter 4. Treating Rare
Diseases: Business Model for Orphan Drug Development". In Pryde, David C.; Palmer, Michael J. (eds.).
967:
512:
766:
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860:"Amicus Therapeutics Announces European Commission Approval for Galafold (Migalastat) in Patients with Fabry Disease in European Union"
178:
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In late 2009, the company faced a major financial setback with the termination of a multi-year collaboration agreement with
804:
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823:"Amicus Therapeutics Plans to Submit NDA for Migalastat for Fabry Disease Following Positive Pre-NDA Meeting With FDA"
125:
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In
November 2013, Amicus acquired competitor Callidus Biopharma for its enzyme replacement therapy treatment for
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913:"A $ 100 Million Biotech Deal Is Also A Tale Of Two Executives Facing Their Kids' Deadly Diseases"
59:
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In 2008, the company expanded from its single site in New Jersey to a second research site in
340:
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deficiency; Amicus paid $ 1.8M in cash and around $ 4.7M in stock, with $ 83M in biodollars.
271:
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26:
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There have been five withdrawn IPOs so far this month, including ... Amicus
Therapeutics.
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37:
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842:"FDA rejects quick Amicus Fabry drug read-through, new data not expected till 2019"
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894:"Once rejected, FDA now rolls out a short red carpet for Amicus' migalastat"
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for $ 229 million in cash and stock, with potentially $ 618 million more in
399:
534:"Amicus Leader, BIO Board Member John Crowley Named Trade Group's New CEO"
786:"Xconomy: With $ 229M Deal, Amicus Gets a New Drug And Perhaps a Voucher"
431:
442:; additionally, if the drug was approved the FDA would give its owner a
875:"Amicus spends $ 90M on MiaMed; gains rare disease preclinical program"
416:
The next year, the company signed an exclusive license agreement with
613:
352:
51:
767:"GlaxoSmithKline politely dumps $ 230M Fabry drug deal with Amicus"
465:
In 2016 Amicus acquired MiaMed which was working on drugs to treat
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240:
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Also in
September 2015, Amicus announced that it would submit a
805:"Amicus ditches skin disorder drug after late-stage failure"
315:
413:, and two other products. Amicus cut 20% of its workforce.
712:"Amicus Therapeutics Opens Research Facility in San Diego"
569:"Amicus Therapeutics IPO raises $ 75 mln, in range"
310:
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149:
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438:. Scioderm had a drug in Phase III trials for
383:, particularly disorders collectively called
8:
963:Biotechnology companies of the United States
953:Pharmaceutical companies based in New Jersey
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19:
633:"Amicus IPO: A Very Risky Prospect (AMTX)"
25:
18:
652:
650:
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497:
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430:In September 2015, the company acquired
489:
379:The therapeutic focus of Amicus is on
739:"Form 10-Q: Amicus Therapeutics, Inc"
658:"Form 10-K: Amicus Therapeutics, Inc"
588:"Amicus Therapeutics files $ 86M IPO"
503:"Form 10-K: Amicus Therapeutics, Inc"
7:
892:Carroll, John (February 12, 2018).
803:Taylor, Phil (September 13, 2017).
142:David Clark (chief people officer)
14:
943:2002 establishments in New Jersey
840:Adams, Ben (November 29, 2016).
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720:. United States. Archived from
555:"Amicus Corporate Headquarters"
328:Footnotes / references
968:Companies listed on the Nasdaq
784:Fidler, Ben (31 August 2015).
683:Orphan Drugs and Rare Diseases
387:. The company has focused on
1:
862:. GlobeNewswire. 31 May 2016.
765:Carroll, John (20 Nov 2013).
631:Rubin, Evelyn (18 May 2006).
586:Gelsi, Steve (17 May 2006).
873:Adams, Ben (July 7, 2016).
536:. MedCity News. Dec 5, 2023
385:lysosomal storage disorders
984:
687:Royal Society of Chemistry
607:Moyer, Liz (16 Aug 2006).
393:enzyme replacement therapy
389:pharmacological chaperones
99:Philadelphia, Pennsylvania
609:"IPOs Head For The Exits"
369:New Enterprise Associates
337:Amicus Therapeutics, Inc.
326:
24:
20:Amicus Therapeutics, Inc.
948:Drug discovery companies
381:rare and orphan diseases
444:priority review voucher
409:for its lead compound,
231:($ 449,121,000) (2017)
223:($ 349,089,000) (2018)
200:($ 441,985,000) (2017)
192:($ 328,777,000) (2018)
81:; 22 years ago
60:Russell 2000 Component
16:Pharmaceutical company
724:on 24 September 2015.
440:epidermolysis bullosa
339:is a public American
79:February 4, 2002
829:. 15 September 2015.
710:Staff (1 Oct 2008).
455:accelerated approval
451:new drug application
293:$ 352,850,000 (2017)
285:$ 342,912,000 (2018)
262:$ 627,024,000 (2017)
254:$ 789,951,000 (2018)
302:Number of employees
169:$ 36,930,000 (2017)
161:$ 91,245,000 (2018)
121:(chairman emeritus)
21:
515:. 2018. p. 61
351:in 2007 under the
124:Bradley Campbell (
911:Herper, Matthew.
345:Philadelphia, PA.
343:company based in
341:biopharmaceutical
334:
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306:508 (31 Dec 2018)
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418:GlaxoSmithKline
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365:Canaan Partners
361:Radius Ventures
357:venture capital
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751:. 30 Sep 2009.
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575:. 30 May 2007.
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135:Daphne Quimi (
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425:Pompe disease
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104:United States
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70:Biotechnology
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958:Gene therapy
920:. Retrieved
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722:the original
717:Biotech Week
715:
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538:. Retrieved
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517:. Retrieved
506:
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471:
464:
448:
429:
422:
415:
404:
397:
378:
347:The company
336:
335:
327:
272:Total equity
241:Total assets
119:John Crowley
94:Headquarters
34:Company type
593:MarketWatch
349:went public
937:Categories
922:2018-09-24
540:2024-03-04
519:2024-03-04
484:References
459:migalastat
453:(NDA) for
436:biodollars
411:migalastat
210:Net income
111:Key people
86:2002-02-04
898:Endpoints
827:Drugs.com
400:San Diego
318:.amicusrx
126:president
46:Traded as
432:Scioderm
66:Industry
790:Xconomy
670:. 2014.
573:Reuters
375:History
311:Website
150:Revenue
84: (
76:Founded
54::
917:Forbes
693:
614:Forbes
472:After
353:NASDAQ
52:Nasdaq
38:Public
749:USSEC
744:EDGAR
668:USSEC
663:EDGAR
513:USSEC
508:EDGAR
467:CDKL5
407:Shire
691:ISBN
391:and
367:and
320:.com
128:and
56:FOLD
457:of
316:www
137:CFO
130:COO
939::
915:.
896:.
877:.
844:.
825:.
807:.
788:.
769:.
757:^
747:.
741:.
730:^
714:.
689:.
685:.
666:.
660:.
647:^
635:.
617:.
611:.
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492:^
427:.
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371:.
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773:.
699:.
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522:.
139:)
132:)
88:)
Text is available under the Creative Commons Attribution-ShareAlike License. Additional terms may apply.
