In 2008, the company expanded from its single site in New Jersey to a second research site in San Diego.[9]
In late 2009, the company faced a major financial setback with the termination of a multi-year collaboration agreement with Shire for its lead compound, migalastat, and two other products.[10]: 24 Amicus cut 20% of its workforce.[10]: 24
The next year, the company signed an exclusive license agreement with GlaxoSmithKline for migalastat; GSK paid $60 million in upfront and equity payments while promising up to $170 million to help develop their products,[11] GSK terminated the arrangement in 2013.[11]
In November 2013, Amicus acquired competitor Callidus Biopharma for its enzyme replacement therapy treatment for Pompe disease.[7]: 3, 12
In September 2015, the company acquired Scioderm for $229 million in cash and stock, with potentially $618 million more in biodollars. Scioderm had a drug in Phase III trials for epidermolysis bullosa; additionally, if the drug was approved the FDA would give its owner a priority review voucher, which itself can be sold to another company.[12] 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.[13]
Also in September 2015, Amicus announced that it would submit a new drug application (NDA) for accelerated approval of migalastat to the FDA by the end of 2015.[14] An FDA committee recommended approval in April 2016, but the FDA rejected the application in November for having insufficient data in November 2016.[15] The drug was approved in the European Union in May 2016.[16]
In 2016 Amicus acquired MiaMed which was working on drugs to treat CDKL5 deficiency; Amicus paid $1.8M in cash and around $4.7M in stock, with $83M in biodollars.[17]
After Scott Gottlieb 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.[18]
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.[19]
^"Amicus Therapeutics IPO raises $75 mln, in range". Reuters. 30 May 2007.
^Gelsi, Steve (17 May 2006). "Amicus Therapeutics files $86M IPO". MarketWatch.
^Moyer, Liz (16 Aug 2006). "IPOs Head For The Exits". Forbes. There have been five withdrawn IPOs so far this month, including ... Amicus Therapeutics.
^Rubin, Evelyn (18 May 2006). "Amicus IPO: A Very Risky Prospect (AMTX)". Seeking Alpha.
^Williams, Cory (2014). "Chapter 4. Treating Rare Diseases: Business Model for Orphan Drug Development". In Pryde, David C.; Palmer, Michael J. (eds.). Orphan Drugs and Rare Diseases. Royal Society of Chemistry. ISBN9781849738064.
^Staff (1 Oct 2008). . Biotech Week. United States. Archived from the original on 24 September 2015.
^ abCarroll, John (20 Nov 2013). "GlaxoSmithKline politely dumps $230M Fabry drug deal with Amicus". FierceBiotech.
^Fidler, Ben (31 August 2015). "Xconomy: With $229M Deal, Amicus Gets a New Drug And Perhaps a Voucher". Xconomy.
^Taylor, Phil (September 13, 2017). "Amicus ditches skin disorder drug after late-stage failure". FierceBiotech.
^"Amicus Therapeutics Plans to Submit NDA for Migalastat for Fabry Disease Following Positive Pre-NDA Meeting With FDA". Drugs.com. 15 September 2015.
^Adams, Ben (November 29, 2016). "FDA rejects quick Amicus Fabry drug read-through, new data not expected till 2019". FierceBiotech.
^"Amicus Therapeutics Announces European Commission Approval for Galafold (Migalastat) in Patients with Fabry Disease in European Union". GlobeNewswire. 31 May 2016.
^Adams, Ben (July 7, 2016). "Amicus spends $90M on MiaMed; gains rare disease preclinical program". FierceBiotech.
^Carroll, John (February 12, 2018). "Once rejected, FDA now rolls out a short red carpet for Amicus' migalastat". Endpoints.
^Herper, Matthew. "A $100 Million Biotech Deal Is Also A Tale Of Two Executives Facing Their Kids' Deadly Diseases". Forbes. Retrieved 2018-09-24.
February 16, 2024
amicus, therapeutics, public, american, biopharmaceutical, company, based, philadelphia, company, went, public, 2007, under, nasdaq, trading, symbol, fold, this, followed, 2006, planned, offering, subsequent, withdrawal, which, would, have, established, tradin. Amicus Therapeutics Inc is a public American biopharmaceutical company based in Philadelphia PA 2 The company went public in 2007 under the NASDAQ trading symbol FOLD 3 This followed a 2006 planned offering and subsequent withdrawal which would have established the trading symbol as AMTX 4 5 Prior to their IPO Amicus was funded by a variety of venture capital firms including Radius Ventures Canaan Partners and New Enterprise Associates 6 Amicus Therapeutics Inc Company typePublicTraded asNasdaq FOLDRussell 2000 ComponentIndustryBiotechnologyFoundedFebruary 4 2002 22 years ago 2002 02 04 1 28 HeadquartersPhiladelphia Pennsylvania United StatesKey peopleJohn Crowley chairman and CEO Bradley Campbell president and COO Daphne Quimi CFO David Clark chief people officer Revenue 91 245 000 2018 36 930 000 2017 Operating income 328 777 000 2018 441 985 000 2017 Net income 349 089 000 2018 449 121 000 2017 Total assets 789 951 000 2018 627 024 000 2017 Total equity 342 912 000 2018 352 850 000 2017 Number of employees508 31 Dec 2018 1 28 Websitewww wbr amicusrx wbr comFootnotes referencesfinancials 1 61 History editThe therapeutic focus of Amicus is on rare and orphan diseases particularly disorders collectively called lysosomal storage disorders 7 2 The company has focused on pharmacological chaperones and enzyme replacement therapy 7 2 18 8 95 In 2008 the company expanded from its single site in New Jersey to a second research site in San Diego 9 In late 2009 the company faced a major financial setback with the termination of a multi year collaboration agreement with Shire for its lead compound migalastat and two other products 10 24 Amicus cut 20 of its workforce 10 24 The next year the company signed an exclusive license agreement with GlaxoSmithKline for migalastat GSK paid 60 million in upfront and equity payments while promising up to 170 million to help develop their products 11 GSK terminated the arrangement in 2013 11 In November 2013 Amicus acquired competitor Callidus Biopharma for its enzyme replacement therapy treatment for Pompe disease 7 3 12 In September 2015 the company acquired Scioderm for 229 million in cash and stock with potentially 618 million more in biodollars Scioderm had a drug in Phase III trials for epidermolysis bullosa additionally if the drug was approved the FDA would give its owner a priority review voucher which itself can be sold to another company 12 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 13 Also in September 2015 Amicus announced that it would submit a new drug application NDA for accelerated approval of migalastat to the FDA by the end of 2015 14 An FDA committee recommended approval in April 2016 but the FDA rejected the application in November for having insufficient data in November 2016 15 The drug was approved in the European Union in May 2016 16 In 2016 Amicus acquired MiaMed which was working on drugs to treat CDKL5 deficiency Amicus paid 1 8M in cash and around 4 7M in stock with 83M in biodollars 17 After Scott Gottlieb 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 18 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 19 References edit a b c Form 10 K Amicus Therapeutics Inc EDGAR USSEC 2018 Amicus Corporate Headquarters Amicus Therapeutics IPO raises 75 mln in range Reuters 30 May 2007 Gelsi Steve 17 May 2006 Amicus Therapeutics files 86M IPO MarketWatch Moyer Liz 16 Aug 2006 IPOs Head For The Exits Forbes There have been five withdrawn IPOs so far this month including Amicus Therapeutics Rubin Evelyn 18 May 2006 Amicus IPO A Very Risky Prospect AMTX Seeking Alpha a b c Form 10 K Amicus Therapeutics Inc EDGAR USSEC 2014 Williams Cory 2014 Chapter 4 Treating Rare Diseases Business Model for Orphan Drug Development In Pryde David C Palmer Michael J eds Orphan Drugs and Rare Diseases Royal Society of Chemistry ISBN 9781849738064 Staff 1 Oct 2008 Amicus Therapeutics Opens Research Facility in San Diego Biotech Week United States Archived from the original on 24 September 2015 a b Form 10 Q Amicus Therapeutics Inc EDGAR USSEC 30 Sep 2009 a b Carroll John 20 Nov 2013 GlaxoSmithKline politely dumps 230M Fabry drug deal with Amicus FierceBiotech Fidler Ben 31 August 2015 Xconomy With 229M Deal Amicus Gets a New Drug And Perhaps a Voucher Xconomy Taylor Phil September 13 2017 Amicus ditches skin disorder drug after late stage failure FierceBiotech Amicus Therapeutics Plans to Submit NDA for Migalastat for Fabry Disease Following Positive Pre NDA Meeting With FDA Drugs com 15 September 2015 Adams Ben November 29 2016 FDA rejects quick Amicus Fabry drug read through new data not expected till 2019 FierceBiotech Amicus Therapeutics Announces European Commission Approval for Galafold Migalastat in Patients with Fabry Disease in European Union GlobeNewswire 31 May 2016 Adams Ben July 7 2016 Amicus spends 90M on MiaMed gains rare disease preclinical program FierceBiotech Carroll John February 12 2018 Once rejected FDA now rolls out a short red carpet for Amicus migalastat Endpoints Herper Matthew A 100 Million Biotech Deal Is Also A Tale Of Two Executives Facing Their Kids Deadly Diseases Forbes Retrieved 2018 09 24 Retrieved from https en wikipedia org w index php title Amicus Therapeutics amp oldid 1206924281, wikipedia, wiki, book, books, library,
